Swiss drug major Novartis (NOVN: VX) has announced results from the pivotal Phase III FUTURE 1 and FUTURE 2 studies showing AIN457 (secukinumab) demonstrated rapid and significant clinical improvements versus placebo in improving the signs and symptoms of psoriatic arthritis (PsA).
These results were presented yesterday at the American College of Rheumatology (ACR) Congress in Boston, USA. FUTURE 1 and FUTURE 2 are the first multicenter, randomized, placebo-controlled Phase III studies to evaluate the efficacy of secukinumab in IL-17A inhibition in PsA. In the FUTURE 1 study patients received an intravenous loading dose every two weeks for the first four weeks of treatment followed by monthly subcutaneous doses of 75mg or 150mg compared to placebo, and FUTURE 2 compared subcutaneous loading dose secukinumab 75mg, 150mg and 300mg to placebo. The intravenous loading period used in FUTURE 1 was designed to provide high systemic exposure for induction of response, in keeping with the initial proof of concept study in PsA with secukinumab. FUTURE 2 utilized an administration route (subcutaneous loading dose) and dose range (up to 300 mg) that is more consistent with the psoriasis program. A combined total of more than 1,000 patients were enrolled in the studies.
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