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- Title
Determining Effectiveness of "Off-Label Therapies" for Multiple Sclerosis in a Real-World Setting.
- Authors
Pandit, Lekha; Mustafa, Sharik; Sudhir, Akshatha; Malapur, Puneeth; D'Cunha, Anitha
- Abstract
Objective: To determine the factors, if any, that are associated with the efficacy of "off-label therapies" (OLTs) for multiple sclerosis (MS). Methods: Consecutive patients (N = 174) with relapsing--remitting MS (RRMS) or secondary progressive MS (SPMS) with relapses, on OLTs with a generic formulation of azathioprine, mycophenolate mofetil, or rituximab biosimilar for ≥2 years were included. Annualized relapse rate (ARR) and expanded disability status score (EDSS) 1 year before and ≥2 years after starting OLTs were recorded. Optical coherence tomography (OCT) was done at baseline and at the end of the study. Results: During a median period of 4.1 years (2.4-24), ARR reduced in all (P < 0.0001) and EDSS improved in RRMS (P < 0.0001) patients but not in SPMS (P < 0.31) patients. Good responders were those who had RRMS (P = 0.001, odds ratio [OR] 0.04, 95% confidence interval [CI] 0.01-0.15), female gender (P 0.008, OR 6.67, 95% CI 1.7-26.8), and had early access to OLT (P = 0.006, OR 1.2, 95% CI 1.05-1.40). Baseline peripapillary retinal nerve fiber layer thickness identified the risk of conversion to SPMS (P < 0.01, OR 1.03; 95% CI 1.01-1.06). Conclusions: This limited prospective study suggests that early identification of patients who could potentially respond to unconventional but accessible therapies may be valuable in the treatment of MS, particularly in resource-poor regions.
- Subjects
INDIA; OFF-label use (Drugs); MULTIPLE sclerosis; PATIENT safety; COST effectiveness; MYCOPHENOLIC acid; OPTICAL coherence tomography; CLINICAL trials; TREATMENT effectiveness; RITUXIMAB; DESCRIPTIVE statistics; AZATHIOPRINE; ODDS ratio; DRUG efficacy; BIOSIMILARS; CONFIDENCE intervals; DISEASE progression; THERAPEUTICS
- Publication
Annals of Indian Academy of Neurology, 2024, Vol 27, Issue 3, p250
- ISSN
0972-2327
- Publication type
Article
- DOI
10.4103/aian.aian_114_24