title: Partial remission in ankylosing spondylitis and non-radiographic axial spondyloarthritis in treatment with infliximab plus naproxen or naproxen alone: associations between partial remission and baseline disease characteristics.
abstract: OBJECTIVE
  To evaluate partial remission during treatment with infliximab (IFX) + naproxen (NPX) vs NPX alone in patients from the two subgroups of SpA and explore baseline predictors of partial remission.
  
  
  METHODS
  Infliximab as First Line Therapy in Patients with Early Active Axial Spondyloarthritis Trial was a double-blind, randomised controlled trial of IFX in biologic-naïve patients with early, active axial SpA. Patients were randomised (2:1) to receive 28 weeks of treatment with i.v. IFX 5 mg/kg (weeks 0, 2, 6, 12, 18 and 24) + NPX 1000 mg/day or i.v. placebo (PBO) + NPX 1000 mg/day. The current post hoc analysis evaluated outcomes in patients who did or did not meet modified New York radiographic criteria for AS.
  
  
  RESULTS
  The analysis included 94 patients who met AS criteria and 56 with non-radiographic axial SpA (nr-axSpA). At week 28, Assessment of SpondyloArthritis international Society (ASAS) partial remission was greater with IFX + NPX than PBO + NPX for both the AS group (70.5 vs 33.3%, respectively) and the nr-axSpA group (50.0 vs 37.5%, respectively). A similar pattern occurred with several efficacy measures. Larger treatment effects occurred in the AS group than the nr-axSpA group, possibly due to baseline differences in disease characteristics. Multivariable analyses identified the type of treatment, age and HLA-B27 status as predictors of ASAS partial remission in the total study population. MRI sacroiliac joint scores were associated with partial remission during IFX + NPX treatment.
  
  
  CONCLUSIONS
  Patients with AS had greater partial remission with IFX + NSAID than NSAID therapy alone; patients with nr-axSpA had a smaller treatment effect. Baseline disease characteristics and age were associated with partial remission with IFX therapy.
authors.affiliation: Department of Gastroenterology, Infectiology, and Rheumatology, Charité, University Medicine Berlin, Berlin, Germany joachim.sieper@charite.de.
authors.forename: Joachim
authors.initials: J
authors.lastname: Sieper
authors.affiliation: Department of Gastroenterology, Infectiology, and Rheumatology, Charité, University Medicine Berlin, Berlin, Germany.
authors.forename: Martin
authors.initials: M
authors.lastname: Rudwaleit
authors.affiliation: Department of Rheumatology, REUMA Instituut, Hasselt, Belgium.
authors.forename: Jan
authors.initials: J
authors.lastname: Lenaerts
authors.affiliation: Department Rheumatology and Clinical Immunology, Schön-Klinik, Hamburg, Germany.
authors.forename: Jürgen
authors.initials: J
authors.lastname: Wollenhaupt
authors.affiliation: Department of Rheumatology, Kazan State Medical University, Kazan, Russia.
authors.forename: Leysan
authors.initials: L
authors.lastname: Myasoutova
authors.affiliation: Division of Rheumatology, Department of Internal Medicine, Seoul St. Mary's Hospital, Catholic University of Korea.
authors.forename: Sung-Hwan
authors.initials: SH
authors.lastname: Park
authors.affiliation: Division of Rheumatology, Department of Internal Medicine, Seoul National University Hospital, Seoul, South Korea.
authors.forename: Yeong W
authors.initials: YW
authors.lastname: Song
authors.affiliation: Division of Rheumatology, Department of Internal Medicine.
authors.forename: Ruji
authors.initials: R
authors.lastname: Yao
authors.affiliation: Department of Biostatistics, Merck & Co, Kenilworth, NJ, USA.
authors.forename: Susan
authors.initials: S
authors.lastname: Huyck
authors.affiliation: Department of Immunology, MSD Italy, Global Medical Affairs, Rome, Italy.
authors.forename: Marinella
authors.initials: M
authors.lastname: Govoni
authors.affiliation: Department of Clinical Research, Merck & Co, Kenilworth, NJ, USA.
authors.forename: Denesh
authors.initials: D
authors.lastname: Chitkara
authors.affiliation: Department of Medical Affairs, MSD Belgium, Brussels, Belgium.
authors.forename: Nathan
authors.initials: N
authors.lastname: Vastesaeger
mesh_terms: D000293:Adolescent; D000328:Adult; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D000069285:Infliximab / Q000008:administration & dosage*; D007262:Infusions, Intravenous; D008297:Male; D008875:Middle Aged; D009288:Naproxen / Q000008:administration & dosage*; D012074:Remission Induction; D025241:Spondylarthritis / Q000188:drug therapy*; D013167:Spondylitis, Ankylosing / Q000188:drug therapy*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D009288:Naproxen; D000069285:Infliximab
keywords: ankylosing spondylitis; axial spondyloarthritis; biological products; early disease; infliximab; remission induction; treatment outcome; tumour necrosis factor α