A head-to-head comparison of the efficacy and safety of ixekizumab and adalimumab in biological-naïve patients with active psoriatic arthritis: 24-week results of a randomised, open-label, blinded-assessor trial
Articolo
Data di Pubblicazione:
2020
Abstract:
Objectives To compare efficacy and safety of ixekizumab (IXE) to adalimumab (ADA) in biological disease-modifying antirheumatic drug-naïve patients with both active psoriatic arthritis (PsA) and skin disease and inadequate response to conventional synthetic disease-modifying antirheumatic drug (csDMARDs). Methods Patients with active PsA were randomised (1:1) to approved dosing of IXE or ADA in an open-label, head-to-head, blinded assessor clinical trial. The primary objective was to evaluate whether IXE was superior to ADA at week 24 for simultaneous achievement of a ≥50% improvement from baseline in the American College of Rheumatology criteria (ACR50) and a 100% improvement from baseline in the Psoriasis Area and Severity Index (PASI100). Major secondary objectives, also at week 24, were to evaluate whether IXE was: (1) non-inferior to ADA for achievement of ACR50 and (2) superior to ADA for PASI100 response. Additional PsA, skin, treat-to-target and quality-of-life outcome measures were assessed at week 24. Results The primary efficacy endpoint was met (IXE: 36%, ADA: 28%; p=0.036). IXE was non-inferior for ACR50 response (IXE: 51%, ADA: 47%; treatment difference: 3.9%) and superior for PASI100 response (IXE: 60%, ADA: 47%; p=0.001). IXE had greater response versus ADA in additional PsA, skin, nail, treat-to-target and quality-of-life outcomes. Serious adverse events were reported in 8.5% (ADA) and 3.5% (IXE) of patients. Conclusions IXE was superior to ADA in achievement of simultaneous improvement of joint and skin disease (ACR50 and PASI100) in patients with PsA and inadequate response to csDMARDs. Safety and tolerability for both biologicals were aligned with established safety profiles.
Tipologia CRIS:
1.1 Articolo in rivista
Keywords:
adalimumab; clinical trial; head-to-head; ixekizumab; psoriatic arthritis; Adalimumab; Adult; Antibodies, Monoclonal, Humanized; Antirheumatic Agents; Arthritis, Psoriatic; Female; Humans; Male; Middle Aged; Psoriasis; Single-Blind Method; Treatment Outcome
Elenco autori:
P. J., Mease; J. S., Smolen; F., Behrens; P., Nash; S., Liu Leage; L., Li; H., Tahir; M., Gooderham; E., Krishnan; H., Liu-Seifert; P., Emery; S. G., Pillai; P. S., Helliwell; Verzero, Beatriz; adma asnal, Cecilia; Fabian Mysler, Eduardo; Berman, Alberto; Javier ariel, Federico; Rischmueller, Maureen; Margaret Zochling, Jane; a Bird, Paul; Hall, Stephen; Ostor, Andrew; Romas, Evange; Stummvoll, Georg; Machold, Klaus; Spellitz, Peter; Hanusch, Ursula; Vanden Berghe, Marc; Marc, Leon; louis Magda Vanhoof, Johan; eduard Jeanne Van den Bosch, Filip; leo Francois De Vlam, Kurt; Morin, Frederic; Bessette, Louis; a Haaland, Derek; Margrethe schlemmer, Annette; erik Kristensen, Lars; Jarvinen, Pentti; liisa Peltomaa, Ritva; Pirila, Laura; Vuotila, Jorma; Lespessailles, Eric; Goupille, Philippe; Combe, Bernard; Constantin, Arnaud; Cormier, Gregoire; Cozic, Celine; B Confavreux, Cyrille; schulze-Koops, Hendrik; Everding, Andrea; Kohm, Micheala; Wassenberg, Siegfried; Nagy, Magdolna; Bakos, Noemi; Melegh, Eva; Drescher, Edit; Duggal, Lalit; narayanbhai Joshi, Piyush; Ghosh Zoha, Srabani; Ramakrishnam naidu, A; Pushkarkumar srivastava, Puja; Devkinandan sharma, Vishnu; Bapurao nalawadae, Ajit; laxmikant Oak, Jyotsna; Chandra Mouli Veeravalli, Sarath; Kishore Kadel, Jugal; ashwin Daware, Manisha; s Marfatia, Yogesh; Agarwal, Sumeet; Braun Moscovici, Yolanda; Elkayam, Ori; Molad, Yair; Reitblat, Tatiana; Tishler, Moshe; Levy, Yair; Lidar, Merav; Zisman, Devy; Costanzo, Antonio; Amerio, Paolo; Meliconi, Riccardo; Foti, Rosario; Perricone, Roberto; Rossini, Maurizio; Gremese, Elisa; elena Zazueta Montiel, Beatriz; Manuel Miranda limon, Juan; antonio Maradiaga Cecena, Marco; araceli sicsik ayala, Sandra; angel alvarez Guerrero, Miguel; Rojas serrano, Jorge; antonio Canul novelo, Efren; Fidencio Cons-Molina, Francisco; n Griep, Ed; Kaszuba, Andrzej; Bogna Węgłowska, Jolanta; Bazela, Barbara; Rell-Bakalarska, Maria; Miakisz, Malgorzata; elizabeth spargo, Catherine; Margaretha Van Duuren, Elsa; Naidoo, Asokan; Cleopatra Matsiliza, Nomawethu; Breedt, Johannes; scott Tarr, Gareth; Potts, Jenny; Nayiager, Savithree; Moosa Tar Mahomed ally, Mahmood; Javier Blanco Garcia, Francisco; Mera Varela, Antonio; Rosas, Jose; Miguel sanchez Burson, Juan; Garcia Miguel, Javier; Lampa, Jon; Rizk, Milad; Cagnotto, Giovanni; Larsson, Per; Fei, Guozhong; Mueller-Mar, Ruediger; Rubbert-Roth, Andrea; John nissen, Michael; Iaremenko, Oleh; anatoliivna Trypilka, Svitlana; Rekalov, Dmytro; Stanislavchuk, Mykola; Viktorivna Vasylets, Viktoriia; Garmish, Olena; Smiyan, Svitlana; Walker, David; Jadon, Deepak; Ralston, Stuart; Boyle, Stephen; anne Watson, Pippa; e Dale, James; Carty, Sara; Douglas, Karen; J edwards, Christopher; Hutchinson, David; Barkham., Nick
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