Subgroup and sensitivity analyses of annualized relapse rate over 2 years in the ADVANCE trial of peginterferon beta-1a in patients with relapsing-remitting multiple sclerosis.
ADVANCE was a 2-year, double-blind, placebo-controlled, Phase 3 study in 1512 patients aged 18-65 years with relapsing-remitting multiple sclerosis, which demonstrated that peginterferon beta-1a 125 mcg administered subcutaneously every 2 or 4 weeks led to significant reductions in annualized relapse rate (ARR) compared with placebo. This analysis examined ARR over 2 years in ADVANCE across subgroups. Patients were treated with peginterferon beta-1a every 2 weeks or every 4 weeks, or placebo during Year 1. Thereafter, patients on placebo were re-randomized to peginterferon beta-1a every 2 weeks or every 4 weeks (delayed treatment). Subgroup analyses were conducted by demographics and baseline disease characteristics. The following results compared ARR in these subgroups for patients in continuous 2-week treatment versus continuous 4-week treatment. ARR was similar in most demographic and baseline disease characteristic subgroups evaluated within the peginterferon beta-1a every-2-week arm or every-4-week arm over 2 years. Although for both doses some differences in the point estimates for ARR were noted among the subgroups, considerable overlap in the confidence intervals suggested that the efficacy of peginterferon beta-1a is similar in all patients irrespective of gender, age, body weight, geographical region, and disease activity at initiation of treatment. Within each peginterferon beta-1a dosing group, ARR was generally similar across most subgroups.
Department of Neurology, Johns Hopkins University, Baltimore, MD, USA. snewsom2@jhmi.edu.|Pathology 627, Johns Hopkins Neuroimmunology and Neuroinfectious Diseases, Johns Hopkins Hospital, 600 N. Wolfe St., Baltimore, MD, 21287, USA. snewsom2@jhmi.edu.
Scott D
SD
Newsome
Department of Neurology, Medical Faculty, Heinrich-Heine University, Düsseldorf, Germany.|Biogen, Cambridge, MA, USA.
Bernd C
BC
Kieseier
Montreal Neurological Institute, McGill University, Montreal, QC, Canada.|NeuroRx Research, Montreal, QC, Canada.
Douglas L
DL
Arnold
Biogen, Cambridge, MA, USA.
Shulian
S
Shang
Biogen, Cambridge, MA, USA.
Shifang
S
Liu
Biogen, Cambridge, MA, USA.
Serena
S
Hung
Biogen, Cambridge, MA, USA.
Guido
G
Sabatella
D000293:Adolescent; D000328:Adult; D000368:Aged; D004185:Disability Evaluation; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007155:Immunologic Factors / Q000627:therapeutic use*; D016899:Interferon-beta / Q000627:therapeutic use*; D038622:Internationality; D008297:Male; D008875:Middle Aged; D020529:Multiple Sclerosis, Relapsing-Remitting / Q000188:drug therapy* / Q000453:epidemiology / Q000503:physiopathology; D011092:Polyethylene Glycols / Q000627:therapeutic use*; D012008:Recurrence; D012680:Sensitivity and Specificity; D016896:Treatment Outcome; D055815:Young Adult
D007155:Immunologic Factors; D011092:Polyethylene Glycols; D016899:Interferon-beta; C428112:peginterferon beta-1a
Clinical trial; Interferon; Multiple sclerosis; Peginterferon beta-1a; Pegylated; Phase 3; Relapsing-remitting