May 2024

Adverse events with risankizumab in the real world: Postmarketing pharmacovigilance assessment of the FDA adverse event reporting system

Front Immunol 2023;14:1169735 DOI 10.3389/fimmu.2023.1169735 Epub ahead of print

Shu, et al. identified 37 preferred terms as unexpected AEs following risankizumab treatment, and found 48 AEs with an increased risk of risankizumab-induced AE severity. They also identified that risankizumab signal strengths were significantly higher in eight system organ classes.

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Janus kinase inhibitors and tumour necrosis factor inhibitors show a favourable safety profile and similar persistence in rheumatoid arthritis, psoriatic arthritis and spondyloarthritis: Real-world data from the BIOBADASER registry

Ann Rheum Dis 2024 doi: 10.1136/ard-2023-225271 Epub ahead of print

Results of this analysis by Hernández-Cruz, et al. show that infections, herpes zoster and gastrointestinal AEs in patients with RA tended to be more frequent with JAKi treatment versus TNFi. They also found that treatment persistence was similar with JAKi and TNFi in patients with RA and axSpA, and only slightly higher for TNFi in patients with PsA.

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Efficacy and safety of bimekizumab in the treatment of psoriatic arthritis: A systematic review and meta-analysis

doi: 10.1080/14740338.2024.2343017 Epub ahead of print

Bimekizumab was superior to placebo in achieving ACR, MDA, and PASI outcomes and had an acceptable safety profile. This meta-analysis also showed that 160mg and 320mg doses of bimekizumab were both superior to placebo in achieving these outcome measures.

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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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Guselkumab for the Treatment of Crohn’s Disease: Induction Results From the Phase 2 GALAXI-1 Study

Gastroenterology 2023;165:1588 doi 10.1053/j.gastro.2022.01.047

Guselkumab induced greater clinical and endoscopic improvements in patients with Crohn’s disease versus placebo, with a favourable safety profile in this Phase 2 trial by Sandborn, et al.

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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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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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April 2024

Does obesity affect treatment response to secukinumab and survival in ankylosing spondylitis? Real-life data from the TURKBIO Registry

Modern Rheumatology. 2024;34(3):584–91 doi: 10.1093/mr/road061

This study by Karakas, et al. found that obesity did not affect secukinumab treatment response and drug retention in ankylosing spondylitis patients.

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Long-term etanercept response for patients with radiographic axial spondyloarthritis based on achievement of early, intermediate, or late responses during index studies

Rheumatol Ther 2024 doi: 10.1007/s40744-024-00656-3

This post-hoc analysis by Baraliakos, et al. found a response in short-term index studies was maintained in the long-term OLE studies, and where no response occurred in the index studies, continued treatment led to a response in a large proportion of patients.

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