Anti-gm-csf Otilimab versus Sarilumab or Placebo in Patients with Rheumatoid Arthritis and Inadequate Response to Targeted Therapies: A Phase III Randomised Trial (contRAst 3)
Ann Rheum Dis. 2023 doi 10.1136/ard-2023-224449 Epub ahead of print
The ContRAst 3 study investigated otilimab, in RA patients with inadequate responses to multiple treatments. Otilimab did not significantly improve ACR20 versus placebo at Weeks 12 or 24. In addition, there we no significant improvements in secondary endpoints, including disease activity, disability, and pain.
Anti-GM-CSF Otilimab Versus Tofacitinib or Placebo in Patients With Active Rheumatoid Arthritis and an Inadequate Response to Conventional or Biologic DMARDs: Two Phase 3 Randomised Trials (contRAst 1 and contRAst 2)
Ann Rheum Dis 2023;0:1–11 doi 10.1136/ard-2023-224482
Fleischmann, et al investigated the safety and efficacy of otilimab versus tofacitinib and placebo in RA patients treated with MTX (contRAst 1) or csDMARDs (contRAst 2). They found that while otilimab achieved the primary endpoint of ACR20 versus placebo in Week 12, it did not demonstrate non-inferiority to tofacitinib.
Safety profile of upadacitinib in patients at risk of cardiovascular disease: integrated post hoc analysis of the SELECT phase III rheumatoid arthritis clinical programme
Ann Rheum Dis. 2023 doi: 10.1136/ard-2023-223916
Pots hoc analysis of safety data in patients with RA at increased risk of CV events from the upadacitinib SELECT phase III RA clinical programme helps to contextualise the overall risk profile of upadacitinib.
Analysis of Disease Activity Metrics in a Methotrexate Withdrawal Study among Patients with Rheumatoid Arthritis Treated with Tofacitinib plus Methotrexate
Rheumatol Ther. 2022. Epub ahead of print doi: 10.1007/s40744-022-00511-3
This post hoc analysis of data from the ORAL Shift study, concludes that DAS28-4(ESR), CDAI remission and SDAI remission are the metrics most likely to reflect actual disease activity, in the context of tofacitinib in a randomised withdrawal of MTX.
N Engl J Med. 2022;387(8):715–726. doi: 10.1056/NEJMoa2201302
Phase 3 trial of olokizumab, a direct inhibitor of the IL-6 ligand, demonstrates superiority to placebo with respect to an ACR20 response at week 12 and noninferiority to adalimumab (all combined with methotrexate), in patients with RA.
Impact of initial therapy with upadacitinib or adalimumab on achievement of 48-week treatment goals in patients with rheumatoid arthritis: post hoc analysis of SELECT-COMPARE
Rheumatology (Oxford). 2022. Epub ahead of print doi: 10.1093/rheumatology/keac477
Post hoc analysis findings provide the first data evaluating the importance of treatment order with JAKinib vs TNFi as initial therapy, suggesting that a JAKinib first strategy leads to more rapid improvements in treatment outcomes following csDMARD failure.
Consensus statement on blocking interleukin-6 receptor and interleukin-6 in inflammatory conditions: an update
Blocking the IL-6R is a major therapeutic advance for many diseases in adults and children. Updated consensus statement provides guidance to rheumatologists and other experts, as well as patients and administrators, on managing patients with the use of drugs blocking the IL-6 pathway.
Achieving pain control in early rheumatoid arthritis with baricitinib monotherapy or in combination with methotrexate versus methotrexate monotherapy
RMD Open. 2022;8(1):e001994 doi: 10.1136/rmdopen-2021-001994Post hoc analysis of the RA-BEGIN trial finds that, over a one-year period, patients treated with baricitinib (monotherapy or in combination with methotrexate [MTX]) report greater pain relief and a more rapid attainment of clinically meaningful thresholds of pain improvement, than patients who receive MTX monotherapy.Often overlooked, when treating RA solely to a disease activity target, patient-reported pain is common in RA, even in those reaching inflammatory remission. The fact that pain per...
Long-term safety and efficacy of upadacitinib or adalimumab in patients with rheumatoid arthritis: results through 3 years from the SELECT-COMPARE study
RMD Open. 2022;8(1):e002012 doi: 10.1136/rmdopen-2021-002012Upadacitinib continues to show consistently better clinical responses, compared with adalimumab, through 3 years, including rates of remission and low disease activity, physical function and pain severity.Following the favourable upadacitinib efficacy data seen in the SELECT-COMPARE study at 72 weeks, Fleischmann, et al. assessed the long-term safety and efficacy of upadacitinib versus adalimumab over 3 years in the long-term extension of this study, with promising results. ...
N Engl J Med 2022;386:316–26. doi: 10.1056/NEJMc2202778In this paper, Ytterberg et al. compare incidence of MACE and cancers (excluding NMSC) with tofacitinib 5 mg BID, tofacitinib 10 mg BID and TNFi. They found that risk of MACE and cancer were higher with tofacitinib versus TNFi, and did not meet noninferiority criteria.This prospective head-to-head safety trial compared tofacitinib to TNFi, and was required by the FDA after increases in lipid levels and cancers were observed during tofacitinib drug development. ...