Clinical Study Synopsis

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1 Clinical Study Synopsis This file is posted on the Bayer HealthCare Clinical Trials Registry and Results website. It is provided for patients and healthcare professionals to increase the transparency of Bayer's clinical research. This document is not intended to replace the advice of a healthcare professional and should not be considered as a recommendation. Patients should always seek medical advice before making any decisions on their treatment. Healthcare Professionals should always refer to the specific labeling information approved for the patient's country or region. Data in this document or on the related website should not be considered as prescribing advice. The study listed may include approved and non-approved formulations or treatment regimens. Data may differ from published or presented data and are a reflection of the limited information provided here. The results from a single trial need to be considered in the context of the totality of the available clinical research results for a drug. The results from a single study may not reflect the overall results for a drug. The following information is the property of Bayer HealthCare AG. Reproduction of all or part of this report is strictly prohibited without prior written permission from Bayer HealthCare AG. Commercial use of the information is only possible with the written permission of the proprietor and is subject to a license fee. Please note that the General Conditions of Use and the Privacy Statement of bayerhealthcare.com apply to the contents of this file.

2 Clinical Trial Results Synopsis Study Design Description Study Sponsor: Bayer Healthcare AG Bayer Healthcare Pharmaceuticals Inc. Study Number: (N IMPACT) BF0610FR (Trial Alias) NCT Study Phase: IV (Prospective Non-Interventional) Official Study Title: Prospective multicenter, non-interventional study to evaluate the impact of the introduction of interferon beta-1 b treatment on daily life activities in patients at high risk of developing Multiple Sclerosis after a first clinical demyelinating event or having received a confirmed diagnosis of RRMS DAILY LIFE Study Therapeutic Area: Neurology Test Product Name of Test Product: Interferon beta-1b (Betaseron, BAY ) Name of Active Ingredient: Dose and Mode of Administration: BAY microgrammes, parenteral pathway Reference Therapy/Placebo Reference Therapy: NA Dose and Mode of Administration: NA Duration of Treatment: 12 months Studied period: Date of first subjects first visit: {09 May 2007} Page 1 of 5

3 Date of last subjects last visit: {29 March 2010} Study Center(s): Multicenter (27 sites) in France Methodology: 1- clinical assessement and evaluation of treatment tolerability by the neurologist in CRF 2- Four self-questionnary completed by the patient to evaluate the patient's well-being (Daily Life questionnary), Duality of Life (SF36), Fatigue (FSS) and depression questionnary (Beck's depression) Indication/ Main Inclusion Criteria: Confirmed diagnosis of Relapsing-Remitting Multiple Sclerosis (RRMS) patients at high risk of developing Multiple Sclerosis after a first clinical demyelinating Male or females aged 18 years or over having received a confirmed diagnosis of RRMS as defined by the MacDonald or Poser criteria or after a first clinical demyelinating event suggestive of Multiple Sclerosis The choice of treatment must be clearly dissociated from the decision to enroll the patient in the study Study Objectives: Overall: Evolution of Daily life score of Daily life scale Primary: To evaluate the evolution of the impact on daily life activities over the first 12 months following the introduction of interferon beta-1b treatment in patients presenting RRMS (in line with Market a authorization) or patients at high risk of developing Multiple Sclerosis after a first clinical demyelinating event Secondary: - Evolution of the SF 36 score, fatigue score, Beck's depression score: analysis of variance for repeated measurements over 12 months - Correlation coefficient with quality of life scales over 12 months Kinetics of treatment discontinuation by Kaplan Meier over 12 months - Rate of treatment continuation after 12 months Evaluation Criteria: Efficacy (Primary): Evolution of Daily Life score: Analysis of variance for repeated measurements after 1, 3 6, 9 and 12 months Efficacy (Secondary): Evolution of the SF36 score, fatigue score, Beck's depression score: analysis of variance for repeated measurements Page 2 of 5

