Publications by authors named "Baojin Zhu"

64 Publications

Real-World Treatment Patterns and Healthcare Costs in Patients with Psoriatic Arthritis Treated with Ixekizumab: A Retrospective Study.

ACR Open Rheumatol 2021 Sep 22. Epub 2021 Sep 22.

Hospital of the University of Pennsylvania, Philadelphia.

Objective: To describe adherence, persistence, discontinuation, restarting, switching, dosing, and health care costs among patients with psoriatic arthritis (PsA) treated with ixekizumab (IXE).

Methods: MarketScan administrative claims databases were used to select adults (≥18 years) initiating IXE between January 1, 2016, and June 30, 2019, for this retrospective study (earliest IXE claim = index). Eligible patients had one or more PsA diagnoses during the 12 months preceding the index and had 12 months of follow-up time after the index. Adherence (measured by proportion of days covered [PDC]) persistence (<60-day gap), discontinuation (≥90-day gap), switching, and dosing patterns were reported. Health care costs were reported per patient per month (PPPM) during follow-up and were assessed after adjusting PsA treatment costs for discount rates reported by the Institute for Clinical and Economic Review (ICER).

Results: A total of 496 patients met the selection criteria (mean age, 51.1 years; 50.4% female). Over the 12-month follow-up, 52.8% remained persistent, 38.7% discontinued, 13.5% had no other treatment, 4.6% restarted, and 20.6% switched to a new biologic/traditional synthetic disease-modifying antirheumatic drug. 70.6%of patients were identified as highly adherent (i.e. PDC > 0.80)to IXE prior to discontinuation. Dose values were consistent with prescribing information for patients with and without comorbid psoriasis. Although IXE costs ($5233 [SD = $2497]) accounted for 85.6% of PsA-related health care costs, only 3.5% of IXE costs were patient out-of-pocket expenses. Adjusting for the ICER discounts decreased all-cause and PsA-related costs by $2509 PPPM.

Conclusion: Results from this real-world analysis suggest that treatment patterns and costs among patients with PsA initiating IXE are consistent with prior literature for other biologics.
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http://dx.doi.org/10.1002/acr2.11347DOI Listing
September 2021

Alopecia Areata Treatment Patterns, Healthcare Resource Utilization, and Comorbidities in the US Population Using Insurance Claims.

Adv Ther 2021 09 22;38(9):4646-4658. Epub 2021 Jul 22.

Yale School of Medicine, New Haven, CT, USA.

Introduction: Alopecia areata (AA) is an autoimmune disorder causing sudden, non-scarring hair loss. There are currently no drugs approved for AA treatment. This study assessed prevalence of comorbidities, treatments, and healthcare costs and resource utilization among patients with AA in the USA.

Methods: Patients diagnosed with AA between January 2011 and December 2018 were identified in IBM MarketScan Research Databases. Eligible patients had no other hair loss-related disorders and were continuously enrolled with medical and pharmacy benefits at least 12 months before and after AA diagnosis. Descriptive statistics were used to summarize comorbid conditions, treatments related to AA or other autoimmune/inflammatory conditions, and all-cause and AA-specific healthcare costs and resource utilization identified from claims data.

Results: A total of 68,121 patients with AA were identified. Mean (SD) age was 40.3 (17.8) years and 61.0% were female. The most common comorbidities included hyperlipidemia (22.4%), hypertension (21.8%), thyroid disorders (13.1%), contact dermatitis or eczema (10.8%), depression (9.5%), and anxiety (8.4%). Comorbid autoimmune diseases included atopic dermatitis (2.8%), psoriasis (2.1%), chronic urticaria (1.5%), and rheumatoid arthritis (1.1%). During the 12-month follow-up period, 37,995 patients (55.8%) were prescribed treatment for their AA or other comorbid autoimmune/inflammatory disease; 44.9% of treated patients were prescribed therapy within 7 days of AA diagnosis. Of patients receiving treatment, 80.3% received topical steroids and 30.0% received oral steroids. Mean (SD) total healthcare costs were $11,241.21 ($43,839.69) for all-causes and $419.12 ($1534.99) for AA. AA-related expenses were driven by outpatient and prescription costs.

Conclusion: Patients with AA have a high comorbidity burden and lack of treatment. Current AA treatments, including systemic therapies other than oral steroids, were not frequently utilized in this study population. Healthcare costs incurred by patients with AA went beyond AA-related expenses. Longitudinal data are needed to better understand treatment trajectories and the disease burden in patients with AA.
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http://dx.doi.org/10.1007/s12325-021-01845-0DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8408067PMC
September 2021

Comparison of two-year treatment adherence, persistence, discontinuation, reinitiation, and switching between psoriasis patients treated with ixekizumab or secukinumab in real-world settings.

J Am Acad Dermatol 2021 Jul 9. Epub 2021 Jul 9.

Eli Lilly and Company, Indianapolis, Indiana. Electronic address:

Background: Real-world data on long-term treatment patterns associated with interleukin-17A inhibitors in plaque psoriasis are lacking.

Objective: To compare ixekizumab or secukinumab treatment patterns over a 24-month period among plaque psoriasis patients.

Methods: Adult patients with psoriasis who had 1 or more claims for ixekizumab or secukinumab between March 1, 2016, and October 31, 2019, and with 24 months of follow-up after starting treatment were identified from IBM MarketScan claims databases. Inverse probability of treatment weighting and multivariable models were employed to balance cohorts and estimate the risks of nonpersistence, discontinuation, and switching and odds of highly adherent treatment (proportion of days covered ≥ 80%).

Results: A total of 471 ixekizumab and 990 secukinumab users were included. Compared to secukinumab, ixekizumab use was associated with a 20% lower risk of nonpersistence (hazard ratio, 0.80; 95% CI, 0.70-0.92), a 17% lower risk of discontinuation (hazard ratio, 0.83; 95% CI, 0.72-0.96), and a 42% higher odds of being highly adherent to treatment (odds ratio, 1.42; 95% CI, 1.12-1.80). No difference in risk of switching was observed (hazard ratio, 0.83; 95% CI, 0.68-1.01).

Limitations: Disease severity and clinical outcomes were unavailable.

Conclusion: Over 24 months, ixekizumab users exhibited better persistence and adherence, and a lower risk of discontinuation than secukinumab users in real-world settings.
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http://dx.doi.org/10.1016/j.jaad.2021.06.878DOI Listing
July 2021

Psoriasis treatment patterns and outcomes with ixekizumab in a real-world setting: results from a single US dermatology referral practice.

J Dermatolog Treat 2021 Jul 30:1-7. Epub 2021 Jul 30.

Eli Lilly USA, LLC, Indianapolis, IN, USA.

Objective: To assess treatment patterns of Ixekizumab (IXE) and evaluate the speed of onset and long-term clinical and quality-of-life outcomes among a subset of patients who switched from adalimumab (ADA) and secukinumab (SEC) to IXE in a real-world setting.

Method: A retrospective chart review study was conducted at a single US dermatology referral center.

Result: 153 patients were included in the study, 69.3% of patients were biologic-experienced. ADA was the most commonly used biologic prior to IXE initiation. 66.7% of patients remained on IXE at the study end. 47.7% of patients received concomitant methotrexate, and usage decreased consistently after 1 month. IXE treatment duration was longer among patients who were early responders (achieved sPGA (0,1) at 1 month) vs. non-early responders. 69.4% and 43.3% of patients who switched from ADA and SEC to IXE achieved sPGA (0,1) by week 4, respectively.

Conclusion: Patients who switched to IXE, specifically from ADA or SEC, had rapid treatment response as well as desirable long-term outcomes. IXE persistence was longer among early responders than non-early responders. Concomitant usage of methotrexate prior to switching to IXE and as a concomitant bridging treatment was reduced after IXE initiation while the proportion of patients achieving treatment targets remained high.
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http://dx.doi.org/10.1080/09546634.2021.1952154DOI Listing
July 2021

Real-World Claims Analyses of Comorbidity Burden, Treatment Pattern, Healthcare Resource Utilization, and Costs in Pediatric Psoriasis.

