Publications by authors named "José Manuel Carrascosa"

54 Publications

Brodalumab Is Associated with High Rates of Complete Clearance and Quality of Life Improvement: A Subgroup Analysis of Patients with Psoriasis and Concomitant Psoriatic Arthritis.

Dermatology 2021 Nov 25:1-10. Epub 2021 Nov 25.

Department of Dermatology, Hospital Universitari Germans Trias i Pujol, Universitat Autònoma of Barcelona, IGTP, Badalona, Spain.

Background: Psoriatic arthritis (PsA) is a chronic inflammatory disease associated with psoriasis that significantly impairs physical function and quality of life (QoL). Prompt therapeutic intervention is crucial for limiting PsA progression and preventing disability.

Objectives: The aim of this study was to compare the efficacy of brodalumab versus ustekin-umab and the impact on QoL in patients with moderate-to-severe plaque psoriasis, by concomitant PsA status.

Methods: This post hoc analysis of pooled data from the phase 3 AMAGINE-2 and -3 trials evaluated complete skin clearance (100% improvement of Psoriasis Area and Severity Index [PASI 100]), improvement in symptom severity (Psoriasis Symptom Inventory [PSI] response), and QoL (Dermatology Life Quality Index [DLQI] score of 0/1) by concomitant PsA status. A competing risk model assessed cumulative incidence over 52 weeks with outcomes of PASI 100 or inadequate response.

Results: This analysis included 929 patients with moderate-to-severe psoriasis. Concomitant PsA was present in 79/339 (23%) and 110/590 (19%) patients receiving brodalumab 210 mg and ustekinumab, respectively. At Week 52, odds ratios (ORs) (95% confidence intervals [CIs]) for complete clearance with brodalumab versus ustekin-umab were 3.15 (1.52-6.55, p = 0.0015) in patients with concomitant PsA and 3.05 (2.19-4.26, p < 0.0001) in patients without concomitant PsA. Corresponding Week 52 ORs (95% CIs) for DLQI 0/1 with brodalumab versus ustekinumab were 2.05 (1.07-3.90, p = 0.0277) and 1.83 (1.32-2.53, p = 0.0002); Week 52 ORs (95% CIs) for PSI ≤8 with brodalumab versus ustekinumab were 3.42 (1.43-8.18, p = 0.0036) and 1.40 (1.01-1.95, p = 0.0434). The 52-week cumulative incidence of patients achieving PASI 100 was significantly higher for brodalumab versus ustekinumab in patients with concomitant PsA (p = 0.0001) and in those without concomitant PsA (p < 0.0001).

Conclusions: Treatment with brodalumab rapidly results in high levels of complete and sustained skin clearance and greater cumulative treatment benefit in patients with moderate-to-severe psoriasis versus ustekinumab, regardless of concomitant PsA status.
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http://dx.doi.org/10.1159/000520290DOI Listing
November 2021

Effectiveness and safety of guselkumab for the treatment of psoriasis in real-world settings at 24 weeks: A retrospective, observational, multicentre study by the Spanish Psoriasis Group.

Dermatol Ther 2021 Nov 24:e15231. Epub 2021 Nov 24.

Department of Dermatology, Hospital Universitari Germans Trias i Pujol. Universitat Autònoma de Barcelona (UAB), Badalona, Spain.

Background: Data on the effectiveness and safety of a drug in real-world clinical practice complement the evidence from clinical trials, which are carried out in a different setting. Little has been published on the effectiveness and safety of guselkumab in the treatment of psoriasis in clinical practice.

Objectives: To assess the effectiveness and safety of guselkumab at 24 weeks in patients with moderate to severe plaque psoriasis in routine clinical practice.

Methods: Retrospective, multicentre study of adult patients with moderate to severe plaque psoriasis treated with guselkumab for at least 24 weeks in Spain.

Results: We studied 343 patients, 249 of whom were followed for 24 weeks. By week 24, the mean (SD) Psoriasis Area and Severity Index (PASI) had decreased from 11.1 (7.3) to 1.7 (2.8) (-9.3; [-10.2;-8.4]), 85.9% of the patients had achieved PASI score of 4 or less and 77.9% a PASI score of 2 or less. In terms of relative PASI response, 59.4% of the patients achieved a PASI-90 response and 49.0% a PASI-100 response. On multivariate analysis, 2 factors reduced the probability of a PASI of 2 or less at 24 weeks: a BMI ≥30 (OR, 0.44; 95% CI, 0.22-0.88) and a greater previous exposure to biologic therapy (OR, 0.69; 95% CI, 0.56-0.84]). Adverse events were rare (9.9%) and led to withdrawal from treatment in only 9 patients (2.6%) by the end of the follow-up period.

