July 2024

Efficacy and Safety of Bimekizumab in Patients with Psoriatic Arthritis With or Without Methotrexate: 52-Week Results From Two Phase 3 Studies

ACR Open Rheumatol. 2024 Jul 30 doi: 10.1002/acr2.11727 Epub ahead of print

McInnes et al. reported that bimekizumab demonstrated sustained efficacy and safety over 52 weeks in patients with psoriatic arthritis (PsA), regardless of concomitant methotrexate (MTX) use. Both bimekizumab groups (with and without MTX) showed similar improvements in achieving ACR50 and PASI100 responses.

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Upadacitinib monotherapy versus methotrexate monotherapy in patients with rheumatoid arthritis: efficacy and safety through 5 years in the SELECT-EARLY randomized controlled trial

Journal Reference: Arthritis Res Ther 2024;26:143 doi: 10.1186/s13075-024-03358-x

van Vollenhoven et al. compared the efficacy and safety of upadacitinib monotherapy to methotrexate monotherapy over five years in methotrexate-naïve patients with rheumatoid arthritis. The study found that upadacitinib provided better long-term efficacy and higher rates of disease activity remission than methotrexate; however, it was associated with higher incidences of adverse events, particularly at the higher dose of 30 mg.

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Efficacy and safety of upadacitinib in patients with rheumatoid arthritis and inadequate response or intolerance to biological treatments: results through 5 years from the SELECT-BEYOND study

Journal Reference: RMD Open. 2024;10:e003918 doi: 10.1136/rmdopen-2023-003918

Fleischmann et al. evaluated the long-term efficacy and safety of upadacitinib in rheumatoid arthritis patients with inadequate response or intolerance to bDMARDs over five years. The study demonstrated that upadacitinib 15 mg and 30 mg were effective in maintaining disease control, with >75% of patients achieving CDAI LDA by week 260. The safety profile remained consistent with no new issues identified.

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Risankizumab versus ustekinumab for moderate-to-severe Crohn’s disease

N Engl J Med. 2024 Jul 18;391(3):213-223. DOI 10.1056/NEJMoa2314585

Risankizumab was noninferior to ustekinumab with respect to clinical remission at Week 24, and superior with respect to endoscopic remission at Week 48. This study aimed to present data from SEQUENCE, a direct head-to-head trial assessing the efficacy and safety of risankizumab vs ustekinumab in patients with moderate-to-severe CD, in whom at least one anti-TNF treatment had failed.

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Pregnancy outcomes in patients treated with upadacitinib: Analysis of data from clinical trials and postmarketing reports

Drug Saf 2024 doi: 10.1007/s40264-024-01454-0 Epub ahead of print

This study by Mahadevan, et al. evaluated pregnancy outcomes in patients exposed to upadacitinib during pregnancy. Rates of adverse pregnancy outcomes with upadacitinib exposure were comparable to rates observed in the general population or patients with autoimmune inflammatory diseases not receiving upadacitinib. The data were limited for in utero exposure to upadacitinib, so definitive conclusions cannot be drawn regarding the effect of upadacitinib on pregnancy outcomes.

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Efficacy and safety of filgotinib for the treatment of perianal fistulising Crohn’s disease [DIVERGENCE 2]: A Phase 2, randomised, placebo-controlled trial

J Crohns Colitis 2024;18:864–74 doi: 10.1093/ecco-jcc/jjae003

Filgotinib (FIL) 200mg was associated with numerical reductions in the number of draining perianal fistulas based on combined clinical and MRI findings compared with placebo. Reinisch et al. reported a numerically higher proportion of patients achieving the primary endpoint of a combined fistula response and/or remission at Week 24 with FIL 200mg compared with placebo.

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Risankizumab induction therapy achieves early symptom improvements that are associated with future clinical and endoscopic outcomes in Crohn's disease: Post hoc analysis of the ADVANCE, MOTIVATE, and FORTIFY Phase 3 studies

J Crohns Colitis 2024;18:818–27 doi: 10.1093/ecco-jcc/jjad206

This post hoc analysis provides additional support for the utility of risankizumab therapy in patients with moderately to severely active CD. Investigators examined the efficacy of risankizumab for providing early symptom relief, along with the prognostic value of early symptom relief for achieving future clinical and endoscopic endpoints.

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Patients with high baseline neutrophil-to-lymphocyte ratio exhibit better response to filgotinib as treatment for rheumatoid arthritis

Rheumatol Ther 2024 Epub ahead of print doi: 10.1007/s40744-024-00695-w

Patients classified as having a high neutrophil-to-lymphocyte ratio (NLR-High) who received filgotinib 200mg + MTX/csDMARDs exhibited consistently better responses after 12 weeks across clinical trials, clinical endpoints, and PROs, compared with NLR-Low patients. Taylor et al. analysed data from the 3 FINCH trials to investigate the potential association of baseline NLR with improved clinical response to filgotinib in MTX-naïve or MTX-experienced RA populations.

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Low uveitis rates in patients with axial spondyloarthritis treated with bimekizumab: Pooled results from Phase 2b/3 trials

Ann Rheum Dis 2024 doi: 10.1136/ard-2024-225933 Epub ahead of print

In a large pool of Phase 2b/3 trial data, the incidence rate of uveitis with bimekizumab over 2034.4 patient years (PYs) remained low at 1.2/100 PYs, suggesting bimekizumab may be an appropriate treatment option for patients with axSpA and uveitis. Compared with placebo, bimekizumab had a lower incidence rate of uveitis in patients with and without a history of uveitis.

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Vedolizumab, Adalimumab, and Methotrexate Combination Therapy in Crohn's Disease (EXPLORER)

Clin Gastroenterol Hepatol 2024;22:1487–96 doi: 10.1016/j.cgh.2023.09.010

This Phase 4, prospective, open-label study provides additional support for the utility of vedolizumab, adalimumab, and methotrexate combination therapy in biologic-naïve patients with newly diagnosed, moderate to high-risk Crohn's disease. Investigators examined the efficacy of this triple therapy for achieving endoscopic and clinical remission at Week 26.

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