No evidence of disease activity in patients receiving daclizumab versus intramuscular interferon beta-1a for relapsing-remitting multiple sclerosis in the DECIDE study.
| Publication Type | Academic Article |
| Authors | Kappos L, Havrdova E, Giovannoni G, Khatri B, Gauthier S, Greenberg S, You X, Wang P, Giannattasio G |
| Journal | Mult Scler |
| Volume | 23 |
| Issue | 13 |
| Pagination | 1736-1747 |
| Date Published | 12/22/2016 |
| ISSN | 1477-0970 |
| Keywords | Adjuvants, Immunologic, Antibodies, Monoclonal, Humanized, Immunoglobulin G, Immunosuppressive Agents, Interferon beta-1a, Multiple Sclerosis, Relapsing-Remitting, Outcome Assessment, Health Care |
| Abstract | BACKGROUND: No evidence of disease activity (NEDA) is a composite endpoint being increasingly applied as an outcome measure in clinical trials as well as proposed for individual therapeutic decisions in multiple sclerosis (MS). OBJECTIVE: Assess the proportion of patients with relapsing-remitting MS achieving NEDA in the DECIDE study of daclizumab 150 mg subcutaneous versus intramuscular interferon beta-1a 30 µg for 96-144 weeks. METHODS: NEDA was defined as no relapses, no onset of 12-week confirmed disability progression (CDP), no new/newly enlarging T2 hyperintense lesions (NET2), and no gadolinium-enhancing (Gd+) lesions. Logistic regression models adjusted for baseline covariates compared treatment groups for baseline to week 96, weeks 0-24, and weeks 24-96. RESULTS: From baseline to week 96, more daclizumab versus intramuscular interferon beta-1a patients achieved NEDA (24.6% vs 14.2%; odds ratio (OR; 95% confidence interval): 2.059 (1.592-2.661); p < 0.0001). ORs for clinical NEDA (no relapses, no CDP) and magnetic resonance imaging (MRI) NEDA (no NET2, no Gd+ lesions) were 1.651 (1.357-2.007; p < 0.0001) and 2.051 (1.628-2.582; p < 0.0001), respectively. ORs in favor of daclizumab for weeks 24-96 were consistently higher than for weeks 0-24. CONCLUSION: More daclizumab versus intramuscular interferon beta-1a patients achieved NEDA early in DECIDE, with effects increasing over time. |
| DOI | 10.1177/1352458516683266 |
| PubMed ID | 28080250 |