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.

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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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Pregnancy outcomes in patients treated with upadacitinib: Analysis of data from clinical trials and postmarketing reports

Drug Saf 2024 doi: 10.1007/s40264-024-01454-0 Epub ahead of print

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.

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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.

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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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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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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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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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"I couldn't carry on taking a drug like that": A qualitative study of patient perspectives on side effects from rheumatology drugs

Journal Reference: Rheumatology 2024 Epub ahead of print

In the treatment of rheumatic and musculoskeletal diseases (RMDs), there is a need for feasible measures of patient-reported bother (impact on life and cumulative burden) from side effects and the benefit-harm-balance. Berthelsen et al. evaluated what with RMDs considered important to know about symptomatic side effects they may experience from a new prescription drug.

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Long-term safety and efficacy of upadacitinib versus adalimumab in patients with rheumatoid arthritis: 5-year data from the Phase 3, randomised SELECT-COMPARE study

RMD Open 2024;10:e004007 doi: 10.1136/rmdopen-2023-004007

More RA patients on upadacitinib versus adalimumab achieved clinical remission, LDA, and DAS28 (CRP) <2.6. Radiographic progression was less with continuous upadacitinib versus continuous adalimumab. Upadacitinib showed similar safety to adalimumab, with higher incidences of HZ, lymphopenia, CPK elevation, hepatic disorder and nonmelanoma skin cancer.

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