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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June 2024

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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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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April 2024

Efficacy and safety of bimekizumab in the treatment of psoriatic arthritis: A systematic review and meta-analysis

Expert Opin Drug Saf 2024;23:1–9 doi: 10.1080/14740338.2024.2343017 Epub ahead of print

Bimekizumab was superior to placebo in achieving ACR, MDA, and PASI outcomes and had an acceptable safety profile. This meta-analysis also showed that 160mg and 320mg doses of bimekizumab were both superior to placebo in achieving these outcome measures.

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Integrated safety analysis of filgotinib in patients with moderate-to-severe rheumatoid arthritis over a treatment duration of up to 8.3 years

Ann Rheum Dis 2024;0:1–8 doi: 10.1136/ard-2024-225759 Epub ahead of print

Burmester, et al. found that long-term filgotinib exposure was well tolerated in patients with moderate-to-severe active RA, with a stable rate of TEAEs over time. However, potential dose-dependent relationships for herpes zoster infections, malignancies and all-cause mortality were observed in patients aged ≥65 years, indicating the potential impact of age on the safety profile of Filgotinib. Therefore, some patients aged ≥65 years may benefit from the filgotinib 100 mg dose option.

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Janus kinase inhibitors and tumour necrosis factor inhibitors show a favourable safety profile and similar persistence in rheumatoid arthritis, psoriatic arthritis and spondyloarthritis: Real-world data from the BIOBADASER registry

Ann Rheum Dis 2024 doi: 10.1136/ard-2023-225271 Epub ahead of print

Results of this analysis by Hernández-Cruz, et al. show that infections, herpes zoster and gastrointestinal AEs in patients with RA tended to be more frequent with JAKi treatment versus TNFi. They also found that treatment persistence was similar with JAKi and TNFi in patients with RA and axSpA, and only slightly higher for TNFi in patients with PsA.

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February 2024

Bimekizumab treatment in patients with active psoriatic arthritis and prior inadequate response to tumour necrosis factor inhibitors: 52-week safety and efficacy from the phase III BE COMPLETE study and its open-label extension BE VITAL

RMD Open. 2024 Feb 22;10(1):e003855 doi: 10.1136/rmdopen-2023-003855

Bimekizumab was well tolerated in patients with PsA and TNFi-IR up to 52 weeks, with a safety profile consistent with that observed in prior studies. This study aimed to assess 52-week safety and efficacy of bimekizumab in patients with active PsA and prior IR/intolerance to TNFi.

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Abatacept in Individuals at High Risk of Rheumatoid Arthritis (APIPPRA): A Randomised, Double-blind, Multicentre, Parallel, Placebo-controlled, Phase 2b Clinical Trial

Lancet doi.org/10.1016/S0140-6736(23)02649-1

Therapeutic intervention during the at-risk phase of RA with abatacept is feasible, with acceptable safety profiles. However, the efficacy of intermittent administration at multiple intervals remains to be assessed.

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Impact of Upadacitinib on Laboratory Parameters and Related Adverse Events in Patients with RA: Integrated Data Up to 6.5 Years

Rheumatol Ther 2024;11(1):157–175 doi 10.1007/s40744-023-00624-3

Charles-Schoeman, et al. carried out a descriptive integrated analysis on patients with RA that were treated in the SELECT programme, with up to 6.5 years of exposure. They concluded that upadacitinib 15 mg QD had an acceptable safety profile, but long-term upadacitinib treatment was associated with dose-dependent laboratory abnormalities.

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October 2023

Long-term Safety of Guselkumab in Patients with Psoriatic Disease: An Integrated Analysis of Eleven Phase II/III Clinical Studies in Psoriasis and Psoriatic Arthritis

Drug Saf 2023;47(1)39–57 doi:10.1007/s40264-023-01361-w

Data gathered from 11 phase 2 and phase 3 trials have shown that guselkumab has a favourable safety profile in treating psoriatic disease. The data were gathered from 4399 patients over 10787 patient years. In the placebo-controlled periods, guselkumab showed a similar safety profile to placebo, and this remained consistent and stable in the non-placebo controlled preiods.

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