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Ritlecitinib and brepocitinib were associated with improved efficacy outcomes compared with placebo in patients with moderate to severe Crohn’s disease.

Ritlecitinib and brepocitinib were associated with improved efficacy outcomes compared with placebo in patients with moderate to severe Crohn’s disease (CD). The agents were generally safe and well tolerated.

The double-blind, phase 2 PIZZICATO trial (NCT03395184) tested the JAK3/TEC family inhibitor ritlecitinib and the TYK2/JAK1 inhibitor brepocitinib in a population of patients with moderate to severe CD (n=244). Researchers randomized approximately half of the participants 2:1 to ritlecitinib or placebo, and the other half was randomized 2:1 to brepocitinib or placebo. After 12 weeks, all participants received a maintenance dose of either ritlecitinib or brepocitinib up to week 52. The primary outcome measure was Simple Endoscopic Score for Crohn’s Disease (SES-CD) 50 at week 12. Severine Vermeire, MD, PhD, presented the results at the 19^th Congress of ECCO.¹

At week 12, treatment with brepocitinib (33.8%) and treatment with ritlecitinib (27.2%) resulted in higher SES-CD 50 rates than treatment with placebo (12.8%; P=0.0012 and P=0.012, respectively). Similar results were observed for Clinical Disease Activity Index (CDAI)-100 response rates, CDAI remission (CDAI<150) rates, and outcomes related to abdominal pain or stool frequency. “Both ritlecitinib and brepocitinib were generally well tolerated, and their safety profiles were consistent with previous publications on these agents,” said Dr. Vermeire. Treatment-emergent AEs that occurred in at least 5% of the participants in the brepocitinib group included headache, abdominal pain, acne, and lymphopenia. In the ritlecitinib arm, only COVID-19 was reported in 5% or more participants.

“Both ritlecitinib and brepocitinib resulted in a statistically significant improvement in SES-CD 50 and met the primary endpoint in the 12-week induction period, compared with placebo, in participants with CD,” concluded Dr Vermeire.

Medical writing support was provided by Robert van den Heuvel.
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