Objective. To compare the efficacy and safety of subcutaneous (SC) versus oral administration of methotrexate (MTX) in patients with active rheumatoid arthritis (RA).Methods. MTX-naive patients with active RA (Disease Activity Score in 28 joints >4) were eligible for the study if they had not previously taken biologic agents and had not taken disease-modifying antirheumatic drugs for 2 weeks prior to randomization. Patients were randomly assigned to receive 15 mg/week of MTX either orally (2 7.5-mg tablets plus a dummy prefilled syringe; n ‫؍‬ 187 patients) or SC (prefilled syringe containing 10 mg/ml plus 2 dummy tablets; n ‫؍‬ 188 patients) for 24 weeks. At week 16, patients who did not meet the American College of Rheumatology criteria for 20% improvement (ACR20) were switched from 15 mg of oral MTX to 15 mg of SC MTX and from 15 mg of SC MTX to 20 mg of SC MTX for the remaining 8 weeks, still in a blinded manner. The primary outcome was an ACR20 response at 24 weeks.Results. At week 24, significantly more patients treated with SC MTX than with oral MTX showed ACR20 (78% versus 70%) and ACR70 (41% versus 33%) responses. Patients with a disease duration >12 months had even higher ACR20 response rates (89% for SC administration and 63% for oral). In 52 of the ACR20 nonresponders (14%), treatment was switched at week 16. Changing from oral to SC MTX and from 15 mg to 20 mg of SC MTX resulted in 30% and 23% ACR20 response rates, respectively, in these patients. MTX was well tolerated. The rate of adverse events was similar in all groups. Conclusion. This 6-month prospective, randomized, controlled trial is the first to examine oral versus SC administration of MTX. We found that SC administration was significantly more effective than oral administration of the same MTX dosage. There was no difference in tolerability.

Background Glucocorticoids play a pivotal role in managing rheumatoid arthritis due to their anti-inflammatory and immunosuppressive properties.1 A clinically relevant reduction of morning stiffness was observed with the modified-release prednisone tablet compared to conventional immediate-release prednisone.2 Objectives This non-interventional study (NIS) investigated the functional ability in patients treated with low-dose prednisone in daily practice. In addition, improvement of Quality of Life was also assessed in terms of daily performance. Methods Patients with rheumatoid arthritis (n=2661) were included in this 3-month non-interventional study. This analysis addresses a subgroup of patients treated by general practitioners. Data were recorded at three visits (baseline, at 6 and 12 weeks/study end). The primary endpoint was change of functional ability from baseline utilising the Questionnaire on Activity Status QAS (Numeric Rating Scale: 0 – 100 = severely impaired – completely unimpaired) for 3 parameters (occupational performance, household duties, leisure activities). The second endpoint daily performance was documented using a Visual Analogue Scale VAS (0 – 10 = least daily performance - full daily performance). Laboratory assessments included hematologic and inflammatory markers (C-reactive protein CRP, erythrocyte sedimentation rate ESR). Results The subgroup consisted of 928 patients (Ø age 62 years, 70% female) treated with modified-release prednisone. The mean total QAS score of these patients increased markedly from 45.5 to 73.7. The three QAS single dimensions improvement was comparable. Occupational performance increased from 56.7 to 80.5, household duties from 46.8 to 74.0 and leisure activities from 40.4 to 71.0. Median daily performance improved from 5 to 8 on the VAS. Median CRP decreased from 8.3 mg/dl to 5.0 mg/dl and the erythrocyte sedimentation rate decreased from 28 mm/h to 15 mm/h at the end of the NIS. Conclusions In this non-interventional study patients treated with modified-release prednisone tablets benefited from better functional ability and Quality of Life being shown under daily practice conditions. These results add to those obtained from previous clinical studies. References Buttgereit F et al. EULAR Compendium on Rheumatic Diseases 2009. Buttgereit F et al. Lancet 2008. Disclosure of Interest None Declared