Study describes efficacy of infliximab plus methotrexate in AS

Combination therapy with infliximab and methotrexate is an effective treatment for ankylosing spondylitis (AS). However, the report identifies that the addition of methotrexate did not extend the period of response beyond eight weeks.To examine the efficacy and safety of infliximab plus methotrexate compared with methotrexate alone in the treatment of AS, Professor Paul Emery's team randomised 42 patients to 30 weeks of therapy.Subjects were allocated to methotrexate and five infusions of either 5 mg/kg infliximab or placebo. The primary outcome was improvement in disease activity as shown by the BASDAI at week 30. MRI was used to assess the effect of treatments on sacroiliac and spinal enthesitis/osteitis and DXA to monitor bone mineral density. The results indicate a significantly greater improvement in mean BASDAI score for subjects receiving infliximab at week 10 (p=0.017), however, this was not maintained by week 30 (p=0.195). Emery's group reports that some patients in the infliximab arm experienced a flare by week six after the last study infusion.Magnetic resonance imaging showed that the mean number of lesions resolving for each subject from week 0 to week 30 was significantly greater in the combination group than in the methotrexate monotherapy group (p=0.016).According to the authors, both methotrexate and infliximab were well tolerated. Most side effects were mild to moderate. No severe adverse events were reported."Infliximab in combination with methotrexate was a safe and efficacious treatment in AS over 6 months and was associated with significant regression in enthesitis/osteitis as determined by MRI. However, disease flares were reported 8 weeks after the last infusion, indicating that addition of methotrexate failed to extend the infliximab dosing interval," the group concludes.Reference...