Adv Ther 2021 07 6;38(7):3948-3961. Epub 2021 Jun 6.

St. Luke's Children's Hospital, Boise, ID, USA.

Introduction: There are limited real-world data on treatment patterns, comorbidities, and healthcare burden in pediatric patients with psoriasis. We examined patient demographics, comorbidity burden, treatment patterns, and healthcare use and costs in pediatric psoriasis.

Methods: A retrospective, real-world, exploratory study was conducted using US claims databases. Pediatric patients aged < 18 years with newly diagnosed psoriasis (index date) were selected from IBM MarketScan databases (2016-2018). Patients were enrolled continuously for ≥ 12 months pre- and post-index date. Pre-index demographics, comorbidity, treatment drug classes prescribed, and post-index healthcare resource utilization and costs were studied. Study measures are reported for total population and by severity (categorized as mild and moderate-to-severe psoriasis). Variables were compared using t-test (continuous) or chi-square and Fisher's exact test (categorical).

Results: Overall, 4754 pediatric patients with psoriasis (58.3% females) met the selection criteria and were included in the study. Mean and standard deviation (SD) age was 12.6 (3.7) years on index date, with 13.4% patients having moderate-to-severe psoriasis. The mean (SD) Deyo-Charlson Comorbidity Index was 0.14 (0.40); anxiety (6.6%), depression (4.1%), and obesity (3.9%) were the most prevalent comorbidities observed. Topical treatments were prescribed to most patients as first-line treatment of mild (79.1%) and moderate-to-severe (52.0%) psoriasis. Other first-line therapies prescribed in moderate-to-severe cases included non-biologic systemics (21.0%), phototherapy (15.0%), and biologics (9.2%). Healthcare use and costs increased with psoriasis severity during the post-index period. Mean annual total all-cause costs per patient were higher for patients with moderate-to-severe psoriasis compared with mild psoriasis ($27,541 vs. $5,034; P < 0.001).

Conclusions: Psychiatric, metabolic, and inflammatory disorders were observed comorbidities in pediatric patients with psoriasis. For moderate-to-severe psoriasis, topicals, phototherapy, and biologics were a common first-, second-, and third-line treatment sequence. Higher unadjusted healthcare costs by severity were driven by outpatient prescription costs.
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http://dx.doi.org/10.1007/s12325-021-01795-7DOI Listing
July 2021

Early Treatment Targets for Predicting Long-term Dermatology Life Quality Index Response in Patients with Moderate-to-Severe Plaque Psoriasis: A Analysis from a Long-term Clinical Study.

J Clin Aesthet Dermatol 2020 Oct 1;13(10):18-22. Epub 2020 Oct 1.

Dr. Puig is with Hospital de la Santa Creu i Sant Pau and Universitat Autonoma de Barcelona in Spain.

: Rapid improvements in health-related quality of life (HRQoL) and psoriasis severity have been reported in patients treated with ixekizumab (IXE), an interleukin (IL)-17A antibody. : We assessed the relationship between early Psoriasis Area and Severity Index (PASI) response and long-term Dermatology Life Quality Index (DLQI) improvement in patients in the randomized clinical trial IXORA-S (NCT0256186) treated with IXE or IL-12/23 (ustekinumab [UST]). : The proportion of patients achieving DLQI (0,1), an outcome equivalent to the patient's skin condition having no impact on HRQoL after 52 weeks of IXE or UST by PASI response at Weeks 4, 12, and 24 was quantified. Optimal thresholds for PASI response by treatment to predict Week 52 DLQI (0,1) were calculated based on Youden's Index. : Early and higher levels of skin clearance were associated with improved patient outcomes regardless of treatment. Patients treated with IXE achieved faster and more pronounced PASI response than patients treated with UST. The optimal thresholds at Weeks 4, 12, and 24 for predicting DLQI (0,1) at Week 52 were ~PASI 75 for IXE versus ~PASI 50 for UST at Week 4, PASI 90 for IXE versus PASI 75 for UST at Week 12, and ~PASI 100 for IXE versus ~PASI 90 for UST at Week 24. Among patients achieving these thresholds, the probability of achieving a DLQI (0,1) was significantly higher. : Earlier and higher levels of skin clearance are associated with improved patient outcomes over the long term, regardless of treatment.
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7840086PMC
October 2020

Drug survival of ixekizumab, TNF inhibitors, and other IL-17 inhibitors in real-world patients with psoriasis: The Corrona Psoriasis Registry.

Dermatol Ther 2021 03 15;34(2):e14808. Epub 2021 Feb 15.

Eastern Virginia Medical School, Norfolk, Virginia, USA.

To compare drug survival of ixekizumab to other IL-17 inhibitors (IL-17i) and TNF inhibitors (TNFi) among patients with psoriasis (PsO) in a real-world setting. Participants included adult PsO patients enrolled in the Corrona Psoriasis Registry who initiated ixekizumab, TNFi, or other IL-17i between 16 March 2016 to 10 August 2019 and completed ≥1 follow-up visit. Multivariable adjusted hazard ratios (HR) were calculated to estimate the risk for drug discontinuation in the ixekizumab group relative to the other drugs. Among the 1604 drug initiations, 552 initiated ixekizumab, 450 initiated TNFi, and 602 initiated other IL-17i. Mean age was 51 years, 49% were women, and 52% were obese (BMI > 30). Ixekizumab patients had a higher proportion of patients with PASI >12 at drug initiation (24%) than TNFi (15%) and other IL-17i (19%). Over a median of 11 months of follow-up, 723/1604 (45%) drug discontinuations occurred. Persistence of ixekizumab, TNFi, and other IL-17i at 24-months were 68%, 33%, and 46%, among biologic-naïve patients (n = 543), and 46%, 23%, and 36%, for biologic-experienced patients (n = 1061), respectively. Ixekizumab patients had a 64% lower risk of discontinuation vs TNFi (HR = 0.36; 95% CI 0.27-0.47) and a 31% lower risk vs other IL-17i (HR = 0.69, 95% CI 0.55-0.87) after adjustment for biologic experience and other covariates. HRs were similar when limited to patients with moderate-to-severe PsO (BSA > 3, PASI > 3, and IGA > 1, n = 1076) at initiation. In our study of real-world patients with PsO, initiators of ixekizumab had more prolonged drug survival than both initiators of TNFi and other IL-17i up to 2 years of follow-up.
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http://dx.doi.org/10.1111/dth.14808DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8047872PMC
March 2021

Cost per cumulative clinical benefit of biologic therapies for patients with plaque psoriasis: a systematic review.

J Manag Care Spec Pharm 2021 Jan;27(1):84-94

Eli Lilly and Company, Indianapolis, IN.

Measuring cumulative clinical treatment benefit over time captures speed and magnitude of effects. Assessing the cost of biologics relative to their cumulative clinical benefits versus a single time point represents an alternative to evaluate the value of a given biologic used to treat psoriasis. To compare cumulative benefit and cost per cumulative benefit of biologics in treatment of moderate to severe psoriasis from a network meta-analysis (NMA). Biologics included in the analysis were ixekizumab, adalimumab, guselkumab, ustekinumab, secukinumab, risankizumab, and certolizumab pegol. Psoriasis Area and Severity Index (PASI) responses over the initial 16-week treatment period were obtained from 31 articles. Cumulative benefits for PASI 75, PASI 90, and PASI 100 responses were measured as area under the curve (AUC) using the trapezoidal method. Bayesian-based NMA modeled percent maximum AUC through week 16 (%Max_AUC). The AUC estimates over 16 weeks were converted to total skin clearance threshold days achieved for PASI 75, PASI 90, and PASI 100 with each biologic. Cost per cumulative benefit was estimated by multiplying number of doses (per FDA label) by nationally representative discounted wholesale acquisition costs (WACs) for 16 weeks of treatment divided by %Max_AUC. The primary cost analysis used WACs, including week 16 doses. Co-primary cost analysis used discounted WACs, including week 16 doses. Sensitivity analysis was conducted using WACs and discounted WACs, excluding doses administered at week 16. Among biologics with available week 16 AUC data for PASI 90 and PASI 100, cumulative benefits over the initial 16-week treatment period ranged from 20.2% (certolizumab pegol) to 47.0% (ixekizumab) for PASI 90 and from 7.4% (adalimumab) to 22.2% (ixekizumab) for PASI 100. The total number of estimated PASI 90 and PASI 100 days achieved over the first 16 weeks of treatment was highest with ixekizumab (53 days and 25 days, respectively). In the primary analysis, guselkumab had the lowest cost per cumulative benefit (95% credible interval [CrI]; $99,742 [$89,941-$111,653]), followed by ixekizumab ($108,906 [$95,928-$126,093]) and adalimumab ($111,233 [$97,549-$129,022]) for PASI 90, and ixekizumab had the lowest cost per cumulative benefit ($230,884 [$191,611-$291,115]), followed by secukinumab ($238,945 [$204,029-$288,072]) and risankizumab ($279,968 [$250,683-$316,872]) for PASI 100 responses. In the co-primary analysis, ixekizumab had the lowest discounted cost per AUC (95% CrI; $60,988 [$53,719-$70,612]), followed by guselkumab ($66,827 [$60,260-$74,807]) and secukinumab ($69,622 [$61,783-$79,786]) for PASI 90, and ixekizumab had the lowest cost per cumulative benefit ($129,295 [$107,302-$163,024]), followed by secukinumab ($148,146 [$126,498-$178,605]) and guselkumab ($188,190 [$166,791-$215,969]) for PASI 100 responses. Among biologics studied, ixekizumab demonstrated the greatest cumulative clinical benefit, maintaining the lowest cost per cumulative benefit for PASI 100 responses and lowest discounted cost per cumulative benefit for PASI 90 and PASI 100 responses for moderate to severe psoriasis over the initial 16-week treatment period. This study was funded by Eli Lilly and Company (Indianapolis, IN). Blauvelt has served as a scientific adviser and/or clinical study investigator for AbbVie, Aclaris, Almirall, Arena, Athenex, Boehringer Ingelheim, Bristol-Myers Squibb, Dermavant, Dermira, Eli Lilly and Company, Forte, Galderma, Incyte, Janssen, Leo, Novartis, Ortho, Pfizer, Rapt, Regeneron, Sandoz, Sanofi Genzyme, Sun Pharma, and UCB Pharma and as a paid speaker for AbbVie. Burge, Zhu, Malatestinic, Brnabic, Guo, and Janardhanan are employees and shareholder of Eli Lilly and Company.
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http://dx.doi.org/10.18553/jmcp.2021.27.1.084DOI Listing
January 2021

Understanding characteristics of patients newly initiating ixekizumab: findings from the Corrona Psoriasis Registry.

J Comp Eff Res 2021 02 23;10(2):157-167. Epub 2020 Dec 23.

Eli Lilly & Company, Indianapolis, IN 46225, USA.

Real-world data on patients newly initiating ixekizumab is limited. Our study describes the characteristics of patients who initiated ixekizumab and other biologics for psoriasis treatment in North American dermatological practices. Characteristics of patients ascertained at registry enrollment are described via means and frequencies. Compared with other biologic initiators, ixekizumab initiators had: longer disease duration (17.1 vs 15.1 years); more were considered least severe by body surface area (33 vs 26%); moderate-to-severe by IGA (56 vs 48%); were biologic-experienced (80 vs 52%); obese (54 vs 47%); and experienced greater impact in work productivity (5.3 vs 2.9%) versus other biologic initiators. Psoriasis patients initiating ixekizumab had more severe disease, biologic experience, and worse patient-reported outcomes than those initiating other biologics.
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http://dx.doi.org/10.2217/cer-2020-0113DOI Listing
February 2021

Ixekizumab Improves Functioning and Health in the Treatment of Active Non-Radiographic Axial Spondyloarthritis: 52-Week Results, COAST-X Trial.

Arthritis Care Res (Hoboken) 2020 Oct 12. Epub 2020 Oct 12.

Rheumazentrum Ruhrgebiet, Herne, Germany.

Objective: To evaluate the effect of ixekizumab on self-reported functioning and health in patients with active non-radiographic axial spondyloarthritis (nr-axSpA).

Methods: COAST-X is a randomized, controlled trial conducted in patients with nr-axSpA of 52-weeks duration. Participants were randomized 1:1:1 to receive subcutaneous 80 mg ixekizumab every 4 weeks (Q4W) or every 2 weeks (Q2W), or placebo for 52 Weeks. Self-reported functioning and health endpoints included the Medical Outcomes Study 36-Item Short Form Health Survey 36-item (SF-36), Assessment of SpondyloArthritis international Society Health Index (ASAS HI), and European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) health-utility.

Results: Compared with placebo, ixekizumab treatment improved SF-36 Physical Component Summary scores from baseline (4.7 versus 8.9 IXE Q4W, p<0.05, 9.3 IXE Q2W, p<0.01), with greatest improvements observed in Physical Functioning, Role-physical and Bodily Pain domains at Weeks 16 and 52. Higher proportion of patients receiving ixekizumab reported ASAS HI improvements ≥3 from baseline at Weeks 16 (Q2W, p<0.05) and 52 (p<0.05). Significantly more patients on ixekizumab reported improvements in ASAS HI "good health status" (ASAS HI ≤5) at Weeks 16 (Q4W, p<0.05) and 52 (p<0.05). Patients on ixekizumab reported improvements in EQ-5D-5L versus placebo at Week 16 (0.11 versus 0.17 Q4W, 0.19 Q2W, p<0.05), which remained consistent at Week 52. There were no clinical meaningful differences in responses based on the ixekizumab dosing regimen (Q2W or Q4W).

Conclusion: Ixekizumab was superior to placebo improving self-reported functioning and health in patients with nr-axSpA at Weeks 16 and 52.
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http://dx.doi.org/10.1002/acr.24482DOI Listing
October 2020

Relationship Between Rapid Skin Clearance and Quality of Life Benefit: Post Hoc Analysis of Japanese Patients with Moderate-to-Severe Psoriasis Treated with Ixekizumab (UNCOVER-J).

Dermatol Ther (Heidelb) 2020 Dec 10;10(6):1397-1404. Epub 2020 Sep 10.

Eli Lilly Japan K.K., Kobe, Japan.

Introduction: Ixekizumab has demonstrated rapid onset of action, high levels of skin clearance, and improvements in quality of life in patients with moderate-to-severe psoriasis, including plaque, erythrodermic, or generalized pustular psoriasis.

Methods: This was a post hoc analysis of UNCOVER-J, a phase 3, multicenter, single-arm, open-label study of ixekizumab for treatment of Japanese patients with psoriasis. The objective was to assess the proportion of patients who achieved Dermatology Life Quality Index (DLQI) (0,1) and Itch Numeric Rating Scale (NRS) (0) at weeks 4 and 12 according to Psoriasis Area and Severity Index (PASI) percentage improvement levels. All intent-to-treat patients with plaque, erythrodermic, or generalized pustular psoriasis were analyzed.

Results: A total of 91 patients were treated with ixekizumab and included in the analysis. Rapid improvements in PASI at weeks 4 and 12 were associated with improvements in DLQI (0,1) response at week 4 and at week 12. Complete skin clearance (PASI 100) achieved either at week 4 or week 12 was associated with a higher Itch NRS (0) response at week 12.

