May 2024

Efficacy and safety of subcutaneous vedolizumab in patients with moderately to severely active crohn’s disease: Results from the VISIBLE 2 randomised trial

J Crohns Colitis. 2022 Jan 28;16(1):27-38 doi: 10.1093/ecco-jcc/jjab133

The authors highlighted a significantly greater clinical remission rate at Week 52 for vedolizumab SC versus placebo in patients with moderately to severely active CD. This study aimed to report results from VISIBLE 2 which evaluated a new SC vedolizumab formulation as maintenance treatment in adults with moderately to severely active CD.

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Guselkumab for the Treatment of Crohn’s Disease: Induction Results From the Phase 2 GALAXI-1 Study

Gastroenterology 2023;165:1588 doi 10.1053/j.gastro.2022.01.047

Guselkumab induced greater clinical and endoscopic improvements in patients with Crohn’s disease versus placebo, with a favourable safety profile in this Phase 2 trial by Sandborn, et al.

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Risankizumab as maintenance therapy for moderately to severely active Crohn’s disease: Results from the multicentre, randomised, double-blind, placebo-controlled, withdrawal Phase 3 FORTIFY maintenance trial

Lancet 2022;399:2031–36 doi: 10.1016/S0140-6736(22)00466-4

Maintenance treatment with risankizumab was associated with an improvement in coprimary endpoints of clinical remission and endoscopic response in patients with Crohn’s disease compared with placebo.

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Risankizumab as induction therapy for Crohn’s disease: Results from the phase 3 ADVANCE and MOTIVATE induction trials

Lancet 2022;399:2015–30 doi 10.1016/S0140-6736(22)00467-6

Risankizumab was effective and well tolerated as induction therapy in patients with moderately to severely active Crohn’s disease, though there were no significant differences in efficacy between 600mg and 1200mg doses.

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Upadacitinib as induction and maintenance therapy for moderately to severely active ulcerative colitis: Results from three Phase 3, multicentre, double-blind, randomised trials

Lancet 2022;399(10341):2113–28 doi: 10.1016/S0140-6736(22)00581-5

The results of two induction studies (UC1 and UC2) and a maintenance study (UC3) show upadacitinib superiority to placebo in treating ulcerative colitis (UC). Rates of clinical remission were significantly higher for all upadacitinib doses versus placebo in all three studies.

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Filgotinib as induction and maintenance therapy for ulcerative colitis (SELECTION): A phase 2b/3 double-blind, randomised, placebo-controlled trial

The Lancet 2021;397:2372–2384 doi: 10.1016/S0140-6736(21)00666-8

Treatment of patients with UC with filgotinib 200 mg was associated with an increase in clinical remission at Week 10 and Week 58. The proportion of patients with clinical remission at Week 58 was significantly greater in patients who continued FIL 200 mg therapy throughout the trial. The incidence of TEAEs was similar across all treatment groups.

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December 2022

Implementation of the OMERACT Psoriatic Arthritis Magnetic Resonance Imaging Scoring System in a Randomized Phase IIb Study of Abatacept in Psoriatic Arthritis

Rheumatology (Oxford) 2022 doi: 10.1093/rheumatology/keac073

In this study abatacept 30/10 mg/kg and 10 mg/kg doses were associated with greater improvements from baseline in MRI detected synovitis and tenosynovitis, respectively, compared with placebo, confirming the clinical outcomes. Indeed, inflammatory components demonstrated the greatest change from baseline.

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Evaluation of VTE, MACE, and Serious Infections Among Patients with RA Treated with Baricitinib Compared to TNFi: A Multi-Database Study of Patients in Routine Care Using Disease Registries and Claims Databases

Rheumatol Ther. 2022. Epub ahead of print doi: 10.1007/s40744-022-00505-1

Salinas, et al. evaluate baricitinib safety with respect to VTE, MACE, and serious infection relative to TNFi in patients with RA, in routine care and observe an increased risk of VTE in patients taking baricitinib, compared to TNFi.

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November 2022

Tofacitinib and Risk of Malignancy: Results From the Safety of Tofacitinib in Routine Care Patients With Rheumatoid Arthritis (STAR-RA) Study

Arthritis Rheumatol. 2022;74:1648–1659 doi: 10.1002/art.42250

Large, population-based, real-world cohort of study in patients with RA finds tofacitinib not to be associated with an increased risk of malignancies, in comparison to TNFi agents, although a numerically increased risk of malignancies was observed in older patients with risk factors for cardiovascular disease.

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October 2022

Toxicity Signals Associated with Secukinumab: A Pharmacovigilance Study Based on The United States Food And Drug Administration Adverse Event Reporting System Database

Br J Clin Pharmacol. 2022 doi: 10.1111/bcp.15535

This study explored the clinical characteristics, outcomes, and time to onset of the four main toxicities of secukinumab with hypersensitivity identified as the most common toxicity.

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