Publications by authors named "Mitsumasa Kishimoto"

92 Publications

Clinical significance of monitoring hypothyroidism in patients with autoimmune rheumatic disease: a retrospective cohort study.

Sci Rep 2021 Jul 5;11(1):13851. Epub 2021 Jul 5.

Immuno-Rheumatology Center, St. Luke's International Hospital, 9-1 Akashi-cho, Chuo-ku, Tokyo, 104-8560, Japan.

We evaluated whether thyroid function test (TFT) screening is warranted for patients with autoimmune rheumatic diseases (ARD) by comparing the incidence of hypothyroidism requiring treatment (HRT) in ARD patients and healthy controls (HCs). Medical records of 2307 ARD patients and 78,251 HCs for whom thyroid-stimulating hormone (TSH) levels were measured between 2004 and 2018 were retrospectively reviewed. Cumulative incidence of HRT in ARD patients and HCs was compared. HRT development was evaluated with age- and sex-adjusted Kaplan-Meier curve. Risk factors were identified with Cox proportional hazard models. HRT was significantly more common in ARD patients than in HCs (6.3% vs. 1.9%, P < 0.001). After adjusting for age, sex, and baseline TSH level, hazard ratios for HRT were significantly higher in overall ARD patients (hazard ratio [95% confidence interval] 3.99 [3.27-4.87]; P < 0.001), particularly with rheumatoid arthritis and antinuclear antibody-associated diseases in female, and antinuclear antibody-associated diseases, spondyloarthritis, and vasculitis in male patients. Baseline high TSH level, thyroid-related autoantibody positivity, high IgG, and renal impairment were significant risk factors for hypothyroidism development in ARD patients; 20% of high-risk patients developed HRT during follow-up. HRT was significantly more frequent in ARD patients. Careful TFT screening and follow-up could help detecting clinically important hypothyroidism.
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http://dx.doi.org/10.1038/s41598-021-93300-xDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8257694PMC
July 2021

Upadacitinib in Active Ankylosing Spondylitis: 1-Year Results From the Double-Blind, Placebo-Controlled SELECT-AXIS 1 Study and Open-Label Extension.

Arthritis Rheumatol 2021 Jul 1. Epub 2021 Jul 1.

AbbVie Inc, North Chicago, IL, United States.

Objective: To report efficacy and safety of upadacitinib through 1 year in patients with ankylosing spondylitis (AS).

Methods: In the SELECT-AXIS 1 study, adults with active AS and inadequate response to non-steroidal anti-inflammatory drugs were randomized to upadacitinib 15 mg once daily (QD) or placebo. At week 14, patients continued in the open-label extension and received upadacitinib up to week 104; reported here are interim data up to week 64.

Results: Of 187 patients, 178 completed week 14 on study drug and entered the open-label extension. Similar proportions of patients in either group (continuous upadacitinib or placebo-to-upadacitinib) achieved Assessment of SpondyloArthritis international Society (ASAS) 40 or Ankylosing Spondylitis Disease Activity Score (ASDAS) low-disease activity at week 64: ≥70% of patients achieved these endpoints based on non-responder imputation (NRI) and ≥81% based on as-observed (AO) analyses. Furthermore, ≥34% (NRI) and ≥39% (AO) of patients achieved ASDAS inactive disease or ASAS partial remission at week 64. Mean changes from baseline (week 0) to week 64 in pain, function, and inflammation showed consistent improvement or sustained maintenance through the study. Among 182 patients receiving upadacitinib (237.6 PY), 618 adverse events (260.1/100 PY) were reported. No serious infections, major adverse cardiovascular events, venous thromboembolic events, gastrointestinal perforation, or deaths were reported.

Conclusion: Upadacitinib 15 mg QD showed sustained and consistent efficacy over 1 year. Patients who switched from placebo to upadacitinib at week 14 showed similar efficacy versus those who received continuous upadacitinib.
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http://dx.doi.org/10.1002/art.41911DOI Listing
July 2021

Patient Preference for Treatment Mode of Biologics in Rheumatoid Arthritis: A 2020 Web-based Survey in Japan.

Rheumatol Ther 2021 Jun 5. Epub 2021 Jun 5.

Data Science Department, Ikuyaku. Integrated Value Development Division, Mitsubishi Tanabe Pharma Corporation, Tokyo, Japan.

Introduction: Although the proportion of patients with rheumatoid arthritis (RA) using biologic disease-modifying antirheumatic drugs (bDMARDs) has increased steadily, the relationship between patient background and preference for bDMARDs has not been fully investigated.

Methods: We conducted a web-based questionnaire survey among patients aged ≥ 20 years with RA receiving bDMARDs. Participants were recruited through an internet research company in Japan. Study endpoints included factors affecting the preferred bDMARD treatment mode, namely, in-hospital intravenous infusion (infusion), in-hospital subcutaneous injection (in-hospital injection), or self-administered subcutaneous injection (self-injection), and discrepancies between the current and preferred treatment mode.

Results: Of the 400 patients surveyed for preferred treatment mode, 15.3% preferred infusion, 18.0% preferred in-hospital injection, and 66.8% preferred self-injection. A preference for infusion (odds ratio [OR] 2.218 and 6.165) and in-hospital injection (OR 4.735 and 6.026) versus self-injection was significantly associated with higher current frequency of hospital visits and anxiety or other hurdles related to self-injection. A flexible administration setting was significantly associated with a preference for self-injection versus infusion (OR 0.401) and versus in-hospital injection (OR 0.445). Further, age (< 40 vs. ≥ 60 years) was significantly associated with a preference for self-injection versus in-hospital injection (OR 0.120). Many patients reported no discrepancy between their current and preferred treatment mode (patients receiving infusion, 68.0%; in-hospital injection, 71.2%; and self-injection, 94.0%). However, > 90% of patients responded that they would change their current mode in the future following a recommendation by a medical professional, aging, or a change in RA symptoms.

Conclusions: This web-based survey showed that patient preference for bDMARD treatment mode was significantly associated with age, frequency of hospital visits, flexible administration setting, and anxiety or other hurdles to self-injection. Changes in patient background which affect the preferred treatment mode should be considered in decision-making for RA therapy with bDMARDs.

Trial Registration: R000048089 (UMIN-CTR).
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http://dx.doi.org/10.1007/s40744-021-00325-9DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8178669PMC
June 2021

Pustular Psoriasis and Associated Musculoskeletal Disorders.

J Rheumatol Suppl 2021 Jun;97:34-38

P.S. Helliwell, MD, PhD, Professor of Clinical Rheumatology, Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Harehills Lane, Leeds, and NIHR Leeds Biomedical Research Centre, Leeds, UK.

Pustular psoriasis (PsO) is an uncommon variant of PsO that may present in a generalized or localized fashion with or without musculoskeletal or systemic inflammatory involvement.Generalized pustular PsO (GPP) presents as a widespread acute or subacute pustular eruption that may be familial and is often associated with severe flares and systemic inflammation. The palmoplantar pustulosis variant is localized to palms and soles, whereas acrodermatitis continua of Hallopeau is localized to the nail apparatus. Patients with pustular PsO may have overlapping plaque PsO and may develop psoriatic arthritis (PsA). Pustulosis is also a feature of both synovitis, acne, pustulosis, hyperostosis, osteomyelitis (SAPHO) syndrome and chronic non-bacterial osteomyelitis. At the 2020 Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) annual meeting, members were given an overview of the cutaneous features of pustular PsO, SAPHO, and recent insights into the genetics of GPP, leading to new targeted drug therapies and the development of validated endpoints.
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http://dx.doi.org/10.3899/jrheum.201673DOI Listing
June 2021

Comprehensive risk analysis of postoperative complications in patients with rheumatoid arthritis for the 2020 update of the Japan college of rheumatology clinical practice guidelines for the management of rheumatoid arthritis.