Conclusion: The results of this study confirm the high efficacy and safety of guselkumab indicated by the clinical trial data. In clinical practice, the absolute PASI score appears to be a better marker of response to treatment than the relative value.
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http://dx.doi.org/10.1111/dth.15231DOI Listing
November 2021

Knowledge, perceptions, attitude, barriers and facilitators of biosimilars use across specialty physicians and hospital pharmacists: A national survey.

Farm Hosp 2021 07 7;45(5):240-246. Epub 2021 Jul 7.

Pharmacy Department, Drug Clinical Area, Hospital Universitario y Politécnico La Fe, Valencia. España..

Objective: To analyze knowledge, perceptions, attitude, barriers and facilitators of biosimilars uptake across physicians managing immune diseases and hospital pharmacists.

Method: Two structured and closed anonymous online surveys were designed and sent to 41 physicians (rheumatologists, dermatologists, gastroenterologists) and 32 hospital pharmacists.  Sociodemographic and clinical practice related variables were collected. We also gathered information about biosimilars knowledge and importance,  access, attitude in clinical practice and perceptions, barriers and facilitators to biosimilars uptake. A descriptive analysis was performed.

Results: Surveys response rate was 100% (hospital pharmacists) and 96% (physicians). We found certain lack of biosimilars knowledge  about key aspects including switching, extrapolation, interchangeability or  substitution. There was a great variability in the types and brands of  biosimilars depending on the hospital. We observed several organization  preferences, policies, and practices regarding biosimilars. General  perception and attitude to biosimilars was positive. If used, biosimilars  were predominantly prescribed in biologic treatment-naive patients (this  indication was considered adequate and participants felt comfortable with  it). Reluctance to switch in clinical practice was common. The main  barriers to biosimilars uptake were the lack of confidence and knowledge.  The main facilitators were the development of recommendations from  professional associations and societies and the demonstration of  interchangeability efficacy. We gathered concerns about biosimilar long  term efficacy and safety, lack of real-life data, lack of biosimilars  traceability or the risk of biologic reference medicines stock shortages.

Conclusions: Biosimilar education and more evidence filling current gaps  might help increase prescriber knowledge, comfort and use of biosimilars.
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July 2021

Increased Skin Clearance and Quality of Life Improvement with Brodalumab Compared with Ustekinumab in Psoriasis Patients with Aggravating Lifestyle Factors.

Dermatol Ther (Heidelb) 2021 Dec 2;11(6):2027-2042. Epub 2021 Oct 2.

Department of Dermatology, Hospital Universitari Germans Trias i Pujol, Universitat Autònoma of Barcelona, IGTP, Carretera de Canyet, s/n, 08916, Badalona, Barcelona, Spain.

Introduction: Obesity, smoking, and alcohol consumption are prevalent in psoriasis patients and have been associated with increased disease severity and reduced treatment adherence and response. This post hoc analysis of pooled data from the phase 3 AMAGINE-2 and -3 trials compared the efficacy of brodalumab versus ustekinumab in psoriasis patients with aggravating and potentially treatment-confounding lifestyle risk factors.

Methods: This post hoc analysis evaluated complete skin clearance, as measured by a 100% reduction of Psoriasis Area and Severity Index (PASI100) and quality of life (QoL), as measured by a Dermatology Life Quality Index (DLQI) score of 0/1, by the presence of risk factors (obesity, tobacco or alcohol use). A competing risk model assessed cumulative incidence over 52 weeks with outcomes of PASI100 or inadequate response.

Results: This analysis included 929 patients (brodalumab 210 mg, n = 339; ustekinumab, n = 590) with moderate-to-severe psoriasis. At week 52, odds ratios (95% confidence intervals [CIs]) for complete clearance with brodalumab versus ustekinumab were 2.50 (1.14-5.46, P = 0.0186), 4.64 (2.80-7.69, P < 0.0001), 2.06 (1.25-3.40, P = 0.0045), and 2.55 (0.55-11.91, P = 0.2117) in patients with no, one, two, or three risk factors, respectively. Corresponding odds ratios (ORs) (95% CIs) for DLQI 0/1 with brodalumab versus ustekinumab were 1.72 (0.78-3.79, P = 0.1883), 2.49 (1.54-4.02, P < 0.0002), 1.57 (0.97-2.54, P = 0.0666), and 2.07 (0.45-9.57, P = 0.3438). The 52-week cumulative incidence of patients achieving PASI100 was consistently higher for brodalumab versus ustekinumab, regardless of number of risk factors (P < 0.0001 for one or two risk factors and P = 0.0029 for three risk factors).

Conclusions: Higher levels of complete skin clearance and QoL were achieved and maintained with brodalumab versus ustekinumab in patients with moderate-to-severe psoriasis, regardless of the presence of lifestyle risk factors.