Conclusions: Patients with rapid improvement in clinical symptoms of psoriasis had better patient outcomes than those with slower responses. These findings highlight the clinical importance of achieving a fast response in patients with psoriasis, which may lead to better treatment outcomes.

Trial Registration: ClinicalTrials.gov identifier, NCT01624233.
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http://dx.doi.org/10.1007/s13555-020-00441-4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7649171PMC
December 2020

Impact of Ixekizumab on Work Productivity in Patients with Ankylosing Spondylitis: Results from the COAST-V and COAST-W Trials at 52 Weeks.

Rheumatol Ther 2020 Dec 19;7(4):759-774. Epub 2020 Aug 19.

Division of Arthritis and Rheumatic Diseases, Oregon Health and Science University, Portland, OR, USA.

Introduction: Patients with ankylosing spondylitis (AS) are burdened with symptoms impacting work productivity measured by presenteeism, absenteeism, overall work impairment, and activity impairment. Ixekizumab, a high-affinity monoclonal antibody selectively targeting interleukin-17A, has been demonstrated to improve disease signs and symptoms in two phase 3 trials of AS. This study investigated for 52 weeks the effect of ixekizumab treatment on work productivity in patients with active AS.

Methods: COAST-V (NCT02696785) and COAST-W (NCT02696798) were phase 3, multicenter, randomized, controlled trials investigating the efficacy of ixekizumab 80 mg every 4 weeks (Q4W) and every 2 weeks (Q2W) in patients with AS naïve to biologic disease-modifying antirheumatic drugs (bDMARDs; COAST-V) or who were inadequate responders or intolerant to tumor necrosis factor inhibitors (TNFi; COAST-W). Work productivity was measured with the Work Productivity and Activity Impairment Questionnaire for Spondyloarthritis at weeks 16 and 52. Absenteeism, presenteeism, and overall work impairment were assessed for patients reporting paid work. Activity impairment was assessed regardless of work status.

Results: At baseline, 66.2% (434/656) of patients reported paid work. At week 16, bDMARD-naïve patients treated with both ixekizumab dose regimens and TNFi-experienced patients treated with ixekizumab Q2W reported significant improvements in activity impairment (p < 0.01 and p < 0.05, respectively). TNFi-experienced patients treated with ixekizumab showed significant improvements versus placebo in presenteeism and overall work impairment (p < 0.05); bDMARD-naïve patients had numeric improvements. After week 16, patients initially on placebo switched to ixekizumab and patients already treated with ixekizumab continued treatment. Improvements in work productivity and daily activity were sustained through week 52 for both bDMARD-experienced and -naïve patients.

Conclusion: Both bDMARD-naïve and TNFi-experienced patients with AS had greater improvements in work productivity and activity impairment when receiving ixekizumab compared to placebo at week 16. Improvements in work productivity and activity impairment achieved at week 16 were sustained through week 52 with ixekizumab treatment.
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http://dx.doi.org/10.1007/s40744-020-00225-4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7695773PMC
December 2020

Comparison of Real-World Treatment Patterns Among Psoriasis Patients Treated with Ixekizumab or Adalimumab.

Patient Prefer Adherence 2020 9;14:517-527. Epub 2020 Mar 9.

Eli Lilly and Company, Indianapolis, IN, USA.

Background: There is lack of real-world treatment pattern comparison data between ixekizumab and adalimumab which are approved for the treatment of moderate-to-severe plaque psoriasis.

Objective: To compare real-world treatment patterns among psoriasis patients initiating ixekizumab or adalimumab in the United States.

Methods: Psoriasis patients with ≥1 claim for ixekizumab or adalimumab between March 1, 2016, and May 31, 2018, were identified (index date = date of first ixekizumab or adalimumab claim) from the IBM Watson Health MarketScan databases. Patients were required to be continuously enrolled for ≥12 months before the index date and followed for a minimum of 6 months until inpatient death, enrollment end, or study end, whichever occurred first. Treatment persistence, adherence, discontinuation, restart, and switching were analyzed. Inverse probability of treatment weighting and multivariable regression modeling were employed to address cohort imbalances and estimate the adjusted risk of non-persistence, discontinuation, and switching, and the odds of adherence.

Results: A total of 646 ixekizumab and 3668 adalimumab users were included and followed for a mean of 14.0 and 16.5 months, respectively. Compared to adalimumab, ixekizumab was associated with 19% lower risk of non-persistence (hazard ratio [HR]=0.81, 95% confidence interval [CI]: 0.69-0.95), 26% lower risk of discontinuation (HR=0.74, 95% CI: 0.62-0.88), and 28% lower risk of switching (HR=0.72, 95% CI: 0.57-0.91). Ixekizumab users had higher odds of medication possession ratio ≥80% (odds ratio [OR]=1.36, 95% CI: 1.10-1.69) but similar odds by proportion of days covered ≥80% (OR=1.22, 95% CI: 0.98-1.53).

Conclusion: Psoriasis patients treated with ixekizumab demonstrated longer persistency, higher adherence and were less likely to discontinue or switch treatment compared to adalimumab users. However, while patients achieving highly adherent threshold significantly differed by MPR ≥80%, it did not by PDC ≥80%; hence, further analysis using fixed-length follow-up is required.
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http://dx.doi.org/10.2147/PPA.S233993DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7074803PMC
March 2020

Comparison of cumulative clinical benefits of biologics for the treatment of psoriasis over 16 weeks: Results from a network meta-analysis.

J Am Acad Dermatol 2020 May 26;82(5):1138-1149. Epub 2019 Dec 26.

Oregon Medical Research Center, Portland, Oregon.

Background: Cumulative clinical improvement and speed of improvement are important to psoriasis patients.

Objective: Compare cumulative benefits of biologics over 12 to 16 weeks in the treatment of moderate to severe psoriasis.

Methods: A systematic literature review identified phase III trial data on Psoriasis Area and Severity Index (PASI) responses for biologics during 12 and 16 weeks of treatment. Cumulative clinical benefit, measured by the area under the curve for PASI ≥75% improvement (PASI 75), ≥90% improvement (PASI 90), and 100% improvement (PASI 100), was compared using the network meta-analysis and Bayesian methodology on the relative probability of achieving percentage of maximum area under the curve.

Results: Among biologics approved for psoriasis treatment, anti-interleukin-17 biologics demonstrated consistently greater cumulative clinical benefits on PASI 75, PASI 90, and PASI 100 over the 12- or 16-week period than anti-interleukin-23 and other biologics. For biologics with 12-week data, ixekizumab and brodalumab showed greater cumulative benefits for PASI 75, PASI 90, and PASI 100 than secukinumab, followed by guselkumab, infliximab, adalimumab, ustekinumab, and etanercept. Ixekizumab showed greater cumulative benefits than all other biologics reporting 16-week data.

Limitations: Recently approved biologics were not included.

Conclusion: Ixekizumab (at 12 weeks and 16 weeks) and brodalumab (at 12 weeks) had greater cumulative clinical benefit than all of other biologics studied.
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http://dx.doi.org/10.1016/j.jaad.2019.12.038DOI Listing
May 2020

Comparison of Health Care Costs Among Patients with Psoriasis Initiating Ixekizumab, Secukinumab, or Adalimumab.

J Manag Care Spec Pharm 2019 Dec;25(12):1366-1376

Eli Lilly and Company, Indianapolis, Indiana.

Background: As more biologics become available for the treatment of psoriasis (PsO), there is a lack of direct comparisons of health care costs between patients who are treated by different medications, including ixekizumab (IXE), secukinumab (SEC), and adalimumab (ADA).

Objective: To compare the real-world health care costs of patients with PsO initiating IXE with those of patients initiating either SEC or ADA.

