THU0274 Double-blind, placebo-controlled, 28-week trial of efficacy and safety of infliximab plus naproxen vs naproxen alone in patients with early, active axial spondyloarthritis treated with a submaximal dose of NSAIDS: Preliminary results of INFAST part I:
Authors: J. Sieper, J. Lenaerts, J. Wollenhaupt, V.I. Mazurov, L. Myasoutova, S.-H. Park, Y.-W. Song, R. Yao, D. Chitkara, N. Vastesaeger
Journal: Annals of the Rheumatic Diseases (2013)

<h3>Background</h3> Efficacy of anti–tumor necrosis factor (TNF) therapy in patients with axial spondyloarthritis (SpA) has been tested only in patients who are refractory to NSAID therapy. <h3>Objectives</h3> To determine whether combination infliximab (IFX)+NSAID therapy is superior to NSAID monotherapy for reaching clinical and MRI remission in patients with early, active axial SpA who were naïve to NSAIDs or had a submaximal dose of NSAIDs. <h3>Methods</h3> INFAST was a double-blind, randomized controlled trial of IFX in biologic-naïve patients 18–48 years of age with early, active axial SpA (Assessment in Ankylosing Spondylitis [ASAS] criteria, disease duration ≤3 years with chronic back pain and active inflammatory lesions of the sacroiliac [SI] joints on MRI). Patients naïve to NSAIDs or treated with a submaximal dose of NSAIDs were randomized (2:1) to receive 28 weeks of treatment with either IV IFX 5 mg/kg (weeks 0, 2, 6, 12, 18, and 24)+naproxen (NPX) 1000 mg/d or IV placebo (PBO)+NPX 1000 mg/d. The primary endpoint was the proportion of subjects meeting ASAS partial remission criteria at week 28. ASAS-20 and ASAS-40 responses were also assessed. Treatment group differences were analyzed using Fisher exact tests. MRI lesions of spine and SI joints were also evaluated. <h3>Results</h3> In preliminary results, 106 patients were randomized to IFX+NPX and 52 to PBO+NPX. At baseline, mean BASDAI scores (100 mm VAS) were 64.4 (SD=15.37) mm and 63.0 (SD=15.43) mm and HLA-B27–positive statuses were 82.1% and 90.4% in the IFX+NPX and PBO+NPX groups, respectively. At week 28, ASAS partial remission, ASAS-40, and complete absence of MRI lesions (spine+SI joints [MRI remission] and SI joints alone) were achieved by significantly greater percentages of patients in the IFX+NPX group than in the PBO+NPX group (Table 1). Serious adverse events were reported in 5 (4.8%) patients in the IFX+NPX group (possibly related to study medication in 3 [2.9%] patients) and 3 (5.8%) patients the PBO+NPX group (possibly related in 2 [3.8%] patients). No deaths occurred. <h3>Conclusions</h3> 62% of patients with early, active axial SpA reached clinical remission with IFX+NPX vs 35% with NPX alone; clear superiority of combination therapy over NPX monotherapy was also evident for ASAS-40, but not ASAS-20, response. MRI remission was achieved with combination treatment but not NPX alone. The safety profile was consistent with that of other anti-TNF biologics. <h3>Disclosure of Interest</h3> J. Sieper Grant/Research support from: Merck, Abbott, Pfizer, Consultant for: Merck, Abbott, Pfizer, UCB, Roche, Lilly, Speakers Bureau: Merck, Abbott, Pfizer, J. Lenaerts Consultant for: Abbott, BMS, MSD, Pfizer, Roche, Astra Zeneca, J. Wollenhaupt: None Declared, V. Mazurov: None Declared, L. Myasoutova: None Declared, S.-H. Park: None Declared, Y.-W. Song: None Declared, R. Yao Employee of: Merck, D. Chitkara Employee of: Merck, N. Vastesaeger Employee of: Merck