Clinical Trial Registration: AMAGINE-2 (NCT01708603); AMAGINE-3 (NCT01708629).
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http://dx.doi.org/10.1007/s13555-021-00618-5DOI Listing
December 2021

Patient Journey in Atopic Dermatitis: The Real-World Scenario.

Dermatol Ther (Heidelb) 2021 Oct 23;11(5):1693-1705. Epub 2021 Aug 23.

Pfizer SLU, Avenida Europa 20B, Parque Empresarial La Moraleja, 28108, Madrid, Spain.

Introduction: The diagnosis and management of atopic dermatitis (AD) is extensively addressed in detailed clinical guidelines. However, the high heterogeneity regarding presentation and progression and the increasingly broad therapeutic landscape suggest a complex real-world scenario, leading to multiple trajectories of AD patients.

Methods: Using a Delphi methodology for assessing the degree of consensus, we explored the views of a panel of dermatologists regarding the patients' trajectory through the diagnosis (block 1), treatment (block 2), and long-term management (block 3) of AD. Based on a systematic search of the literature, a scientific committee prepared a questionnaire of relevant items that were rated on a 10-point scale (from "totally agree" to "totally disagree") by a panel of dermatologists attending patients with AD in the hospital setting. Consensus was established based on predefined rules.

Results: The final questionnaire included 58 items and was answered by 17 dermatologists. Overall, consensus was reached on 22 items (37.9%), each of which was a consensus for agreement. The consensus rates in blocks 1, 2, and 3 were 22.7%, 19.0%, and 86%, respectively.

Conclusions: Our analysis revealed a remarkable lack of consensus on various aspects of the routine diagnosis and treatment of AD. These findings suggest the presence of unmet needs or limited implementation of guidelines for the management of AD and encourage further research to explore the causes of this low consensus on the management of AD in the real-world setting.
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http://dx.doi.org/10.1007/s13555-021-00592-yDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8484426PMC
October 2021

Baricitinib for the treatment of atopic dermatitis.

J Dermatolog Treat 2021 Aug 23:1-10. Epub 2021 Aug 23.

Instituto de Ciências Biomédicas Abel Salazar, University of Porto, Porto, Portugal.

Atopic dermatitis is a common, chronic and recurrent inflammatory skin disease, which often appears in childhood but can last into adulthood. It negatively impacts patients, their families and society in general. There is a therapeutic unmet need, with patients requiring new drugs that are safe and effective. The increasing knowledge of the pathophysiology of AD and the role of the Janus kinase (JAK) and signal transducer and activator of transcription (STAT) pathway in the development and maintenance of AD, has led to the development of agents blocking this intracellular signaling pathway, the JAK inhibitors. Baricitinib shows high selectivity for JAK1 and JAK2, making it appealing for the treatment of this condition. Phase II and phase III trials evaluated the efficacy and safety of baricitinib in the treatment of AD, and the results have been encouraging, showing a good efficacy and a favorable safety and tolerability profile. At the end of 2020, EMA approved baricitinib for the treatment of adult patients with moderate-to-severe atopic dermatitis who are candidates for systemic therapy, increasing the therapeutic option for this debilitating disease.
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http://dx.doi.org/10.1080/09546634.2021.1967268DOI Listing
August 2021

A New Classification of the Severity of Psoriasis: What's Moderate Psoriasis?

Life (Basel) 2021 Jun 29;11(7). Epub 2021 Jun 29.

Dermatology Department, Hospital General Universitario de Alicante-ISABIAL-UMH, 03010 Alicante, Spain.

The purpose of this study is to propose a ranking system for the severity of psoriasis. The consensus method of selecting the indices to include and the classification of real patient profiles by an expert panel to create a gold standard of severity were used. The performance of potential cut-offs was evaluated to create a ranking algorithm. The combined use of PASI, BSA, and sPGA may allow the classification of the severity of psoriatic patients. The final algorithm identifies severe patients in a single step (2 out 3 are met: PASI ≥ 11 or BSA ≥ 10 or sPGA ≥ 3), while two steps are required for mild ((2 out 3 are met: PASI ≤ 3 or BSA ≤ 5 or sPGA ≤ 2) and DLQI < 5) and moderate forms (the patient does not meet 2 out 3 (PASI ≥ 11 or BSA ≥ 10 or sPGA ≥ 3) but has a DLQI ≥ 5. A ranking algorithm is presented, consisting of different measures of disease which classifies psoriatic patients into three categories: mild, moderate, and severe.
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http://dx.doi.org/10.3390/life11070627DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8307918PMC
June 2021

[Contributions from a multidisciplinary committee for the prevention of infections in patients with targeted immunosuppressive therapy].

Med Clin (Barc) 2021 11 5;157(10):489-494. Epub 2021 Jun 5.

Servicio de Dermatología, Hospital Universitari Germans Trias i Pujol, Universitat Autònoma de Barcelona, Badalona, Barcelona, España.

