Background: In SELECT-COMPARE, a randomised double-blind study, upadacitinib 15 mg once daily was superior to placebo or adalimumab on background methotrexate (MTX) for treating rheumatoid arthritis signs and symptoms and inhibited radiographical progression versus placebo at 26 weeks. Here we report 48-week safety and efficacy in patients who continued their original medication or were rescued to the alternative medication for insufficient response.
Methods: Patients on MTX received upadacitinib 15 mg, placebo or adalimumab for 48 weeks. Rescue without washout, from placebo or adalimumab to upadacitinib or upadacitinib to adalimumab occurred if patients had <20% improvement in tender joint count (TJC) or swollen joint count (SJC) (weeks 14/18/22) or Clinical Disease Activity Index (CDAI) >10 (week 26); remaining placebo patients were switched to upadacitinib at week 26. Efficacy was analysed by randomised group (non-responder imputation), as well as separately for rescued patients (as observed). Treatment-emergent adverse events per 100 patient-years were summarised.
Results: Consistent with responses through week 26, from weeks 26 to 48, responses by randomised group including low disease activity, clinical remission and improvements in pain and function remained superior for upadacitinib versus adalimumab; radiographical progression remained lower for upadacitinib versus placebo (linear extrapolation). Although both switch groups responded, a higher proportion of patients rescued to upadacitinib from adalimumab achieved CDAI ≤10 at 6 months postswitch versus patients rescued from upadacitinib to adalimumab. Safety at week 48 was comparable to week 26.
Conclusion: Upadacitinib+MTX demonstrated superior clinical and functional responses versus adalimumab+MTX and maintained inhibition of structural damage versus placebo+MTX through week 48. Patients with an insufficient response to adalimumab or upadacitinib safely achieved clinically meaningful responses after switching to the alternative medication without washout.
Download full-text PDF |
Source |
|---|---|
| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6837258 | PMC |
| http://dx.doi.org/10.1136/annrheumdis-2019-215764 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
Pulmonary toxicity assessment of tumor necrosis factor α inhibitors in the treatment of IBD: a real world study based on US food and drug administration adverse events reporting system (FAERS).
Expert Opin Drug Saf
December 2024
Department of pharmacy, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
Background: Tumor necrosis factor α (TNF-α) inhibitors are widely used in the treatment of inflammatory bowel disease (IBD), but there is still a lack of systematic risk assessment for pulmonary toxicity.
Methods: We calculated the pulmonary-related risk signals for four TNF-α inhibitors using the disproportionality analysis and also compared them with the pulmonary-related signals of seven other therapies.
Results: There were 8736 reports of pulmonary-related adverse events (AEs) to TNF-α inhibitors as the 'primary suspect (PS)' therapies.
Association Between Biologics and Janus Kinase Inhibitors With Inflammatory Bowel Disease as Paradoxical Reactions: A Real-World Assessment.
United European Gastroenterol J
December 2024
Division of Gastroenterology and Hepatology, NHC Key Laboratory of Digestive Diseases, State Key Laboratory for Oncogenes and Related Genes, School of Medicine, Shanghai Institute of Digestive Disease, Renji Hospital, Shanghai Jiao Tong University, Shanghai, China.
Background And Objective: With limited evidence connecting paradoxical inflammatory bowel disease (paradoxical IBD) to the newest biologics and Janus kinase inhibitors, our study aims to investigate the occurrence of paradoxical IBD induced by these agents in treating other immune-mediated inflammatory diseases (IMIDs). We aim to identify associated risk signals, the primary affected population, and the risk profile changes over time.
Methods: We performed disproportionality analysis to evaluate paradoxical IBD risk signals using data from the FDA Adverse Event Reporting System.
Article Synopsis
- * The study evaluates the effectiveness and safety of various treatments for non-radiographic axial spondyloarthritis (nr-axSpA), including tumour necrosis factor inhibitors (TNFi), interleukin-17 inhibitors (IL-17i), and Janus kinase inhibitors (JAKi).
- * A systematic review covered 10 randomized controlled trials with 2,418 participants, utilizing multiple databases and statistical software to analyze data on treatment efficacy and adverse events.
- * Results showed that certolizumab pegol was the most effective, followed by other treatments like golimumab and bimekizumab, with most therapies significantly improving symptoms compared to placebo; however, safety profiles varied among treatments.
Development of Extra-Musculoskeletal Manifestations in Upadacitinib-Treated Patients With Psoriatic Arthritis or Axial Spondyloarthritis.
Arthritis Rheumatol
December 2024
Department of Medicine and Health Sciences Vincenzo Tiberio, University of Molise, Campobasso, Italy.
Article Synopsis
- The study aimed to evaluate the occurrence of extra-musculoskeletal manifestations (EMMs) in patients with psoriatic arthritis (PsA) or axial spondyloarthritis (axSpA) treated with a specific medication, upadacitinib (UPA15).
- Data from five clinical trials were analyzed to compare adverse events like uveitis and inflammatory bowel disease (IBD) among patients receiving either UPA15, a placebo, or adalimumab (ADA).
- Results showed that most patients did not have a history of EMMs, and the occurrence of uveitis and IBD was generally low, particularly in those treated with UPA15 compared to the placebo.
AGA Living Clinical Practice Guideline on Pharmacological Management of Moderate-to-Severe Ulcerative Colitis.
Gastroenterology
December 2024
Division of Gastroenterology, Massachusetts General Hospital, Boston, Massachusetts; Harvard Medical School, Boston, Massachusetts.
Background & Aims: This American Gastroenterological Association (AGA) living guideline is intended to support practitioners in the pharmacological management of moderate-to-severe ulcerative colitis (UC).
Methods: A multidisciplinary panel of content experts and guideline methodologists used the Grading of Recommendations Assessment, Development and Evaluation (GRADE) framework to prioritize clinical questions, identify patient-centered outcomes, conduct an evidence synthesis, and develop recommendations on the pharmacological management of moderate-to-severe UC.
Results: The AGA guideline panel made 14 recommendations.
Want AI Summaries of new PubMed Abstracts delivered to your In-box?
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!