PMID- 26271141 OWN - NLM STAT- MEDLINE DCOM- 20160504 LR - 20181202 IS - 1502-7732 (Electronic) IS - 0300-9742 (Linking) VI - 44 IP - 6 DP - 2015 TI - Effect of golimumab and pamidronate on clinical efficacy and MRI inflammation in axial spondyloarthritis: a 48-week open randomized trial. PG - 480-6 LID - 10.3109/03009742.2015.1038300 [doi] AB - OBJECTIVES: To compare the effect of golimumab (GLM) and pamidronate (PAM) on clinical efficacy and magnetic resonance imaging (MRI) inflammation in axial spondyloarthritis (aSpA). METHOD: Patients who fulfilled the Assessment of SpondyloArthritis Society (ASAS) criteria for aSpA and had active disease [Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score >/= 4] were randomized in a 2:1 ratio to receive either GLM (50 mg) or PAM (60 mg) 4 weekly for 48 weeks. Clinical efficacy was assessed at intervals. Inflammation of the spine and sacroiliac joints (SIJs) on MRI was graded by the Spondyloarthritis Research Consortium of Canada (SPARCC) scoring system. RESULTS: Twenty patients were assigned to GLM and 10 to PAM (83% men; age 33.4 +/- 10.9 years; disease duration 4.4 +/- 3.4 years). The baseline characteristics of the two groups were similar. At week 48, the proportions of patients who achieved an ASAS20 response were not significantly different between the GLM and PAM groups (65% vs. 56%; p = 0.69). Although there were no differences in BASDAI, spinal pain, and Medical Outcomes Study 36-item Short Form Health Survey (SF-36) scores between the two groups at week 48, the Ankylosing Spondylitis Disease Activity Score (ASDAS), Bath AS Functional Index (BASFI), C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR) levels were significantly lower in GLM-treated patients. The SPARCC scores of the spine and SIJs decreased significantly in GLM- but not in PAM-treated patients. The differences in SPARCC scores between the two groups at week 48 were statistically significant. The frequency of adverse events (AEs) was similar in both arms. CONCLUSIONS: In patients with aSpA, the clinical response rate and improvement in pain and quality of life (QoL) were similar between GLM and PAM groups after 48 weeks. However, significant reduction in inflammatory markers and MRI inflammation was only observed with GLM treatment. FAU - Mok, C C AU - Mok CC AD - a Departments of Medicine. FAU - Li, O C AU - Li OC AD - b Radiology , Tuen Mun Hospital , Hong Kong , SAR China. FAU - Chan, K L AU - Chan KL AD - a Departments of Medicine. FAU - Ho, L Y AU - Ho LY AD - a Departments of Medicine. FAU - Hui, P K AU - Hui PK AD - b Radiology , Tuen Mun Hospital , Hong Kong , SAR China. LA - eng PT - Journal Article PT - Randomized Controlled Trial DEP - 20150814 PL - England TA - Scand J Rheumatol JT - Scandinavian journal of rheumatology JID - 0321213 RN - 0 (Anti-Inflammatory Agents) RN - 0 (Antibodies, Monoclonal) RN - 0 (Biomarkers) RN - 0 (Diphosphonates) RN - 9007-41-4 (C-Reactive Protein) RN - 91X1KLU43E (golimumab) RN - OYY3447OMC (Pamidronate) SB - IM MH - Adult MH - Anti-Inflammatory Agents/administration & dosage/*therapeutic use MH - Antibodies, Monoclonal/administration & dosage/*therapeutic use MH - *Axis, Cervical Vertebra MH - Biomarkers/blood MH - Blood Sedimentation MH - C-Reactive Protein/metabolism MH - Diphosphonates/administration & dosage/*therapeutic use MH - Disability Evaluation MH - Dose-Response Relationship, Drug MH - Female MH - Humans MH - Injections, Intravenous MH - Injections, Subcutaneous MH - *Magnetic Resonance Imaging MH - Male MH - Pamidronate MH - Severity of Illness Index MH - Spondylarthritis/blood/*drug therapy/*pathology MH - Treatment Outcome EDAT- 2015/08/15 06:00 MHDA- 2016/05/05 06:00 CRDT- 2015/08/15 06:00 PHST- 2015/08/15 06:00 [entrez] PHST- 2015/08/15 06:00 [pubmed] PHST- 2016/05/05 06:00 [medline] AID - 10.3109/03009742.2015.1038300 [pii] AID - 10.3109/03009742.2015.1038300 [doi] PST - ppublish SO - Scand J Rheumatol. 2015;44(6):480-6. doi: 10.3109/03009742.2015.1038300. Epub 2015 Aug 14.