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http://dx.doi.org/10.1016/j.medcli.2021.03.031DOI Listing
November 2021

Efficacy of dimethyl fumarate treatment for moderate-to-severe plaque psoriasis: presentation extracts from the 29 EADV virtual congress, 29-31 October 2020.

Expert Rev Clin Immunol 2021 May 17;17(sup2):1-11. Epub 2021 May 17.

Derma-Köln, Cologne, Germany.

The 29th EADV Virtual Congress took place between the 29th-31st of October 2020. On October 29th, there was a Session on systemic treatment in which Professors Ulrich Mrowietz and Mar Llamas-Velasco presented the latest research on the efficacy of dimethyl fumarate (DMF) treatment for moderate-to-severe plaque psoriasis (BRIDGE and DIMESKIN 1 studies, respectively). The accepted DMF abstract from Professor Matthias Augustin, on the SKILL study, is also presented here. Data from either prospective interventional (BRIDGE) or non-interventional (DIMESKIN 1, SKILL) studies among patients with moderate-to-severe psoriasis showed that DMF provides a positive efficacy profile in all four body regions included in the Psoriasis Area and Severity Index assessment (head and neck, trunk, upper and lower extremities) and a particularly interesting profile (strong efficacy) in the head and neck region. These findings may be of special interest to patients with scalp psoriasis who have been using topical therapies for a long time. Patient-reported outcomes (quality of life, pruritus) also improved during the 24 weeks of DMF treatment. The safety profile of DMF was similar to the previously described with fumaric acid esters. In summary, these results confirm the favorable efficacy and safety profile of DMF in long-term treatment.
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http://dx.doi.org/10.1080/1744666X.2021.1919510DOI Listing
May 2021

Prevalence and stages of chronic kidney disease in psoriasis and psoriatic arthritis: A cross-sectional study.

Indian J Dermatol Venereol Leprol 2021 Mar-Apr;87(2):321

Department of Dermatology Germans Trias i Pujol University Hospital, Universitat Autònoma de Barcelona, Badalona, Barcelona, Spain.

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http://dx.doi.org/10.25259/IJDVL_372_19DOI Listing
November 2021

The Role of Photoprotection in Optimizing the Treatment of Atopic Dermatitis.

Dermatol Ther (Heidelb) 2021 Apr 13;11(2):315-325. Epub 2021 Feb 13.

Department of Clinical Medicine and Surgery, University of Naples Federico II, Napoli, Italy.

Atopic dermatitis (AD) is a chronic inflammatory skin disease with an estimated prevalence of 10-15% in children and 2-10% in adults. Clinically, there is notable phenotypic variability driven by a complex interaction between genetics, immune function, and the environment. Impairment of the skin barrier plays a significant role in the pathogenesis of AD. The apparent beneficial effect of sunlight in patients with atopic eczema is questioned due to its capacity to disrupt the skin barrier and generate free radicals that can damage proteins, lipids, and DNA. The sum of the external factors that an individual is exposed to throughout their lifetime is termed the exposome. Environmental factors such as sun exposure, temperature, and humidity contribute to both AD flares and regional prevalence variation. Literature on photoprotection in atopic dermatitis is very scarce. The use of adequate sunscreens in atopic dermatitis can ensure the level of photoprotection required to prevent skin photoaging and skin cancer and to mitigate skin barrier dysfunction, decrease inflammation, and neutralize facial redness. Herein we discuss and review the role of UV radiation and the exposome in the etiology of AD, as well as the role of adequate photoprotection.
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http://dx.doi.org/10.1007/s13555-021-00495-yDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8019014PMC
April 2021

Spotlight on Topical Long-Term Management of Plaque Psoriasis.

Clin Cosmet Investig Dermatol 2020 29;13:495-498. Epub 2020 Jul 29.

Institute and Comprehensive Center for Inflammation Medicine, University of Lübeck, Lübeck, Germany.

During the 28th Congress of the European Academy of Dermatology and Venereology (EADV) held in Madrid in October 2019, an industry hub was dedicated to the long-term management of psoriasis. Psoriasis is a systemic inflammatory disease primarily involving the skin that affects up to 4% of the European population, the majority of whom present with chronic plaque psoriasis. Topical therapies are well established in the first-line treatment of psoriatic plaque flares. Nevertheless, as psoriasis is a chronic disease, long-term control should be considered. The aim of the session was to provide expert opinion on the benefit of long-term maintenance therapy in chronic plaque psoriasis and introduce the concept of pro-active management to decrease the number of relapses and improve patient quality of life. The current guidelines and recommendations were reviewed, as well as the available data on published clinical trials. There is still an important role for topical therapy in psoriasis and current recommendations suggest a maintenance regimen for psoriasis. Adherence optimization and proactive management of relapse can be key factors for obtaining clinical outcomes in topical long-term therapy. Calcipotriol/betamethasone dipropionate foam is the only topical formulation with long-term data as a twice-weekly proactive treatment approach for up to 52 weeks for chronic plaque psoriasis.
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http://dx.doi.org/10.2147/CCID.S254114DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7397561PMC
July 2020

Ichthyosiforme Hautveränderungen und Gesichtserythem nach Behandlung mit Ponatinib.