Mod Rheumatol 2021 Apr 15:1-25. Epub 2021 Apr 15.

Department of Rheumatology, Tokyo Women's Medical University School of Medicine, Tokyo, Japan.

Objectives: To examine the risk factors of surgical site infection (SSI), delayed wound healing, and death after orthopedic surgery in patients with rheumatoid arthritis (RA).

Methods: We identified articles indexed in the Cochrane Library, PubMed, and Japan Centra Revuo Medicina Web published from 2013 to 2019 and other articles. Articles fulfilling the predefined inclusion criteria were reviewed systematically and their quality was appraised according to the Grading of Recommendations Assessment, Development, and Evaluation system with some modifications.

Results: After inclusion and exclusion by full-text review, 29 articles were analyzed. Use of biological disease modifying antirheumatic drugs was a risk factor of SSI (risk ratio 1.66, 95% confidence interval 1.25 to 2.19), but not of delayed wound healing. RA itself was a risk factor of SSI, and oral glucocorticoid use was a risk factor of SSI in three of the four studies analyzed and of postoperative death. Age, male sex, comorbidities such as diabetes mellitus and chronic obstructive pulmonary disease, surgical factors such as foot/ankle and spine surgery and longer operative time were risk factors of those postoperative complications.

Conclusion: Patients with those factors should be dealt with appropriate cautions to strike a risk-benefit balance of orthopedic surgeries.
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http://dx.doi.org/10.1080/14397595.2021.1913824DOI Listing
April 2021

Patients' perspectives of rheumatoid arthritis treatment: a questionnaire survey for the 2020 update of the Japan college of rheumatology clinical practice guidelines.

Mod Rheumatol 2021 May 19:1-6. Epub 2021 May 19.

Department of Rheumatology, Tokyo Women's Medical University School of Medicine, Tokyo, Japan.

Objectives: This study aimed to evaluate patients' opinions regarding their rheumatoid arthritis (RA) therapy and to reflect the patients' perspectives in the 2020 update of the Japan College of Rheumatology clinical practice guidelines.

Methods: A self-administered questionnaire was mailed to 1600 members of the Japan Rheumatology Friendship Association, who were randomly selected by age and prefecture.

Results: A total of 1156 patients returned the questionnaire (response rate, 72.3%; mean age, 63.0 ± 11.9 years). Those who reported having discussed their treatment goals with their doctors (450 respondents, 38.9%) were more likely to be satisfied with their current medical care (odds ratio, 7.13; 95% CI 4.72-10.8) compared with those who had not discussed their goals nor had them explained (287 respondents, 24.8%). The benefits exceeded the adverse effects for all pharmacotherapy (methotrexate, corticosteroids, conventional synthetic antirheumatic drugs, biological agents, Janus kinase inhibitor, and anti-RANKL antibodies). However, while 74.2% of the respondents using biological agents perceived that 'the favorable aspects outweighed the unfavorable aspects,' most of those taking anti-RANKL antibodies (69.2%) felt uncertain.

Conclusions: The questionnaire successfully collected information regarding patients' perceptions regarding their therapy. Further implementation of treat-to-target is necessary in Japan to improve patient satisfaction.
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http://dx.doi.org/10.1080/14397595.2021.1913276DOI Listing
May 2021

Systematic review for the treatment of older rheumatoid arthritis patients informing the 2020 update of the Japan College of Rheumatology clinical practice guidelines for the management of rheumatoid arthritis.

Mod Rheumatol 2021 May 19:1-15. Epub 2021 May 19.

Department of Rheumatology, Tokyo Women's Medical University School of Medicine, Tokyo, Japan.

Objectives: To provide an evidence base for clinical practice guidelines (CPG) for the management of rheumatoid arthritis (RA) in older adults.

Methods: PubMed, Cochrane library, and Japan Centra Revuo Medicina databases were searched for articles published between 1990 and 2019. Quality of the evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation system, with some modifications.

Results: Among 702 identified articles, there were 5 post-hoc analyses of randomized controlled trials and 10 observational studies. Meta-analysis of the former yielded a mean difference of the van der Heijde-modified total Sharp score of -2.79 (95% confidence interval [CI] - 3.74 to -1.84) for treatment with tumor necrosis factor inhibitors. The risk ratio (RR) for the American College of Rheumatology 50% response rate, and for serious adverse events was 2.83 (95%CI 1.90-4.21) and 1.32 (95%CI 0.53-3.31), respectively, for Janus kinase inhibitors. Meta-analysis of the observational studies yielded an RR for disease activity score-28 remission and serious infections of 0.76 (95%CI 0.64-0.91) and 1.92 (95%CI 1.31-2.81) for older-versus-younger patients receiving biological disease-modifying antirheumatic drugs, respectively.

Conclusion: This systematic review provides the necessary evidence for developing CPG for the management of RA in older adults.
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http://dx.doi.org/10.1080/14397595.2021.1912922DOI Listing
May 2021

Performance of a pre-administration infection screening questionnaire in patients with rheumatoid arthritis administered biological disease-modifying antirheumatic drugs.

Int J Rheum Dis 2021 May 13;24(5):647-653. Epub 2021 Apr 13.

Immuno-Rheumatology Center, St. Luke's International Hospital, Tokyo, Japan.

Aim: Pre-administration screening of active infections is imperative for the safe use of biological disease-modifying antirheumatic drugs (bDMARDs) in patients with rheumatoid arthritis (RA). However, a standardized screening method is lacking. We therefore implemented a novel systematic screening method with a simple predetermined questionnaire on infections and assessed its effectiveness.

Methods: We retrospectively reviewed medical records of individuals for whom intravenous bDMARDs were administered for RA from January 2016 to April 2019. We evaluated the performance of the new screening method based on physicians' assessments. In addition, a survey was administered to nurses, regarding their assessment of the usefulness of this new screening. The incidence of infections was also assessed.

Results: A total of 1636 cases underwent this new screening. The new screening method showed high sensitivity (0.97) and specificity (0.89) with a negative predictive value of 99.9%, as determined based on the physician's decision. Administration of bDMARDs was postponed in 37 (2.5%) patients, and there was only one case in which the screening failed to note an active infection. The nurses' survey demonstrated high agreement (87.5%) about the usefulness of this screening on the grounds of clarity, simplicity, ease, and time-saving effects. There was no significant increase in infections after implementation of this method.

Conclusions: Systematic screening with a predetermined simple questionnaire is effective as an infection screening method, with a high negative predictive value. This approach contributes to high satisfaction of nurses and a time-efficient practice by focusing on screen-positive cases without increasing infections.
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http://dx.doi.org/10.1111/1756-185X.14108DOI Listing
May 2021

Efficacy and safety of brodalumab, an anti-IL17RA monoclonal antibody, in patients with axial spondyloarthritis: 16-week results from a randomised, placebo-controlled, phase 3 trial.

Ann Rheum Dis 2021 Apr 7. Epub 2021 Apr 7.

Department of Internal Medicine and Rheumatology, Juntendo University Koshigaya Hospital, Saitama, Japan

Objective: To investigate the efficacy and safety of brodalumab, a fully human anti-interleukin-17 receptor A monoclonal antibody, in patients with axial spondyloarthritis (axSpA).

