Evaluation of the cumulative (repeated application) eye irritation and corneal staining potential of FD&C yellow no. 5, FD&C blue no. 1 and FD&C blue no. 1 aluminium lake.

A protocol to evaluate the ocular irritation, staining, and embedding potential of FD&C colours (Yellow No. 5, Blue No. 1, Blue No. 1 Aluminium Lake) produced by repeated topical application to rabbit eyes is described. Test materials (3%, w/v in aqueous vehicle) were administered once daily, for a total of 21 days, to the conjunctival sac of the right eye of New Zealand White Rabbits (6 of each sex per group) at a dose volume of 30 microliters. Control animals (6 of each sex) received 30 microliters of the vehicle daily. All animals survived and were free of significant clinical signs of toxicity throughout the study. Ophthalmoscopic examinations revealed that all animals were free of abnormalities considered to be of clinical importance; all animals were free of significant signs of ocular irritation, staining and particle embedment. The results of this study support the safe use of these materials in consumer products intended for use in the eye area.

Cost effectiveness of adalimumab for the treatment of ankylosing spondylitis in the United Kingdom.

OBJECTIVES: This study evaluated the cost effectiveness of adalimumab vs conventional therapy in patients with active ankylosing spondylitis (AS). METHODS: The analysis was based on pooled data from two Phase III studies of adalimumab in active AS. Patients with an inadequate response to >/=1 NSAID received adalimumab 40 mg every other week (n = 246) or placebo (n = 151) for 24 weeks. A microsimulation model was developed with patients being treated with adalimumab according to the International ASAS Consensus Statement and BSR guidelines. The pooled adalimumab data, as well as data from the Outcome Assessment in AS International Study (OASIS) database and the literature, were used to model patients' BASDAI and BASFI scores and costs and health-related quality of life associated with various degrees of disease activity. Costs (in 2004 British pound) of AS, drug, administration, monitoring, hospitalization and AEs were calculated from the perspective of the UK NHS. Discounting was applied at 3.5% per year for costs and benefits as per the NICE reference case for economic evaluations. Uncertainty was addressed via sensitivity analyses. RESULTS: The incremental cost-effectiveness ratio (ICER) of adalimumab vs conventional therapy was estimated to improve with longer time horizons (48 weeks to 5 and 30 yrs). The central estimate was that, over 30 yrs, adalimumab therapy yielded 1.03 more quality-adjusted life-years (QALYs) per patient initiating therapy. Some AS treatment-related costs were estimated to be offset by adalimumab (at 10,750 pounds/patient), leaving a total incremental cost (adalimumab vs conventional therapy) at 23,857 pounds per patient. The 30-yr ICER of adalimumab vs conventional therapy was estimated at 23 pounds 097/QALY. Sensitivity analyses demonstrated robustness of results. When indirect costs were also included (analysis from societal perspective), ICER improved to 5093 pounds/QALY. CONCLUSIONS: This analysis indicates that adalimumab, when used according to UK treatment guidelines, is cost-effective vs conventional therapy for treating AS patients.