J Dtsch Dermatol Ges 2020 Jul;18(7):743-748

Department of Dermatology, Hospital Universitari Germans Trias i Pujol, Universitat Autònoma de Barcelona, Badalona, Barcelona, Spain.

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http://dx.doi.org/10.1111/ddg.14154_gDOI Listing
July 2020

Ichthyosiform eruption and facial erythema secondary to ponatinib therapy.

J Dtsch Dermatol Ges 2020 Jul 26;18(7):743-747. Epub 2020 Jun 26.

Department of Dermatology, Hospital Universitari Germans Trias i Pujol, Universitat Autònoma de Barcelona, Badalona, Barcelona, Spain.

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http://dx.doi.org/10.1111/ddg.14154DOI Listing
July 2020

Real World SB4 (Etanercept Biosimilar) Use in Patients With Psoriasis: Data from the British Association of Dermatologists Biologic Interventions Register (BADBIR).

J Drugs Dermatol 2020 Mar;19(3):316-318

Psoriasis is a chronic, systemic, inflammatory skin disease with a risk of comorbidities and a potential high impact on patients’ quality of life.
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March 2020

Apremilast for psoriasis treatment.

G Ital Dermatol Venereol 2020 Aug 15;155(4):421-433. Epub 2020 Jun 15.

Department of Dermatology, Hospital Universitari Germans Trias i Pujol, Universitat Autònoma de Barcelona, Badalona, Spain.

Apremilast is a small-molecule inhibitor of phosphodiesterase 4 with an intracellular mechanism of action that increases levels of cyclic adenosine monophosphate (cAMP) indicated for the oral treatment of moderate to severe plaque psoriasis and for the treatment of psoriatic arthritis. Efficacy of apremilast in moderate-to-severe psoriasis has been demonstrated in the pivotal trials, with a 30% PASI-75 response rate at week 16, an efficacy that was maintained through week 52. Apremilast also achieved significant responses in disease involving specific sites, such as palmoplantar, nail and scalp psoriasis, improved patient quality of life, and achieved rapid improvements in pruritus. The findings of some of the real world series indicate that the PASI-75 response may be higher in patients with a lower baseline PASI than that observed in the pivotal trials, enhancing the importance of using the absolute PASI score as a marker of therapeutic success rather than a relative PASI index in this setting. Apremilast has demonstrated good safety and tolerability in both clinical trials and clinical practice series. The most frequent adverse effects were diarrhea (17.3%), nausea (15.7%), upper respiratory tract infections (15.5%), nasopharyngitis (14.4%), tension headache (9.0%) and headache (6.3%). The rate of adverse events recorded in the clinical practice series has been lower compared to the clinical trials.
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http://dx.doi.org/10.23736/S0392-0488.20.06684-5DOI Listing
August 2020

Median rhomboid glossitis associated with candida infection in a woman treated with ixekizumab.

Eur J Dermatol 2020 Apr 16. Epub 2020 Apr 16.

Department of Dermatology of Hospital Universitari Germans Trias i Pujol. Carretera del Canyet s/n, 08916, Badalona, Spain.

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http://dx.doi.org/10.1684/ejd.2020.3724DOI Listing
April 2020

Long-term safety of nine systemic medications for psoriasis: A cohort study using the Spanish Registry of Adverse Events for Biological Therapy in Dermatological Diseases (BIOBADADERM) Registry.

J Am Acad Dermatol 2020 Jul 22;83(1):139-150. Epub 2020 Mar 22.

Research Unit, Fundación Piel Sana Academia Española de Dermatología, Madrid, Spain; Department of Dermatology, Complexo Hospitalario Universitario de Vigo, Vigo, Spain.

Background: Registry studies broadly describing the safety of systemic drugs in psoriasis are needed.

Objective: To describe the safety findings of the systemic drugs acitretin, adalimumab, apremilast, cyclosporine, etanercept, infliximab, methotrexate, secukinumab, and ustekinumab used for the treatment of moderate to severe psoriasis in patients included in the Spanish Registry of Adverse Events for Biological Therapy in Dermatological Diseases (BIOBADADERM) Registry.

Methods: The incidence rate ratio (IRR) and adjusted IRR (including propensity scores) of identified adverse events for each drug, using methotrexate as reference, were determined by means of a prospective cohort.

