Monoclonal antibody no better than placebo for early Parkinson's disease: NEJM
USA: Cinpanemab, a monoclonal antibody, is no better than placebo as a disease-modifying treatment for Parkinson's disease, according to a recent study published in the New England of Medicine.
The study stated that "the effects of cinpanemab on clinical measures of disease progression and changes in dopamine transporter single-photon-emission computed tomography (DaT-SPECT) imaging did not differ from those of placebo over a 52-week period in patients with early Parkinson's disease."
Aggregated α-synuclein plays an important part in the pathogenesis of Parkinson's disease. Cinpanemab is a human-derived monoclonal antibody that binds to α-synuclein. It is being evaluated as a disease-modifying treatment for Parkinson's disease.
For this purpose, Anthony E. Lang and colleagues conducted a 52-week, multicenter, double-blind, phase 2 trial that included 357 participants with early Parkinson's disease. They were randomly assigned in the ratio of 2:1:2:2 to receive intravenous infusions of placebo (control; n=100) or cinpanemab at a dose of 250 mg (n=55), 1250 mg (n=102), or 3500 (n=100) mg every 4 weeks. This was followed by an active-treatment dose-blinded extension period for up to 112 weeks.
Changes from baseline in the Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) total score (range, 0 to 236, with higher scores indicating worse performance) at weeks 52 and 72 were the primary endpoints. Secondary endpoints were MDS-UPDRS subscale scores and striatal binding as assessed on DaT-SPECT.
Key findings of the study include:
- The trial was stopped after the week 72 interim analysis owing to lack of efficacy.
- The change to week 52 in the MDS-UPDRS score was 10.8 points in the control group, 10.5 points in the 250-mg group, 11.3 points in the 1250-mg group, and 10.9 points in the 3500-mg group (adjusted mean difference vs. control, −0.3 points; and 0.1 points respectively.
- The adjusted mean difference at 72 weeks between participants who received cinpanemab through 72 weeks and the pooled group of those who started cinpanemab at 52 weeks was −0.9 points for the 250-mg dose, 0.6 points for the 1250-mg dose, and −0.8 points for the 3500-mg dose.
- Results for secondary endpoints were similar to those for the primary endpoints.
- DaT-SPECT imaging at week 52 showed no differences between the control group and any cinpanemab group.
- The most common adverse events with cinpanemab were headaches, nasopharyngitis, and falls.
"The effects of cinpanemab on clinical measures of disease progression and changes in DaT-SPECT imaging did not differ from those of placebo in In participants with early Parkinson's disease, over a 52-week period," the researchers conclude.
Reference:
The study titled, "Trial of Cinpanemab in Early Parkinson's Disease," was published in the New England Journal of Medicine.
DOI: 10.1056/NEJMoa2203395
Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.
NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.