title: Maintenance of biologic-free remission with naproxen or no treatment in patients with early, active axial spondyloarthritis: results from a 6-month, randomised, open-label follow-up study, INFAST Part 2.
abstract: OBJECTIVE
  To investigate whether biologic-free remission can be achieved in patients with early, active axial spondyloarthritis (SpA) who were in partial remission after 28 weeks of infliximab (IFX)+naproxen (NPX) or placebo (PBO)+NPX treatment and whether treatment with NPX was superior to no treatment to maintain disease control.
  
  
  METHODS
  Infliximab as First-Line Therapy in Patients with Early Active Axial Spondyloarthritis Trial (INFAST) Part 1 was a double-blind, randomised, controlled trial in biologic-naïve patients with early, active, moderate-to-severe axial SpA treated with either IFX 5 mg/kg+NPX 1000 mg/d or PBO+NPX 1000 mg/d for 28 weeks. Patients achieving Assessment of SpondyloArthritis international Society (ASAS) partial remission at week 28 continued to Part 2 and were randomised (1:1) to NPX or no treatment until week 52. Treatment group differences in ASAS partial remission and other efficacy variables were assessed through week 52 with Fisher exact tests.
  
  
  RESULTS
  At week 52, similar percentages of patients in the NPX group (47.5%, 19/40) and the no-treatment group (40.0%, 16/40) maintained partial remission, p=0.65. Median duration of partial remission was 23 weeks in the NPX group and 12.6 weeks in the no-treatment group (p=0.38). Mean Bath Ankylosing Spondylitis Disease Activity Index scores were low at week 28, the start of follow-up treatment (NPX, 0.7; no treatment, 0.6), and remained low at week 52 (NPX, 1.2; no treatment, 1.7).
  
  
  CONCLUSIONS
  In axial SpA patients who reached partial remission after treatment with either IFX+NPX or NPX alone, disease activity remained low, and about half of patients remained in remission during 6 months in which NPX was continued or all treatments were stopped.
authors.affiliation: Medical Department I, Rheumatology, Charité Campus Benjamin Franklin, , Berlin, Germany.
authors.forename: J
authors.initials: J
authors.lastname: Sieper
authors.forename: J
authors.initials: J
authors.lastname: Lenaerts
authors.forename: J
authors.initials: J
authors.lastname: Wollenhaupt
authors.forename: M
authors.initials: M
authors.lastname: Rudwaleit
authors.forename: V I
authors.initials: VI
authors.lastname: Mazurov
authors.forename: L
authors.initials: L
authors.lastname: Myasoutova
authors.forename: S
authors.initials: S
authors.lastname: Park
authors.forename: Y
authors.initials: Y
authors.lastname: Song
authors.forename: R
authors.initials: R
authors.lastname: Yao
authors.forename: D
authors.initials: D
authors.lastname: Chitkara
authors.forename: N
authors.initials: N
authors.lastname: Vastesaeger
mesh_terms: D000293:Adolescent; D000328:Adult; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage* / Q000009:adverse effects; D004311:Double-Blind Method; D042241:Early Diagnosis; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D009288:Naproxen / Q000008:administration & dosage* / Q000009:adverse effects; D010919:Placebos; D012074:Remission Induction; D025241:Spondylarthritis / Q000175:diagnosis / Q000188:drug therapy*; D013167:Spondylitis, Ankylosing / Q000175:diagnosis / Q000188:drug therapy*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D010919:Placebos; D009288:Naproxen
keywords: NSAIDs; Spondyloarthritis; TNF-alpha