Results: Our study included 2845 patients (8954 treatment cycles; 9642 patient-years). Ustekinumab and secukinumab had the lowest rate of adverse events for several of the system organ classes, with a statistically significant decreased rate ratio (IRR of <1), whereas cyclosporine and infliximab had the highest, with an increased rate ratio (IRR of ≥5).

Limitations: Observational study, drug allocation not randomized, depletion of susceptibles, and prescribed doses not registered.

Conclusion: Our data provide comparative safety information in the real-life setting that could help clinicians selecting between available products.
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http://dx.doi.org/10.1016/j.jaad.2020.03.033DOI Listing
July 2020

Cost per PASI-75 responder of calcipotriol plus betamethasone dipropionate cutaneous foam versus nonbiologic systemic therapies for the treatment of plaque psoriasis in seven European countries.

J Dermatolog Treat 2021 Nov 6;32(7):701-708. Epub 2020 Mar 6.

LEO Pharma A/S, Ballerup, Denmark.

Purpose: To compare the short-term cost and effectiveness of calcipotriol/betamethasone dipropionate (Cal/BD) cutaneous foam against nonbiologic systemics in psoriasis patients for whom oral systemic or topical therapy is considered appropriate in seven European countries.

Methods: Matching-adjusted indirect comparisons of four-week PASI-75 responses of Cal/BD foam were performed versus 12-week responses of methotrexate, acitretin, fumaric acid esters (FAE) and 16-week responses of apremilast. Analyses took a payer perspective and included drug, physician visit and monitoring costs.

Results: In all countries, Cal/BD foam generated the lowest cost per responder (CPR). Against methotrexate, apremilast and acitretin, Cal/BD foam generated response for less than €190 in Italy, €195 in Portugal, €216 in Greece, £218 in the United Kingdom, €250 in Belgium, €319 in Spain, and €359 in the Netherlands. Relative to treatment with FAE, Cal/BD foam resulted in response for less than €298, €430, €382 and £262 in Belgium, the Netherlands, Spain and the United Kingdom, respectively. For Cal/BD foam, apremilast and FAE, total costs were driven by drug costs; for methotrexate and acitretin, by monitoring.

Conclusions: Driven by its lower costs and high response rates, Cal/BD foam is likely to be a cost-effective option over the short-term in the investigated psoriasis population.
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http://dx.doi.org/10.1080/09546634.2019.1707754DOI Listing
November 2021

Drug survival of conventional systemic and biologic therapies for moderate-to-severe psoriasis in clinical practice in Spain: prospective results from the SAHARA study.

J Dermatolog Treat 2020 Jun 20;31(4):344-351. Epub 2019 Jun 20.

Medical Department, Janssen, Madrid, Spain.

A better understanding of determinants for drug survival of antipsoriatic agents may guide dermatologists in the right therapeutic choice.: To describe 2-year drug survival of conventional and biologic antipsoriatic treatments.: SAHARA was a prospective study in patients with moderate-to-severe psoriasis who initiated a conventional or biologic drug. Kaplan-Meier analysis estimated the drug survival and Cox regression the predictors of treatment persistence at two years.: A total of 552 patients were included (conventional group  181, biologic group  371). After a median treatment duration of 21.4 months, more than 50% of patients remained on methotrexate, etanercept, and ustekinumab whereas the median exposition time to cyclosporine, acitretin, and adalimumab was 11.8, 10.6, and 25.5 months, respectively. There were 178 discontinuations for all causes, mainly in patients who initiated cyclosporine (58.3%), acitretin (52.8%), and adalimumab (46%), and less frequently with ustekinumab (14%). The main reason for discontinuing biologics was lack of efficacy (70%), especially for etanercept (76%).: Biologics have a superior drug survival rate than conventional therapies. Ustekinumab is the biologic with the longest drug survival, only affected by the gradual loss of efficacy assumed for biological therapies.
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http://dx.doi.org/10.1080/09546634.2019.1597244DOI Listing
June 2020

Safety and effectiveness of conventional systemic therapy and biological drugs in patients with moderate to severe psoriasis and HIV infection: a retrospective multicenter study.

J Dermatolog Treat 2019 Aug 28;30(5):461-465. Epub 2018 Nov 28.

a Department of Dermatology , Hospital Universitario de La Princesa , Madrid , Spain.

