Efficacy and safety of methotrexate in articular and cutaneous manifestations of systemic lupus erythematosus

Int J Rheum Dis. 2012 Feb;15(1):62-8. doi: 10.1111/j.1756-185X.2011.01665.x. Epub 2011 Sep 21.


Aim: A prospective open-label study comparing the efficacy and safety of methotrexate (MTX) and chloroquine (CQ) in articular and cutaneous manifestations of systemic lupus erythematosus (SLE).

Methods: Consecutive SLE patients were randomly assigned to either 10 mg MTX weekly or 150 mg CQ daily during 24 weeks. Outcome measures were: numbers of swollen and tender joints, duration of morning stiffness, visual analog scale (VAS) for articular pain, physician global assessment index, patient global assessment index, SLE Disease Activity Index (SLEDAI), disappearance of skin rash and erythrocyte sedimentation rate (ESR).

Results: Forty-one patients consented to participate, 15 were allocated in the MTX group and 26 in the CQ group. Two patients on MTX dropped out due to side-effects and two in the CQ group, one due to side-effects and one due to inefficacy. Baseline demographic, clinical and laboratory parameters of the two groups were nearly identical. In both groups the clinical and laboratory parameters improved significantly over 24 weeks, except the ESR in the MTX group. The results of the outcome measures at the end of the trial did not differ significantly between the two groups, except morning stiffness (P < 0.05 in favor of the MTX group) and ESR (P < 0.01 in favor of the CQ group). Rise of serum alanine aminotransferase was observed in two cases in the MTX group and in none in the CQ group.

Conclusion: Low-dose MTX appears to be as effective as CQ in patients with articular and cutaneous manifestations of SLE, having an acceptable toxicity profile. Results of this prospective study need to be confirmed in a larger study.

Publication types

  • Comparative Study
  • Randomized Controlled Trial

MeSH terms

  • Adolescent
  • Adult
  • Arthralgia / diagnosis
  • Arthralgia / drug therapy*
  • Arthralgia / etiology
  • Arthralgia / immunology
  • Arthritis / diagnosis
  • Arthritis / drug therapy*
  • Arthritis / etiology
  • Arthritis / immunology
  • Bangladesh
  • Blood Sedimentation
  • Chloroquine / adverse effects
  • Chloroquine / therapeutic use*
  • Female
  • Humans
  • Immunosuppressive Agents / adverse effects
  • Immunosuppressive Agents / therapeutic use*
  • Joints / drug effects*
  • Joints / immunology
  • Joints / pathology
  • Lupus Erythematosus, Systemic / complications
  • Lupus Erythematosus, Systemic / diagnosis
  • Lupus Erythematosus, Systemic / drug therapy*
  • Lupus Erythematosus, Systemic / immunology
  • Lupus Erythematosus, Systemic / pathology
  • Male
  • Methotrexate / adverse effects
  • Methotrexate / therapeutic use*
  • Pain Measurement
  • Prospective Studies
  • Severity of Illness Index
  • Skin / drug effects*
  • Skin / immunology
  • Skin / pathology
  • Surveys and Questionnaires
  • Time Factors
  • Treatment Outcome
  • Young Adult


  • Immunosuppressive Agents
  • Chloroquine
  • Methotrexate