Lundbeck’s partner Teva has announced that results from the ADAGIO trial, which demonstrated that Parkinson’s disease patients receiving Azilect (rasagiline) 1mg/day at the start of the study (early-start group) experienced superior benefit over 18 months compared with those who started the exact same treatment nine months later (delayed-start group). The finding is consistent with a possible disease-modifying effect for Azilect 1mg/day.
The company claims that Azilect is the first Parkinson’s disease treatment to succeed in a prospective delayed-start study, a trial design specifically developed to test for the possibility of a disease-modifying effect.
Professor C Warren Olanow, department of neurology at Mount Sinai School of Medicine, NY and co-principal investigator of the ADAGIO study, said: “A therapy that slows or stops disease progression is the greatest unmet need in the treatment of patients with Parkinson’s disease. Current therapies do not prevent the development of disability in such patients. The results of the ADAGIO study provide support for the possibility that early treatment with Azilect 1mg/day may slow the development of disability.”
ADAGIO (Attenuation of Disease progression with Azilect Given Once-daily) was a randomised, multi-center, double-blind, placebo-controlled, parallel-group study prospectively examining rasagiline’s potential disease-modifying effects in 1,176 patients with early, untreated Parkinson’s disease. Patients from 129 centers in 14 countries participated and were randomised to initiate treatment for 72 weeks with rasagiline 1mg/day or 2mg/day, or to initiate treatment for 36 weeks with a placebo followed by 36 weeks with rasagiline 1mg/day or 2 mg/day.
The primary analysis included three hierarchical endpoints based on total scores in the Unified Parkinson’s Disease Rating Scale (UPDRS). Azilect 1mg/day early-start met all endpoints of the primary analysis: less deterioration in UPDRS score than placebo between weeks 12 and 36; less worsening than delayed-start in UPDRS score in comparing change between baseline and week 72 despite being on the same medication for the last 9 months; and non-inferiority to delayed-start in rate of deterioration between weeks 48 and 72. The ADAGIO study also confirmed the positive symptomatic effect and safety profile of Azilect, in line with prior studies.
Professor Olivier Rascol, department of clinical pharmacology at University Hospital, Toulouse, France and ADAGIO co-principal investigator, said: “The results of the ADAGIO study provide novel data to support the use of Azilect 1mg daily as initial treatment of patients with Parkinson’s disease. The ADAGIO study, which utilized a novel trial design with three primary endpoints, suggests that the drug has a positive impact on slowing the progression of patients’ disability, beyond its already known symptomatic benefit.”