OP33 Oral ritlecitinib and brepocitinib in patients with Moderate to Severe Active Ulcerative Colitis: Data from the VIBRATO umbrella study

Sandborn, William J.; Danese, Silvio; Leszczyszyn, Jarosław; Romatowski, J; Altıntaş, Engin; Peeva, E; Vincent, Michael S.; Reddy, Padma; Banfield, Christopher; Banerjee, Anindita; Gale, Jeremy D.; Hung, Kenneth E.

doi:10.1093/ecco-jcc/jjab075.032

Cited by 15 publications

(4 citation statements)

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“…Brepocitinib (PF-06700841), a TYK2 and JAK1 inhibitor, has been clinically promising and well tolerated in the phase I and IIa trials for the treatment of psoriasis [ 84 ], and a phase III trial is currently in progress. Currently, phase II trials are recruiting participants to study brepocitinib as a treatment for CD [ 85 ]. VIBRATO, an umbrella study evaluating the efficacy and safety of brepocitinib and ritlecitinib, which are JAK3 and TEC inhibitors, indicated that both drugs are effective in patients with moderate-to-severe active UC compared to a placebo, as they met all the trial’s endpoints.…”

Section: Biologics and Small Moleculesmentioning

confidence: 99%

Exploring the Pipeline of Novel Therapies for Inflammatory Bowel Disease; State of the Art Review

2023

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Crohn’s disease (CD) and ulcerative colitis (UC), known as inflammatory bowel diseases (IBD), are characterized by chronic inflammation of the gastrointestinal tract. Over the last two decades, numerous medications have been developed and repurposed to induce and maintain remission in IBD patients. Despite the approval of multiple drugs, the major recurring issues continue to be primary non-response and secondary loss of response, as well as short- and long-term adverse events. Most clinical trials show percentages of response under 60%, possibly as a consequence of strict inclusion criteria and definitions of response. That is why these percentages appear to be more optimistic in real-life studies. A therapeutic ceiling has been used as a term to define this invisible bar that has not been crossed by any drug yet. This review highlights novel therapeutic target agents in phases II and III of development, such as sphingosine-1-phosphate receptor modulators, selective Janus kinase inhibitors, anti-interleukins, and other small molecules that are currently under research until 1 January 2023. Emerging treatments for CD and UC that have just received approval or are undergoing phase III clinical trials are also discussed in this review.

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Section: Biologics and Small Moleculesmentioning

confidence: 99%

Exploring the Pipeline of Novel Therapies for Inflammatory Bowel Disease; State of the Art Review

2023

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“…Filgotinib 200 mg was efficacious in inducing and maintaining remission compared with placebo in this study. 15 16 Oral brepocitinib and ritlecitinib have completed phase II clinical studies for moderate to severe UC (VIBRATO umbrella study) with primary results suggesting significantly higher proportion of clinical remission and endoscopic improvement (p<0.05) with ritlecitinib 70 mg and 200 mg and brepocitinib 30 mg and 60 mg vs placebo at week 8 17 (table 1).…”

Section: Novel Therapies Jak-stat Inhibitorsmentioning

confidence: 99%

IBD therapeutics: what is in the pipeline?

Toskas

Akbar

2022

Frontline Gastroenterol

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Inflammatory bowel disease (IBD) is an idiopathic long-term relapsing and remitting disorder including ulcerative colitis and Crohn’s disease. The aim of therapy is to induce and maintain remission. Anti-TNF therapies dramatically improved clinical outcomes but primary failure or secondary loss is a common problem as well as potential side effects potentially limiting efficacy and long-term use. The advent of new targeted agents with the potential for greater safety is welcomed in IBD and offers the potential for different agents as the disease becomes refractory or even combination therapies to maximise effectiveness without compromising safety in the future. More data are required to understand the best positioning in pathways and longer-term safety effects.

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“…Results from a previous phase IIa study demonstrated significant improvements in the Psoriasis Area and Severity Index (PASI) scores in participants with plaque psoriasis treated with brepocitinib compared with placebo (19). Safety results from phase IIa studies of brepocitinib in plaque psoriasis, alopecia areata, and ulcerative colitis demonstrated an acceptable safety and tolerability profile with brepocitinib, with few serious adverse events (SAEs), opportunistic infections, or major adverse cardiovascular events including vascular thrombosis (19)(20)(21).…”

Section: Introductionmentioning

confidence: 99%

Efficacy and Safety of the TYK2/JAK1 Inhibitor Brepocitinib for Active Psoriatic Arthritis: A Phase IIb Randomized Controlled Trial

Mease,

Helliwell,

Silwinska‐Stanczyk

et al. 2023

Arthritis & Rheumatology

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Objective Brepocitinib is a TYK2/JAK1 inhibitor in development for the treatment of several immunologic diseases. The efficacy and safety of oral brepocitinib were assessed in participants with moderately‐to‐severely active psoriatic arthritis (PsA) for up to 52 weeks. Methods In this placebo‐controlled, dose‐ranging, phase IIb study, participants were randomized to receive 10 mg, 30 mg, or 60 mg of brepocitinib once daily or placebo, advancing to 30 mg or 60 mg of brepocitinib once daily at week 16. The primary endpoint was the response rate according to the American College of Rheumatology criteria for 20% improvement (ACR20) in disease activity at week 16. Secondary endpoints included response rates according to the ACR50/ACR70 response criteria, 75% and 90% improvement in the Psoriasis Area and Severity Index (PASI75/PASI90) score, and minimal disease activity (MDA) at weeks 16 and 52. Adverse events were monitored throughout the study. Results Overall, 218 participants were randomized and treated. At week 16, the brepocitinib 30 mg and 60 mg once daily groups had significantly greater ACR20 response rates (66.7% [P = 0.0197] and 74.6% [P = 0.0006], respectively), versus the placebo group (43.3%), and significantly higher ACR50/ACR70, PASI75/PASI90, and MDA response rates. Response rates were maintained or improved through week 52. Adverse events were mostly mild/moderate; serious adverse events (15) in 12 participants (5.5%) included infections in 6 participants (2.8%) in the brepocitinib 30 mg and 60 mg once daily groups. No major adverse cardiovascular events or deaths occurred. Conclusion Treatment with brepocitinib at dosages of 30 mg and 60 mg once daily was superior to placebo at reducing signs and symptoms of PsA. Brepocitinib was generally well tolerated throughout the 52‐week study, with a safety profile consistent with those found in other brepocitinib clinical trials.

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OP33 Oral ritlecitinib and brepocitinib in patients with Moderate to Severe Active Ulcerative Colitis: Data from the VIBRATO umbrella study

Cited by 15 publications

References 0 publications

Exploring the Pipeline of Novel Therapies for Inflammatory Bowel Disease; State of the Art Review

Exploring the Pipeline of Novel Therapies for Inflammatory Bowel Disease; State of the Art Review

IBD therapeutics: what is in the pipeline?

Efficacy and Safety of the TYK2/JAK1 Inhibitor Brepocitinib for Active Psoriatic Arthritis: A Phase IIb Randomized Controlled Trial

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