The management of HIV-positive patients with psoriasis is controversial and limited to individual cases or short series of patients. To evaluate the safety and effectiveness of conventional and biologic immunosuppressive drugs in the treatment of patients with psoriasis and concomitant HIV infection. A retrospective multicenter study was conducted. The study included data from 2008 to 2016. Inclusion criteria were: HIV adult patients with moderate-to-severe psoriasis, HIV viral load determinations at baseline and at least after 6 months of treatment, and systemic immunosuppressive treatment for at least 6 months. A descriptive analysis was performed. Twenty-three patients with plaque-type psoriasis and HIV infection (five with AIDS) were included. Median follow-up time was 3.2 years. The main drugs used were etanercept, methotrexate, and ustekinumab. In most cases, viral load and CD4 cell count not only remained stable but also improved throughout the follow-up. Six patients presented severe adverse events during the follow-up, four of them in the AIDS stage. At the end of the follow-up period, 76.5% of the patients had achieved a PASI 75. Biologic drugs, both anti-TNF alpha agents and ustekinumab, seem to have an acceptable safety profile and high effectiveness in HIV-positive patients.
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http://dx.doi.org/10.1080/09546634.2018.1535690DOI Listing
August 2019

[Introduction].

Rev Alerg Mex 2018;65 Suppl 2:s7-s8

Hospital Universitari Germans Trias i Pujol. Universidad Autónoma de Barcelona, Departamento de Dermatología, Barcelona, España.

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http://dx.doi.org/10.29262/ram.v65i6.556DOI Listing
September 2019

Treatment of patients with plaque psoriasis with secukinumab in a real-life setting: a 52-week, multicenter, retrospective study in Spain.

J Dermatolog Treat 2019 Aug 3;30(5):424-429. Epub 2018 Dec 3.

b Department of Dermatology , Hospital del Mar- Institut Mar d'Investigacions Mèdiques , Barcelona , Spain.

The efficacy and safety of secukinumab in patients with plaque psoriasis (PsO) have been demonstrated in randomized clinical trials (RCTs). However, data regarding its efficacy and safety in real-life settings are scarce. To evaluate the efficacy and safety of secukinumab in clinical practice in patients with PsO attending 10 dermatology centers in Spain. Data from 136 patients consecutively treated with secukinumab for at least 52 weeks were collected in a retrospective observational study. After 52 weeks of treatment, 69% and 46% of patients achieved a PASI-75, PASI-90, respectively. PASI-score ≤5 was achieved in 83% of patients, PASI-score ≤3 in 73% and PASI-score ≤1 in 47%. Response rates were found significantly lower in patients with obesity and non-naïve to biologics ( < .05). The most common adverse event (AE) was candidiasis (5/136). Thirty-six patients (26.5%) discontinued treatment by week 52 due to lack or loss of response ( = 29), AEs ( = 2) or other causes ( = 5). These findings complement the efficacy and safety profiles of secukinumab in PsO outlined in RCTs. The effectiveness in clinical practice may be lower in patients with a BMI ≥30 and those previously treated with other biologic agents.
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http://dx.doi.org/10.1080/09546634.2018.1528000DOI Listing
August 2019

Determining the Value of Two Biologic Drugs for Chronic Inflammatory Skin Diseases: Results of a Multi-Criteria Decision Analysis.

BioDrugs 2018 Jun;32(3):281-291

Fundación Weber, Majadahonda, Madrid, Spain.

Background And Objective: Multi-criteria decision analysis (MCDA) is a tool that systematically considers multiple factors relevant to health decision-making. The aim of this study was to use an MCDA to assess the value of dupilumab for severe atopic dermatitis compared with secukinumab for moderate to severe plaque psoriasis in Spain.

Method: Following the EVIDEM (Evidence and Value: Impact on DEcision Making) methodology, the estimated value of both interventions was obtained by means of an additive linear model that combined the individual weighting (between 1 and 5) of each criterion with the individual scoring of each intervention in each criterion. Dupilumab was evaluated against placebo, while secukinumab was evaluated against placebo, etanercept and ustekinumab. A retest was performed to assess the reproducibility of weights, scores and value estimates.

Results: The overall MCDA value estimate for dupilumab versus placebo was 0.51 ± 0.14. This value was higher than those obtained for secukinumab: 0.48 ± 0.15 versus placebo, 0.45 ± 0.15 versus etanercept and 0.39 ± 0.18 versus ustekinumab. The highest-value contribution was reported by the patients' group, followed by the clinical professionals and the decision makers. A fundamental element that explained the difference in the scoring between pathologies was the availability of therapeutic alternatives. The retest confirmed the consistency and replicability of the analysis.

Conclusions: Under this methodology, and assuming similar economic costs per patient for both treatments, the results indicated that the overall value estimated of dupilumab for severe atopic dermatitis was similar to, or slightly higher than, that of secukinumab for moderate to severe plaque psoriasis.
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http://dx.doi.org/10.1007/s40259-018-0284-3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5990558PMC
June 2018

Effects of etanercept on the patient-perceived results (PROs) in patients with moderate-to-severe plaque psoriasis: systematic review of the literature and meta-analysis.

J Dermatolog Treat 2018 Dec 8;29(8):806-811. Epub 2018 May 8.

c Dermatology Service , Infanta Leonor University Hospital , Madrid , Spain.

Purpose: To evaluate the efficacy of etanercept (ETN) compared with placebo for moderate-to-severe psoriasis regarding patient-reported outcomes (PROs).

