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AB0664 Efficacy and Safety of Methylprednisolone Administered Intravenously for the Treatment of Patients with Active Ankylosing Spondylitis: Results of A 12-Week, Prospective, Open-Label Study (METALL)
  1. I. Gaydukova1,
  2. A. Rebrov1,
  3. D. Poddubnyy2
  1. 1Saratov State Medical University, Saratov, Russian Federation
  2. 2Charité Universitätsmedizin, Berlin, Germany

Abstract

Background Treatment options for patients with ankylosing spondylitis (AS) are limited to non-steroidal anti-inflammatory drugs (NSAIDs) and to tumour necrosis factor (TNF) α blockers. Treatment of the patients with contraindications/intolerance/absence of response to NSAIDs and/or anti-TNF α requires the development of new approaches of therapy.

Objectives The aim of the present study was to evaluate the short-term efficacy and safety of methylprednisolone (MP) 500 mg administered intravenously in patients with active AS.

Methods A total of 20 AS patients fulfilling the modified New York criteria with the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) ≥4 who have had an inadequate response to ≥2 NSAIDs or NSAIDs contraindications/intolerance were included (mean age 35.35±8.19 years, disease duration 10.2±9.2 years). MP in a dose of 500 mg was given as a single intravenous infusion at baseline. The primary study endpoint was the percentage of patients who met ASAS40 (Assessment of Spondyloarthritis International Society 40) response criteria at week 2. Secondary endpoints included rates of a 50% BASDAI improvement (BASDAI50), ASAS20, ASAS partial remission, the AS disease activity score (ASDAS), clinically important and major improvements, ASDAS inactive disease, changes in the levels of the erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP) up to week 12.

Results At week 2, ASAS40 response was reached by 9 (45%) patients. ASAS20 response, ASAS partial remission and BASDAI50 responses were achieved by 11 (55%), 15 (15%) and 7 (35%) patients, respectively. ASDAS clinically important improvement improvement at week 2 was observed in 11 (55%) patients, respectively, while ASDAS inactive disease state was achieved by 5 (25%) patients. At week 12, ASAS40 response was observed in 12 (60%) patients, ASAS20 response, ASAS partial remission and BASDAI50 response in 13 (65%), 5 (25%) and 8 (40%) patients, respectively. ASDAS clinically important improvement, ASDAS major improvements and ASDAS inactive disease state at week 12 were noted in 11 (55%), 6 (30%) and 3 (15%) patients, respectively. A significant reduction of BASDAI, ASDAS, CRP and ESR was observed at week 2 and sustained up to week 12 - table.

Table 1.

AS activity parameters and response to treatment with intravenous methylprednisolone

Totally, 13 adverse events (AE) occurred during the study, no serious AE were observed.

Conclusions Intravenous administration of 500 mg of MP could be effective and safe in a short-term treatment of active AS.

Disclosure of Interest None declared

DOI 10.1136/annrheumdis-2014-eular.3955

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