May 2022

Two Phase 3 Trials of Baricitinib for Alopecia Areata

N Engl J Med. 2022. Epub ahead of print doi: 10.1056/NEJMoa2110343

Phase 3 trials in patients with severe alopecia areata show that baricitinib is superior to placebo with respect to hair regrowth at 36 weeks.
Alopecia areata is characterised by nonscarring hair loss that can affect any hair-bearing site. Although mild cases of this emotionally- and psychosocially-distressing autoimmune disease may resolve within 12 months, more severe forms of the disease are unlikely to remit without treatment.

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April 2022

The Impact of Tofacitinib on Fatigue, Sleep, and Health‑Related Quality of Life in Patients with Rheumatoid Arthritis: A Post Hoc Analysis of Data from Phase 3 Trials

Arthritis Res Ther. 2022;24(1):83 doi:10.1186/s13075-022-02724-x

This was an exploratory post hoc analysis of pooled data, from over 2000 patients in three Phase 3 studies of tofacitinib, which demonstrates an association between tofacitinib treatment and significantly greater improvements in fatigue, sleep, and health-related quality of life (HRQoL), compared with placebo.

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March 2022

The effect of secukinumab on patient-reported outcomes in patients with active psoriatic arthritis in a randomised phase 3 trial

Lancet. 2022. Epub ahead of print

Predefined analysis of FUTURE 5, the largest Phase 3 randomised trial of secukinumab in patients with PsA to date, demonstrates that secukinumab results in early, statistically significant, clinically meaningful, sustained improvements in PROs across all doses, compared with placebo.The fully human anti-interleukin 17A monoclonal antibody, secukinumab has shown clinical and radiographical efficacy in patients with PsA, yet the clinical significance of improvements across a wide variety of PROs r...

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January 2022

Pain Reduction in Rheumatoid Arthritis Patients Who Use Opioids: A Post Hoc Analysis of Phase 3 Trials of Baricitinib

ACR Open Rheumatol. 2021. Epub ahead of print. doi: 10.1002/acr2.11380

This post hoc analysis shows that pain reduction was similar between opioid users and nonusers with baricitinib 2 mg and 4 mg, but not adalimumab.Use of opioids to treat RA-related pain has increased, yet long-term use has been associated with reduced efficacy and safety concerns. In addition, the misuse of opioids has resulted in a public health crisis in the United States and highlights the need for safe, effective nonaddictive alternatives for pain management. As such, Pope, et al. assessed p...

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February 2021

Bimekizumab efficacy and safety in moderate to severe plaque psoriasis (BE READY): a multicentre, double-blind, placebo-controlled, randomised withdrawal Phase 3 trial

https://pubmed.ncbi.nlm.nih.gov/33549192/

Bimekizumab therapy was associated with a rapid and sustained improvement in PASI response and IGA score in patients with moderate to severe plaque psoriasis. Dual inhibition of IL-17A/F with bimekizumab can affect a more durable response in PsO patients than sole IL-17A inhibition. Gordon et al. compared the safety and efficacy of two different maintenance dosing schedules, in addition to the effects of treatment withdrawal in the 52-week BE READY trial.

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Bimekizumab versus ustekinumab for the treatment of moderate to severe plaque psoriasis (BE VIVID): Efficacy and safety from a 52-week, multicentre, double-blind, active comparator and placebo controlled Phase 3 trial

Lancet 2021;397:487–98. doi: 10.1016/S0140-6736(21)00125-2

Bimekizumab was more efficacious than ustekinumab and placebo in the treatment of moderate to severe plaque psoriasis. Previous bimekizumab Phase 2 clinical studies have shown both rapid and durable clinical improvements in skin clearance, as well as a safety profile in line with expectations from this MoA. This study aimed to evaluate the efficacy and safety of bimekizumab in moderate to severe plaque PsO over 1 year compared with both placebo and ustekinumab.

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January 2021

Upadacitinib for psoriatic arthritis refractory to biologics: SELECT-PsA 2

Annals of the rheumatic diseases. 2021 Mar 1;80(3):312-20.

In this trial of patients with active PsA who had inadequate response or intolerance to at least one biologic DMARD, upadacitinib 15 mg and 30 mg was more effective than placebo over 24 weeks in improving signs and symptoms of PsA. Despite the availability of bDMARDs in PsA, only a small proportion of patients achieve the recommended target of minimal disease activity; as such, additional treatment options are needed. Upadacitinib is under evaluation for PsA. This paper reports the 24-week data ...

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August 2020

Efficacy and Safety of Upadacitinib Monotherapy in Methotrexate-naïve Patients with Moderately to Severely Active Rheumatoid Arthritis (SELECT-EARLY): A Randomized, Double-blind, Active-comparator, Multi-center, Multi-country Trial

Arthritis Rheumatol 2020

Upadacitinib monotherapy demonstrated superior clinical, radiographic, and patient-reported outcomes versus methotrexate in methotrexate-naïve RA patients.This 48-week double-blind active comparator study investigated upadacitinib monotherapy in patients with early RA, who were either methotrexate-naïve, or who had very limited exposure. 947 patients were randomised to once-daily upadacitinib 15 or 30 mg, or weekly methotrexate. Unusually, there were two separate primary endpoints, selected for ...

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June 2020

Safety Profile of Baricitinib For the Treatment of Rheumatoid Arthritis Over a Median of 3 Years of Treatment: An Updated Integrated Safety Analysis

Lancet Rheumatol 2020;2:e347–57

RA is a chronic, life-long disease requiring long-term treatment. As such, it is important to understand the long-term safety profile of DMARDs. In this analysis, baricitinib maintained a stable safety profile during long-term exposure. This baricitinib safety analysis included integrated data from nine Phase 3, 2, and 1b clinical trials, and one long-term extension, with data up to 360 weeks. 3700 patients were included, with maximum follow-up of almost 7 years – representing an additional 3,54...

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August 2019

Risankizumab compared with adalimumab in patients with moderate-to-severe plaque psoriasis (IMMvent): A randomised, double-blind, active-comparator-controlled Phase 3 trial

Lancet 2019;394:576–86. doi: 10.1016/S0140-6736(19)30952-3

Treatment with risankizumab showed significantly greater efficacy over adalimumab in providing substantial skin clearance in patients with moderate-to-severe chronic plaque PsO. This study aimed to assess the safety and efficacy of risankizumab compared with adalimumab in an active-comparator Phase 3 trial.

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