New natural history of interferon-β treated relapsing multiple sclerosis

被引:235
作者
Trojano, Maria
Pellegrini, Fabio
Fuiani, Aurora
Paolicelli, Damiano
Zipoli, Valentina
Zimatore, Giovanni B.
Di Monte, Elisabetta
Portaccio, Emilio
Lepore, Vito
Livrea, Paolo
Amato, Maria Pia
机构
[1] Univ Bari, Dept Neurol & Psychiat Sci, I-70124 Bari, Italy
[2] Consorzio Mario Negri Sud, Dept Clin Pharmacol & Epidemiol, Chieti, Italy
[3] Univ Florence, Dept Neurol, Florence, Italy
关键词
D O I
10.1002/ana.21102
中图分类号
R74 [神经病学与精神病学];
学科分类号
摘要
Objective: To investigate the impact of interferon-beta (IFN beta) on disease progression in relapsing-remitting multiple sclerosis patients. Methods: A cohort of 1,504 relapsing-remitting multiple sclerosis (1,103 IFN beta-treated and 401 untreated) patients was followed for up to 7 years. Cox proportional hazards regression adjusted for propensity score inverse weighting was used to assess the differences between the two groups for three different clinical end points: secondary progression (SP) and irreversible Expanded Disability Status Scale (EDSS) scores 4 and 6. Times from first visit and from date of birth were used as survival time variables. Results-The IFN beta-treated group showed a highly significant reduction in the incidence of SP (hazard ratio [HR], 0.38, 95% confidence interval [CI], 0.24-0.58 for time from 1st visit; HR, 0.36, 95% CI, 0.23-0.56 for time from date of birth; p < 0.0001), EDSS score of 4 (HR, 0.70, 95% CI, 0.53-0.94 for time from first visit; HR, 0.69, 95% CI, 0.52-0.93 for time from date of birth; p < 0.02), and EDSS score of 6 (HR, 0.60, 95% CI, 0.38-0.95 for time from first visit; HR, 0.54, 95% CI, 0.34-0.86 for time from date of birth; p <= 0.03) when compared with untreated patients. SP and EDSS scores of 4 and 6 were reached with significant delays estimated by times from first visit (3.8, 1.7, and 2.2 years) and from date of birth (8.7, 4.6, and 11.7 years) in favor of treated patients. Sensitivity analysis confirmed findings. Interpretation: IFN-beta slows progression in relapsing-remitting multiple sclerosis patients.
引用
收藏
页码:300 / 306
页数:7
相关论文
共 45 条
[21]   Long-term subcutaneous interferon beta-1a therapy in patients with relapsing-remitting MS [J].
Kappos, L. ;
Traboulsee, A. ;
Constantinescu, C. ;
Eraelinna, J.-P. ;
Forrestal, F. ;
Jongen, P. ;
Pollard, J. ;
Sandberg-Wollheim, M. ;
Sindic, C. ;
Stubinski, B. ;
Uitdehaag, B. ;
Li, D. .
NEUROLOGY, 2006, 67 (06) :944-953
[22]   The natural history of multiple sclerosis: a geographically based study - 9: Observations on the progressive phase of the disease [J].
Kremenchutzky, M ;
Rice, GPA ;
Baskerville, J ;
Wingerchuk, DM ;
Ebers, GC .
BRAIN, 2006, 129 :584-594
[23]  
KURTZKE JF, 1983, NEUROLOGY, V33, P1444, DOI 10.1212/WNL.33.11.1444
[24]   Observational studies of treatment effectiveness: Some cautions [J].
Laupacis, A ;
Mamdani, M .
ANNALS OF INTERNAL MEDICINE, 2004, 140 (11) :923-924
[25]   Assessing the sensitivity of regression results to unmeasured confounders in observational studies [J].
Lin, DY ;
Psaty, BM ;
Kronmal, RA .
BIOMETRICS, 1998, 54 (03) :948-963
[26]   Placebo-controlled clinical trials in multiple sclerosis: Ethical considerations [J].
Lublin, FD ;
Reingold, SC .
ANNALS OF NEUROLOGY, 2001, 49 (05) :677-681
[27]   Stratification and weighting via the propensity score in estimation of causal treatment effects: a comparative study [J].
Lunceford, JK ;
Davidian, M .
STATISTICS IN MEDICINE, 2004, 23 (19) :2937-2960
[28]   Recommended diagnostic criteria for multiple sclerosis: Guidelines from the International Panel on the Diagnosis of Multiple Sclerosis [J].
McDonald, WI ;
Compston, A ;
Edan, G ;
Goodkin, D ;
Hartung, HP ;
Lublin, FD ;
McFarland, HF ;
Paty, DW ;
Polman, CH ;
Reingold, SC ;
Sandberg-Wollheim, M ;
Sibley, W ;
Thompson, AJ ;
van den Noort, S ;
Weinshenker, BY ;
Wolinsky, JS .
ANNALS OF NEUROLOGY, 2001, 50 (01) :121-127
[29]  
Mechati S., 2001, MULT SCLER J, V7, pS31
[30]   Readers guide to critical appraisal of cohort studies: 3. Analytical strategies to reduce confounding [J].
Normand, SLT ;
Sykora, K ;
Li, P ;
Mamdani, M ;
Rochon, PA ;
Anderson, GM .
BMJ-BRITISH MEDICAL JOURNAL, 2005, 330 (7498) :1021-1023