July 2024

Low uveitis rates in patients with axial spondyloarthritis treated with bimekizumab: Pooled results from Phase 2b/3 trials

Ann Rheum Dis 2024 doi: 10.1136/ard-2024-225933 Epub ahead of print

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.

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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.

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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.

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Mental health outcomes in patients with moderate to severe psoriasis treated with bimekizumab: Analysis of Phase 2/3 randomized trials

J Am Acad Dermatol 2024;91:72–81 doi: 10.1016/j.jaad.2024.02.039

Results of this analysis by Blauvelt, et al. showed a low adjudicated suicidal ideation and behaviour (SIB) rate of 0.13/100 patient-years for bimekizumab, consistent with general psoriasis population ranges. Bimekizumab did not increase the risk of SIB compared to other anti-IL-17A/anti-IL-23 therapies.

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June 2024

Granulocyte-macrophage colony-stimulating factor neutralisation in patients with axial spondyloarthritis in the UK (NAMASTE): a randomised, double-blind, placebo-controlled, phase 2 trial

Lancet Rheumatol 2024:S2665-9913(24)00099-7 DOI 10.1016/S2665-9913(24)00099-7 Epub ahead of print

Worth, et al. found that namilumab did not show efficacy compared with placebo in patients with active axSpA, but the treatment was generally well tolerated. An unusually high proportion of ASAS20 responders at Week 12 were observed in the placebo group, which had a small sample size compared to the namilumab arm.

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Guselkumab demonstrates long-term efficacy and maintenance of treatment response postwithdrawal in systemic treatment-naïve patients and nonresponders to fumaric acid esters: Results from parts II and III of a randomized active-comparator-controlled Phase IIIb trial (POLARIS)

Br J Dermatol 2024;191:36–48 doi: 10.1093/bjd/ljad523

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.

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Maintenance risankizumab sustains induction response in patients with Crohn’s disease in a randomized Phase 3 trial

J Crohns Colitis 2024;18:416–423 doi: 10.1093/ecco-jcc/jjad168

Subcutaneous risankizumab maintenance therapy results in durable improvement in clinical and endoscopic outcomes over one year in patients with moderately to severely active Crohn’s disease. Endpoint achievement tended to be achieved in a higher proportion of patients treated with 360mg risankizumab than 160mg risankizumab, and both doses were higher when compared to placebo.

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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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The outcomes of children born to mothers with autoimmune rheumatic diseases

Lancet Rheumatol 2024:S2665-9913(24)00096-1 doi: 10.1016/S2665-9913(24)00096-1 Epub ahead of print

This Series paper by Andreoli, et al. provides a comprehensive overview of the literature for pregnancy outcomes for mothers with autoimmune rheumatic disease, and provides guidance on discussing these topics with patients. They also provide a list of frequently asked questions related to pregnancy and children by women with autoimmune rheumatic diseases.

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Durable Control of Psoriatic Arthritis with Guselkumab Across Domains and Patient Characteristics: Post Hoc Analysis of a Phase 3 study

Clin Rheumatol 2024 doi: 10.1007/s10067-024-06991-8 Epub ahead of print

Ritchlin et al. conducted a post hoc analysis of the DISCOVER-2 trial, evaluating the efficacy of guselkumab in biologic-naïve patients with PsA. Guselkumab provided durable disease control across key PsA domains and PROs over 2 years, regardless of baseline characteristics. A significant proportion of patients achieved stringent endpoints such as ACR50/70, complete skin clearance, and resolution of dactylitis/enthesitis.

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