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Objectives To assess the usefulness and onset of nocebo effects after switching from the original etanercept (ETN) to a biosimilar (BS) in routine clinical practice at rheumatology clinics in Japan (13 sites). Methods A total of 165 patients (87.0% women, age = 57.88 ± 15.07 years, and disease duration = 10.32 ± 7.71 years), whose low disease activity was maintained with the original ETN for ≥12 weeks, and who agreed to switch treatment to its BS, were included. The end-points were disease activity score 28 (DAS28)-C-reactive protein and DAS28-erythrocyte sedimentation rate. Results No significant difference was observed between the changes in DAS28-C-reactive protein and DAS28-erythrocyte sedimentation rate >12 weeks before switching and >12 weeks after switching (P = 0.132 and 0.334, respectively). The treatment continuation rate during the 52 weeks after switching to BS was 97.3%. During this period, BS was discontinued in only four patients, and no nocebo effects were suspected in these four patients. Conclusion Switching from ETN to BS was effective even in routine clinical practice at rheumatology clinics in Japan, and no nocebo effects were observed. Sufficient explanations to patients by rheumatologists and the additional payment for drug costs between patients at hospital visits effectively improved the continuation rate without any nocebo effect.

To determine the proper management of treatment for rheumatoid cervical lesions, we investigated the clinical course of the cervical spine in rheumatoid arthritis (RA). The severity of RA was classified into three groups according to the disease subsets advocated by Ochi et al.: the less erosive subset (LES), the more erosive subset (MES), and mutilating disease (MUD). Then the following radiographic assessments were performed on cervical roentogenograms: atlantoaxial subluxation (AAS), vertical subluxation (VS), and subaxial subluxation (SAS). One hundred and seventy-four patients were available for this study. The mean age of the patients was 60.9 years (19-85 years). The average duration from the onset of RA was 19.1 years (10-40 years). Eighty-seven patients were classified as LES, 69 were MES, and 18 were MUD. We found that few patients in the LES group had required an operation on the cervical spine. AAS was seen in about 60% of the MES patients, but few cases had VS or SAS, and most operations were atlantoaxial fusion. All patients in the MUD group had some cervical instabilities. Not only VS but also SAS were seen in more than half of these patients, and many patients had required occipitothoracic fusion.

A 68-year-old man with a 3-year history of rheumatoid arthritis (RA) developed gynecomastia 3 months after beginning oral low-dose methotrexate (MTX) therapy. Four months after MTX therapy was discontinued, the gynecomastia symptoms improved. Only eight cases of gynecomastia resulting from low-dose MTX administration have been reported worldwide, and no cases have previously been reported in Japan. Although it occurs infrequently, gynecomastia resulting from low-dose MTX therapy should be considered in male patients with RA.