Rituximab versus an alternative TNF inhibitor in patients with rheumatoid arthritis who failed to respond to a single previous TNF inhibitor: SWITCH-RA, a global, observational, comparative effectiveness study.

OBJECTIVES: To compare the effectiveness of rituximab versus an alternative tumour necrosis factor (TNF) inhibitor (TNFi) in patients with rheumatoid arthritis (RA) with an inadequate response to one previous TNFi. METHODS: SWITCH-RA was a prospective, global, observational, real-life study. Patients non-responsive or intolerant to a single TNFi were enrolled ≤4 weeks after starting rituximab or a second TNFi. Primary end point: change in Disease Activity Score in 28 joints excluding patient's global health component (DAS28-3)-erythrocyte sedimentation rate (ESR) over 6 months. RESULTS: 604 patients received rituximab, and 507 an alternative TNFi as second biological therapy. Reasons for discontinuing the first TNFi were inefficacy (n=827), intolerance (n=263) and other (n=21). A total of 728 patients were available for primary end point analysis (rituximab n=405; TNFi n=323). Baseline mean (SD) DAS28-3-ESR was higher in the rituximab than the TNFi group: 5.2 (1.2) vs 4.8 (1.3); p<0.0001. Least squares mean (SE) change in DAS28-3-ESR at 6 months was significantly greater in rituximab than TNFi patients: -1.5 (0.2) vs -1.1 (0.2); p=0.007. The difference remained significant among patients discontinuing the initial TNFi because of inefficacy (-1.7 vs -1.3; p=0.017) but not intolerance (-0.7 vs -0.7; p=0.894). Seropositive patients showed significantly greater improvements in DAS28-3-ESR with rituximab than with TNFi (-1.6 (0.3) vs -1.2 (0.3); p=0.011), particularly those switching because of inefficacy (-1.9 (0.3) vs -1.5 (0.4); p=0.021). The overall incidence of adverse events was similar between the rituximab and TNFi groups. CONCLUSIONS: These real-life data indicate that, after discontinuation of an initial TNFi, switching to rituximab is associated with significantly improved clinical effectiveness compared with switching to a second TNFi. This difference was particularly evident in seropositive patients and in those switched because of inefficacy.

Cost-effectiveness of wound management in France: pressure ulcers and venous leg ulcers.

OBJECTIVES: This study set out to define realistic protocols of care for the treatment of chronic venous leg ulcers and pressure ulcers in France and, by developing cost-effectiveness models, to compare the different protocols of care for the two ulcer groups, enabling a calculation of direct medical costs per ulcer healed in a typical French health insurance plan. METHOD: Clinical outcomes and some treatment patterns were obtained from published literature. Validations of different treatment patterns were developed using an expert consensus panel similar to the Delphi approach. Costs were calculated based on national averages and estimates from the UK and Germany. The models were used to measure costs per healed ulcer over a 12-week period. RESULTS: For both the pressure ulcer and venous leg ulcer models, three protocols of care were identified. For pressure ulcers and venous leg ulcers, the hydrocolloid DuoDERM (ConvaTec, also known as Granuflex in the UK and Varihesive in Germany) was most cost-effective in France. CONCLUSION: The combination of published data and expert consensus opinion is a valid technique, and in this case suggests that treating pressure ulcers and venous leg ulcers with hydrocolloid dressings is more cost-effective than treating them with saline gauze, in spite of the lower unit cost of the latter.