Three Multicenter, Randomized, Double‐Blind, Placebo‐Controlled Studies Evaluating the Efficacy and Safety of Ustekinumab in Axial Spondyloarthritis. Issue 2 (29th December 2018)

• Record Type: Journal Article
• Authors: Deodhar, Atul; Gensler, Lianne S.; Sieper, Joachim; Clark, Michael; Calderon, Cesar; Wang, Yuhua; Zhou, Yiying; Leu, Jocelyn H.; Campbell, Kim; Sweet, Kristen; Harrison, Diane D.; Hsia, Elizabeth C.; van der Heijde, Désirée
• Other Names: Ariel Frederico investigator.; Asnal Cecilia Adma investigator.; Berman Alberto investigator.; Citera Gustavo investigator.; Rodriguez Graciela investigator.; Savio Veronica Gabriela investigator.; Bird Paul investigator.; Griffiths Hedley investigator.; Nicholls David investigator.; Rischmueller Maureen investigator.; Zochling Jane investigator.; De Vlam Kurt investigator.; Malaise Michel investigator.; Toukap Adrien Nzeusseu investigator.; Van den Bosch Filip investigator.; Vanhoof Johan investigator.; Bonfiglioli Rubens investigator.; Keiserman Mauro investigator.; Scotton Antonio Scafuto investigator.; Xavier Ricardo investigator.; Ximenes Antonio Carlos investigator.; Atanasov Assen investigator.; Goranov Ivan investigator.; Kazmin Ivan investigator.; Licheva Rodina Nestorova investigator.; Nikolov Nikolay investigator.; Oparanov Boycho investigator.; Stoilov Rumen investigator.; Bessette Louis investigator.; Rodrigues Jude investigator.; Bortilik Ladislav investigator.; Dokoupilova Eva investigator.; Dvoarak Zdenek investigator.; Galatikova Dagmar investigator.; Nemec Petr investigator.; Podrazilova Lucie investigator.; Simkova Gabriela investigator.; Stejfova Zuzana investigator.; Moravcova Radka investigator.; Vitek Petr investigator.; Cantagrel Alain investigator.; Baillet Athan investigator.; Banneville Beatrice investigator.; Combe Bernard investigator.; Breban Maxime investigator.; Nguyen Minh investigator.; Goupille Philippe investigator.; Braun Juergen investigator.; Everding Andrea investigator.; Kekow Joern investigator.; Koenig Ramona investigator.; Rubbert‐Roth Andrea investigator.; Witte Torsten investigator.; Bartha Attila investigator.; Drescher Edit investigator.; Kerekes Kata investigator.; Kovacs Attila investigator.; Pulai Judit investigator.; Rojkovich Bernadette investigator.; Szanto Sandor investigator.; Toth Edit investigator.; Avila Hilario investigator.; de la Torre Igancio Garcia investigator.; Irazoque Fedra investigator.; Maradiaga Marco investigator.; Pacheco Cesar investigator.; Brzosko Marek investigator.; Dudek Anna investigator.; Jeka Slawomir investigator.; Krogulec Marek investigator.; Kwiatkowska Brygida investigator.; Wiland Piotr investigator.; Wojciechowski Rafal investigator.; Zielinska Agnieszka investigator.; Santos Helena investigator.; Bugrova Olga investigator.; