May 2024

Upadacitinib in Rheumatoid Arthritis and Inadequate Response to Conventional Synthetic Disease-Modifying Antirheumatic Drugs: Efficacy and Safety Through 5 Years (SELECT-NEXT)

J Rheumatol. 2024 Apr 15:jrheum.2023-1062 doi: 10.3899/jrheum.2023-1062 Epub ahead of print

The 5-year benefit-risk profile for upadacitinib in RA remains favourable, with clinical outcomes improved or maintained through Week 260. No new safety findings were identified during the LTE. Results remained consistent with earlier analyses of SELECT-NEXT.

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Risk of extended major adverse cardiovascular event endpoints with tofacitinib versus TNF inhibitors in patients with rheumatoid arthritis: A post hoc analysis of a Phase 3b/4 randomised safety study

RMD Open 2024;10:e003912 doi: 10.1136/rmdopen-2023-003912

Risk of composite CV endpoints combining all ischaemic CV events and heart failure were similar for individual and combined TOF doses versus TNFi. The totality of CV risk (MACE-8 plus VTE) was higher with TOF 10mg twice daily versus TNFi. Buch et al conducted a post-hoc analysis on the ORAL Surveillance trial to assess risk across extended MACE endpoints in RA patients treated with either TOF 5mg, TOF 10mg, or TNFi.

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Risankizumab as maintenance therapy for moderately to severely active Crohn’s disease: Results from the multicentre, randomised, double-blind, placebo-controlled, withdrawal Phase 3 FORTIFY maintenance trial

Lancet 2022;399:2031–36 doi: 10.1016/S0140-6736(22)00466-4

Maintenance treatment with risankizumab was associated with an improvement in coprimary endpoints of clinical remission and endoscopic response in patients with Crohn’s disease compared with placebo.

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Risankizumab as induction therapy for Crohn’s disease: Results from the phase 3 ADVANCE and MOTIVATE induction trials

Lancet 2022;399:2015–30 doi 10.1016/S0140-6736(22)00467-6

Risankizumab was effective and well tolerated as induction therapy in patients with moderately to severely active Crohn’s disease, though there were no significant differences in efficacy between 600mg and 1200mg doses.

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Upadacitinib Induction and Maintenance Therapy for Crohn’s Disease

N Engl J Med 2023; 388:1966–1980 doi: 10.1056/NEJMoa2212728

Upadacitinib was associated with higher percentages of remission and endoscopic response regardless of previous failure of biologic therapy. This paper reports the Phase 3 efficacy and safety results of upadacitinib in patients with moderate-to-severe Crohn’s disease.

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Ozanimod as induction therapy and maintenance therapy for ulcerative colitis

N Engl J Med 2021;385:1280–91 doi: 10.1056/NEJMoa2033617

Patients receiving ozanimod displayed a significant improvement in clinical response and all secondary endpoints during both the 10-week induction and 52-week maintenance study periods. Percentage of patients achieving clinical remission at Weeks 10 and 52 was the primary endpoint.

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Etrasimod as induction and maintenance therapy for ulcerative colitis (ELEVATE): two randomised, double-blind, placebo-controlled, phase 3 studies

Lancet 2023 Apr 8;401(10383):1159-1171 DOI 10.1016/S0140-6736(23)00061-2

Etrasimod demonstrated significant efficacy in achieving clinical remission, and was well tolerated compared to placebo in an induction and maintenance therapy.

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Mirikizumab as induction and maintenance therapy for ulcerative colitis

N Engl J Med 2023;388(26):2444–2455 doi: 10.1056/NEJMoa2207940

Mirikizumab was more effective than placebo in inducing and maintaining clinical remission in patients with moderately to severely active ulcerative colitis. D’Haens, et al. also noted that opportunistic infections and cancer developed in a small number of mirikizumab-treated patients.

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Upadacitinib as induction and maintenance therapy for moderately to severely active ulcerative colitis: Results from three Phase 3, multicentre, double-blind, randomised trials

Lancet 2022;399(10341):2113–28 doi: 10.1016/S0140-6736(22)00581-5

The results of two induction studies (UC1 and UC2) and a maintenance study (UC3) show upadacitinib superiority to placebo in treating ulcerative colitis (UC). Rates of clinical remission were significantly higher for all upadacitinib doses versus placebo in all three studies.

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April 2024

Bimekizumab safety in patients with moderate-to-severe plaque psoriasis: pooled data from up to 3 years of treatment in randomized phase III trials

Br J Dermatol 2024;190:477–85 Doi: 10.1093/bjd/ljad429.

No new safety signals were found in the three-year safety data on bimekizumab for plaque PsO. Additionally, incidence of oral candidiasis significantly decreased with each subsequent year.

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