Deodhar et al. investigated the impact on efficacy and safety of escalating secukinumab dose from 150mg to 300mg Q4W in AS patients who did not achieve inactive disease during an initial 16-week period of 150mg secukinumab. At Week 52, clinical safety response rates were similar across groups continuing with 150mg or escalating to 300mg secukinumab.

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.

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.

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

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.

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.

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.

July 2024

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.

Tofacitinib in acute severe ulcerative colitis (TACOS): A randomized controlled trial

Journal Reference: Am J Gastroenterol 2024;119:1365–72 doi: 10.14309/ajg.0000000000002635

A combination of tofacitinib and corticosteroids improved treatment responsiveness and decreased the need for rescue therapy in patients with acute severe ulcerative colitis (ASUC). Singh et al. investigated whether addition of tofacitinib to corticosteroids was superior to corticosteroids alone in patients hospitalised with ASUC.

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.