Methods: In a multicentre, placebo-controlled phase 3 study (NCT02985983) conducted at 48 sites across Japan, Korea and Taiwan, patients with axSpA were randomised 1:1 to receive subcutaneous brodalumab 210 mg (n=80) or placebo (n=79) at baseline, weeks 1 and 2 and every 2 weeks thereafter, during the 16-week double-blind period. The primary endpoint was the proportion of patients with Assessment of SpondyloArthritis International Society (ASAS) 40 response at week 16. Secondary endpoints included the proportion of patients with ASAS 20 response and change in Ankylosing Spondylitis Disease Activity Score using C-reactive protein (ASDAS-CRP) at week 16 and safety.

Results: ASAS 40 response rate (n/N; 95% CI) was 43.8% (35/80; 32.7, 55.3) with brodalumab vs 24.1% (19/79; 15.1, 35.0) with placebo (rate difference, 19.7% (5.3, 34.1); p=0.018 by stratified Cochran-Mantel-Haenszel test). ASAS 20 response rate (n/N; 95% CI) was 67.5% (54/80; 56.1, 77.6) vs 41.8% (33/79; 30.8, 53.4) and least squares mean change (95% CI) from baseline (brodalumab, 2.660; placebo, 2.716) in ASDAS-CRP was -1.127 (-1.322, -0.931) with brodalumab vs -0.672 (-0.872, -0.473) with placebo at week 16. Treatment-emergent adverse events were reported in 44 (55%) and 45 (57%) patients in the brodalumab and placebo groups, respectively.

Conclusion: Brodalumab demonstrated a significant improvement at week 16 in patients with active axSpA. Safety of brodalumab was consistent with that reported in previous global/Japanese psoriasis studies.
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http://dx.doi.org/10.1136/annrheumdis-2020-219406DOI Listing
April 2021

Trial of Upadacitinib and Adalimumab for Psoriatic Arthritis.

N Engl J Med 2021 04;384(13):1227-1239

From the College of Medical Veterinary and Life Sciences, University of Glasgow, Glasgow, United Kingdom (I.B.M.); AbbVie, North Chicago, IL (J.K.A., X.W., L.C., P.Z., J.L., A.L.P.); Case Western Reserve University School of Medicine at MetroHealth Medical Center, Cleveland (M.M.); Brigham and Women's Hospital and Harvard Medical School, Boston (J.F.M.); the Department of Rheumatology, West China Hospital, Sichuan University, Chengdu, China (Y.L.); the Department of Nephrology and Rheumatology, Kyorin University School of Medicine, Tokyo (M.K.); the Department of Rheumatology and Connective Tissue Diseases, Collegium Medicum Uniwersytet Mikołaja Kopernika, 2nd University Hospital, Bydgoszcz, Poland (S.J.); Facultad de Medicina, Universidad Autonoma de Chihuahua, Chihuahua, Mexico (C.P.-T.); and Goethe University and Fraunhofer Institute for Molecular Biology and Applied Ecology-Branch for Translational Medicine and Pharmacology and Cluster of Excellence for Immune-Mediated Diseases, Frankfurt, Germany (F.B.).

Background: The Janus kinase inhibitor upadacitinib is a potential treatment for psoriatic arthritis. The efficacy and safety of upadacitinib as compared with adalimumab, a tumor necrosis factor α inhibitor, in patients who have an inadequate response to nonbiologic disease-modifying antirheumatic drugs are unclear.

Methods: In a 24-week, phase 3 trial, we randomly assigned patients in a 1:1:1:1 ratio to receive oral upadacitinib at a dose of 15 mg or 30 mg once daily, placebo, or subcutaneous adalimumab (40 mg every other week). The primary end point was an American College of Rheumatology 20 (ACR20) response (≥20% decrease in the number of tender and swollen joints and ≥20% improvement in at least three of five other domains) at week 12 with upadacitinib as compared with placebo. Secondary end points included comparisons of upadacitinib with adalimumab.

Results: A total of 1704 patients received an active drug or placebo. The percentage of patients who had an ACR20 response at week 12 was 70.6% with 15-mg upadacitinib, 78.5% with 30-mg upadacitinib, 36.2% with placebo (P<0.001 for both upadacitinib doses vs. placebo), and 65.0% with adalimumab. The difference between groups for 15-mg upadacitinib as compared with adalimumab was 5.6 percentage points (95% confidence interval [CI], -0.6 to 11.8) and for 30-mg upadacitinib as compared with adalimumab was 13.5 percentage points (95% CI, 7.5 to 19.4). Both upadacitinib doses were noninferior to adalimumab for the ACR20 response at week 12; the 30-mg dose but not the 15-mg dose was superior to adalimumab. The incidence of adverse events through week 24 was 66.9% with 15-mg upadacitinib, 72.3% with 30-mg upadacitinib, 59.6% with placebo, and 64.8% with adalimumab. There were serious infections in 1.2%, 2.6%, 0.9%, and 0.7% of the patients, respectively. Hepatic disorders occurred in 9.1% of patients in the 15-mg upadacitinib group and 12.3% in the 30-mg upadacitinib group, but grade 3 increases in aminotransferase levels occurred in 2% of patients or fewer in all groups.

Conclusions: The percentage of patients with psoriatic arthritis who had an ACR20 response at week 12 was significantly higher with 15-mg or 30-mg upadacitinib than with placebo. The 30-mg dose but not the 15-mg dose was superior to adalimumab. Adverse events were more frequent with upadacitinib than with placebo. (Funded by AbbVie; SELECT-PsA 1 ClinicalTrials.gov number, NCT03104400.).
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http://dx.doi.org/10.1056/NEJMoa2022516DOI Listing
April 2021

Clinical features of psoriatic arthritis.

Best Pract Res Clin Rheumatol 2021 Jun 17;35(2):101670. Epub 2021 Mar 17.

Department of Nephrology and Rheumatology, Kyorin University School of Medicine, Tokyo, Japan.

Psoriatic arthritis (PsA) is associated with decreased quality of life. As delayed diagnosis may lead to progressive joint destruction and long-term disability, the key clinical features of PsA should be recognizable to a wide range of clinicians to facilitate early diagnosis. In addition to assessment and identification of skin and nail lesions, which occur in up to 85% of those with musculoskeletal manifestations, clinicians should be aware of both the peripheral and axial manifestations of musculoskeletal disease reviewed here. Peripheral joint diseases include polyarticular, oligoarticular, distal, and arthritis mutilans subtypes, and cognizance of these patterns of disease, as well as periarticular manifestations, including dactylitis and enthesitis, is useful for swift diagnosis of PsA. Axial psoriatic arthritis (axial PsA), also known as the spondylitis subtype, may be limited to the spine and sacroiliac joints, but may also affect peripheral structures. Meticulous history-taking and physical examination and familiarity with appropriate imaging studies are often necessary to distinguish axial-PsA from other differential diagnoses. Swift diagnosis and treatment are necessary to both control PsA disease and mitigate the risks of the many associate comorbidities that may accompany it.
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http://dx.doi.org/10.1016/j.berh.2021.101670DOI Listing
June 2021

Effectiveness and safety of Mizoribine for the treatment of IgG4-related Disease: A Retrospective Cohort Study.

Rheumatology (Oxford) 2021 Mar 16. Epub 2021 Mar 16.

Immuno-Rheumatology Center, St. Luke's International Hospital, Tokyo, Japan.

Objective: Patients with IgG4-Related Disease (IgG4RD) usually require steroid-sparing agents due to relapse with tapering glucocorticoids (GC). The aim of this study was to determine the efficacy and safety of Mizoribine (MZR) among IgG4RD, which inhibits inosine monophosphate dehydrogenase, a rate-limiting enzyme in the de novo pathway of purine synthesis.

