Novartis provides update on Phase III GCAptAIN study of
From GlobeNewswire: 2025-07-03 01:15:00
Novartis announced that the GCAptAIN study did not meet its primary endpoint of sustained remission at Week 52 for adults with newly diagnosed or relapsing giant cell arteritis (GCA). While Cosentyx did not show statistical improvement in remission, it did have better outcomes in steroid dose and toxicity compared to placebo. The safety profile of Cosentyx in GCA patients was consistent with previous data. The Phase III trial results will be evaluated further, with details to be shared later. GCA is a serious condition, with potential complications like vision loss and aortic aneurysms, affecting individuals over 50 years old. Novartis remains committed to advancing research in immune-mediated diseases. The GCAptAIN study did not meet its primary endpoint of sustained remission at Week 52 in adults with newly diagnosed or relapsing GCA1 ACR 2024. Long-term real-world safety profile of Secukinumab was assessed through a 9-year experience in patients with psoriasis, psoriatic arthritis, and ankylosing spondylitis, with results from a multicentric retrospective study. Secukinumab provides sustained improvements in signs and symptoms of psoriatic arthritis, as shown in a final 5-year efficacy and safety results from a Phase 3 trial. The FUTURE 2 study demonstrates long-term efficacy and safety of Secukinumab in patients with psoriatic arthritis, with 5-year end-of-study results. Bissonnette et al. found that Secukinumab demonstrates high sustained efficacy and a favorable safety profile in patients with moderate-to-severe psoriasis through 5 years of treatment in the SCULPTURE Extension Study. Novartis AG’s press release in 2022 highlighted how Cosentyx shows clinically meaningful symptom improvements in patients with hidradenitis suppurativa in pivotal Phase III trials. Novartis AG’s 2021 press release announced that Cosentyx received FDA approval for the treatment of children and adolescents with enthesitis-related arthritis and psoriatic arthritis. In 2022, Novartis AG’s press release stated that Cosentyx received a positive CHMP opinion for expanded use in childhood arthritic conditions. Various studies and publications have contributed to the understanding of psoriatic arthritis, including research by González-Gay MA, García-Porrúa C, Li KJ, Albrecht K, Chen JJ, Donaldson L, Hayreh SS, de Boysson H, Robson JC, and Martins-Martinho J.
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