Abstract

Objective To investigate the prescription patterns and safety of concomitant theraph in Chinese RA patients receiving biological disease modifying antirheumatic drugs (bDMARDs). Methods This was a single group, multi-center, cross-sectional non-interventional observational study. The study period was from December 2013 to August 2014. Patients with confirmed RA according to the ACR 1987 criteria of both genders and who were 18 years and older were included into the study from 15 hospitals in China. They must be taking bDMARDS at enrolment. Relevant information was collected and clinical examination was conducted on the day of enrolment. Altogether 802 patients were eligible for data analysis using the seatistical software SAS 9.2. Results The mean age was (49±14) years (81.3% women, n=652). Among these patients, 89.5% (n=718), 56.1% (n=450), 29.7% (n=238), and 19.1%(n=450) were receiving concomitant conventional synthetic DMARDs (csDMARDs), non-steroidal anti-inflammatory drugs (NSAIDs), glucocorticosteroid (GC), and topical drugs, respectively. The proportion of patients receiving concomitant csDMARDs (718 patients) and using 1, 2, and 3 csDMARDs was 49.3% (n=354), 41.2% (n=296), and 9.5% (n=68), respectively. The most common csDMARDs used were methotrexate [65.9%, (9.8±2.5) mg/week; n=473], hydroxychloroquine [41.8%, (340.3± 96.3) mg/week; n=300], leflunomide [41.5%, (15.4±5.2) mg/week; n=298], and sulfasalazine [6.3%, (1 753.3± 693.3) ng/d; n=45]. Among the 238 patients on concomitant GC, 73.1% (n=174) and 23.1%(n=55) patients were receiving oral prednisone [(8.3±4.6) mg/day] or methylprednisolone [(8.5±21.7) mg/day]. In total, 17.6% (n=42) patients reported at least one GC-associated adverse event (AE). Among the 450 patients receiving concomitant NSAIDs, 43.1% (n=194), 20.2% (n=91), and 12.0% (n=54) patients were receiving celecoxib [(306.2±100.1) mg/d], or meloxicam [(12.8 ± 3.5) mg/d], or loxoprofen sodium [(143.9 ± 45.3) mg/d]. Only 3.6% (n=16) patients who were taking NSAID reported at least one AE. A total of 153 patients were receiving concomitant topical drugs. The most common topical drug was ketoprofen (30.1%, n=46). Conclusion The prescription patterns of concomitant drugs in Chinese RA patients receiving bDMARDs are similar to those in western countries. The most common concomitant csDMARD is methotrexate. Low-dose GC causes adverse reactions even for a short period. Topical drugs including traditional Chinese medicine offer a broad option for patients but the usage pattern was not standardized. Key words: Arthritis, rheumatoid; Antirheumatic agents; Cross-sectional studies; Biological disease modifying antirheumatic drugs; Concomitant drugs

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