Methods: We retrospectively reviewed records of IgG4RD patients at the Immuno-Rheumatology Center in St. Luke's International Hospital, Tokyo, Japan. Patients were classified into the MZR combination group, and those treated with GCs alone or with other immunosuppressants were included in the control group. Disease exacerbation, GC dose, IgG-IgG4 titre, and adverse events were evaluated using univariate analyses, including the Kaplan-Meier method. The Cox proportional hazard model was used to evaluate risk factors for exacerbation.

Results: A total of 14 and 29 cases were included in the MZR combination and control groups, respectively. Multiple organ involvement (≥3 organs) was significantly more frequent in the MZR combination treatment group (10 [71.4%] vs 9 [31.0%], p= 0.021). Kaplan-Meier analysis revealed a significant reduction in exacerbation in patients with multiple organ involvement (p< 0.001), but not in total (p= 0.42). The adjusted hazard ratios of MZR use and multiple organ involvement for exacerbation were 0.34[0.12-1.01] (p= 0.052), and 3.51[1.29-9.51] (p= 0.014). The cumulative GC dose tended to be lower in the MZR combination group (1448[1003, 1642] vs 2179[1264, 3425]; p= 0.09).

Conclusion: MZR showed a significant steroid-sparing effect and decrease in exacerbation among IgG4RD patients with multi-organ involvement. MZR could be a treatment option for IgG4RD.
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http://dx.doi.org/10.1093/rheumatology/keab235DOI Listing
March 2021

Pustular Psoriasis and Associated Musculoskeletal Disorders.

J Rheumatol 2021 Mar 15. Epub 2021 Mar 15.

As part of the supplement series GRAPPA 2020, this report was reviewed internally and approved by the Guest Editors for integrity, accuracy, and consistency with scientific and ethical standards. K. Callis Duffin, MD, MS, Department of Dermatology, University of Utah, Salt Lake City, Utah, USA; H. Bachelez, MD, PhD, Department of Dermatology, Hôpital Saint-Louis, AP-HP, and Laboratory of Genetic Skin Diseases, Imagine Institute, Université de Paris, Paris, France; P.J. Mease, MD, Rheumatology Research, Swedish Medical Center/ Providence St. Joseph Health and University of Washington School of Medicine, Seattle, Washington, USA; C. Rosen, Division of Dermatology, Toronto Western Hospital, University of Toronto, Toronto, Ontario, Canada; A. Garg, MD, Chair, Department of Dermatology, Zucker School of Medicine at Hofstra/Northwell, Hempstead, New York, USA; E. Zudak, BFA, Vice President, Strategic Partnerships, WCG Trifecta, Indianapolis, Indiana, USA; O. Elkayam, MD, V. Furer, MD, Rheumatology Department, Tel Aviv Medical Center, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel; J.F. Merola, MD, MMSc, Harvard Medical School, Brigham and Women's Hospital, Department of Dermatology and Department of Medicine, Division of Rheumatology and Immunology, Boston, Massachusetts, USA; J. Chau, GRAPPA Patient Research Partner, Hong Kong; M. Kishimoto, MD, Department of Nephrology and Rheumatology, Kyorin University School of Medicine, Tokyo, Japan; P.S. Helliwell, MD, PhD, Professor of Clinical Rheumatology, Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Harehills Lane, Leeds, and NIHR Leeds Biomedical Research Centre, Leeds, UK. KCD received grants/is an investigator for Amgen, AbbVie, Celgene, Eli Lilly, Janssen, Bristol Myers Squibb, Stiefel, Novartis, Pfizer, Sienna, UCB, Regeneron, Boehringer Ingelheim; is on the speakers bureau for Novartis (nonpromotional only); and is a consultant/on the advisory board for Amgen, AbbVie, Celgene, Eli Lilly, Janssen, Bristol Myers Squibb, Stiefel, Novartis, Pfizer, Sienna, UCB, Ortho Dermatologic, and Boehringer Ingelheim. PJM received research grants, consultation fees, and/or speaker honoraria from AbbVie, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, Galapagos, Gilead, GlaxoSmithKline, Janssen, Novartis, Pfizer, SUN Pharma, and UCB. AG received grants/is an investigator for the National Psoriasis Foundation, UCB, Incyte; and is a consultant/on the advisory board for AbbVie, Amgen, Asana Biosciences, Bristol Myers Squibb, Boehringer Ingelheim, Incyte, Janssen, Pfizer, UCB, and Viela Biosciences. JFM is consultant and/or investigator for Merck, Bristol Myers Squibb, AbbVie, Dermavant, Eli Lilly, Novartis, Janssen, UCB, Sanofi, Regeneron, Arena, Sun Pharma, Biogen, Pfizer, EMD Sorono, Avotres, and Leo Pharma. MK receives consulting fees and/or honoraria from AbbVie, Amgen-Astellas BioPharma, Asahi-Kasei Pharma, Astellas, Ayumi Pharma, BMS, Celgene, Chugai, Daiichi-Sankyo, Eisai, Eli Lilly, Gilead, Janssen, Kyowa Kirin, Novartis, Ono Pharma, Pfizer, Tanabe-Mitsubishi, Teijin Pharma, and UCB Pharma. OE receives consulting fees or honoraria from AbbVie, Eli Lilly, Gilead, Janssen, Novartis, Roche, Pfizer, Boehringer Ingelheim, and Novartis. This paper does not require institutional review board approval. Address correspondence to Dr. K. Callis Duffin, University of Utah, 4A330 Dermatology, SOM, 30 North 1900 East, Salt Lake City, UT 84132, USA. Email:

Pustular psoriasis (PsO) is an uncommon variant of PsO that may present in a generalized or localized fashion with or without musculoskeletal or systemic inflammatory involvement. Generalized pustular PsO (GPP) presents as a widespread acute or subacute pustular eruption that may be familial and is often associated with severe flares and systemic inflammation. The palmoplantar pustulosis variant is localized to palms and soles, whereas acrodermatitis continua of Hallopeau is localized to the nail apparatus. Patients with pustular PsO may have overlapping plaque PsO and may develop psoriatic arthritis (PsA). Pustulosis is also a feature of both synovitis, acne, pustulosis, hyperostosis, osteomyelitis (SAPHO) syndrome and chronic nonbacterial osteomyelitis. At the 2020 Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) annual meeting, members were given an overview of the cutaneous features of pustular PsO, SAPHO, and recent insights into the genetics of GPP, leading to new targeted drug therapies and the development of validated endpoints.
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http://dx.doi.org/10.3899/jrheum.201673DOI Listing
March 2021

Systematic review and meta-analysis of biosimilar for the treatment of rheumatoid arthritis informing the 2020 update of the Japan College of Rheumatology clinical practice guidelines for the management of rheumatoid arthritis.

Mod Rheumatol 2021 Apr 6:1-13. Epub 2021 Apr 6.

Department of Rheumatology, Tokyo Women's Medical University School of Medicine, Tokyo, Japan.

Objectives: To evaluate the efficacy and safety of biosimilars compared with reference biological disease modifying antirheumatic drugs (bDMARDs) in patients with rheumatoid arthritis (RA) as a part of the process of developing the 2020 update of the Japan College of Rheumatology guidelines for the management of RA.

Methods: PubMed, Cochrane Library, and Japan Centra Revuo Medicina were searched for articles to conduct a systematic review (SR). The quality of evidence was assessed using the Grading of Recommendations Assessment, Development, and Evaluation system.