Methods: Systematic review of studies retrieved by a sensitive search strategy in Medline, Embase, Cochrane Library.

Selection Criteria: (population) studies had to include patients with for moderate-to-severe psoriasis; (intervention and control) studies had to test ETN vs. placebo; and (outcomes), studies had to report PROs including quality of life, pain, pruritus, or sleep. Only randomized controlled trials (RCT) were included. Two reviewers independently selected the articles and collected data. Studies quality was assessed using the Jadad score. For the meta-analysis, a random effects model was followed and statistical heterogeneity was tested with statistic I.

Results: We finally included 12 RCT. Compared with placebo, ETN significantly improved quality of life, patient global assessment, pruritus and pain in the short and medium term, fatigue in the short term (although the effect size and differences with placebo are unclear). ETN also produces a high patient's satisfaction, which increases over time and is higher compared with placebo and might improve depressive symptoms in the long term.

Conclusions: ETN is an effective option for improving PROs in patients with moderate-to-severe psoriasis.
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http://dx.doi.org/10.1080/09546634.2018.1467536DOI Listing
December 2018

Biosimilar Drugs for Psoriasis: Principles, Present, and Near Future.

Dermatol Ther (Heidelb) 2018 Jun 16;8(2):173-194. Epub 2018 Mar 16.

Federal Academic Teaching Hospital of Feldkirch, Feldkirch, Austria.

Psoriasis is a chronic, inflammatory, lifelong disease with a high prevalence (afflicting approximately 1-5% of the population worldwide) and is associated with significant morbidity. The introduction of biologic therapies has improved the management of this disease. Multiple biologic medicines that block cytokine signaling, including tumor necrosis factor (TNF) antagonists (adalimumab, etanercept, and infliximab) and inhibitors of interleukin (IL)-17 (brodalumab, ixekizumab, and secukinumab), IL-23 (guselkumab), or IL-12/23 (ustekinumab), are approved for the treatment of psoriasis. Despite the clinical benefits associated with use of biologics in psoriasis, many patients are not treated with biologic therapy, and access to treatment may be limited for various reasons, such as high treatment costs. Patents for many biologics have expired or will soon expire, and biosimilar versions of these agents are available or in development. A biosimilar is a biological product that is highly similar to an approved biologic (i.e., originator or reference) product, and has no clinically meaningful differences in safety, purity, or potency when compared with the reference product. Biosimilars may offer less expensive treatment options for patients with psoriasis; they also may increase access to and address problems with underutilization of biologic therapy. Biosimilar development and approval follows a well-regulated process in many countries, with guidelines developed by the European Medicines Agency, US Food and Drug Administration, and World Health Organization. Currently, several anti-TNF biosimilars are available for use in patients with psoriasis, and other monoclonal antibodies are in development. This review provides dermatologists and those who treat and/or manage psoriasis with a working knowledge of the scientific principles of biosimilar development and approval. It also examines real-world experience with biosimilars available for or used in dermatology that will enable physicians to make informed treatment decisions for their patients with psoriasis.

Funding: Pfizer Inc.
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http://dx.doi.org/10.1007/s13555-018-0230-9DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6002312PMC
June 2018

Genetic and experimental evidence for the involvement of the CD6 lymphocyte receptor in psoriasis.

Cell Mol Immunol 2018 10 11;15(10):898-906. Epub 2017 Dec 11.

Immunoreceptores del Sistema Innat i Adaptatiu, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, 08036, Spain.

Psoriasis is a chronic inflammatory skin disease with a strong genetic background and is triggered by environmental factors. Available evidence supports CD6, a lymphocyte surface receptor mostly expressed by T cells, as a putative target in autoimmunity. Accordingly, a humanized anti-CD6 antibody has been assayed for the treatment of certain autoimmune disorders, including psoriasis. Here, we present novel evidence in mice and humans for a direct involvement of CD6 in psoriasis pathophysiology. First, an attenuated form of imiquimod-induced psoriasis-like skin inflammation was demonstrated in CD6-deficient mice, as deduced from lower epidermal thickness and local reduced production of pro-inflammatory cytokines, namely, interleukin-17A. Thus, isolated CD4CD62L T cells from CD6-deficient mice displayed decreased in vitro T-helper type 17 polarization. Second, a statistically significant association between CD6 single-nucleotide polymorphisms (rs17824933, rs11230563 and rs12360861) and more severe forms of psoriasis was demonstrated in a cohort of 304 patients at three public hospitals from the metropolitan area of Barcelona. Taken together, these results provide new supportive evidence of the contribution of the CD6 lymphocyte receptor in psoriasis at both experimental and clinical levels.
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http://dx.doi.org/10.1038/cmi.2017.119DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6207571PMC
October 2018
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