Abstract Details

Title Indirect Comparisons of Oral Fingolimod Versus Natalizumab on Measures of Disease Freedom Based on Results from FREEDOMS and AFFIRM

Topic MS and Related Diseases

Presentation(s) P01 - (-)

Poster/Presentation
Number 209

Objective

Background BACKGROUND: A previous indirect comparison adjusting for covariate differences suggested fingolimod may have similar efficacy to natalizumab in reducing relapse rates and delaying disability progression.

Design/Methods DESIGN/METHODS: The probability of being disease free was estimated using binomial regression with an identity link function; baseline patient characteristics as main and treatment-interaction terms to predict the probability of being disease free given the mean baseline characteristics of a population and the treatment assigned.

Results RESULTS: The ratio between fingolimod and placebo with respect to patients free from relapses was predicted to be 1.75 (95 % CI: 1.51 - 2.03) in the modelled population using AFFIRM characteristics, which is similar to that reported for natalizumab (1.63). The corresponding results for the analyses of 3-month disability progression were 1.15 (95 % CI: 1.06 - 1.24) and 1.17 for fingolimod and natalizumab. With respect to MRI endpoints, the predicted ratio of free from Gd T1 lesions in the modelled population using AFFIRM characteristics, 1.65 (95 % CI: 1.44 - 1.89), was similar to that reported for natalizumab (1.68), the predicted ratio of being free from T2 lesions in a AFFIRM-like population, was 2.94 (95 % CI: 2.21 - 3.92), vs 3.93 (95 % CI: 2.96 - 5.20) for natalizumab.

Conclusions CONCLUSIONS: Results suggest that in an AFFIRM-like population, when differences between the FREEDOMS and AFFIRM trials in patient characteristics and endpoint definitions are taken into account, fingolimod may have an effect more similar to natalizumab with respect to probabilities of being free from relapses, disability progression and Gd T1 lesions than trial results suggest. However, this needs to be interpreted with caution, and cannot be compared to evidence from a randomized clinical trial.

Authors/Disclosures
Richard Nixon PRESENTER	No disclosure on file
Niklas Bergvall	No disclosure on file
Stephen Wanaski, PhD (Paragon Biosciences)	Dr. Wanaski has received personal compensation for serving as an employee of Paragon Biosciences. Dr. Wanaski has or had stock in Paragon Biosciences.Dr. Wanaski has or had stock in Emalex Biosciences.
Nicolaos Sfikas (Novartis Pharma AG)	No disclosure on file
Peter S. Chin, MD (Denali)	No disclosure on file
Davorka Tomic-Wallis, PhD (Biogen Idec)	No disclosure on file
Gary R. Cutter, PhD (University of Alabama At Birmingham)	Dr. Cutter has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for onsulting or Advisory Boards: Alexion, Antisense Therapeutics/Percheron, Avotres, Biogen, Clene Nanomedicine, Clinical Trial Solutions LLC, Endra Life Sciences, Cognito Therapeutics, Genzyme, Genentech, Immunic, Klein-Buendel Incorporated, Kyverna Therapeutics, Inc. , Linical, Merck/Serono, Noema, Neurogenesis, Perception Neurosciences, Protalix Biotherapeutics, Regeneron, Revelstone Consulting, Roche, SAB Biotherapeutics, Sapience Therapeutics, Scott&Scott LLP, Tenmile.. Dr. Cutter has received personal compensation in the range of $50,000-$99,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Data and Safety Monitoring Boards: Applied Therapeutics, AI therapeutics, AMO Pharma, Argenx, Astra-Zeneca, Avexis Pharmaceuticals, Bristol Meyers Squibb, CSL Behring, Cynata Therapeutics, DiamedicaTherapeutics, Horizon Pharmaceuticals, Immunic, Inhibrix, Karuna Therapeutics, Kezar Life Sciences, Medtronic, Merck, Meiji Seika Pharma, Mitsubishi Tanabe Pharma Holdings, Prothena Biosciences, Novartis, Pipeline Therapeutics (Contineum), Regeneron, Sanofi-Aventis, Teva Pharmaceuticals, United BioSource LLC, University of Texas Southwestern.. Dr. Cutter has received personal compensation in the range of $5,000-$9,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for JASN.
Ludwig Kappos, MD, FAAN (RC2NB, University Hospital Basel)	Dr. Kappos has nothing to disclose.

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