Darvadstrocel Demonstrates Safety and Efficacy in Perianal Crohn Disease Advances

Perianal fistulizing Crohn disease is one of the most serious complications of inflammatory bowel disease and one of the most challenging to treat. Darvadstrocel is a novel treatment option for this complex and devastating disease that has been demonstrated to help patients achieve and sustain clinical remission for up to 104 weeks.

Darvadstrocel is an expanded allogeneic adipose-derived mesenchymal stem cell therapy for the treatment of complex perianal fistulae.

 The INSPIRE registry is an observational, post-approval study designed to evaluate the real-world effectiveness and safety of darvadstrocel among patients with complex perianal fistulizing Crohn disease for up to 36 months after the stem-cell treatment.

The first interim analysis of clinical and safety outcomes at 6 months post-treatment was conducted among patients treated with darvadstrocel in multiple European centers. Of all eligible patients, 205 had complete treatment data and comprised the All Treated (AT) cohort; of these, 176 were treated per protocol (PP).

The primary outcomes were clinical response—defined as closure of ≥50% of external fistulae openings that were draining at baseline, despite gentle finger compression—and clinical remission, defined as closure of all external fistulae openings under gentle finger compression.

In the AT cohort, 73% (57/78) and of patients had a clinical response, and 65% (51/78) reached clinical remission. In the PP cohort, 74% (51/69) showed clinical response while 65% (45/69) achieved clinical remission. As assessed with the Harvey–Bradshaw Index, most patients showed no change in Crohn disease activity from baseline.

Among patients in the AT cohort, 20% (41/205) of patients had ≥1 AE and 9.3% (19/205) had ≥1 SAE. No formation of ectopic tissue or deaths were reported.

—Rebecca Mashaw

REFERENCE:

1. Zmora O, Baumgart DC, Faubion W et al. P603 INSPIRE: 6-month interim analysis from an observational post-marketing registry on the effectiveness and safety of darvadstrocel in patients with Crohn’s disease and complex perianal fistulas. J Crohn’s Colitis. 2022;16:i536-i537
2. 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. News release. Takeda; February 18, 2022. Accessed July 8, 2022.