title: Prevalence of cutaneous adverse events associated with long-term disease-modifying therapy and their impact on health-related quality of life in patients with multiple sclerosis: a cross-sectional study.
abstract: BACKGROUND
  Glatiramer acetate (GA) and interferon-beta (IFN-β) are disease-modifying therapies (DMTs) for multiple sclerosis that are administered through subcutaneous (SC) or intramuscular (IM) injections. Skin reactions associated with DMTs are common and may influence patient's health-related quality of life (QoL). We aimed to determine the prevalence of cutaneous adverse events associated with long-term DMT use, and to assess the impact of cutaneous adverse events on QoL.
  
  
  METHODS
  A cross-sectional study among patients with multiple sclerosis who had been treated with their first DMT for at least 2 years. Cutaneous events were assessed from photographs of injection-sites by dermatologists blinded for DMT. Generic and dermatology-specific health-related QoL were assessed using validated patient-reported questionnaires.
  
  
  RESULTS
  A total of 229 patients were enrolled, of whom 156 (68%) had at least one skin reaction. The prevalence of cutaneous adverse events was higher for SC DMTs (75-82%) compared to IM DMT (41%) (P < 0.001). Erythema and lipoatrophy were the most common skin reactions, observed in 156 (68%) and 45 (20%) patients, respectively. Dermatology-specific, but not generic, QoL was significantly lower among patients with skin reactions compared to those without.
  
  
  CONCLUSIONS
  The prevalence of cutaneous adverse events was high in long-term DMT-treatment. Patients with cutaneous adverse events had a lower perceived dermatology-specific QoL.
authors.affiliation: Department of Dermatology, Erasmus Medical Center, Burg, s' Jacobsplein 51, 3015 CA, Rotterdam, the Netherlands. d.balak@erasmusmc.nl.
authors.forename: Deepak M W
authors.initials: DM
authors.lastname: Balak
authors.forename: Gerald J D
authors.initials: GJ
authors.lastname: Hengstman
authors.forename: Enes
authors.initials: E
authors.lastname: Hajdarbegovic
authors.forename: Rob J P
authors.initials: RJ
authors.lastname: van den Brule
authors.forename: Raymond M M
authors.initials: RM
authors.lastname: Hupperts
authors.forename: Hok Bing
authors.initials: HB
authors.lastname: Thio
mesh_terms: D000279:Administration, Cutaneous; D000328:Adult; D003430:Cross-Sectional Studies; D064420:Drug-Related Side Effects and Adverse Reactions / Q000175:diagnosis / Q000453:epidemiology* / Q000523:psychology; D004890:Erythema / Q000139:chemically induced / Q000453:epidemiology; D005260:Female; D000068717:Glatiramer Acetate; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage* / Q000009:adverse effects*; D007273:Injections, Intramuscular; D016899:Interferon-beta / Q000008:administration & dosage / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D009103:Multiple Sclerosis / Q000188:drug therapy* / Q000453:epidemiology* / Q000523:psychology; D010455:Peptides / Q000008:administration & dosage / Q000009:adverse effects; D015995:Prevalence; D011788:Quality of Life / Q000523:psychology; D013997:Time Factors
chemical_list: D007166:Immunosuppressive Agents; D010455:Peptides; D000068717:Glatiramer Acetate; D016899:Interferon-beta