Methods: Patients diagnosed with PsO between July 1, 2015, and May 31, 2018, were identified from the IBM MarketScan commercial and Medicare databases. Two weighted patient sample sets were constructed based on drug claims between March 1, 2016, and May 31, 2018: IXE versus SEC and IXE versus ADA. Within each sample, the first claim of eligible drugs was set as the index date. Patients were aged ≥ 18 years and had ≥ 12 months of continuous eligibility before and after the index date. Patients with other indications for the index drug in the preperiod or with use of the index drug within 90 days before the index date were excluded. Inverse probability of treatment weighting (IPTW) was employed to balance cohorts. All-cause and PsO-related health care costs per member per month (PMPM) incurred during the 12-month follow-up period were assessed. Monthly PsO-related pharmacy costs were adjusted using drug discount rates published by the Institute for Clinical and Economic Review (ICER). Annual index drug costs were estimated by adjusting for medication possession ratio and ICER discount rates. All costs were weighted by IPTW.

Results: Two study samples were identified: 357 IXE users were compared with 763 SEC users, and 388 IXE users were separately compared with 2,578 ADA users. Before weighting, IXE users were demographically and clinically similar to SEC users but were older and had worse health status than ADA users. Cohorts were balanced postweighting. After weighting, mean monthly all-cause health care costs were $7,313 and $6,477 ( = 0.002) and mean PsO-related costs were $6,303 and $5,437 ( < 0.001), for IXE and SEC users, respectively. Similarly, mean monthly all-cause health care costs were $6,535 and $5,557 ( = 0.026) and mean PsO-related costs were $5,792 and $4,754 ( = 0.017), for IXE and ADA users, respectively. After applying ICER adjustments, mean monthly PsO-related costs were comparable between groups: $3,637/IXE versus $3,443/SEC ( = 0.132) and $3,320/IXE versus $3,287/ADA ( = 0.907).

Conclusions: After adjusting for drug discount programs (through application of ICER discount rate), this real-world study estimated that average monthly PsO-related costs during the first year of treatment were similar between patients treated with IXE compared with those treated with SEC or ADA.

Disclosures: Funding for this study was provided to IBM Watson Health by Eli Lilly and Company. The analysis was conducted independently by IBM Watson Health. Eli Lilly and Company and IBM Watson Health collaborated on study design and interpretation of results. Shi, Lew, and Zimmerman were employed by IBM Watson Health and received funding from Eli Lilly and Company to conduct this study. Zhu, Burge, Malatestinic, Lin, Goldblum, and Murage were employed by Eli Lilly and Company while this study was conducted. Blauvelt has served as a scientific adviser and/or clinical study investigator for AbbVie, Aclaris, Akros, Allergan, Almirall, Amgen, Arena, Athenex, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Dermavant, Dermira, Eli Lilly and Company, FLX Bio, Galderma, Genentech/Roche, GlaxoSmithKline, Janssen, Leo, Meiji, Merck Sharp & Dohme, Novartis, Pfizer, Purdue Pharma, Regeneron, Revance, Sandoz, Sanofi Genzyme, Sienna Pharmaceuticals, Sun Pharma, UCB Pharma, Valeant, and Vidac, and as a paid speaker for AbbVie, Regeneron, and Sanofi Genzyme. A portion of these results were presented at the 2019 International Society for Pharmacoeconomics and Outcomes Research Annual Meeting; May 18-22, 2019; New Orleans, LA, and the 2019 Academy of Managed Care Pharmacy Annual Meeting; March 25-28, 2019; San Diego, CA.
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http://dx.doi.org/10.18553/jmcp.2019.25.12.1366DOI Listing
December 2019

Comparison of real-world treatment patterns among patients with psoriasis prescribed ixekizumab or secukinumab.

J Am Acad Dermatol 2020 Apr 8;82(4):927-935. Epub 2019 Nov 8.

Eli Lilly and Company, Indianapolis, Indiana. Electronic address:

Background: Real-world data on treatment patterns associated with use of interleukin-17A inhibitors in psoriasis are lacking.

Objective: To compare treatment patterns between ixekizumab or secukinumab users in clinical practice.

Methods: A retrospective cohort study included patients with psoriasis aged ≥18 years treated with ixekizumab or secukinumab between March 1, 2016, and May 31, 2018 in IBM MarketScan (IBM Corp, Armonk, NY) databases. Inverse probability of treatment weighting and multivariable models were used to address cohort imbalances and estimate the risks of nonpersistence (60-day gap), discontinuation (≥90-day gap), switching, and the odds of adherence.

Results: The study monitored 645 ixekizumab users for 13.7 months and 1152 secukinumab users for 16.3 months. Ixekizumab users showed higher persistence rate (54.8% vs 45.1%, P < .001) and lower discontinuation rate (37.8% vs 47.5%, P < .001) than secukinumab. After multivariable adjustment, ixekizumab users had lower risks of nonpersistence (hazard ratio, 0.82; 95% confidence interval, 0.71-0.95) and discontinuation (hazard ratio, 0.82; 95% confidence interval, 0.70-0.96), and higher odds of high adherence to treatment measured by a medication possession ratio ≥80% (hazard ratio, 1.31; 95% confidence interval, 1.07-1.60). The risk of switching was similar between cohorts.

Limitations: Disease severity and clinical outcomes were unavailable.

Conclusion: Ixekizumab users demonstrated longer drug persistence, lower discontinuation rate and risk of discontinuation, higher likelihood of adherence, and similar risk of switching compared with secukinumab users in clinical practices.
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http://dx.doi.org/10.1016/j.jaad.2019.11.015DOI Listing
April 2020

Ixekizumab treatment and the impact on SF-36: results from three pivotal phase III randomised controlled trials in patients with moderate-to-severe plaque psoriasis.

Qual Life Res 2020 Feb 26;29(2):369-380. Epub 2019 Oct 26.

Institute for Health Services Research in Dermatology and Nursing, University Medical Center Hamburg, Hamburg, Germany.

Purpose: To assess improvements in health-related quality of life (HRQoL) with ixekizumab treatment in patients with moderate-to-severe psoriasis.

Methods: Adults with plaque psoriasis were enrolled in phase III, double-blind, randomised, controlled trials (UNCOVER-1, UNCOVER-2, or UNCOVER-3). All 3 protocols included a 12-week, placebo-controlled induction period; UNCOVER-2 and UNCOVER-3 also had an active-control group (50 mg etanercept) during induction. After induction, patients in UNCOVER-1 and UNCOVER-2 entered a 48-week withdrawal (maintenance) period (Weeks 12-60), during which Week-12 sPGA (0,1) responders were rerandomized to receive placebo, or 80 mg ixekizumab every 4 weeks (Q4W) or 12 weeks. As a secondary objective, HRQoL was measured by the generic Medical Outcomes Survey Short Form-36 (SF-36) at baseline and Weeks 12 and 60. Changes in mean SF-36 Physical and Mental Component Summary (PCS and MCS) and domain scores and proportions of patients reporting improvements ≥ minimal important differences in SF-36 scores were compared between groups.

Results: At Week 12, ixekizumab-treated patients (both dose groups in UNCOVER-1, -2, and -3) reported statistically significantly greater improvements in mean SF-36 PCS and MCS and all 8 SF-36 domain scores versus placebo. Further, more ixekizumab-treated patients than placebo-treated patients reported at least minimal treatment responses in SF-36 PCS and MCS scores and domain scores. Overall improvements in SF-36 PCS and MCS scores were maintained through Week 60.

Conclusions: Ixekizumab-treated patients reported statistically significant improvements in HRQoL at 12 weeks that persisted through 1 year.
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http://dx.doi.org/10.1007/s11136-019-02296-5DOI Listing
February 2020

Effect of Baricitinib and Adalimumab in Reducing Pain and Improving Function in Patients with Rheumatoid Arthritis in Low Disease Activity: Exploratory Analyses from RA-BEAM.

