Darvadstrocel, sold under the brand name Alofisel, is a medication used to treat complex perianal fistulas in adults with non-active/mildly active luminal Crohn's disease when fistulas have shown an inadequate response to at least one conventional or biologic therapy.^[1] It contains mesenchymal stem cells from fat tissue of adult donors.^[2]

It was approved for use in the European Union in March 2018.^[2] The approval was spearheaded by data published in the ADMIRE-CD trial.^[2][3]

It was approved for use in Japan by Japan's Ministry of Health, Labour and Welfare (MHLW) in September 2021.^[4]

Medical use

Darvadstrocel has been approved by the European Union for the treatment of adults with complex Crohn's perianal fistulas after conventional or biological medications have not worked.^[2]

Mechanism of action

Darvadstrocel works by reducing inflammation and facilitating the growth of tissue in the fistula tract.^[2][3]

History

ADMIRE-CD

The ADMIRE-CD trial was a phase III trial that assessed the safety and efficacy of darvadstrocel vs. placebo in adults with complex perianal fistulas with Crohn's disease.^[3][5] The study randomized a total of 212 patients.^[3] 107 patients were given darvadstrocel and 105 patients were given placebo.^[3]

After one year, the study found darvadstrocel to be effective in closing external fistula openings, compared to placebo.^[3] Patients taking darvadstrocel had a combined remission of 56.3% and clinical remission of 59.2%.^[3] The placebo controls had a combined remission of 38.6% and clinical remission of 41.6%.^[3]

INSPECT

Published in 2022, the INSPECT study is a retrospective study that evaluated the long-term effectiveness and safety of darvadstrocel in patients with perianal fistulas in Crohn's disease that were treated in the ADMIRE-CD trial.^[6] The study data showed that darvadstrocel or the maintenance treatment used can have long term clinical remission in patients.^[6]