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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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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Patients with high baseline neutrophil-to-lymphocyte ratio exhibit better response to filgotinib as treatment for rheumatoid arthritis

Rheumatol Ther 2024 Epub ahead of print doi: 10.1007/s40744-024-00695-w

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.

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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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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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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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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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Efficacy and safety of filgotinib for the treatment of perianal fistulising Crohn’s disease [DIVERGENCE 2]: A Phase 2, randomised, placebo-controlled trial

J Crohns Colitis 2024;18:864–74 doi: 10.1093/ecco-jcc/jjae003

Filgotinib (FIL) 200mg was associated with numerical reductions in the number of draining perianal fistulas based on combined clinical and MRI findings compared with placebo. Reinisch et al. reported a numerically higher proportion of patients achieving the primary endpoint of a combined fistula response and/or remission at Week 24 with FIL 200mg compared with placebo.

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Risankizumab induction therapy achieves early symptom improvements that are associated with future clinical and endoscopic outcomes in Crohn's disease: Post hoc analysis of the ADVANCE, MOTIVATE, and FORTIFY Phase 3 studies

J Crohns Colitis 2024;18:818–27 doi: 10.1093/ecco-jcc/jjad206

This post hoc analysis provides additional support for the utility of risankizumab therapy in patients with moderately to severely active CD. Investigators examined the efficacy of risankizumab for providing early symptom relief, along with the prognostic value of early symptom relief for achieving future clinical and endoscopic endpoints.

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June 2024

Long-term clinical outcomes of certolizumab pegol treatment in non-radiographic axial spondyloarthritis stratified by baseline MRI and CRP status

RMD Open 2024;10:e003884 doi: 10.1136/rmdopen-2023-003884 https://pubmed.ncbi.nlm.nih.gov/38724259/

The safety follow-up extension of the C-axSpAnd trial showed that long-term clinical outcomes from certolizumab pegol treatment achieved after 1 year were generally sustained at 3 years across MRI+/CRP+, MRI−/CRP+ and MRI+/CRP− subgroups.

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