J Clin Med 2019 Sep 5;8(9). Epub 2019 Sep 5.

Botnar Research Centre, NDORMS, University of Oxford, Old Road, Oxford OX3 7LD, UK.

Patients with rheumatoid arthritis (RA) may experience residual pain and functional impairment despite good control of disease activity. This study compared improvements in pain and physical function in patients with well-controlled RA after 24 weeks' treatment with baricitinib, adalimumab or placebo in the 52-week RA-BEAM phase III study. Adults with active RA and inadequate response to methotrexate received baricitinib 4 mg once daily, adalimumab 40 mg every two weeks or placebo, with background methotrexate. Patients ( = 1010) were categorised as in remission, in remission or low disease activity, or not in remission or low disease activity at week 24. For patients in remission or low disease activity ( = 310), improvements in mean pain and physical function scores at week 24 were significantly greater with baricitinib than placebo ( < 0.001 and < 0.01, respectively) and adalimumab ( < 0.05 for both). For both outcomes, differences between adalimumab and placebo were not significant. The proportions of patients in remission or low disease activity with minimal or no pain and with normalised physical function were numerically greater with baricitinib than placebo. Baricitinib 4 mg once daily provided enhanced improvement in pain and physical function in patients with well-controlled RA, suggesting it may produce effects beyond immunomodulation.
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http://dx.doi.org/10.3390/jcm8091394DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6780319PMC
September 2019

Assessing the Impact of Improvements in PASI and Itch Scores on Patients' Quality of Life in the Treatment of Psoriasis.

Acta Derm Venereol 2019 Oct;99(11):1031-1032

Dr. Phillip Frost Department of Dermatology and Cutaneous Surgery, University of Miami Miller School of Medicine, 33136 Miami, FL, USA.

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http://dx.doi.org/10.2340/00015555-3254DOI Listing
October 2019

Relative Impact of Pain and Fatigue on Work Productivity in Patients with Rheumatoid Arthritis from the RA-BEAM Baricitinib Trial.

Rheumatol Ther 2019 Sep 21;6(3):409-419. Epub 2019 Jun 21.

Division of Rheumatology, Department of Medicine 3, Medical University of Vienna, Vienna, Austria.

Introduction: To explore the relationship of pain and fatigue with daily activity and work productivity in rheumatoid arthritis (RA) patients from the baricitinib clinical trial, RA-BEAM.

Methods: In RA-BEAM, a double-blind phase 3 study, patients were randomized 3:3:2 to placebo (n = 488), baricitinib 4 mg once daily (n = 487), or adalimumab 40 mg biweekly (n = 330) with background methotrexate. The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) measured fatigue and the pain visual analog scale (0-100 mm) assessed pain. Work Productivity and Activity Impairment Questionnaire-RA measured daily activity and work productivity. At weeks 12 and 24, pain was assessed using pain reduction (< 30%, 30% to < 50%, ≥ 50%) and overall pain score; clinically relevant FACIT-F changes were assessed by values < 3.56 and ≥ 3.56 and the FACIT-F normative value score (< 40.1, ≥ 40.1). Pairwise comparisons between pain/fatigue reduction groups were assessed using ANCOVA with pooled data on daily activity and work productivity. A mediator analysis with pain, fatigue, and disease activity measured their contribution to daily activity and work productivity. Data were pooled from all patients for most analyses, and baricitinib-treated patients were assessed as a sensitivity analysis.

Results: Reductions in pain (≥ 50%) and fatigue (≥ 3.56) had significant (p ≤ 0.001) effects on daily activity and work productivity improvement at weeks 12 and 24. Reductions in pain, fatigue, and disease activity accounted for most of the improvements in daily activity and work productivity. At the lowest levels of remaining pain (≤ 10 mm) at weeks 12 and 24, however, fatigue did not appear to impact work productivity. Similar trends were observed with baricitinib-treated patients.

Conclusions: Reductions in pain and fatigue were associated with improved daily activity and work productivity for all RA patients and for baricitinib-treated patients in RA-BEAM.

Trial Registration: ClinicalTrials.gov identifier, NCT01710358.

Funding: Incyte Corporation and Eli Lilly and Company.
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http://dx.doi.org/10.1007/s40744-019-0164-4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6702585PMC
September 2019

Achieving Pain Control in Rheumatoid Arthritis with Baricitinib or Adalimumab Plus Methotrexate: Results from the RA-BEAM Trial.

J Clin Med 2019 Jun 12;8(6). Epub 2019 Jun 12.

Leeds Institute of Rheumatic and Musculoskeletal Medicine University of Leeds, Leeds LS1 3EX, UK.

The purpose of the study was to assess the proportion of patients who achieve pain relief thresholds, the time needed to reach the thresholds, and the relationship between pain and inflammation among patients with rheumatoid arthritis (RA) and an inadequate response to methotrexate in RA-BEAM (NCT0170358). A randomized, double-blind trial was conducted, comparing baricitinib ( = 487), adalimumab ( = 330), and placebo ( = 488) plus methotrexate. Pain was evaluated by patient's assessment on a 0-100 mm visual analog scale (VAS). The following were assessed through a 24-week placebo-controlled period: the proportion of patients who achieved ≥30%, ≥50%, and ≥70% pain relief, the time to achieve these pain relief thresholds, remaining pain (VAS ≤ 10 mm, ≤20 mm, or ≤40 mm), and the relationship between inflammation markers and pain relief. Baricitinib-treated patients were more likely ( < 0.05) to achieve ≥30%, ≥50%, and ≥70% pain relief than placebo- and adalimumab-treated patients, as early as Week 1 vs. placebo and at Week 4 vs. adalimumab. A greater proportion of baricitinib-treated patients achieved ≤20 mm or ≤40 mm remaining pain vs. placebo- and adalimumab-treated patients. Baricitinib-treated patients tended to demonstrate consistent pain relief independent of levels of inflammation control. In RA patients with an inadequate response to methotrexate, baricitinib provided greater and more rapid pain relief than adalimumab and placebo. Analyses suggest the relationship between inflammation and pain may be different for baricitinib and adalimumab treatments.
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http://dx.doi.org/10.3390/jcm8060831DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6617097PMC
June 2019

Development of the Psoriasis Symptoms Scale (PSS) in patients with moderate-to-severe psoriasis: qualitative and quantitative analyses.

J Dermatolog Treat 2020 Aug 15;31(5):452-459. Epub 2019 Jul 15.

Eli Lilly and Company, Indianapolis, IN, USA.

Psoriasis is a chronic inflammatory skin disease. To establish content validity and assess psychometric properties of the Psoriasis Symptoms Scale (PSS) in patients with moderate-to-severe psoriasis (Ps). The PSS is an eight-item patient-completed questionnaire assessing symptoms (itch, pain, stinging, burning), signs (redness, scaling, cracking), and discomfort. Content validity was established during interviews of patients ( = 14) with Ps. PSS Symptoms and Signs domain scores were evaluated for reliability, construct validity, and responsiveness using data from a clinical study (NCT02899988) in Ps ( = 205). Patients confirmed content validity; the PSS was understandable and relevant. Cronbach's alphas were 0.84 (Symptoms) and 0.86 (Signs), demonstrating internal consistency reliability. Test-retest reliability was confirmed in patients before receiving study drug (intraclass coefficient: 0.82 [Symptoms]; 0.81 [Signs]). Convergent and discriminant validity were demonstrated at baseline and Week 16 by large (≥0.50) correlations between PSS Symptoms and Signs domain scores and Dermatology Life Quality Index total and symptoms and feelings domain scores, and small (<0.30) correlations with Short Form-36 Mental Component Summary score, respectively. Symptoms and Signs scores responded to clinical changes ( < .001). The PSS Symptoms and Signs domains are valid and reliable assessments of patient-reported symptoms and signs, useful for assessing treatment efficacy.
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http://dx.doi.org/10.1080/09546634.2019.1623370DOI Listing
August 2020

Clinical outcomes in patients switched from adalimumab to baricitinib due to non-response and/or study design: phase III data in patients with rheumatoid arthritis.

