Biology:Darvadstrocel
| Clinical data | |
|---|---|
| Trade names | Alofisel |
| Other names | CX-601 |
| License data | |
| Routes of administration | Injection |
| ATC code | |
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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]
References
- ↑ 1.0 1.1 "Alofisel 5 million cells/mL suspension for injection - Summary of Product Characteristics (SmPC)". 12 February 2020. https://www.medicines.org.uk/emc/product/9231/smpc.
- ↑ 2.0 2.1 2.2 2.3 2.4 2.5 "Alofisel EPAR". 17 September 2018. https://www.ema.europa.eu/en/medicines/human/EPAR/alofisel.
- ↑ 3.0 3.1 3.2 3.3 3.4 3.5 3.6 3.7 "Long-term Efficacy and Safety of Stem Cell Therapy (Cx601) for Complex Perianal Fistulas in Patients With Crohn's Disease". Gastroenterology 154 (5): 1334–1342.e4. April 2018. doi:10.1053/j.gastro.2017.12.020. PMID 29277560.
- ↑ NS Healthcare Staff Writer (28 September 2021). "Takeda's Alofisel approved in Japan to treat fistulas in patients with Crohn's disease". NS Healthcare. https://www.ns-healthcare.com/news/takedas-alofisel-approved-in-japan/.
- ↑ "Adipose Derived Mesenchymal Stem Cells for Induction of Remission in Perianal Fistulizing Crohn's Disease (ADMIRE-CD)". https://www.clinicaltrials.gov/ct2/show/NCT01541579.
- ↑ 6.0 6.1 "INSPECT: A Retrospective Study to Evaluate Long-term Effectiveness and Safety of Darvadstrocel in Patients With Perianal Fistulizing Crohn's Disease Treated in the ADMIRE-CD Trial". Inflammatory Bowel Diseases 28 (11): 1737–1745. November 2022. doi:10.1093/ibd/izab361. PMID 35099555.
Further reading
- "Darvadstrocel for the treatment of patients with perianal fistulas in Crohn's disease". Drugs of Today 55 (2): 95–105. February 2019. doi:10.1358/dot.2019.55.2.2914336. PMID 30816884.
- "Darvadstrocel for the treatment of perianal fistulas in Crohn's disease". Expert Review of Gastroenterology & Hepatology 14 (6): 405–410. June 2020. doi:10.1080/17474124.2020.1764349. PMID 32354239.
- "Evaluation of Advanced Therapy Medicinal Products by the National Institute for Health and Care Excellence (NICE): An Updated Review". PharmacoEconomics - Open 6 (2): 147–167. March 2022. doi:10.1007/s41669-021-00295-2. PMID 34415514.
- "Darvadstrocel: A Review in Treatment-Refractory Complex Perianal Fistulas in Crohn's Disease". BioDrugs 32 (6): 627–634. December 2018. doi:10.1007/s40259-018-0311-4. PMID 30298387.
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