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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Investigation of plaque psoriasis relapse after secukinumab withdrawal in patients from two Phase III studies

Clin Exp Dermatol 2024;49:793–800 doi: 1093/ced/llad329

Following discontinuation of secukinumab 150mg or 300mg, a proportion of patients sustained low PASI with clear or almost clear skin despite being drug free for up to 2 years. Patients with a shorter disease duration were less likely to relapse, further supporting the hypothesis that earlier intervention with secukinumab may result in long-term control of moderate-to-severe psoriasis.

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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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Deucravacitinib onset of action and maintenance of response in Phase 3 plaque psoriasis trials

J Dermatolog Treat 2024;35:2371045 doi: 10.1080/09546634.2024.2371045

The analysis of the POETYK PSO-1 and POETYK PSO-2 clinical trials showed that deucravacitinib 6mg QD displayed efficacy as early as 1 week, and clinical responses were maintained over 52 weeks in patients with moderate to severe plaque psoriasis.

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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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Improved physical functioning, sleep, work productivity and overall health-related quality of life with bimekizumab in patients with axial spondyloarthritis: Results from two Phase 3 studies

Journal Reference: RMD Open 2024;10:e004202 doi: 10.1136/rmdopen-2024-004202

Bimekizumab (BKZ) treatment led to early improvements in physical function, sleep, work productivity, and overall health-related quality of life at Week 16 in patients across the full axSpA disease spectrum, which were sustained through Week 52. Dubreuil et al. investigated treatment impact over one year using BASFI, MOS-Sleep-R, SF-36 PCS/MCS, WPAI:axSpA, and ASQoL scores in patients with both non-radiographic and radiographic axSpA.

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