Ann Rheum Dis 2019 07 30;78(7):890-898. Epub 2019 Apr 30.

Botnar Research Centre, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, United Kingdom.

Objective: To evaluate clinical outcomes in patients who changed treatment from adalimumab to baricitinib, an oral Janus kinase (JAK)1/JAK2 inhibitor, during a phase III programme.

Methods: In phase III RA-BEAM, patients were randomised 3:3:2 to placebo, baricitinib 4 mg once daily, or adalimumab 40 mg biweekly. At week 16 or subsequent visits, non-responders were rescued to open-label baricitinib 4 mg. At week 52, patients could enter a long-term extension (LTE) and continue on baricitinib or switch from adalimumab to baricitinib 4 mg with no adalimumab washout period. Percentage of patients achieving low disease activity and remission were assessed, along with physical function, patient's assessment of pain, and safety.

Results: Thirty-five (7%) baricitinib-treated and 40 (12%) adalimumab-treated patients were rescued to baricitinib in RA-BEAM; 78% (381/487) of baricitinib-treated and 72% (238/330) of adalimumab-treated patients who were not rescued in RA-BEAM, entered the LTE and continued/were switched to baricitinib. In both baricitinib-rescued and adalimumab-rescued patients, there were significant improvements in all measures up to 12 weeks after rescue compared with the time of rescue. Patients who switched from adalimumab to baricitinib showed improvements in disease control through 12 weeks in the LTE. Exposure-adjusted incidence rates for treatment-emergent adverse events (TEAEs) and infections, including serious events, were similar for patients who switched from adalimumab to baricitinib and those who continued on baricitinib.

Conclusions: Switching from adalimumab to baricitinib (without adalimumab washout) was associated with improvements in disease control, physical function and pain during the initial 12 weeks postswitch, without an increase in TEAEs, serious adverse events or infections.

Trial Registration Numbers: NCT01710358, NCT01885078.
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http://dx.doi.org/10.1136/annrheumdis-2018-214529DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6585288PMC
July 2019

Greater cumulative benefits from ixekizumab versus ustekinumab treatment over 52 weeks for patients with moderate-to-severe psoriasis in a randomized, double-blinded phase 3b clinical trial.

J Dermatolog Treat 2020 Mar 18;31(2):141-146. Epub 2019 Mar 18.

Department of Dermatology, Venerology, and Allergology, University Hospital Frankfurt, Frankfurt, Germany.

: Ixekizumab (IXE), a high-affinity monoclonal antibody that selectively targets interleukin-17A, has shown superiority to ustekinumab (UST) and etanercept in skin clearance from randomized clinical trials in patients with moderate-to-severe psoriasis. To compare cumulative benefits of IXE versus UST over 52 weeks of treatment. Cumulative clinical benefit of IXE and UST was assessed by evaluating the area under the curve (AUC) for responders of Psoriasis Area and Severity Index (PASI), itch numeric rating scale (Itch NRS), and Dermatology Life Quality Index (DLQI) outcomes over 52 weeks using data from IXORA-S trial comparing IXE ( = 136) and UST ( = 166). Normalized cumulative benefit was calculated to obtain the percentage of the maximum AUC for each outcome measure. Missing values were imputed using non-responder imputation. Significantly greater cumulative benefits were obtained for IXE compared with UST. Normalized cumulative benefit with IXE versus UST for PASI 75/90/100, Itch NRS (0), and DLQI (0,1) were 83.1% and 67.6%; 68.9% and 46.5%; 41.1% and 23.4%; 40.4% and 30.9%; and 62.2% and 46.6%, respectively. Cumulative clinical benefit ratios for IXE:UST were 1.23 for PASI 75, 1.48 for PASI 90, and 1.76 for PASI 100, indicating an increase in the cumulative clinical benefit for IXE versus UST as the clearance levels increased. IXE showed greater cumulative clinical benefit than UST.
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http://dx.doi.org/10.1080/09546634.2019.1587146DOI Listing
March 2020

Determinants of Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity in patients with rheumatoid arthritis: A post hoc analysis of overall and Japanese results from phase 3 clinical trials.

Mod Rheumatol 2018 Nov 2;28(6):960-967. Epub 2018 Feb 2.

d The First Department of Internal Medicine, School of Medicine , University of Occupational and Environmental Health , Kitakyushu , Japan.

Objectives: To assess the determinants of Patient's Global Assessment of Disease Activity (PtGA) and Physician's Global Assessment of Disease Activity (PhGA) in overall and Japanese patients with rheumatoid arthritis (RA) from two large randomized controlled trials.

Methods: Post hoc analysis of overall and Japanese RA patients who had previous inadequate responses to methotrexate or who had no/minimal previous disease-modifying antirheumatic drug treatment. We examined correlations between PtGA/PhGA and tender joint count in 28 joints (TJC28), swollen joint count in 28 joints (SJC28), inflammatory markers, pain visual analog scale (VAS), and other patient-reported outcomes at baseline, Week 12, and Week 24. Determinants of PtGA/PhGA were identified.

Results: In overall populations, pain VAS was the main determinant of PtGA, whereas TJC28 was the main determinant of PhGA in both studies. In Japanese populations, consistent with overall populations, pain VAS was the main determinant of PtGA in both studies; in contrast to overall populations, pain VAS and SJC28/TJC28 played an important role in PhGA.

Conclusion: Pain was the most important determinant of PtGA, whereas determinants of PhGA varied between populations/studies and were mostly explained by pain/joint counts. Physicians should be aware of patients' perceptions of disease activity when performing assessments/prescribing treatments.
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http://dx.doi.org/10.1080/14397595.2017.1422304DOI Listing
November 2018

Relationship between disease activity and patient-reported outcomes in rheumatoid arthritis: Post hoc analyses of overall and Japanese results from two phase 3 clinical trials.

Mod Rheumatol 2018 Nov 2;28(6):950-959. Epub 2018 Feb 2.

e The First Department of Internal Medicine, School of Medicine , University of Occupational and Environmental Health , Kitakyushu , Japan.

Objective: To examine patient-reported outcomes (PROs) in patients with different rheumatoid arthritis (RA) disease activity levels and identify residual symptoms.

Methods: Post hoc analyses of overall and Japanese data from two randomized controlled trials including RA patients with previous inadequate responses to methotrexate (NCT01710358) or no/minimal previous disease-modifying antirheumatic drug treatment (NCT01711359) (sponsor: Eli Lilly and Company). Week 24 assessments were disease activity (Simplified Disease Activity Index, Disease Activity Score/Disease Activity Score 28 joints-erythrocyte sedimentation rate) and PROs (pain visual analog scale [VAS], morning joint stiffness [MJS], Health Assessment Questionnaire-Disability Index, Functional Assessment of Chronic Illness Therapy-Fatigue, and Medical Outcomes Study Short Form 36 Health Survey Physical and Mental Component Scores).

Results: Patients achieving remission/low disease activity (LDA) at Week 24 had larger/significant improvements from baseline in pain, MJS, disability, fatigue, and physical and emotional quality of life versus patients with high/moderate disease activity. Some patients achieving remission and LDA, reported residual pain (pain VAS >10 mm): 20.8-39.3% and 48.7-70.0% (overall study populations), 16.0-34.5% and 47.1-62.0% (Japanese patients). Residual MJS and fatigue were also reported.

Conclusion: Remission/LDA were associated with improvements in PROs in overall and Japanese patient populations; however, some patients achieving remission had residual symptoms, including pain.
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http://dx.doi.org/10.1080/14397595.2017.1422232DOI Listing
November 2018

Cost Per Additional Responder Associated With Ixekizumab and Etanercept in the Treatment of Moderate-to-Severe Psoriasis.

