Ludwig Kappos1, Eva Havrdova2, Gavin Giovannoni3, Bhupendra O Khatri4, Susan A Gauthier5, Steven J Greenberg6, Xiaojun You7, Ping Wang7, Giorgio Giannattasio8. 1. Neurology Clinic and Policlinic, Departments of Medicine, Clinical Research and Biomedical Engineering, University Hospital Basel, University of Basel, Basel, Switzerland. 2. Department of Neurology, First Faculty of Medicine, Charles University in Prague, Prague, Czech Republic. 3. Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK. 4. Center for Neurological Disorders and The Regional Multiple Sclerosis Center, Wheaton Franciscan Health Care, Milwaukee, WI, USA. 5. Judith Jaffe Multiple Sclerosis Center, Weill Cornell Medical College, New York, NY, USA. 6. AbbVie, North Chicago, IL, USA. 7. Biogen, Cambridge, MA, USA. 8. Biogen, Zug, Switzerland.
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.
RCT Entities:
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.
Entities:
Keywords:
Composite outcome; clinical endpoints; daclizumab; disease-activity-free; magnetic resonance imaging; no evidence of disease activity; radiological endpoints; relapsing-remitting multiple sclerosis; treatment
Authors: Eva Havrdová; Douglas L Arnold; Amit Bar-Or; Giancarlo Comi; Hans-Peter Hartung; Ludwig Kappos; Fred Lublin; Krzysztof Selmaj; Anthony Traboulsee; Shibeshih Belachew; Iain Bennett; Regine Buffels; Hideki Garren; Jian Han; Laura Julian; Julie Napieralski; Stephen L Hauser; Gavin Giovannoni Journal: Mult Scler J Exp Transl Clin Date: 2018-03-12
Authors: Ludwig Kappos; Stanley Cohan; Douglas L Arnold; Randy R Robinson; Joan Holman; Sami Fam; Becky Parks; Shan Xiao; Wanda Castro-Borrero Journal: Ther Adv Neurol Disord Date: 2021-02-26 Impact factor: 6.570
Authors: Stig P Cramer; Helle J Simonsen; Aravinthan Varatharaj; Ian Galea; Jette L Frederiksen; Henrik B W Larsson Journal: Ann Neurol Date: 2018-05-11 Impact factor: 10.422