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Darvadstrocel (Alofisel°) for complex perianal fistulae in Crohn's disease. A rash marketing authorisation decision

FEATURED REVIEW How effective is darvadstrocel (Alofisel°) in healing perianal fistulae after usual treatments have failed? Does it reduce the need for surgical intervention? And what are darvadstrocel's adverse effects?
Full review (4 pages) available for download by subscribers.


  • Complex perianal fistula is a frequent complication of Crohn's disease, and it has a significant impact on the patient's quality of life. The mainstays of treatment are drainage of the fistula and immunosuppressant therapy. If these measures fail, surgery is an option, but it can have debilitating consequences. Healed fistulae frequently relapse.
  • Darvadstrocel is a cell therapy product, prepared from donor cells, for injection into the tissues around the openings and tracts of a perianal fistula.
  • Darvadstrocel has been evaluated in a single double-blind placebo-controlled trial in 212 patients. Six months after treatment, remission of the fistulae was observed in 49% of patients in the darvadstrocel group, versus 34% in the placebo group. This effect appeared to be maintained after one year of follow-up. Darvadstrocel was not proven to prevent relapse at 6 months, which occurred in about half of patients.
  • Few patients received a second injection of darvadstrocel, despite the high relapse rate.
  • The main adverse effects were serious abscesses around the anus, serious anal fistulae, and rectal pain. One-third of patients developed donor-specific antibodies, which were still present at 52 weeks in half of cases, although any consequences this may have are unknown.
  •  JUDGEMENT RESERVED  For patients with Crohn's disease complicated by a complex perianal fistula that has failed to heal despite usual therapy, darvadstrocel modestly increases the chances of the fistula healing, although this effect has not been shown to last beyond 1 year, and the risk of abscess formation or worsening of the fistula is increased. These data, based on a single trial in 212 patients, are insufficient to determine darvadstrocel's harm-benefit balance. It seems rash to inject patients with donor stem cells outside the setting of a clinical trial until other trial results confirm the reproducibility of the findings of this first trial and provide additional data about the harms of this treatment.

©Prescrire 1 March 2020

"Darvadstrocel (Alofisel°) for complex perianal fistulae in Crohn’s disease. A rash marketing authorisation decision" Prescrire Int 2020; 29 (213): 61-64. (Pdf, subscribers only).

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