J Drugs Dermatol 2017 12;16(12):1246-1252

BACKGROUND: Newer psoriasis treatments can achieve greater levels of efficacy than older systemic therapies; however, current psoriasis costs are substantial. We sought to estimate costs per additional responder associated with ixekizumab and etanercept, versus placebo, using efficacy data from phase 3 clinical trials (UNCOVER-2 and UNCOVER-3). METHODS: In UNCOVER-2/UNCOVER-3, patients received subcutaneous placebo, etanercept 50 mg twice weekly (BIW), or ixekizumab one 80 mg injection every 2 weeks (Q2W) after a 160-mg starting dose. Twelve-week induction-phase Psoriasis Area and Severity Index (PASI) 75, PASI 90, and PASI 100 response rates for ixekizumab, etanercept, and placebo were obtained from pooled data from the overall and United States (US) subgroup intention-to-treat (ITT) populations, and used to calculate numbers needed to treat (NNTs) to achieve one additional PASI 75, PASI 90, or PASI 100 response for ixekizumab Q2W and etanercept BIW versus placebo. Twelve-week drug costs per patient were calculated based on the UNCOVER-2/UNCOVER-3 dosing schedule and wholesale acquisition costs. Mean costs per additional responder for PASI 75, PASI 90, and PASI 100 for each treatment versus placebo were calculated for pooled UN-COVER-2/UNCOVER-3 overall and US subgroup ITT populations. RESULTS: Pooled overall ITT population: costs per additional PASI 75, PASI 90, or PASI 100 responder were US $37,540, US $46,299, or US $80,710 for ixekizumab Q2W and US $57,533, US $120,720, or US $404,695 for etanercept BIW, respectively. US subgroup ITT population: costs per additional PASI 75, PASI 90, or PASI 100 responder were US $38,165, US $49,740, or US $93,536 for ixekizumab Q2W and US $69,580, US $140,881, or US $631,875 for etanercept BIW, respectively. CONCLUSIONS: Twelve-week costs per additional responder were lower for ixekizumab Q2W than for etanercept BIW across all levels of clearance (PASI 75, PASI 90, and PASI 100) in the pooled UNCOVER-2/UNCOVER-3 overall and US subgroup ITT populations.
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December 2017

Cost per additional responder for ixekizumab and other FDA-approved biologics in moderate-to-severe plaque psoriasis.

J Med Econ 2017 Dec 22;20(12):1224-1230. Epub 2017 Aug 22.

e Central Dermatology , St. Louis , MO , USA.

Background: Evidence of the cost-efficacy of ixekizumab for the treatment of moderate-to-severe plaque psoriasis (PsO) in the US is limited.

Objective: To estimate the number needed to treat (NNT) and monthly cost of achieving one additional Psoriasis Area and Severity Index (PASI) 75, 90, and 100 responder for ixekizumab and other Food and Drug Administration (FDA)-approved biologics in PsO.

Methods: A network meta-analysis estimated the probability of achieving PASI 75, 90, or 100 response during induction for each biologic. NNTs were calculated using response difference of each respective biologic vs placebo at the end of induction. Monthly costs per additional PASI responder were based on FDA-approved doses, wholesale acquisition costs, and induction NNTs.

Results: Induction NNTs for ixekizumab 80 mg once every 2 weeks (Q2W) relative to placebo were consistently lower across all levels of clearance compared with the other biologics. Monthly cost per additional responder was lowest for ustekinumab 45 mg at PASI 75 and for secukinumab 300 mg and ixekizumab 80 mg Q2W at PASI 90. Ixekizumab 80 mg Q2W had the lowest cost for PASI 100.

Conclusion: In this analysis, ixekizumab is the most cost-efficient biologic in the US when targeting complete resolution, as measured by PASI 100 in PsO.
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http://dx.doi.org/10.1080/13696998.2017.1362413DOI Listing
December 2017

Healthcare costs in psoriasis and psoriasis sub-groups over time following psoriasis diagnosis.

J Med Econ 2017 Sep 11;20(9):982-990. Epub 2017 Jul 11.

c Wake Forest University School of Medicine , Winston-Salem , NC , USA.

Aims: To quantify healthcare costs in patients with psoriasis overall and in psoriasis patient sub-groups, by level of disease severity, presence or absence of psoriatic arthritis, or use of biologics.

Methods: Administrative data from Truven Health Analytics MarketScan Research Database were used to select adult patients with psoriasis from January 2009 to January 2014. The first psoriasis diagnosis was set as the index date. Patients were required to have ≥6 months of continuous enrollment with medical and pharmacy benefits pre-index and ≥12 months post-index. Patients were followed from index until the earliest of loss to follow-up or study end. All-cause healthcare costs and outpatient pharmacy costs were calculated for the overall psoriasis cohort and for the six different psoriasis patient sub-groups: (a) patients with moderate-to-severe disease and mild disease, (b) patients with psoriatic arthritis and those without, and (c) patients on biologics and those who are not. Costs are presented per-patient-per-year (PPPY) and by years 1, 2, 3, 4, and 5 of follow-up, expressed in 2014 US dollars.

Results: A total of 108,790 psoriasis patients were selected, with a mean age of 46.0 years (52.7% females). Average follow-up was 962 days. All-cause healthcare costs were $12,523 PPPY. Outpatient pharmacy costs accounted for 38.6% of total costs. All-cause healthcare costs were highest for patients on biologics ($29,832), then for patients with psoriatic arthritis ($23,427) and those with moderate-to-severe disease ($21,481). Overall, all-cause healthcare costs and outpatient pharmacy costs presented an upward trend over a 5-year period.

Conclusions: Psoriasis is associated with significant economic burden, which increases over time as the disease progresses. Patients with moderate-to-severe psoriasis, those with psoriatic arthritis, or use of biologics contributes to higher healthcare costs. Psoriasis-related pharmacy expenditure is the largest driver of healthcare costs in patients with psoriasis.
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http://dx.doi.org/10.1080/13696998.2017.1345749DOI Listing
September 2017

Impact of ixekizumab on psoriasis itch severity and other psoriasis symptoms: Results from 3 phase III psoriasis clinical trials.

J Am Acad Dermatol 2016 Dec 27;75(6):1156-1161. Epub 2016 Sep 27.

Temple University, Philadelphia, Pennsylvania.

Background: Itch is a prevalent symptom of psoriasis that impacts quality of life.

Objective: We sought to describe improvements in itch severity, skin pain, and bothersomeness of skin appearance caused by psoriasis among patients who received ixekizumab, etanercept, or placebo in three 12-week, phase III clinical trials (UNCOVER-1, -2, and -3).

Methods: The itch numeric rating scale evaluated psoriasis itch severity in all 3 trials. Skin pain was assessed by skin pain visual analog scale. Bothersomeness because of redness/discoloration, thickness, and scaling/flaking was assessed with the Psoriasis Skin Appearance Bothersomeness instrument. Psoriasis skin appearance bothersomeness and skin pain were assessed at baseline and week 12; itch numeric rating scale score was assessed at baseline and weeks 1, 2, 4, 8, and 12.

Results: Patients who received ixekizumab demonstrated statistically significant improvements (P < .001) in itch severity, reduction in skin pain, and degree of bothersomeness compared with those who received etanercept or placebo. Clinically meaningful improvements in itch severity were achieved as early as week 1.

Limitations: Longer-term evaluations of psoriasis symptom improvement with ixekizumab treatment are needed.

Conclusion: After treatment with ixekizumab, patients reported fast, significant, and clinically meaningful improvements in itch severity and other psoriasis-related symptoms such as skin pain and skin appearance bothersomeness.
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http://dx.doi.org/10.1016/j.jaad.2016.07.034DOI Listing
December 2016
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