Sequencing JAK-inhibitors in ulcerative colitis: effectiveness and safety of switching within treatment class.
Обработка статьи · этапы, ошибки и управление
Ошибки и ограничения
История · было → стало
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Innocenti Tommaso, Hanžel Jurij, Truyens Marie, Lukaš Milan, Gordon Hannah, Cremer Anneline, Molnár Tamás, Julsgaard Mette, Onali Sara, Todeschini Alessia, Nardone Olga Maria, Noor Nurulamin M, Caprioli Flavio, Scaldaferri Franco, Argyriou Konstantinos, Savarino Edoardo Vincenzo, Brinar Marko, Hedin Charlotte R H, Vela González Milagros, Armuzzi Alessandro, Blesl Andreas, Aratari Annalisa, Quadarella Alessandro, Parigi Tommaso Lorenzo, Bertani Lorenzo, Ferracane Concetta, Uzzan Mathieu, Michalopoulos George, De Bernardi Alice, Katsanos Konstantinos, Balestrieri Paola, Piñero Gisela, Karmiris Konstantinos, Casbas Ana Gutierrez, Nikolic Sara, Felice Carla, Pugliese Daniela, Pastras Ploutarchos, Mocci Giammarco, Pouillon Lieven, Mantzaris Gerassimos J, Ramos Laura, Casanova María José, Koutroubakis Ioannis E, García María José, Lobaton Triana, Dragoni Gabriele, Study Group The JAKi-Seq
Аннотация
METHODS: We conducted a multicenter retrospective study, including patients with UC starting a second JAKi after prior JAKi exposure. The primary endpoint was Week 12 steroid-free clinical remission (SFCR-rectal bleeding subscore = 0, stool frequency subscore ≤ 1, and no steroids).
RESULTS: We included 243 patients (median follow-up: 38 [21-57] weeks). At Weeks 12, 26, and 52, SFCR was achieved in 116/243 (48%), 120/243 (49%), and 69/243 (28%), respectively. Secondary loss of response to the first JAKi was associated with higher SFCR at Week 12 compared to primary failure (odds ratio [OR] = 1.92, 95% confidence interval [CI] = 1.11-3.30, P = 0.02). Higher baseline disease activity (OR = 0.68, 95% CI = 0.68-0.55, P < 0.01) and steroid use (OR = 0.23, 95% CI = 0.13-0.42, P < 0.01) had lower odds of Week 12 SFCR. Endoscopic remission occurred in 22/243 (9%) (<Week 26) and 27/243 (11%) (26-78 weeks), and endoscopic improvement in 53/243 (22%) and 45/243 (19%), respectively. Sixty-seven (28%) patients discontinued the second JAKi, mostly due to primary (36/67) or secondary failure (22/67). Sixty-six adverse events (mostly acne and infections) occurred in 56 (23%) patients, without major thromboembolic or cardiovascular events.
CONCLUSION: Treatment with a second JAKi is effective and safe in patients with UC already exposed to JAKi. Primary failure to a first JAKi and steroid use at initiation of the second JAKi might reduce the likelihood of success with the second JAKi.