Risankizumab for Ulcerative Colitis Two Randomized Clinical Trials

JAMA. 2024;332:881-897 doi: 10.1001/jama.2024.12414

Louis et al. demonstrated risankizumab to significantly improve clinical remission rates compared to placebo in both an induction trial and in a maintenance trial for patients with moderately to severely active ulcerative colitis.

Deodhar et al. evaluated the efficacy and safety of intravenous secukinumab in patients with active axial spondyloarthritis. The study found a significant improvement in the ASAS40 response at Week 16 (40.9% vs 22.9% in placebo, P<0.0001), with responses maintained through Week 52. No new safety signals were observed.

IV secukinumab provided rapid and sustained improvements in disease signs and symptoms at Week 16 and through 52 weeks. Kivitz et al. evaluated the long-term efficacy, safety, and tolerability of IV secukinumab in patients with active PsA.

September 2024

Peyrin-Biroulet et al. evaluated the efficacy and safety of etrasimod in patients with moderately to severely active isolated proctitis, demonstrating significant improvement in clinical outcomes compared to placebo. The study reported a favourable safety profile, making etrasimod a viable treatment option for this population.

Mease et al. assessed the comparative effectiveness of bimekizumab and risankizumab in patients with PsA over 52 weeks using a matching-adjusted indirect comparison (MAIC). The study included patients who were biologic disease-modifying anti-rheumatic drug (bDMARD) naïve or had a prior inadequate response or intolerance to tumour necrosis factor inhibitors (TNFi-IR).

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.

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.

August 2024

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.

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.

July 2024

Thaçi, et al. show that guselkumab (GUS) had higher efficacy and a more tolerable safety profile compared with fumaric acid esters (FAE) in patients with moderate. Long-term efficacy through 100 weeks of treatment was seen with GUS as a first-line systemic treatment, and as a second-line systemic treatment in FAE nonresponders.