4 Safety: Gather observational data on the profil of treatment tolerability Statistical Methods: Efficacy (Primary) - if applicable: Analysis of the evolution of Daily Life score involved (1) one-factor analysis of variance for repeated measures (2) comparison between score at inclusion (M0) and M6 after replacement of missing values using LOCF, (3) comparison between score at inclusion (M0) and last value (M12) after replacement of missing values using LOCF Efficacy (Secondary) - if applicable: Evolution of the SF36 score, fatigue score Beck's depression score / Analysis of variance for repeated measurements Correlation coefficient with quality of life scales Kinetics of treatment discontinuation : Kaplan Meier Safety: Treatment tolerability was assessed by AE reporting at M6 and M12. They were coded using the MedDRA dictionary and analysed in terms of frequency, severity and outcome. Number of Subjects: Planned: 80 patients. Selected: 67 patients Safety population: 63 patients Efficacy ITT population: 44 patients Study Results Results Summary Subject Disposition and Baseline In a population of 44 young patients (35.8±9.5 years old) with recent symptoms and diagnosis of MS and with only slight physical disability, if ever (EDSS < 2 in 36%, EDSS 2-3 in 50% and EDSS>3 in 14%), daily life activities were found to be not deeply impaired. The difficulties involved mostly activities which required sustained physical strength such as working/studying (3.34±4.17), doing sports (1.78±1.49), gardening/doing-it-yourself (1.36±1.50) and house keeping (1.17±1.36). Other activities were less impaired. The patient quality of life was also impaired as shown by the bad scores in two main dimensions (role physical 47.02±42.12 and role emotional 44.44±42.72). Symptoms of depression were unfrequent (5 patients (11.36%) reported signs of moderate depression and 4 patients (9.09%) were receiving antidepressants. Fatigue was important in most patients (mild 18%, moderate 43%, severe 39%) even if no patient was receiving any antiasthenic treatment at inclusion Page 3 of 5

5 Results Summary Efficacy Over of the 12-month follow-up period: - 16 patients (36%) reported a total of 37 relapses over the follow-up period. According to the investigator s judgement, physical condition worsened in 30% of patients over the followup period but no relation was found with the occurrence of relapses. EDSS remained stable (p=0.08) and no more than 2 patients (4.55%) showed a relevant increase of 1 point or more from baseline to endpoint. - Patient s capacities in daily activities worsened globally over the follow-up period: DL mean score increased from 0.98±1.10 at baseline to 1.26±1.16 at endpoint (p=0.02) but there was no dramatic increase of DL mean score in the months following the start of interferon beta- 1b. - The patient s quality of life, the severity of fatigue and the depression level remained globally unchanged over the study. A secondary objective of the study was to evaluate the sensitivity to change of the DL scale. This implied to separate the population into subsets characterized by relevant differences in terms of clinical evolution. However, the population of MS patients could not be split into relevant subsets since globally the condition of patients remained stable over the follow-up period. Therefore the responsiveness to change of DL could not be evaluated. This cannot mean that DL is not sensitive to change because responsiveness to change of the SF36 score (although well validated) was found to be very poor in this study evocating a classification bias. A correlation was found between the DL mean score with all dimensions of the SF-36 scale with higher coefficients for physical dimensions than for mental dimensions. However a correlation was found between DL score and the role emotional dimension of the SF36 suggesting that MS impact on daily activities is not limited to physical dimensions. The DL scale was also correlated to the Fatigue Severity Scale (R=0.581) and to the Beck Inventory Depression scale (R=0.667). Investigators and patients were both satisfied with treatment with interferon beta-1b and respectively 72.73% (CI 95% [59.57% %]) and 67.44% (CI 95% [53.44% %]) of them were willing pursue the treatment at the end of study. Results Summary Safety A total of 215 AEs were reported by 60 out of the 63 treated patients (95.24%) during the 12-month treatment period. Among them, 175 AEs were judged related to treatment with interferon beta-1b: they were mostly administration site reactions, flu-like symptoms, abnormal change in hepatic enzymes, headache and fatigue. 7 patients (11.11%) were concerned with at least one AE related to interferon beta-1b that led to definitive treatment discontinuation. Four SAEs were reported among which two SAEs judged related to study treatment that led to study discontinuation: one episode of mild toxic hepatitis and one suicide attempt. Globally, 29% of patients definitively discontinued treatment with interferon beta-1b, mostly at the end of follow-up period without relation to treatment tolerability Conclusion(s) This was a prospective multicenter non-interventional study to evaluate the impact of the introduction of interferon beta-1b treatment on daily life activities in patients at high risk of developing MS after a first demyelinating event or having received a confirmed diagnosis of Page 4 of 5

6 MS. The primary objective of the study was to evaluate the evolution of the impact on daily life activities over the first 12 months following the introduction of interferon beta-1b in these patients. Secondary objectives were to collect more data about psychometric properties of the Daily Life questionnaire including responsiveness to change. The responsiveness to change of Daily Life could not be evaluated, even the change of the SF36 score was found to be very poor in this study evocating a classification bias. The AEs generally reported were judged related to treatment with interferon beta-1b. Publication(s): NA Date Created or Date Last Updated: { } Page 5 of 5

7 Appendix to Clinical Study Synopsis Product Identification Information Product Type US Brand/Trade Name(s) Brand/Trade Name(s) ex-us Generic Name Main Product Company Code Biological product Betaseron Betaseron, Betaferon Interferon beta 1b BAY Other Company Code(s) ZK Chemical Description Recombinant protein Other Product Aliases Date of last Update/Change: 16 Aug 2011

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