INSPIRE研究中，Alofisel®六个月的临床缓解率与ADMIRE-CD研究一致

Introduction: INSPIRE's first six-month interim analysis results show that Alofisel achieved good response rates in the treatment of Crohn's disease, consistent with the previous ADMIRE-CD study.

On February 18, 2022, Takeda announced the results of the first 6-month interim analysis of INSPIRE, with 65% of patients in both groups observing clinical responses.

INSPIRE is a European, observational, multicenter, post-approval, open-label 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 have been enrolled in the study. The all-treatment (AT) cohort included all patients in the study who received Alofisel; the per-protocol (PP) group included all patients in the study who received Alofisel according to protocol recommendations.

Six months after treatment, 138 patients in the all treatment (AT) group and 120 patients in the per-protocol treatment (PP) group were followed up, and 66% of AT patients (92/138) and 58% of PP patients (69/120) completed the half-year follow-up. Among them, 85% (78/92) of the patients in the AT group and 100% (69/69) of the patients in the PP group had clinical outcome data after 6 months. 65% of patients in both groups experienced clinical remission (AT group: 51/78; PP group: 45/69).

CD activity, assessed using the Harvey-Bradshaw index, changed little after treatment. Among the 205 patients with complete treatment data, 20% (41/205) had one or more adverse events and 9.3% (19/205) had one or more serious adverse events. There were no reports of ectopic tissue formation and no deaths.

ADMIRE-CD is a randomized, double-blind, controlled Phase 3 trial investigating the efficacy and safety of Alofisel in the treatment of complex perianal fistulas in 212 adult patients with inactive/mildly active tubular CD. A greater proportion of patients in the Alofisel group compared with the control group achieved the primary endpoint of combined response at 24 weeks of follow-up (51.5% vs 35.6%; difference 15.8 percentage points; 97.5% CI 0.5-31.2; P =0.021) and maintained that at 52 weeks (56.3% vs 38.6%; difference 17.7 percentage points; 95% CI 4.2-31.2; P =0.01). Alofisel treatment was well tolerated through 52 weeks, with a similar safety profile to the control group.

Oded, Colon and Rectal Surgeon and Chairman of the Department of Surgery, Shamir Medical Center, Tel Aviv, Israel, and Chairman of the INSPIRE Steering Committee Professor Zmora said: "Complex perianal fistulas are a painful, disabling and often embarrassing complication of Crohn's disease that are extremely challenging to treat. Despite progress, many patients relapse after treatment and do not achieve fistula closure. The preliminary results of the INSPIRE study give hope to Alofisel as a treatment option in this area, and I look forward to future analyzes with longer follow-up."

Alofisel was originally developed by the Belgian company TiGenix (later acquired by Takeda Pharmaceuticals). It was granted orphan drug status by the EMA and FDA in 2009 and 2017 respectively. In 2019, Alofisel received FDA Regenerative Medicine Advanced Therapy Authorization for the treatment of complex perianal fistulas in adult CD patients.

In March 2018, Alofisel was approved in the EU for the treatment of complex perianal fistulas in adult patients with inactive/mildly active luminal Crohn's disease refractory to at least one conventional or biological therapy.

References:

https://www.takeda.com/newsroom/newsreleases/2022/alofisel-darvadstrocel-shows-clinical-remission-rate--at-six-months-in-the-real-world-inspire-study-interim-analysis-consistent-with-the-pivotal-clinical-admire-cd-study/