Results: Twenty randomized controlled trials were included (biosimilars of infliximab, etanercept, and adalimumab). A meta-analysis revealed that the risk ratios (RRs) and 95% confidence intervals (CIs) of achieving the American College of Rheumatology 50% response (ACR50) at week 24 and serious adverse events (SAEs) for biosimilars compared with the reference bDMARDs were 1.04 (0.98-1.10) and 0.84 (0.61-1.18), respectively. The RRs of achieving ACR50 and SAEs at week 24 were respectively 0.93 (0.69-1.26) and 2.15 (0.55-8.35) in the patients who switched to biosimilars from the reference bDMARDs and 0.92 (0.76-1.12) and 1.41 (0.32-6.15) in those who continued the reference bDMARDs.

Conclusion: Biosimilars and reference bDMARDs were equally useful for the management of RA.
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http://dx.doi.org/10.1080/14397595.2021.1899591DOI Listing
April 2021

Patient satisfaction with total joint replacement surgery for rheumatoid arthritis: a questionnaire survey for the 2020 update of the Japan college of rheumatology clinical practice guidelines.

Mod Rheumatol 2021 Mar 16:1-6. Epub 2021 Mar 16.

Department of Rheumatology, Tokyo Women's Medical University School of Medicine, Tokyo, Japan.

Objective: This study aimed to evaluate satisfaction with total joint replacement (TJR) surgery among patients with rheumatoid arthritis (RA).

Methods: We mailed questionnaires to randomly selected members of the Japan Rheumatism Friendship Association, stratified by age and prefecture, throughout Japan. The questionnaire collected demographic and clinical characteristics as well as patients' satisfaction with TJR and their current therapy.

Results: Of the 1156 patients who returned the questionnaire, 339 (29.3%) responded that they had had TJR of any type. The mean age was 66.6 years, and 94.4% were women. The mean time period from the hip and knee TJR was 14-15 years. Over half of the patients who had had TJR were satisfied with the results, especially those who had had hip (89.6%) and knee TJR (87.3%), who reported a high level of satisfaction. Multivariable linear regression analysis revealed that, in patients with knee TJR, satisfaction with current therapy was significantly related to whether they were satisfied with the results of the surgery.

Conclusion: Most patients with RA who had undergone TJR were satisfied with the results even after a long period of time, and their level of satisfaction was associated with their satisfaction with current therapy.
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http://dx.doi.org/10.1080/14397595.2021.1892258DOI Listing
March 2021

Does exercise therapy improve patient-reported outcomes in rheumatoid arthritis? A systematic review and meta-analysis for the update of the 2020 JCR guidelines for the management of rheumatoid arthritis.

Mod Rheumatol 2021 Feb 22:1-14. Epub 2021 Feb 22.

Department of Rheumatology, Tokyo Women's Medical University School of Medicine, Tokyo, Japan.

Objectives: This study aimed to evaluate the impact of exercise therapy on patient-reported outcomes (PROs) in rheumatoid arthritis (RA) as part of the process of updating the 2020 Japanese guidelines for the management of RA according to the Grading of Recommendations, Assessment, Development, and Evaluation system.

Methods: We searched PubMed, Japana Centra Revuo Medicina Web, and the Cochrane Library (from 2009 to 2018) to identify articles that evaluated PROs of exercise therapy and RA disease activity.

Results: A total of 662 articles were identified, including nine RCTs, and meta-analyses were performed on six RCTs on systemic exercise therapy and three RCTs on upper extremity exercise therapy. Analyzed exercise therapies were diverse, differing in target population, intervention method, and duration. Significant improvements were observed in the Health Assessment Questionnaire Disability Index (mean difference -0.35, 95% confidence interval (CI): -0.60 to -0.10), pain (standardized mean difference -2.04, 95% CI: -3.77 to -0.32), and SF-36. For upper extremity exercise therapy, significant improvements in PROs (Disabilities of the Arm, Shoulder, and Hand Questionnaire, Michigan Hand Outcome Questionnaire) were observed.

Conclusion: Exercise therapy in RA treatment improves patient subjective assessment of pain, physical function, and quality of life.
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http://dx.doi.org/10.1080/14397595.2021.1886653DOI Listing
February 2021

Prevalence and distribution of peripheral musculoskeletal manifestations in spondyloarthritis including psoriatic arthritis: results of the worldwide, cross-sectional ASAS-PerSpA study.

RMD Open 2021 01;7(1)

Rheumatology Department, Cochin Hospital, Assistance Publique Hôpitaux de Paris, Paris, France.

Objectives: To characterise peripheral musculoskeletal involvement in patients with spondyloarthritis (SpA) including psoriatic arthritis (PsA), across the world.

Methods: Cross-sectional study with 24 participating countries. Patients with a diagnosis of axial SpA (axSpA), peripheral SpA (pSpA) or PsA according to their rheumatologist were included. The investigators were asked which diagnosis out of a list of six (axSpA, PsA, pSpA, inflammatory bowel disease-associated SpA, reactive arthritis or juvenile SpA (Juv-SpA)) fitted the patient best. Peripheral manifestations (ie, peripheral joint disease, enthesitis, dactylitis and root joint disease), their localisation and treatments were evaluated.

Results: A total of 4465 patients were included (61% men, mean age 44.5 years) from four geographic areas: Latin America (n=538), Europe plus North America (n=1677), Asia (n=975) and the Middle East plus North Africa (n=1275). Of those, 78% had ever suffered from at least one peripheral musculoskeletal manifestation; 57% had peripheral joint disease, 44% had enthesitis and 15% had dactylitis. Latin American had far more often peripheral joint disease (80%) than patients from other areas. Patients with PsA had predominantly upper limb and small joint involvement (52%).Hip and shoulder involvement was found in 34% of patients. The prevalence of enthesitis ranged between 41% in patients with axSpA and 65% in patients with Juv-SpA. Dactylitis was most frequent among patients with PsA (37%).

Conclusion: These results suggest that all peripheral features can be found in all subtypes of SpA, and that differences are quantitative rather than qualitative. In a high proportion of patients, axial and peripheral manifestations coincided. These findings reconfirm SpA clinical subtypes are descendants of the same underlying disease, called SpA.
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http://dx.doi.org/10.1136/rmdopen-2020-001450DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7816910PMC
January 2021

The Diagnosis and Treatment of Adult Patients with SAPHO Syndrome: Controversies Revealed in a Multidisciplinary International Survey of Physicians.

Rheumatol Ther 2020 Dec 24;7(4):883-891. Epub 2020 Sep 24.

Department of Rheumatology, Tel Aviv Sourasky Medical Center, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.

Introduction: This study aimed to investigate the current practice in the diagnosis and treatment of SAPHO syndrome among the international rheumatology and dermatology communities.

Methods: We conducted an electronic survey among the members of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA), the Japan Spondyloarthritis, and Israeli Societies of Rheumatology.

Results: A total of 78 physicians participated in the survey: rheumatologists (83%, n = 65), dermatologists (11.5%, n = 9), and orthopedics (3.8%, n = 3). SAPHO was considered a subtype of spondyloarthritis by 48.7% (n = 38), a subtype of psoriatic arthritis by 19.2% (n = 15), a separate entity by 25.6% (n = 20), and a subtype of reactive arthritis by 6.4% (n = 5). Palmoplantar pustulosis was the most prevalent cutaneous manifestation (n = 44, 56.4%) and anterior chest pain-the most prevalent osteoarticular manifestation (n = 66, 84.6%). The majority (84.6%, n = 66) voted for the update of the present diagnostic criteria by Khan 1994. Magnetic resonance imaging was considered the preferred imaging modality for the diagnosis of SAPHO by 41% (n = 32). Conduction of bone biopsy for diagnosis of non-infectious osteitis was supported only by 10.3% (n = 8). Patient-reported outcomes were considered the most appropriate measure for the assessment of disease activity by 47.4% (n = 37). The treatment approach was overall similar among the rheumatology and dermatology communities, including non-steroidal anti-inflammatory drugs, bisphosphonates, conventional disease-modifying anti-inflammatory drugs, and biologics.

