TY - JOUR
T1 - Evaluating the safety of beta-interferons in MS A series of nested case-control studies
AU - de Jong, Hilda J. I.
AU - Kingwell, Elaine
AU - Shirani, Afsaneh
AU - Tervaert, Jan Willem Cohen
AU - Hupperts, Raymond
AU - Zhao, Yinshan
AU - Zhu, Feng
AU - Evans, Charity
AU - van der Kop, Mia L.
AU - Traboulsee, Anthony
AU - Gustafson, Paul
AU - Petkau, John
AU - Marrie, Ruth Ann
AU - Tremlett, Helen
AU - British Columbia Multiple Sclerosi
PY - 2017/6/13
Y1 - 2017/6/13
N2 - Objective: To examine the association between interferon-beta (IFN-beta) and potential adverse events using population-based health administrative data in British Columbia, Canada.Methods: Patients with relapsing-remitting multiple sclerosis (RRMS) who were registered at a British Columbia Multiple Sclerosis Clinic (1995-2004) were eligible for inclusion and were followed up until death, absence from British Columbia, exposure to a non-IFN-beta disease-modifying drug, or December 31, 2008. Incidence rates were estimated for each potential adverse event (selected a priori and defined with ICD-9/10 diagnosis codes from physician and hospital claims). A nested case-control study was conducted to assess the odds of previous IFN-beta exposure for each potential adverse event with at least 30 cases. Cases were matched by age (65 years), sex, and year of cohort entry, with up to 20 randomly selected (by incidence density sampling) controls. Odds ratios (ORs) with 95% confidence intervals (95% CIs) were estimated with conditional logistic regression adjusted for age at cohort entry.Results: Of the 2,485 eligible patients, 77.9% were women, and 1,031 were treated with IFN-beta during follow-up. From the incidence analyses, 27 of the 47 potential adverse events had at least 30 cases. Patients with incident stroke (ORadj 1.83, 95% CI 1.16-2.89), migraine (ORadj 1.55, 95% CI 1.18-2.04), depression (ORadj 1.33, 95% CI 1.13-1.56), and hematologic abnormalities (ORadj 1.32, 95% CI 1.01-1.72) were more likely to have previous exposure to IFN-beta than controls.Conclusions: Among patients with RRMS, IFN-beta was associated with a 1.8-and 1.6-fold increase in the risk of stroke and migraine and 1.3-fold increases in depression and hematologic abnormalities.
AB - Objective: To examine the association between interferon-beta (IFN-beta) and potential adverse events using population-based health administrative data in British Columbia, Canada.Methods: Patients with relapsing-remitting multiple sclerosis (RRMS) who were registered at a British Columbia Multiple Sclerosis Clinic (1995-2004) were eligible for inclusion and were followed up until death, absence from British Columbia, exposure to a non-IFN-beta disease-modifying drug, or December 31, 2008. Incidence rates were estimated for each potential adverse event (selected a priori and defined with ICD-9/10 diagnosis codes from physician and hospital claims). A nested case-control study was conducted to assess the odds of previous IFN-beta exposure for each potential adverse event with at least 30 cases. Cases were matched by age (65 years), sex, and year of cohort entry, with up to 20 randomly selected (by incidence density sampling) controls. Odds ratios (ORs) with 95% confidence intervals (95% CIs) were estimated with conditional logistic regression adjusted for age at cohort entry.Results: Of the 2,485 eligible patients, 77.9% were women, and 1,031 were treated with IFN-beta during follow-up. From the incidence analyses, 27 of the 47 potential adverse events had at least 30 cases. Patients with incident stroke (ORadj 1.83, 95% CI 1.16-2.89), migraine (ORadj 1.55, 95% CI 1.18-2.04), depression (ORadj 1.33, 95% CI 1.13-1.56), and hematologic abnormalities (ORadj 1.32, 95% CI 1.01-1.72) were more likely to have previous exposure to IFN-beta than controls.Conclusions: Among patients with RRMS, IFN-beta was associated with a 1.8-and 1.6-fold increase in the risk of stroke and migraine and 1.3-fold increases in depression and hematologic abnormalities.
KW - MULTIPLE-SCLEROSIS
KW - DISEASE
KW - MIGRAINE
KW - DRUG
KW - ASSOCIATION
KW - PROGRESSION
KW - INDUCTION
KW - EXPOSURE
KW - STROKE
KW - IMPACT
U2 - 10.1212/WNL.0000000000004037
DO - 10.1212/WNL.0000000000004037
M3 - Article
C2 - 28500224
SN - 0028-3878
VL - 88
SP - 2310
EP - 2320
JO - Neurology
JF - Neurology
IS - 24
ER -