title: Safety and efficacy of hydroxychloroquine as maintenance therapy for rheumatoid arthritis after combination therapy with methotrexate and hydroxychloroquine.
abstract: OBJECTIVE
  To evaluate the ability of hydroxychloroquine sulfate (HCQ) to extend the response to combination therapy with HCQ and methotrexate (MTX) and the safety of longterm HCQ maintenance therapy in patients with active rheumatoid arthritis (RA).
  
  
  METHODS
  Two-part study consisting of an open label segment evaluating combination HCQ/MTX therapy followed by a double blind segment evaluating maintenance therapy for a total of 60 weeks. First, all patients were treated with HCQ 400 mg/day and MTX 7.5 to 15 mg/week for 24 weeks. Then, responders were randomized into 3 groups: (1) HCQ with MTX as needed for disease flare (n = 40), (2) HCQ 400 mg/day (n = 41), or (3) placebo with MTX as needed for disease flare (n = 40), each for 36 weeks.
  
  
  RESULTS
  Clinical disease and laboratory variables improved significantly during initial combination therapy with HCQ and MTX. After MTX withdrawal, HCQ-containing maintenance regimens delayed the onset of disease flare (p = 0.023). There were no unexpected adverse events at any time or between-group differences in the distribution of adverse events during the double blind segment.
  
  
  CONCLUSIONS
  Combination of HCQ and MTX appeared to be effective and well tolerated for 24 weeks. After withdrawal of MTX, HCQ extended the response seen with combination therapy and was well tolerated for 36 weeks. Initial therapy with HCQ and MTX, followed by maintenance HCQ, may be a useful alternative for the treatment of RA.
authors.affiliation: Department of Medicine, University of Utah School of Medicine, Salt Lake City, Utah, USA.
authors.forename: D O
authors.initials: DO
authors.lastname: Clegg
authors.forename: F
authors.initials: F
authors.lastname: Dietz
authors.forename: J
authors.initials: J
authors.lastname: Duffy
authors.forename: R F
authors.initials: RF
authors.lastname: Willkens
authors.forename: E
authors.initials: E
authors.lastname: Hurd
authors.forename: B F
authors.initials: BF
authors.lastname: Germain
authors.forename: B
authors.initials: B
authors.lastname: Wall
authors.forename: D J
authors.initials: DJ
authors.lastname: Wallace
authors.forename: C L
authors.initials: CL
authors.lastname: Bell
authors.forename: J
authors.initials: J
authors.lastname: Sleckman
mesh_terms: D000368:Aged; D001172:Arthritis, Rheumatoid / Q000188:drug therapy*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D006886:Hydroxychloroquine / Q000008:administration & dosage*; D008297:Male; D008727:Methotrexate / Q000008:administration & dosage*; D008875:Middle Aged; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D006886:Hydroxychloroquine; D008727:Methotrexate