July 2024

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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Efficacy of brodalumab in moderate-to-severe plaque psoriasis after failure of previous biologic therapy: A phase 4, multicenter, open-label study

J Am Acad Dermatol 2024;90:1254–1256 doi 10.1016/j.jaad.2024.01.025

In this letter to the editor, Papp, et al. reported that brodalumab treatment in patients with psoriasis and an inadequate response to another biologic resulted in high rates of complete skin clearance with concurrent improvements in patient-reported outcomes after 26 weeks. The mean and median times to PASI 100 were 96.8 and 112 days, respectively.

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June 2024

Upadacitinib in active non-radiographic axial spondyloarthritis: 1-year data from a double-blind, randomized, placebo-controlled, Phase 3 trial

ACR Open Rheumatol 2024 doi: 10.1002/acr2.11669 Epub ahead of print

The 1-year results of the SELECT-AXIS 2 study showed significant improvements in ASAS40 achievement in patients with nr-axSpA that were treated with upadacitinib 15mg QD versus placebo. Improvements in ASDAS endpoints, back pain, BASFI, and hsCRP from baseline were also observed.

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Long-term clinical outcomes of certolizumab pegol treatment in non-radiographic axial spondyloarthritis stratified by baseline MRI and CRP status

RMD Open 2024;10:e003884 doi: 10.1136/rmdopen-2023-003884 https://pubmed.ncbi.nlm.nih.gov/38724259/

The safety follow-up extension of the C-axSpAnd trial showed that long-term clinical outcomes from certolizumab pegol treatment achieved after 1 year were generally sustained at 3 years across MRI+/CRP+, MRI−/CRP+ and MRI+/CRP− subgroups.

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Adverse cardiovascular events in rheumatoid arthritis patients treated with JAK inhibitors: An analysis of postmarketing spontaneous safety reports

Semin Arthritis Rheum 2024;67:152461 doi: 10.1016/j.semarthrit.2024.152461 Epub ahead of print

Goldman, et al. conducted a pharmacovigilance study to evaluate the cardiovascular safety of JAK inhibitors in RA patients. The study demonstrated an increase in the reporting of VTE, stroke, and ischemic heart disease in patients treated with JAK inhibitor compared to bDMARDs, especially within the first year of treatment. This suggests a class effect of JAK inhibitors on cardiovascular risk, emphasising the need for ongoing surveillance and proactive cardiovascular risk management.

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Integrated safety analysis of filgotinib in patients with moderate-to-severe rheumatoid arthritis over a treatment duration of up to 8.3 years

Ann Rheum Dis 2024;0:1–8 doi: 10.1136/ard-2024-225759 Epub ahead of print

Burmester, et al. found that long-term filgotinib exposure was well tolerated in patients with moderate-to-severe active RA, with a stable rate of TEAEs over time. However, potential dose-dependent relationships for herpes zoster infections, malignancies and all-cause mortality were observed in patients aged ≥65 years, indicating the potential impact of age on the safety profile of Filgotinib. Therefore, some patients aged ≥65 years may benefit from the filgotinib 100 mg dose option.

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Efficacy and safety of ustekinumab for ulcerative colitis through 4 years: Final results of the UNIFI long-term maintenance study

Am J Gastroenterol. 2024;119:910–21 doi: 10.14309/ajg.0000000000002621

Long-term SC maintenance therapy of q8w and q12w ustekinumab in patients who responded to IV ustekinumab induction was safe and effective at maintaining symptomatic remission. Investigators aimed to present the final efficacy and safety results of the UNIFI LTE study through 4 years.

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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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Risk of gastrointestinal perforation in patients with rheumatic diseases exposed to janus kinase inhibitors versus adalimumab: Nationwide cohort study

Arthritis Rheumatol 2024 doi: 10.1002/art.42862 Epub ahead of print

Crude gastrointestinal perforation (GIP) incidence rate was higher for the JAKi group compared with those receiving adalimumab, however rates of GIP did not differ between JAKi and adalimumab groups in the weighted and adjusted model. Hoisnard et al compared the risk of GIP in patients initiating treatment with JAKis or adalimumab among real-world patients with rheumatic disease.

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