No efficacy of subcutaneous methotrexate in active ankylosing spondylitis: a 16-week open-label trial

Abstract

Objective: To examine the potential therapeutic effect of methotrexate 20 mg given weekly as subcutaneous injections to 20 patients with ankylosing spondylitis refractory to nonsteriodal antirheumatic drugs. Patients and methods: 20 patients with ankylosing spondylitis, a mean Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of 5.6 (range 4-9.3) and predominantly axial manifestations were treated with weekly 15 mg methotrexate subcutaneously for 4 weeks, which was then increased to 20 mg subcutaneously for the next 12 weeks. Clinical outcome assessments included, among others, BASDAI score physical function, spinal mobility, patients' and physicians' global assessment (visual analogue scale), peripheral joint assessment, quality of life (Short Form 36) and C reactive protein. The primary end point of the study was a 20% improvement on the ASsessments in Ankylosing Spondylitis (ASAS 20) scale. Results: Using an intention-to-treat analysis, ASAS 20 was achieved in only 25% of patients. An ASAS 40 response was achieved in 10% of patients, and no patient reached an ASAS 70 response or the ASAS criteria for partial remission. For the mean BASDAI score, no change was observed between baseline and week 16 (baseline 5.6 v week 16, 5.6). No improvement was observed in any of the clinical parameters or C reactive protein, except a small but non-significant decrease in the number of swollen joints. Conclusions:In this open study, methotrexate did not show any benefit for axial manifestations in patients with active ankylosing spondylitis beyond the expected placebo response.

Enthesitis-Related Arthritis: Time to Re-define?

“…The patients with axial disease seem to respond readily to anti-tumor necrosis factor (TNF) medications, a phenomenon also seen repeatedly in the adult literature [15•]. Several studies have shown a lack of efficacy for DMARDs in axial disease [16][17][18]. Additionally, there is evidence in the adult literature that while symptoms can be well controlled by anti-TNF agents, radiographic progression may be difficult to halt once initiated [14,19,20].…”

Lessons from Genomic Profiling in AS

“…The ASAS criteria have been developed as classification criteria but they are likely be useful as diagnostic criteria, especially in patients with non-radiographic axial SpA at an outpatient rheumatology clinic (van den Berg & van der Heijde, 2010). This may help to make an early diagnosis and prevent the current diagnostic delay, described as 5 to 10 years between the first occurrence of symptoms and an AS diagnosis (Feldtkeller et al, 2003;Haibel et al, 2007). It prevents unnecessary diagnostic tests and more importantly makes it possible to commence more effective therapies earlier.…”

A Prospective Double Blind Placebo Controlled Trial of Combination Disease Modifying Antirheumatic Drugs vs. Monotherapy (Sulfasalazine) in Patients with Inflammatory Low Backache in Ankylosing Spondylitis and Undifferentiated Spondyloarthropathy

“…Gonzalez-Lopez et al, reported significant improvement with MTX in physical well-being, BASDAI, BASFI, physician and patient global assessments, the HAQ, and spinal pain [14]. Haibel et al studied the role of subcutaneous MTX at doses of 20 mg/week for 16 weeks in a NSAID refractory AS patients with axial symptoms and found ASAS 20, 50 and 70 responses of 25%, 10% and none respectively, with no change in BASDAI [11]. In a recent Cochrane review, it was concluded that MTX may not improve overall disease activity, physical function, overall pain, tenderness or swelling in the ligaments of the joints, movement of the spine, stiffness and overall well-being [15].…”

“…Though MTX monotherapy has not been found to be effective in axial symptoms of SpA in a number of studies, it has been reported to be useful in patients with peripheral arthritis [9][10][11][12][13]. Gonzalez-Lopez et al, reported significant improvement with MTX in physical well-being, BASDAI, BASFI, physician and patient global assessments, the HAQ, and spinal pain [14].…”