Abatacept is a co-stimulation blocker that inhibits T-cell activation and interrupts the process leading to inflammation in rheumatoid arthritis. Patients with severe arthritis who took abatacept with at least one other disease-modifying antirheumatic drug in six and 12-month clinical trials demonstrated statistically significant improvement in tender, swollen joints and other clinical measures compared with placebo. Mild to moderate adverse events included headache, nasopharyngitis, hypertension and back pain. The adverse events were similar to those seen in placebo groups. Abatacept should not be used in combination with other biologic agents because of reported increased rates of serious adverse events, including serious infections. With its different mechanism of action, abatacept may be an alternative add-on therapy for patients with an inadequate response to other arthritis therapies.
Alefacept is a new biotechnology product designed for the treatment of patients with chronic plaque-type psoriasis who have disease severe enough to make them eligible for phototherapy or systemic therapy. In two randomized controlled phase III trials of patients with moderate-to-severe disease, alefacept showed a modest but statistically significant increase in the number of responders compared to placebo. Alefacept's dose-dependent CD4+ T lymphocyte-depleting effect requires monitoring; however, no association has been found between this adverse effect and serious adverse events, particularly infection. Due to lack of direct comparative data, it is difficult to predict exactly how alefacept will fit into the current rotational psoriasis therapy paradigm.
(1) Anakinra is an interleukin-1 receptor antagonist (IL-1ra), which blocks interleukin-1 (IL-1), a protein involved in the inflammation and the joint destruction associated with rheumatoid arthritis (RA). (2) The manufacturer's submission for drug approval is currently under review by Health Canada and the FDA. (3) In randomized controlled trials, patients with severe RA were treated with anakinra. Significant improvement was demonstrated in several clinical, radiologic and health-related quality of life measures in patients treated with anakinra versus placebo. (4) Minimal adverse effects, mainly injection site reactions, were reported.
In 1978, the Food and Drug Administration (FDA), developed a generic anesthesia equipment preuse checklist. The checklist was first released by the FDA in August 1986 and endorsed by the American Association of Nurse Anesthetists on October 18, 1986. The FDA checklist was revised in 1992 to improve the abilities of anesthesia providers to detect machine faults. In the present study, the investigators attempted to determine the effectiveness of the revised FDA checklist in detection of anesthesia machine faults as compared to providers' usual methods. Whereas no published study of preanesthesia safety inspection had been performed since the revision of the FDA checklist, the authors compared the detection abilities of anesthesia providers before and after inclusion of the revised FDA checklist. Twenty-two anesthesia providers were tested to compare the number of prearranged anesthesia machine faults that could be detected with (1) their usual checkout methods, and (2) with the revised FDA checklist. Data describing the subjects' fault detection abilities were analyzed using the t test for paired observation (P value