Glatiramer Acetate Depot Reduces ARR in Patients With Relapsing Forms of MS

Patients with MS who received GA Depot experienced a higher incidence of treatment emergent adverse events.

Glatiramer Acetate (GA) Depot, a long-acting intramuscular injection of glatiramer acetate, significantly reduced the annualized relapse rate (ARR) compared with placebo in patients with relapsing forms of multiple sclerosis (MS). These study findings were presented at the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum 2023, held in San Diego, California, from February 23 to 25.

In the phase 3 randomized double-blind study, 1016 participants with relapsing forms of MS received GA Depot 40 mg or placebo every 4 weeks for 52 weeks. Participants were adults younger than 55 years and experienced 1 or 2 relapses in the last 12 or 24 months, respectively. The primary endpoint was the ARR and secondary endpoints were cumulative T1 new enhancing lesions and cumulative number of new or newly enlarging hyperintense T2 lesions at week 52.

Participants who received GA Depot experienced a statistically significant reduction of ARR compared with placebo (30%; P =.0066). Participants who received GA Depot also experienced a 28.5% reduction in cumulative T1 new enhancing lesions (P =.0083) and 17.3% reduction in the cumulative number of new or newly enlarging hyperintense T2 lesions at week 52 (P =.0305).

Use of GA Depot was associated with a higher incidence of treatment emergency adverse events, including mild injection site reactions. According to study authors, GA Depot’s injection schedule is preferred over other available regimens using glatiramer acetate, which could result in improved patient satisfaction and adherence.

The significant treatment effect of GA Depot in reducing ARR, … strengthened by MRI endpoints, supports the use of GA Depot as a disease modifying therapy for RMS patients.

“The significant treatment effect of GA Depot in reducing ARR, … strengthened by MRI endpoints, supports the use of GA Depot as a disease modifying therapy for RMS patients,” the researchers concluded.

Disclosure: Multiple authors declared affiliations with industry. Please refer to the original abstract for a full list of disclosures.

References:

Miller AE, Popper L, Berger JR, et al. Results of a phase III, multinational, double blind, placebo-controlled study in subjects with relapsing forms of multiple sclerosis to assess the efficacy, safety, and tolerability of GA Depot, a long-acting IM injection of glatiramer acetate, administered once every four weeks. Presented at: ACTRIMS Forum 2023; February 23-25; San Diego, CA. Poster 087.