Clinical investigation of methotrexate in the treatment of ankylosing spondylitis

Scand J Rheumatol. 2001;30(5):255-9. doi: 10.1080/030097401753180318.


Objectives: To investigate the efficacy and possible side effects of Methotrexate (MTX) treatment in patients with ankylosing spondylitis.

Methods: A total of 51 patients with a diagnosis of AS according to NewYork criteria were randomly distributed into 2 groups. In Group I (n = 25) only Naproxen (1000 mg/day) and in Group II (n = 26) oral MTX (7.5 mg/week) combined with Naproxen were given for 12 months. The patients were evaluated at 3, 6, and 12 months after the start of the treatment according to a number of clinical parameters using objective and subjective variables. Data were analysed using ki-square and Mann-Whitney U tests.

Results and conclusions: The comparison of the values using the percent changes and difference scores with respect to pretreatment values showed significant improvement in the "global evaluation of the physician" in Group II compared to Group I while no other parameter was found to be significantly different between the two groups. Those results have led us to conclude that a combination of MTX with Naproxen did not prove to be superior to Naproxen-alone treatment in terms of statistical significance. Further trials with MTX employing larger doses and different patient populations, mainly comprised of peripheral arthritis are necessary for delineation of the role of MTX in AS treatment.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial

MeSH terms

  • Administration, Oral
  • Adult
  • Aged
  • Anti-Inflammatory Agents, Non-Steroidal / administration & dosage
  • Anti-Inflammatory Agents, Non-Steroidal / pharmacology
  • Drug Therapy, Combination
  • Female
  • Humans
  • Immunosuppressive Agents / administration & dosage
  • Immunosuppressive Agents / pharmacology*
  • Male
  • Methotrexate / administration & dosage
  • Methotrexate / pharmacology*
  • Middle Aged
  • Naproxen / administration & dosage
  • Naproxen / pharmacology
  • Severity of Illness Index
  • Spondylitis, Ankylosing / drug therapy*
  • Spondylitis, Ankylosing / pathology
  • Treatment Outcome


  • Anti-Inflammatory Agents, Non-Steroidal
  • Immunosuppressive Agents
  • Naproxen
  • Methotrexate