SLE

Osteoporosis is a significant public health concern, particularly for postmenopausal women. Current treatment options may not be appropriate for all women. Selective estrogen-receptor modulators (SERMs) are a class of molecules with tissue-selective activity. Bazedoxifene is currently in clinical development for the prevention and treatment of postmenopausal osteoporosis. In a 2-year, phase III, osteoporosis prevention study (N = 1583), bazedoxifene 10, 20, and 40 mg was shown to preserve bone mineral density and decrease biochemical markers of bone turnover compared with placebo in postmenopausal women at risk for osteoporosis. In a pivotal 3-year, phase III, osteoporosis treatment study (N = 7492), bazedoxifene 20 and 40 mg significantly reduced the incidence of new vertebral fractures compared with placebo (p < 0.05 for both) in postmenopausal women with osteoporosis. In a post hoc subgroup analysis of women at higher risk for fracture (n = 1772), bazedoxifene 20 mg significantly reduced the risk of nonvertebral fractures versus placebo (p = 0.02) and raloxifene 60 mg (p = 0.05). Bazedoxifene 20 mg has demonstrated sustained efficacy in reducing the risk of vertebral fractures over 5 and 7 years. Overall, bazedoxifene was generally safe and well tolerated, with favorable endometrial and breast safety profiles. As with other SERMs, the rate of deep vein thrombosis was higher in the bazedoxifene groups compared with placebo at 3 and 5 years. Considering its demonstrated efficacy and safety, bazedoxifene may be an appropriate osteoporosis therapy for women who cannot take or are unwilling to take bisphosphonates because of safety or tolerability issues. Bazedoxifene may also be appropriate for younger women at increased fracture risk who are concerned about the effects of long-term bisphosphonate therapy. This article reviews the results of key clinical trials of bazedoxifene for the prevention and treatment of postmenopausal osteoporosis and describes its role in clinical practice.

Background/objectives: This postmarketing surveillance study assessed the preference, satisfaction, usability, and tolerability of subcutaneous self-administration of a high-concentration (50 mg/ml) ready-to-use formulation of methotrexate (MTX) in patients with rheumatoid arthritis or psoriatic arthritis.

Methods: The study enrolled 403 patients with rheumatoid or psoriatic arthritis. The first injection was administered by the attending physician or nurse, followed by five self-administered injections at weekly intervals. The high-concentration formulation consisted of a prefilled syringe with MTX 50 mg/ml solution and a pre-attached needle. Questionnaires were used to document outcomes.

Results: The overall assessment was ‘very good’ and ‘good’ in 87.6% of the patients and in 92.8% of the physicians/study nurses. Availability and use of a pre-attached needle was considered as very advantageous and advantageous by 91.8% of the patients and 88.8% of the physicians/study nurses. A total of 96% of the patients described the feeling of the injection as comfortable or tolerable. Patients reported that self-administration led to a feeling of more independence (89.1%) and an improved quality of life (83.6%). A total of 109 patients reported previous self-administration of low-concentration MTX formulations; 94.5% of them stated that they would prefer the high-concentration MTX formulation in the future. The formulation was generally well tolerated. Physicians’ expectations concerning the benefit of switching to MTX self-administration was met in 92.8% of the patients. A total of 96.3% of the patients were considered suitable for subcutaneous self-administration of the MTX formulation.

Conclusions: The 50 mg/ml prefilled syringe appears to be a valuable treatment option for patients with rheumatoid and psoriatic arthritis in need of MTX. This is supported by the strong appreciation of the patients as well as their attending healthcare professionals for its convenience and tolerability. The results confirm the findings and experience from a clinical study performed in Germany in 2009, which showed that 93% of the patients prefer the 50 mg/ml prefilled syringe with a pre-attached needle.

Hepatitis C virus (HCV) infection is present in 1.8% of the general US population and its prevalence worldwide is estimated at 2–3%. HCV infected patients with concomitant rheumatoid arthritis (RA) pose a particular challenge to the rheumatologist because of the risks of treatment with disease-modifying medications in patients with chronic liver infection. In this paper the difficulties of diagnosing RA in HCV patients and the safety of RA treatment in patients with both conditions are discussed.

Background: Osteoarthritis (OA) is the most common cause of chronic pain and disability in the elderly. It involves progressive destruction of articular cartilage as a consequence of various factors including augmented oxidative stress with advancing age which has not yet been controlled. It is conceivable that exogenous vitamin E supplementation ameliorates the modifiable indexes via regulation of free radical production and the consumption of antioxidant reserve. The objectives of the present study were to investigate the therapeutic effect of vitamin E supplementation in ameliorating the altered activity of antioxidant enzymes (superoxide dismutase, ceruloplasmin, glutathione peroxidase and catalase), erythrocyte malondialdehyde level (MDA, i.e. marker of lipid peroxidation) and markers of systemic inflammation (plasma C-reactive protein [CRP] and synovial fluid interleukin 6 [IL-6]) in osteoarthritic elderly.

Methods: Antioxidant enzymes status, MDA, IL-6 and CRP levels were estimated by using standard methods in 40 healthy individuals (control group) and in 40 osteoarthritic patients aged 50–70 years before and after 3 months of vitamin E supplementation, i.e. group I (nonsupplemented) and group II (200 mg/day vitamin E supplemented). The obtained values were compared statistically by using Student’s t-test.

Results: Marked alteration in antioxidant enzymes, MDA and inflammatory markers were observed in group I (p < 0.05) as compared with controls. These levels were ameliorated significantly after vitamin E supplementation (p < 0.05) in group II. However, elevated levels of serum CRP and synovial fluid IL-6 (r = 0.034; p < 0.05) were decreased insignificantly (p < 0.1) after vitamin E supplementation in knee OA patients.

Conclusions: These findings confirm the protective role of vitamin E supplementation against oxidative stress mediated biomolecular deterioration in OA. However, the anti-inflammatory role of vitamin E remains to be explored.