Darvadstrocel
Darvadstrocel, sold under the brand name Alofisel, is a medication 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]
| Clinical data | |
|---|---|
| Trade names | Alofisel |
| License data | |
| Routes of administration | Injection |
| ATC code | |
| Legal status | |
| Legal status | |
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| KEGG | |
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]
Dosage and administration
A specialist injects darvadstrocel into the fistula tract tissue.[1][2] Four vials (each vial has 30 million stem cells) of darvastrocel are used in a procedure.[2] Two vials of darvadstrocel are injected in the tissue surrounding the internal opening of the fistula.[2] The two remaining vials are injected in the walls the external opening of the fistula.[2]
Mechanism of action
Darvadstrocel works by reducing inflammation and facilitating the growth of tissue in the fistula tract.[2][3]
ADMIRE-CD trial
The ADMIRE-CD trial was a phase 3 trial that assed the safety and efficacy of darvadstrocel vs. placebo in adult patients with Crohn's perianal fistulas.[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 darvastrocel to be effective in closing external fistula openings, compared to placebo.[3] Patients taking darvadstrocel had a combined 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]
References
- "Alofisel 5 million cells/mL suspension for injection - Summary of Product Characteristics (SmPC)". (emc). 12 February 2020. Retrieved 27 February 2020.
- "Alofisel EPAR". European Medicines Agency (EMA). 17 September 2018. Retrieved 27 February 2020.
- Panes, Julian (1 April 2018). "Long-term Efficacy and Safety of Stem Cell Therapy (Cx601) for Complex Perianal Fistulas in Patients With Crohn's Disease". Gastroenterology Journal. 154: 1334–1342.
- NS Healthcare Staff Writer (28 September 2021). "Takeda's Alofisel approved in Japan to treat fistulas in patients with Crohn's disease". NS Healthcare.
- "Adipose Derived Mesenchymal Stem Cells for Induction of Remission in Perianal Fistulizing Crohn's Disease (ADMIRE-CD)". Clinicaltrials.gov.
Further reading
- Kotze PG, Spinelli A, Warusavitarne J, Di Candido F, Sahnan K, Adegbola SO, Danese S (February 2019). "Darvadstrocel for the treatment of patients with perianal fistulas in Crohn's disease". Drugs Today. 55 (2): 95–105. doi:10.1358/dot.2019.55.2.2914336. PMID 30816884.
- Scott LJ (December 2018). "Darvadstrocel: A Review in Treatment-Refractory Complex Perianal Fistulas in Crohn's Disease". BioDrugs. 32 (6): 627–634. doi:10.1007/s40259-018-0311-4. PMID 30298387. S2CID 52936920.
- Panés J, García-Olmo D, Van Assche G, Colombel JF, Reinisch W, Baumgart DC, Dignass A, Nachury M, Ferrante M, Kazemi-Shirazi L, Grimaud JC, de la Portilla F, Goldin E, Richard MP, Diez MC, Tagarro I, Leselbaum A, Danese S; ADMIRE CD Study Group Collaborators. Long-term Efficacy and Safety of Stem Cell Therapy (Cx601) for Complex Perianal Fistulas in Patients With Crohn's Disease. Gastroenterology. 2018 Apr;154(5):1334-1342.e4. doi: 10.1053/j.gastro.2017.12.020. Epub 2017 Dec 24. PMID: 29277560.
External links