Conclusions: Our study underlines the controversy on diagnosis and treatment of SAPHO syndrome among specialists in rheumatology and dermatology and emphasizes an unmet need for update and validation of diagnostic criteria and treatment approach.
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http://dx.doi.org/10.1007/s40744-020-00235-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7695776PMC
December 2020

Reactive arthritis after COVID-19 infection.

RMD Open 2020 08;6(2)

Department of Nephrology and Rheumatology, Kyorin University School of Medicine, Shinkawa, Mitaka-shi, Tokyo, Japan.

Reactive arthritis (ReA) is typically preceded by sexually transmitted disease or gastrointestinal infection. An association has also been reported with bacterial and viral respiratory infections. Herein, we report the first case of ReA after the he severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. This male patient is in his 50s who was admitted with COVID-19 pneumonia. On the second day of admission, SARS-CoV-2 PCR was positive from nasopharyngeal swab specimen. Despite starting standard dose of favipiravir, his respiratory condition deteriorated during hospitalisation. On the fourth hospital day, he developed acute respiratory distress syndrome and was intubated. On day 11, he was successfully extubated, subsequently completing a 14-day course of favipiravir. On day 21, 1 day after starting physical therapy, he developed acute bilateral arthritis in his ankles, with mild enthesitis in his right Achilles tendon, without rash, conjunctivitis, or preceding diarrhoea or urethritis. Arthrocentesis of his left ankle revealed mild inflammatory fluid without monosodium urate or calcium pyrophosphate crystals. Culture of synovial fluid was negative. Plain X-rays of his ankles and feet showed no erosive changes or enthesophytes. Tests for syphilis, HIV, anti-streptolysin O (ASO), , antinuclear antibody, rheumatoid factor, anticyclic citrullinated peptide antibody and Human Leukocyte Antigen-B27 (HLA-B27) were negative. Gonococcal and urine PCR were also negative. He was diagnosed with ReA. Nonsteroidal Anti-Inflammatory Drug (NSAID)s and intra-articular corticosteroid injection resulted in moderate improvement.
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http://dx.doi.org/10.1136/rmdopen-2020-001350DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7722270PMC
August 2020

Elevating the role of carers in rheumatoid arthritis management in the Asia-Pacific region.

Int J Rheum Dis 2020 Jul 1;23(7):898-910. Epub 2020 Jul 1.

Johnson & Johnson Pte Ltd, Singapore, Singapore.

Aim: Carers may offer valuable insight into the true health status of patients with rheumatoid arthritis (RA). This multinational, multi-stakeholder, exploratory study in Australia, China and Japan aimed to enrich our understanding of the role and potential impact of carers on RA management.

Method: This study used a 2-phase sequential mixed methods approach involving 3 key stakeholder groups: rheumatologists, RA patients and carers. The first phase involved an in-depth qualitative exploratory survey (n = 30), which informed the development of the subsequent quantitative validation survey (n = 908). In both phases, patients and carers provided self-assessments of disease and support parameters.

Results: In the qualitative phase, patients usually understated the amount of physical support required, compared to carers. Rheumatologists underestimated the amount of physical and emotional care required, compared to carers and patients; however, in the quantitative phase, rheumatologists overestimated the level of support provided by carers. Levels of support provided by carers increased as disease severity increased. Active participation of carers in clinical consultations and treatment decision-making was deemed important by 55% of all patients and 82% of all carers. All stakeholders believed carers' insights into the physical and emotional conditions of patients were useful and should be considered in clinical decision-making. Over 95% of rheumatologists reported soliciting input from the carer.

Conclusion: Carers provide valuable input that can give clinicians greater insight into the patients' physical and emotional states, and treatment adherence. Development of standardized carer-reported outcomes that correlate with patient-reported outcomes and clinical parameters will ensure clinical meaningfulness and external validity.
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http://dx.doi.org/10.1111/1756-185X.13893DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7496573PMC
July 2020

Validation of the 2019 ACR/EULAR classification criteria of systemic lupus erythematosus in 100 Japanese patients: a real-world setting analysis.

Clin Rheumatol 2020 Jun 12;39(6):1823-1827. Epub 2020 Feb 12.

Immuno-Rheumatology Centre, St. Luke's International Hospital, St. Luke's International University, 9-1 Akashi-cho Chuo-ku, Tokyo, 104-8560, Japan.

The objective of the study is to evaluate the sensitivity of the new criteria for the classification of systemic lupus erythematosus (SLE), when applied to real SLE cases. We retrospectively reviewed the electronic medical records of 100 consecutive patients who visited St. Luke's International Hospital. Patients were included if they were clinically diagnosed as having SLE and excluded if they had other autoimmune disease or if they were less than 18 years old. Each patient was evaluated if they satisfied the American College of Rheumatology (ACR) 1997 classification criteria (1997 criteria), 2012 Systemic Lupus International Collaborating Clinics criteria (2012 criteria), or 2019 ACR/European League Against Rheumatism (EULAR) criteria. Among the 100 patients, the sensitivity of the 1997, 2012, and 2019 criteria was, 97, 99, and 92%, respectively. The total patient score with the 2019 criteria ranged from 12 to 44 (mean, 27.3). All patients who were classified as non-SLE with the 2019 criteria had an anti-nuclear antibody (ANA) titre of < 1:80. The 2019 criteria for SLE accomplished modestly high sensitivity in the real-world practice, but not as high as the 1997 and 2012 criteria. They possibly misclassify the real SLE cases as non-SLE, especially if patients have a low titre (< 1:80) of ANA.
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http://dx.doi.org/10.1007/s10067-019-04848-zDOI Listing
June 2020

Efficacy and safety of tacrolimus in patients with rheumatoid arthritis - A systematic review and meta-analysis.

Mod Rheumatol 2021 Jan 30;31(1):61-69. Epub 2020 Jan 30.

Institute of Rheumatology, Tokyo Women's Medical University, Tokyo, Japan.

Objectives: To evaluate the efficacy and safety of tacrolimus in adult patients with rheumatoid arthritis (RA) by using the GRADE approach.

Methods: We searched PubMed, Japana Centra Revuo Medicina Web (Ichu-shi web), and the Cochrane Database of Systematic Reviews. Articles fulfilling the predefined inclusion criteria were appraised and used for meta-analysis. The primary outcomes were American College of Rheumatology 20 (ACR20) and serum creatinine elevation. Other outcomes included ACR50, ACR70, changes in C-reactive protein, modified Health Assessment Questionnaire Disability Index, gastrointestinal disorders, metabolic and nutritional disorders, and infections and infestations.

Results: We identified five randomized controlled studies, four of which compared tacrolimus to placebo and were included in the meta-analysis. The risk ratio of ACR20 achievement was 1.71 (95% confidence interval [CI] 1.20-2.42) for 1-2 mg/day and 2.30 (95% CI 1.79-2.96) for 3 mg/day. The risk ratio of creatinine elevation was 1.95 (95% CI 1.18-3.23) for 1-2 mg/day and 3.81 (95% CI 2.43-5.99) for 3 mg/day.

Conclusion: Tacrolimus is effective with acceptable safety in the management of RA.
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http://dx.doi.org/10.1080/14397595.2020.1719607DOI Listing
January 2021

Efficacy and safety of upadacitinib in patients with active ankylosing spondylitis (SELECT-AXIS 1): a multicentre, randomised, double-blind, placebo-controlled, phase 2/3 trial.

