No abstract

Risedronate reduces the risk of clinical vertebral fractures in postmenopausal women with osteoporosis within 6 months of commencing treatment.

To determine the efficacy and safety of risedronate in patients with knee osteoarthritis (OA), the British study of risedronate in structure and symptoms of knee OA (BRISK), a 1-year prospective, double-blind, placebo-controlled study, enrolled patients (40–80 years of age) with mild to moderate OA of the medial compartment of the knee. The primary aims were to detect differences in symptoms and function. Patients were randomized to once-daily risedronate (5 mg or 15 mg) or placebo. Radiographs were taken at baseline and 1 year for assessment of joint-space width using a standardized radiographic method with fluoroscopic positioning of the joint. Pain, function, and stiffness were assessed using the Western Ontario and McMaster Universities (WOMAC) OA index. The patient global assessment and use of walking aids were measured and bone and cartilage markers were assessed. The intention-to-treat population consisted of 284 patients. Those receiving risedronate at 15 mg showed improvement of the WOMAC index, particularly of physical function, significant improvement of the patient global assessment (P < 0.001), and decreased use of walking aids relative to patients receiving the placebo (P = 0.009). A trend towards attenuation of joint-space narrowing was observed in the group receiving 15 mg risedronate. Eight percent (n = 7) of patients receiving placebo and 4% (n = 4) of patients receiving 5 mg risedronate exhibited detectable progression of disease (joint-space width ≥ 25% or ≥ 0.75 mm) versus 1% (n = 1) of patients receiving 15 mg risedronate (P = 0.067). Risedronate (15 mg) significantly reduced markers of cartilage degradation and bone resorption. Both doses of risedronate were well tolerated. In this study, clear trends towards improvement were observed in both joint structure and symptoms in patients with primary knee OA treated with risedronate.

Purpose To evaluate the safety and potential efficacy of gevokizumab, an anti-interleukin 1β (IL-1β) monoclonal antibody, in the treatment of active, non-infectious, non-necrotizing, anterior scleritis. Design Phase 1/2, open label, non-randomized, prospective, single-arm, pilot trial Methods Eight patients with active, non-infectious, non-necrotizing, anterior scleritis with a scleral inflammatory grade of +1 to +3 in at least one eye were enrolled. In one patient, both eyes were enrolled, for a total of nine eyes (four eyes with +1, one eye with +2, and four eyes with +3). Patients received one subcutaneous injection of 60 mg gevokizumab at baseline and then every four weeks for 12 weeks. Complete physical and ocular examinations were performed at each visit. The primary outcome was at least a 2-step reduction or reduction to grade 0 in scleral inflammation on a 0 to +4 scale according to a standardized photographic scleritis grading system by 16 weeks in the study eye compared to baseline. Secondary outcomes included changes in visual acuity, intraocular pressure, and trends in scleral grading. Participants who met the primary outcome were eligible to continue in the study for up to 52 weeks and received additional gevokizumab injections every four weeks until week 36 followed by two safety visits at weeks 40 and 52. Results Seven eyes from seven patients met the primary outcome within a median time of two weeks following the first gevokizumab injection. No definitive changes in visual acuity or IOP were identified. There were no serious adverse events related to the study drug. A total of 43 adverse effects were reported with 93% described as mild, 95% as non-ocular, and only 14% deemed possibly caused by the investigational treatment. Conclusions The results of this small study suggest that blockage of IL-1β using gevokizumab may be beneficial in treating active, non-infectious, anterior scleritis and that gevokizumab is well-tolerated. Larger randomized trials are warranted to assess the true efficacy of gevokizumab in the treatment of non-necrotizing anterior scleritis.