The last analysis examined overall survival from baseline to week 60 in patients newly treated with Esbriet during RECAP. While neither RECAP nor CAPACITY was powered to evaluate the effect of treatment on survival, analyses showed that overall survival at 60 weeks post initiation of therapy was similar in patients newly treated with Esbriet in RECAP and CAPACITY, and greater than that of patients who were treated with placebo in CAPACITY. Additionally, fewer treatment emergent deaths, defined as deaths occurring within 28 days of the last dose of study drug, were observed among Esbriet-treated patients in both RECAP and CAPACITY compared with patients who were treated with placebo during CAPACITY. Treatment-emergent death occurred in 3.4% and 2.9% of Esbriet-treated patients in RECAP and CAPACITY, respectively, compared with 5.8% of patients treated with placebo in CAPACITY.
These results, coupled with new results to be presented at ERS during a poster discussion session on Tuesday, September 4 on the long-term safety data in IPF patients treated with Esbriet for up to 7.7 years, provide further evidence to support the clinical efficacy and safety of Esbriet in patients with IPF.
About RECAPRECAP is an open-label extension study for patients who participated in the Phase 3 program for Esbriet, known as CAPACITY. The CAPACITY program (studies 004 and 006) was designed to evaluate the safety and efficacy of Esbriet in IPF patients with mild to moderate impairment in lung function. In the CAPACITY studies, 779 patients were randomized to treatment with Esbriet or placebo and 626 patients completed the study. Of these, 603 (96 percent) were enrolled in RECAP.
Long-term safety results from RECAP were initially presented at the Annual Congress of the European Respiratory Society (ERS) in September 2011. These results demonstrated that long-term treatment with Esbriet was safe and generally well-tolerated, with a long-term safety profile similar to that observed in CAPACITY.