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.
Safety Profile of Upadacitinib over 15 000 Patient-years Across Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis and Atopic Dermatitis
RMD Open. 2023;9(1):e002735 doi: 10.1136/rmdopen-2022-002735
Integrated analysis of the safety profile of upadacitinib demonstrates that it was generally well-tolerated in RA, PsA, AS and AD, with no new safety risks identified, compared with previous reports.
Efficacy and Safety of Upadacitinib in Patients with Psoriatic Arthritis: 2-Year Results from the Phase 3 SELECT-PsA 1 Study
Rheumatol Ther. 2022 Oct 15:1–18 doi: 10.1007/s40744-022-00499-w
Results from the long-term extension of SELECT-PsA 1 show efficacy responses similar or greater with upadacitinib, 15 or 30mg, versus adalimumab through 104 weeks.
Safety Profile of Upadacitinib up to 3 Years in Psoriatic Arthritis: An Integrated Analysis of Two Pivotal Phase 3 Trials
Rheumatol Ther. 2022 doi: 10.1007/s40744-021-00410-z
Upadacitinib 15 mg once daily demonstrated a similar safety profile to adalimumab 40 mg every other week, except for higher rates of HZ and opportunistic infections with upadacitinib treatment in patients treated for PsA
Upadacitinib in patients with psoriatic arthritis and an inadequate response to non-biological therapy: 56-week data from the phase 3 SELECT-PsA 1 study
RMD Open. 2021;7(3):e001838Analysis of data over 56 weeks shows that efficacy responses are maintained with upadacitinib 15 mg and 30 mg.Following the publication of 12-week data from the Phase III, randomised double-blind, SELECT-PsA 1 study, earlier this year, McInnes, et al. now report the 56-week efficacy and safety data of upadacitinib 15 mg and 30 mg in patients with PsA and an inadequate response to non-biological therapyEfficacy responses and inhibition of radiographic progression were maintained with upadacitinib...
N Engl J Med. 2021;384(13):1227-1239.Upadacitinib efficacy proves to be greater than placebo, and non-inferior to adalimumab, in treating patients with psoriatic arthritis (PsA). Already approved for the treatment of rheumatoid arthritis, McInnes, et al. studied oral upadacitinib at a dose of 15 mg or 30 mg, alongside placebo or adalimumab, in this 24-week, Phase III trial, in over 1700 patients with PsA. At the primary endpoint (Week 12), ACR20 response was greater with upadacitinib than placebo, and non-inferior to adalimumab; wi...
Drug Saf. 2021 Feb 2. DOI: 10.1007/s40264-020-01036-wUpadacitinib 15 mg has a favourable benefit–risk profile according to an assessment of data from the phase III SELECT clinical trial programme.In this review of data for the once-daily, oral JAK inhibitor, Conaghan PG, et al. provided insights into the benefit–risk profile of upadacitinib in approximately 4400 patients with RA. Based on pooled data from five pivotal studies, benefits and risks were assessed up to the time of regulatory submission, and additional long-term integrated safety revie...
Baricitinib in Patients with Inadequate Response or Intolerance to Conventional Synthetic DMARDs: Results from the RA-BUILD Study
Ann Rheum Dis 2017;76:88–95.Baricitinib improved symptoms of RA in the RA-BUILD trial, a Phase 3 study of baricitinib in patients with moderately to severely active RA, refractory to or intolerant to csDMARDs. As well as providing a short-term (24 weeks) benefit, there appeared to be joint damage benefit, considered a marker of long-term disability.RA-BUILD was a 24-week randomised, double-blind, placebo-controlled parallel-group study. Patients were randomised 1:1:1 to receive once-daily doses of placebo (n=228) or barici...