Alofisel (Darvadstrocel) Demonstrates 65% Clinical Remission Rate in Real-World INSPIRE Study for Complex Perianal Fistulas in Crohn’s Disease Patients

News on February 20, 2022 /BioValleyBIOON/ -- Takeda Pharmaceutical Company Limited (Takeda) recently announcedAllogeneic Adipose-Derived Mesenchymal Stem Cell Product Alofisel (darvadstrocel) for the Treatment of Complex Perianal Fistulas (CPF) in Crohn's Disease (CD) PatientsResults of the First 6-Month Interim Analysis of the INSPIRE Study. This is the first observational, multicenter, post-marketing, open-enrollment study (EUPAS24267) assessing the real-world efficacy and safety of Alofisel for the treatment of CPF in CD patients. The results showed that, in two cohorts,Six months after treatment, 65% of the patients who were evaluated achieved clinical remission.

Complex Perianal Fistulas (CPF) are a painful, disabling, and often embarrassing complication of Crohn’s Disease (CD), and are extremely difficult to treat. Despite advances, many patients experience recurrence after treatment and fail to achieve fistula closure. These promising preliminary results from the INSPIRE study establish knowledge about Alofisel as a treatment option in this field.

As of September 2021, 230 patients were enrolled in the study. The All-Treated (AT) cohort includes all patients who received Alofisel in the study; the Per-Protocol (PP) cohort includes all patients who received Alofisel according to the protocol recommendations in the study.

At 6 months post-treatment, the AT cohort included 138 patients and the PP cohort included 120 patients. Of these, 66% of AT patients (92/138) and 58% of PP patients (69/120) completed the 6-month follow-up. Among these patients, 85% (78/92) in the AT cohort and 100% (69/69) in the PP cohort had clinical outcome data available at the 6-month follow-up.

Data shows,A clinical response was observed in 73% (57/78) of the AT cohort and 74% (51/69) of the PP cohort.. In addition,Clinical remission was observed in 65% of patients in both cohorts (AT cohort: 51/78; PP cohort: 45/69).。As assessed by the Harvey–Bradshaw Index, there was minimal change in CD activity following treatment. Among 205 patients with complete treatment data, 20% (41/205) experienced one or more adverse events, and 9.3% (19/205) had one or more serious adverse events. No cases of ectopic tissue formation were reported, and there were no deaths.

Elisabeth Genestin, Senior Medical Affairs Director of Takeda's Global Brand for Gastrointestinal (GI) Rare Diseases, stated: "We are pleased to present the results of the first interim analysis of the real-world multicenter INSPIRE study. These results are consistent with the pivotal Phase 3 ADMIRE-CD study in terms of efficacy and safety. The aim of the INSPIRE study is to engage more patients to enhance understanding of disease presentation, patient characteristics, care patterns, and clinical outcomes within a large, multicenter, heterogeneous patient population. We look forward to sharing more data and insights with the community as the study progresses."

ADMIRE-CD is a randomized, double-blind, controlled, Phase 3 trial that evaluated the efficacy and safety of Alofisel in treating complex perianal fistulas (CPF) in 212 adult patients with non-active/mildly active luminal Crohn's disease (CD).Compared with the control group, the proportion of patients in the Alofisel group who achieved the primary endpoint of composite remission at 24 weeks was significantly increased (51.5% vs 35.6%).; Difference=15.8%; 97.5%CI:0.5-31.2; P=0.021),This situation persisted until week 52 (56.3% vs 38.6%; difference=17.7%; 95%CI:4.2-31.2; P=0.01).Alofisel was well-tolerated during the 52-week treatment period. The safety profile was similar between the control group and the Alofisel group.

Crohn's Disease (CD) is a chronic inflammatory condition of the gastrointestinal tract. Complex Perianal Fistulas (CPF), a potential complication of this disease, can lead to perianal swelling, pus discharge, infection, and fecal incontinence, severely impacting patients' quality of life. Currently, clinical treatment options for CPF in CD patients are limited.

Alofisel is indicated for the treatment of complex perianal fistulas (CPF) in adult patients with non-active or mildly active luminal Crohn's disease (CD). Alofisel is a locally injected allogeneic adipose-derivedStem CellsSuspension, which is isolated from human adipose tissue and cultured and expanded in vitro, is adipose-derived.Stem Cells(ASC), Cytokines secreted by ASC have the function of regulating the immune system and suppressing inflammation, thus are considered to have the potential for treating CPF in CD patients.

In March 2018, Alofisel became the first allogeneic product to receive centralized marketing authorization approval from the European Union.Stem CellsTherapy. In 2019, the United StatesFDAGranted Alofisel for the treatment of adult CD patients with CPFRegenerative MedicineAdvanced Therapy (RMAT) designation. In September 2021, Alofisel became the first approved expanded human allogeneic adipose-derived mesenchymalStem CellsTherapy.

Alofisel offers a potential cell-mediated closure option. In the EU/EEA, Israel, Switzerland, and the UK, Alofisel is approved for the treatment of complex perianal fistulas (CPF) in adult patients with non-active/mildly active luminal Crohn's disease (CD) who have had an inadequate response to at least one conventional or biologic therapy. In Japan, Alofisel is approved for CPF in patients with non-active or mildly active luminal CD who have had an inadequate response to at least one existing therapy. (Bioon.com)

Source of Original Text:Alofisel (darvadstrocel) Shows Clinical Remission Rate at Six-Months in the Real-World INSPIRE Study Interim Analysis Consistent with the Pivotal Clinical ADMIRE-CD Study