Lancet 2019 12 12;394(10214):2108-2117. Epub 2019 Nov 12.

Department of Gastroenterology, Infectious Diseases, and Rheumatology, Charité Universitätsmedizin Berlin, Berlin, Germany.

Background: The JAK pathway is a potential therapeutic target in ankylosing spondylitis. This study assessed the efficacy and safety of upadacitinib, a selective JAK1 inhibitor, in patients with ankylosing spondylitis.

Methods: This multicentre, randomised, double-blind, placebo-controlled, two-period, parallel-group, phase 2/3 study, SELECT-AXIS 1, enrolled adults in 62 sites in 20 countries. Eligible patients had active ankylosing spondylitis, fulfilled modified New York criteria, were previously untreated with biological disease-modifying antirheumatic drugs, and had inadequate response to at least two or intolerance or contraindication to non-steroidal anti-inflammatory drugs. Patients were randomly assigned 1:1 using interactive response technology to take oral upadacitinib 15 mg once daily or oral placebo for the 14-week period 1; only period 1 data are reported here. The primary endpoint was the composite outcome measure of the Assessment of SpondyloArthritis international Society 40 response at week 14. Analyses were done in the full analysis set of patients who were randomly assigned and received at least one dose of study drug. This study is registered with ClinicalTrials.gov, NCT03178487.

Findings: Between Nov 30, 2017, and Oct 15, 2018, 187 patients were randomly assigned to upadacitinib 15 mg (93 patients) or to placebo (94 patients), and 178 (95%) patients (89 in the upadacitinib group and 89 in the placebo group) completed period 1 on study drug (by the completion date of Jan 21, 2019). Significantly more patients had an Assessment of SpondyloArthritis international Society 40 response in the upadacitinib group versus in the placebo group at week 14 (48 [52%] of 93 patients vs 24 [26%] of 94 patients; p=0·0003; treatment difference 26% [95% CI 13-40]). Adverse events were reported in 58 (62%) of 93 patients in the upadacitinib group versus 52 (55%) of 94 in the placebo group. The most common adverse event in the upadacitinib group was increased creatine phosphokinase (eight [9%] of 93 patients in the upadacitinib group vs two [2%] of 94 patients with placebo). No serious infections, herpes zoster, malignancy, venous thromboembolic events, or deaths were reported; one serious adverse event was reported in each group.

Interpretation: Upadacitinib 15 mg was efficacious and well tolerated in patients with active ankylosing spondylitis who had an inadequate response or contraindication to non-steroidal anti-inflammatory drugs. These data support the further investigation of upadacitinib for the treatment of axial spondyloarthritis.

Funding: AbbVie.
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http://dx.doi.org/10.1016/S0140-6736(19)32534-6DOI Listing
December 2019

2018 APLAR axial spondyloarthritis treatment recommendations.

Int J Rheum Dis 2019 Mar 28;22(3):340-356. Epub 2019 Feb 28.

Division of Rheumatology and Clinical Immunology, Department of Medicine, The University of Hong Kong, Pokfulam, Hong Kong.

Introduction: Despite the availability of axial spondyloarthritis (SpA) recommendations proposed by various rheumatology societies, we considered that a region-specific guideline was of substantial added value to clinicians of the Asia-Pacific region, given the wide variations in predisposition to infections and other patient factors, local practice patterns, and access to treatment across countries.

Materials And Methods: Systematic reviews were undertaken of English-language articles published between 2000 and 2016, identified from MEDLINE using PubMed, EMBASE and Cochrane databases. The strength of available evidence was graded using the Grading of Recommendations, Assessment, Development and Evaluations (GRADE) approach. Recommendations were developed through consensus using the Delphi technique.

Results: Fourteen axial SpA treatment recommendations were developed based on evidence summaries and consensus. The first 2 recommendations cover non-pharmacological approaches to management. Recommendations 3 to 5 describe the following: the use of non-steroidal anti-inflammatory drugs as first-line symptomatic treatment; the avoidance of long-term corticosteroid use; and the utility of conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) for peripheral or extra-articular manifestations. Recommendation 6 refers to the indications for biological DMARDs (bDMARDs). Recommendation 7 deals specifically with screening for infections endemic to Asia, prior to use of bDMARDs. Recommendations 7 to 13 cover the role of bDMARDs in the treatment of active axial SpA and include related issues such as continuing therapy and use in special populations. Recommendation 14 deals with the utility of surgical intervention in axial SpA.

Conclusion: These recommendations provide up-to-date guidance for treatment of axial SpA to help meet the needs of patients and clinicians in the Asia-Pacific region.
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http://dx.doi.org/10.1111/1756-185X.13510DOI Listing
March 2019

2018 update of the APLAR recommendations for treatment of rheumatoid arthritis.

Int J Rheum Dis 2019 Mar 27;22(3):357-375. Epub 2019 Feb 27.

Department of Medicine, Subang Jaya Medical Centre, Subang Jaya, Malaysia.

Aim: To update recommendations based on current best evidence concerning the treatment of rheumatoid arthritis (RA), focusing particularly on the role of targeted therapies, to inform clinicians on new developments that will impact their current practice.

Materials And Methods: A search of relevant literature from 2014 to 2016 concerning targeted therapies in RA was conducted. The RA Update Working Group evaluated the evidence and proposed updated recommendations using the Grading of Recommendations, Assessment, Development and Evaluations (GRADE) approach, to describe the quality of evidence and strength of recommendations. Recommendations were finalized through consensus using the Delphi technique.

Results: This update provides 16 RA treatment recommendations based on current best evidence and expert clinical opinion. Recommendations 1-3 deal with the use of conventional synthetic disease-modifying antirheumatic drugs. The next three recommendations (4-6) cover the need for screening and management of infections and comorbid conditions prior to starting targeted therapy, while the following seven recommendations focus on use of these agents. We address choice of targeted therapy, switch, tapering and discontinuation. The last three recommendations elaborate on targeted therapy for RA in special situations such as pregnancy, cancer, and major surgery.

Conclusion: Rheumatoid arthritis remains a significant health problem in the Asia-Pacific region. Patients with RA can benefit from the availability of effective targeted therapies, and these updated recommendations provide clinicians with guidance on their use.
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http://dx.doi.org/10.1111/1756-185X.13513DOI Listing
March 2019

Clinical Characteristics of Patients with Spondyloarthritis in Japan in Comparison with Other Regions of the World.

J Rheumatol 2019 08 15;46(8):896-903. Epub 2019 Feb 15.

From the Immuno-Rheumatology Center, St. Luke's International Hospital, St. Luke's International University; Institute of Rheumatology, Tokyo Women's Medical University; Department of Orthopedic Surgery, Juntendo University School of Medicine; Division of Rheumatology, Department of Rheumatology, Keio University School of Medicine, Tokyo; Department of Orthopedic Surgery, Shiga University of Medical Science, Shiga; Department of Rheumatology, Tonan Hospital, Hokkaido; Department of Orthopedic Surgery, Fujita Health University, Aichi; Department of Internal Medicine and Rheumatology, Juntendo University School of Medicine, Tokyo; Department of Rheumatology, Chubu Rosai Hospital, Aichi; Department of Endocrinology, Metabolism and Nephrology, Kochi Medical School, Kochi; Department of Orthopedics, Osaka Minami Medical Center, Osaka; Department of Rheumatology, Daido Hospital, Aichi; Department of Internal Medicine, Juntendo University Koshigaya Hospital, Saitama; Department of Orthopedic Biomaterial Science, Osaka University Graduate School of Medicine, Osaka, Japan; departments of Epidemiology and Biostatistics, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, USA; Division of Rheumatology, National University Hospital, Singapore; Division of Rheumatology, The Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, China; Department of Rheumatology, Hanyang University Hospital for Rheumatic Diseases, Seoul, South Korea; Department of Rheumatology, Allergy and Immunology, Chang Gung Memorial Hospital and Chang Gung University, Tao-Yuan, Taiwan; Hospital Universitario Reina Sofía/IMIBIC/University of Córdoba, Córdoba, Spain; Department of Rheumatology, Paris Descartes University, Cochin Hospital, Paris, France; INSERM Unit 1183, CRESS, Paris, France; Department of Rheumatology, Leiden University Medical Center, Leiden, the Netherlands.

