Once-monthly oral ibandronate provides significant improvement in bone mineral density in postmenopausal women treated with glucocorticoids for inflammatory rheumatic diseases: a 12-month, randomized, double-blind, placebo-controlled trial.

OBJECTIVES: To study the efficacy and safety of once-monthly oral ibandronate in the prevention of glucocorticoid (GC)-induced osteoporosis (GIOP) in postmenopausal women with inflammatory rheumatic diseases. METHOD: A randomized, double-blind, placebo-controlled, parallel-group study of 140 postmenopausal women was conducted. At baseline, the mean lumbar spine (LS) (L1-L4) bone mineral density (BMD) was normal or osteopaenic (T-score ≥ -2.0) and the patients were receiving treatment with 5-15 mg/day of prednisone equivalent. Patients were randomized 1:1 to receive either monthly oral ibandronate 150 mg or placebo for 12 months. All patients received vitamin D and calcium supplements. The primary endpoint was the relative change in mean LS BMD from baseline to 12 months. RESULTS: Mean LS BMD increased significantly by 2.6% and 3.2% from baseline to 6 and 12 months with ibandronate compared to 0.3% and -0.1% with placebo, respectively (p < 0.001). Comparable significant mean increases were also found in trochanter, femoral neck and total hip BMDs at 12 months. Reductions in the serum levels of bone turnover markers C-terminal telopeptide of type I collagen (sCTX), N-terminal propeptide of type I procollagen (P1NP), and tartrate-resistant acid phosphatase (TRACP) were significantly more marked in the ibandronate group than in the placebo group at 1, 6, and 12 months. Adverse events (AEs) were reported at a similar frequency in both groups. A higher proportion of serious AEs (SAEs) were reported in the ibandronate group without emergence of any single SAE. CONCLUSIONS: Once-monthly oral ibandronate provides a significant increase in LS and total hip BMD with an acceptable safety profile in postmenopausal women treated with low-dose GCs for inflammatory rheumatic diseases.

Rituximab therapy in patients with rheumatoid arthritis refractory or with contraindication to anti-tumour necrosis factor drugs: real-life experience in Finnish patients.

OBJECTIVES: To describe the effects of rituximab therapy in patients with rheumatoid arthritis (RA) in routine clinical practice in Finland. METHODS: Data were collected retrospectively from patient records in five rheumatology clinics in Finland. All RA patients treated during 2005-2008 (n = 81) were included. Information on disease-modifying anti-rheumatic drugs (DMARDs), DMARD combinations, and biologics prior to rituximab use was collected as well as treatment responses after initiating rituximab therapy. The Disease Activity Score using 28 joint counts (DAS28) was used to determine disease activity and European League Against Rheumatism (EULAR) responses. RESULTS: Mean disease duration was 14 (range 0-47) years and the median number of prior DMARDs and biologics used were 7 (1-12) and 2 (0-4), respectively. Efficacy analysis was performed on 57 patients with available DAS28 data at treatment onset and follow-up visits. Median DAS28 declined from 6.07 (3.19-7.70) to 3.99 (1.53-6.55) by the first rituximab treatment course. Altogether 77% of the patients achieved a EULAR response, 26% with a good response including 18% with remission. Furthermore, the patients treated concomitantly with DMARDs other than methotrexate (MTX) achieved a EULAR response slightly more often than the patients on MTX (85% vs. 70%) only. A second course of rituximab was given to 48% of the patients on an average of 9 months after initial therapy, with the median DAS28 score declining further to 3.49 (0.1-5.74). Safety and tolerability assessment of the 81 patients indicates rituximab to be well tolerated. CONCLUSIONS: Rituximab can effectively control disease activity in patients with active disease and poor response to previous therapies, in combination with MTX but also with other DMARDs.