Interim data from INSPIRE study of Alofisel shows clinical remission rate in Crohn’s disease – Takeda

Takeda announced the first six-month interim analysis results from INSPIRE, in which clinical remission was observed in 65% of patients in both cohorts who were evaluated at 6 months. INSPIRE is a European, observational, multicenter, post-approval, open-enrollment study (EUPAS24267) evaluating the real-world effectiveness and safety of Alofisel (darvadstrocel) in patients with Crohn’s disease (CD) and complex perianal fistulas. As of September 2021, 230 patients had enrolled in the ongoing study.

The All Treated (AT) cohort consisted of all patients in the study who received Alofisel; the Treated Per Protocol (PP) cohort consisted of all patients in the study who received Alofisel according to protocol recommendation. 138 patients in the All Treated (AT) cohort and 120 patients in the Treated Per Protocol (PP) cohort were six-months post treatment and 66% for AT (92/138) and 58% for PP (69/120) had a six-month visit completed. Among them, 85% (78/92) of the AT cohort and 100% (69/69) of the PP cohort had clinical outcome data available at six-months.

Clinical response was observed in 73% (57/78) and 74% (51/69) of patients in the AT and PP cohorts, respectively. Clinical remission was observed in 65% of patients in both cohorts (AT cohort: 51/78; PP cohort: 45/69). Changes in CD activity, assessed using the Harvey–Bradshaw Index, post-treatment were minimal. Of the 205 patients with complete treatment data, 20% (41/205) had one or more adverse event and 9.3% (19/205) had one or more serious adverse event. There were no reports of ectopic tissue formation and no deaths.