Objective: To delineate clinical characteristics of patients with spondyloarthritis (SpA) in Japan in comparison to other areas of the world.

Methods: Using the ASAS-COMOSPA (Assessment of Spondyloarthritis international Society-COMOrbidities in SPondyloArthritis) data, an international cross-sectional observational study of patients with SpA, we analyzed information on demographics, disease characteristics, comorbidities, and risk factors. Patients were classified by region: Japan, other Asian countries (China, Singapore, South Korea, Taiwan), and non-Asian countries (Europe, the Americas, Africa). Patient characteristics, including diagnosis and treatment, were compared.

Results: Among 3984 patients included in the study, 161 were from centers in Japan, 933 from other Asian countries, and 2890 from other regions. Of patients with SpA in Japan, 42 (26.1%) had peripheral SpA, substantially more than in other countries. This trend was explained by the predominance of psoriatic arthritis (PsA) among Japanese patients with SpA. In contrast to the relatively low number in Japan, 54% of patients from other Asian countries had pure axial SpA (axSpA) without peripheral features. HLA-B27 testing, considered an integral part of the classification of axSpA, was performed in only 63.6% of Japanese patients with axSpA. More than half of Japanese patients with axSpA were classified using imaging criteria.

Conclusion: In our study, there was a more substantial number of peripheral SpA cases observed in Japan compared to other parts of Asia and other regions of the world. Aside from ethnic differences, increasing recognition of PsA in Japan, as well as a potential underdiagnosis of axSpA due to the insufficient use of HLA-B27 testing, may partly explain regional discrepancies.
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http://dx.doi.org/10.3899/jrheum.180412DOI Listing
August 2019

Mizoribine is as Effective as Methotrexate for the Treatment of Polymyalgia Rheumatica: A Retrospective Case Series Analysis.

Arch Rheumatol 2018 Sep 15;33(3):302-308. Epub 2018 Jan 15.

St. Luke's International University, St. Luke's International Hospital, Immuno-Rheumatology Center, Tokyo, Japan.

Objectives: This study aims to evaluate the efficacy and safety of mizoribine (MZR) as a steroid-sparing agent compared to methotrexate (MTX) in the treatment of polymyalgia rheumatica in elderly patients.

Patients And Methods: Twenty-four patients (9 males, 15 females; mean age 71.7 years; range 50 to 86 years) diagnosed with polymyalgia rheumatica between April 1998 and August 2014, who received prednisone in combination with either MTX or MZR, were included. We collected the data on the cumulative prednisone dose that patients received within 48 weeks after MTX or MZR and its side effect profile.

Results: There were 10 patients in the MTX group and 14 in the MZR group. The cumulative prednisone dose over 0-48 weeks was 2272±396 mg in the MTX group and 1907±241 mg in the MZR group, which was not significantly different (p=0.41). In terms of side effects, in the MTX group, three patients experienced a transient elevation in liver enzymes, and one patient developed gastrointestinal symptoms that led to MTX withdrawal. In the MZR group, one patient was hospitalized due to pneumonia that led to MZR withdrawal.

Conclusion: Mizoribine was non-inferior to MTX in terms of steroid-sparing effects on polymyalgia rheumatica. Also, MZR tended to have fewer side effects than MTX.
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http://dx.doi.org/10.5606/ArchRheumatol.2018.6418DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6328222PMC
September 2018

Efficacy and safety of secukinumab in Japanese patients with active ankylosing spondylitis: 24-week results from an open-label phase 3 study (MEASURE 2-J).

Mod Rheumatol 2020 Jan 3;30(1):132-140. Epub 2019 Jan 3.

Juntendo Koshigaya Hospital, Juntendo University, Saitama, Japan.

Secukinumab, a fully human monoclonal antibody that neutralizes interleukin-17A, improved the signs and symptoms of ankylosing spondylitis (AS) in three Phase 3 global studies (MEASURE 1, 2, and 3). Here, we describe the efficacy and safety results through Week 24 of a study of secukinumab in Japanese patients with active AS. In this multicenter, open-label, single arm, 52-week study, 30 AS patients self-administered secukinumab 150 mg subcutaneously at baseline, Weeks 1, 2, 3, and 4, and every 4 weeks thereafter. The primary efficacy endpoint was ASAS 20 response at Week 16. Overall safety and tolerability were assessed beyond Week 24 up to the data reporting cut-off date. The ASAS 20 response rate was 70% (21/30) at Week 16, which was sustained to Week 24. Secukinumab was effective in various clinical outcomes including patient's global assessment of disease activity, spinal pain, nocturnal pain, physical function, spinal mobility, and CRP level. Comparable ASAS 20 and 40 responses were observed regardless of previous anti-TNF therapy. Secukinumab was well-tolerated with a safety profile consistent with previous reports. Secukinumab 150 mg provided sustained improvement in the signs and symptoms of Japanese AS patients through 24 weeks, with no new or unexpected safety signals.
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http://dx.doi.org/10.1080/14397595.2018.1538004DOI Listing
January 2020

Concomitant use of intravenous methylprednisolone to increase retention rate of abatacept in rheumatoid arthritis.

Rheumatol Int 2018 Oct 27;38(10):1825-1831. Epub 2018 Jul 27.

Immuno-Rheumatology Center, St. Luke's International Hospital, Tokyo, Japan.

To investigate whether concomitant use of intravenous methylprednisolone (IVMP) with Abatacept (ABA) contributes to earlier remission and higher drug retention rates. This was a retrospective cohort study to assess the retention rate of ABA in rheumatoid arthritis (RA) patients treated at a single center in Japan from January 2010 to May 2017. Patients were divided into an ABA monotherapy group and ABA IVMP group. IVMP (40 mg) was administered with the first three consecutive doses of ABA. ABA retention rates were evaluated using Kaplan-Meier analysis. Hazard ratios for the drug retention rate were also calculated as the sensitivity analysis. A total of 59 seropositive RA patients were analyzed. Twelve patients were treated with ABA IVMP, and 47 patients were treated with ABA monotherapy. The overall ABA retention rate was 76.3% at 24 weeks. The retention rates were 91.7 and 72.3% in the ABA IVMP and ABA monotherapy groups, respectively. Log-rank analysis revealed no statistical difference between the two groups (p = 0.17). The sensitivity analysis showed that the hazard ratio of IVMP was 2.9-3.7 in three models, although there was no statistical significance. Safety analysis revealed that no patients discontinued ABA because of adverse events in the ABA IVMP group, while 7/47 (14.9%) discontinued the drug in the ABA monotherapy group. In this real life study, ABA, concomitantly used with IVMP, showed numerically higher retention rates without additional safety signals, although there was no statistical significance. Concomitant use of IVMP may help RA patients achieve earlier remission.
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http://dx.doi.org/10.1007/s00296-018-4115-0DOI Listing
October 2018
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