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Objectives To compare demographic and clinical characteristics of patients with axial SpA (axSpA) across geographic regions. Methods Patients With Axial Spondyloarthritis: Multicountry Registry of Clinical Characteristics (PROOF) is an observational study that enrolled recently diagnosed (≤1 year) axSpA patients fulfilling the Assessment of SpondyloArthritis international Society classification criteria from rheumatology clinical practices in 29 countries across six geographic regions. Demographics and disease-related parameters were collected. Here we present baseline data for patients who were classified as radiographic axSpA (r-axSpA) or non-radiographic axSpA (nr-axSpA) confirmed by central reading. Results Of the 2170 patients enrolled, 1553 were classified based on central evaluation of sacroiliac radiographs [r-axSpA: 1023 (66%); nr-axSpA: 530 (34%)]. Patients with nr-axSpA had a significantly higher occurrence of enthesitis (40% vs 33%), psoriasis (10% vs 5%) and IBD (4% vs 2%) vs r-axSpA patients. Significant differences in axSpA characteristics were observed between geographic regions. The highest occurrence of peripheral arthritis (60%), enthesitis (52%) and dactylitis (12%) was in Latin America, and the lowest was in Canada (9%, 9% and 2%, respectively). The occurrence of uveitis and psoriasis was highest in Canada (18% and 14%, respectively) and lowest in China (6% and <1%, respectively). IBD was highest in Arabia (21%), and no cases were observed in China. In multivariable analysis adjusted for factors potentially affecting peripheral and extramusculoskeletal manifestations, geographic regions still exhibited significant differences in frequencies of uveitis (P  < 0.01), psoriasis (P  < 0.0001) and peripheral arthritis (P  < 0.0001). Conclusion The multinational PROOF study of axSpA patients showed significant regional differences in peripheral and extramusculoskeletal manifestations of SpA, which could be considered in management guidelines and clinical trials. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the effect of withdrawing ixekizumab in patients with psoriatic arthritis (PsA) in whom minimal disease activity (MDA) has been achieved after open‐label ixekizumab treatment. Methods: SPIRIT‐P3 was a multicenter, randomized, double‐blind withdrawal study of biologic treatment–naive adult patients with PsA who were treated with open‐label ixekizumab for 36 weeks (160 mg at week 0, then 80 mg every 2 weeks). Patients in whom MDA was sustained for >3 consecutive months were randomized 1:1, between weeks 36 and 64, to undergo blinded withdrawal of ixekizumab treatment (placebo) or to continue ixekizumab treatment every 2 weeks up to week 104. The primary efficacy end point was time to relapse (loss of MDA) for randomized patients. Patients who experienced a relapse were re‐treated with ixekizumab every 2 weeks up to week 104. Results: A total of 394 patients were enrolled and received open‐label ixekizumab every 2 weeks. Of those patients, 158 (40%) achieved sustained MDA and were randomized to undergo withdrawal of ixekizumab treatment (placebo every 2 weeks; n = 79) or to continue ixekizumab treatment every 2 weeks (n = 79). Disease relapse occurred more rapidly with treatment withdrawal (median 22.3 weeks [95% confidence interval (95% CI) 16.1–28.3]) compared to those who continued treatment with ixekizumab (median not estimable; P < 0.0001). Sixty‐seven patients (85%) compared to 30 patients (38%) experienced relapse in the placebo group and the continued treatment group, respectively. Median time to achieving MDA again with re‐treatment was 4.1 weeks (95% CI 4.1–4.3); in 64 of 67 patients (96%) who experienced relapse with treatment withdrawal, MDA was achieved again with re‐treatment. Safety was consistent with the known safety profile for ixekizumab. Conclusion: Continued ixekizumab therapy is superior to ixekizumab withdrawal in maintaining low disease activity in biologic treatment–naive patients with PsA. Re‐treatment with ixekizumab following a relapse may restore disease control in cases of treatment interruption. [ABSTRACT FROM AUTHOR]

