A new strategy of drug treatment in NSAID-unresponsive ankylosing spondylitis: combination of pamidronate and methylprednisolone monthly intravenous infusions on the background of a combination of disease modifying drugs sulfasalazine and methotrexate.

ABSTRACT

OBJECTIVES: To assess short term efficacy and tolerability of a therapeutic strategy in patients with ankylosing spondylitis (AS) unresponsive to nonsteroidal anti-inflammatory drugs (NSAIDs) or coxibs and unable to take anti-tumour necrosis factor-alpha (anti-TNFalpha) biological treatment. METHODS: Established AS patients were given a background treatment consisting of subcutaneous injections of methotrexate weekly (MTX, dose stepped up to a maximum of 20 to 25 mg), weekly 12-16 mg of methylprednisolone orally 30 mts before methotrexate dose (for nausea prevention), sulfasalazine (SSZ, 1 gm orally twice per day) with folic acid supplementation (5 mg daily except on the day of MTX). Additionally, they were given monthly cycles of intravenous (IV) methylprednisolone 'pulse' (MPP) and pamidronate infusions (MPP 500 mg 3 consecutive days + pamidronate 60 mg in a slow IV infusion on day 2 of the MPP infusion). A minimum of six treatment cycles at monthly intervals were given. Adjunct treatment consisted of 1 gm elemental calcium supplementation, paracetamol 650 mg 'as-and-when-required' for symptomatic pain relief, amitriptyline 10 mg 2 hours before bed time daily. RESULTS: Of a total of 46 intent-to-treat patients, 39 patients achieved ASAS-20 and BASDAI-50 response (85%, 95% CI, range 71% to 94%); 7 (15 %) patients failed to improve. The expense involved in 6 months of treatment was approximately 10-fold less than anti-TNFalpha treatment over the same period of time. CONCLUSION: For AS patients unresponsive to standard NSAIDs/coxibs and unable to take anti-TNF biological agents a combination therapeutic strategy showed efficacy and good tolerability in a majority of patients evaluated over a short-term.