Takeda's Alofisel has a significant effect in the treatment of patients with Crohn's disease: the clinical remission rate is 65%!

Alofisel is an expanded human allogeneic adipose-derived mesenchymal stem cell therapy

Takeda today announced the results of the first 6-month interim analysis of the INSPIRE study of its allogeneic adipose-derived mesenchymal stem cell product, Alofisel (darvadstrocel), in the treatment of complex perianal fistulas (CPF) in patients with Crohn's disease (CD).

Complex perianal fistula (CPF) is a painful, disabling, and often embarrassing complication of Crohn's disease (CD) that is very difficult to treat

As of September 2021, 230 patients were enrolled in the study

There were 138 patients in the AT cohort and 120 patients in the PP cohort at 6 months after treatment, and 66% of the AT patients (92/138) and 58% of the PP patients (69/120) completed the 6-month follow-up, respectively.

Data showed that clinical responses were observed in 73% (57/78) of the AT cohort and 74% (51/69) of the PP cohort

Elisabeth Genestin, Senior Medical Affairs Director, Global Brands, Rare Diseases, Gastrointestinal (GI) at Takeda, said: "We are pleased to present the results of the first interim analysis of the real-world multicenter INSPIRE study

ADMIRE-CD is a randomized, double-blind, controlled, phase 3 trial evaluating the efficacy and safety of Alofisel in 212 adult patients with inactive/mildly active luminal CD with complex perianal fistula (CPF).

Crohn's disease (CD) is a chronic inflammatory disease of the gastrointestinal tract, and complex perianal fistula (CPF) is a possible complication of the disease, which can lead to perianal swelling, pus, infection, and stool Incontinence seriously affects the quality of life of patients

Alofisel is indicated for the treatment of CPF in adults with inactive or mildly active luminal CD

(Original abridged)