Introduction The current American College of Rheumatology and European League Against Rheumatism treatment recommendations advise tapering biological disease-modifying antirheumatic drug (bDMARD) therapy in patients with rheumatoid arthritis (RA) who achieve stable clinical remission while receiving bDMARDs. However, not all patients maintain remission or low disease activity after tapering or discontinuation of bDMARDs. The aim of the ImPact of Residual Inflammation Detected via Imaging TEchniques, Drug Levels and Patient Characteristics on the Outcome of Dose TaperIng of Adalimumab in Clinical Remission Rheumatoid ArThritis (RA) study, or PREDICTRA, is to generate data on patient and disease characteristics that may predict the clinical course of a fixed dose-tapering regimen with the bDMARD adalimumab. Methods and analysis PREDICTRA is an ongoing, multicentre, phase IV, randomised, double-blind, parallel-group study of adalimumab dose tapering controlled by withdrawal in participants with RA who achieved stable clinical remission while receiving adalimumab. The study includes a screening period, a 4-week lead-in period with open-label adalimumab 40 mg every other week and a subsequent 36-week double-blind period during which participants are randomised 5:1 to adalimumab 40 mg every 3 weeks (taper arm) or placebo (withdrawal arm). The primary explanatory efficacy variables are lead-in baseline hand and wrist MRI-detected synovitis and bone marrow oedema scores, as well as a composite of both scores; the dependent variable is the occurrence of flare up to week 40. Additional efficacy variables, safety, pharmacokinetics, biomarkers and immunogenicity will also be assessed, and an ultrasound substudy will be conducted. Ethics and dissemination The study is conducted in accordance with the International Conference on Harmonisation guidelines, local laws and the ethical principles of the Declaration of Helsinki. All participants are required to sign a written informed consent statement before the start of any study procedures. Trial registration number EudraCT 2014-001114-26 and NCT02198651; Pre-results. [ABSTRACT FROM AUTHOR]

Introduction: The current American College of Rheumatology and European League Against Rheumatism treatment recommendations advise tapering biological disease-modifying antirheumatic drug (bDMARD) therapy in patients with rheumatoid arthritis (RA) who achieve stable clinical remission while receiving bDMARDs. However, not all patients maintain remission or low disease activity after tapering or discontinuation of bDMARDs. The aim of the Im P act of R esidual Inflammation Detected via Imaging T E chniques, D rug Levels and Patient Characteristics on the Outcome of Dose Taper I ng of Adalimumab in C linical Remission Rheumatoid Ar T hritis ( RA ) study, or PREDICTRA, is to generate data on patient and disease characteristics that may predict the clinical course of a fixed dose-tapering regimen with the bDMARD adalimumab., Methods and Analysis: PREDICTRA is an ongoing, multicentre, phase IV, randomised, double-blind, parallel-group study of adalimumab dose tapering controlled by withdrawal in participants with RA who achieved stable clinical remission while receiving adalimumab. The study includes a screening period, a 4-week lead-in period with open-label adalimumab 40 mg every other week and a subsequent 36-week double-blind period during which participants are randomised 5:1 to adalimumab 40 mg every 3 weeks (taper arm) or placebo (withdrawal arm). The primary explanatory efficacy variables are lead-in baseline hand and wrist MRI-detected synovitis and bone marrow oedema scores, as well as a composite of both scores; the dependent variable is the occurrence of flare up to week 40. Additional efficacy variables, safety, pharmacokinetics, biomarkers and immunogenicity will also be assessed, and an ultrasound substudy will be conducted., Ethics and Dissemination: The study is conducted in accordance with the International Conference on Harmonisation guidelines, local laws and the ethical principles of the Declaration of Helsinki. All participants are required to sign a written informed consent statement before the start of any study procedures., Trial Registration Number: EudraCT 2014-001114-26 and NCT02198651; Pre-results., Competing Interests: Competing interests: PE has received research grants and/or consulting fees from AbbVie, Bristol-Myers Squibb, Lilly, Merck, Novartis, Pfizer, Roche, Sandoz and UCB. GRB has received research grants and/or consulting fees from AbbVie, Bristol-Myers Squibb, Lilly, MSD, Novartis, Pfizer, Roche, Sandoz and UCB. EN has received speaker fees from AbbVie, Roche, Bristol-Myers Squibb, Pfizer, UCB, Lilly, Novartis, Janssen and Celgene GmbH and honoraria from AbbVie. YZ and MH are full-time employees of AbbVie and may hold AbbVie stock or stock options. PGC has received speakers’ bureau or consulting fees from AbbVie, Bristol- Myers Squibb, Lilly, Novartis, Pfizer and Roche., (© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.)

Introduction: Data on the effectiveness of biologics in the treatment of nail and scalp psoriasis (PSO) in a routine clinical setting are scarce. The aim of this study was therefore to evaluate the effectiveness of adalimumab in the treatment of nail and scalp psoriatic lesions in routine dermatologic practice., Methods: Five hundred one patients were analyzed in this observational study; 157 patients had nail involvement (nail PSO set; NPS) and 404 had scalp involvement (scalp PSO set; SPS). Patients treated with adalimumab were observed for up to 12 months. Outcomes were evaluated via changes in the Nail Psoriasis Severity Index (NAPSI), Psoriasis Scalp Severity Index (PSSI), Psoriasis Area and Severity Index (PASI), and QoL (using the Dermatology Life Quality Index)., Results: Eighty-four percent of the patients in the NPS and 93.8% in the SPS achieved a good clinical response upon treatment with adalimumab. Complete clearing of local symptoms was achieved by 33.3% of the patients with nail involvement and 66.7% of the patients with scalp involvement. There was also a marked improvement in QoL., Conclusion: Adalimumab appears to be an effective treatment for scalp and nail PSO in patients with moderate to severe plaque PSO. No new clinical concerns were established.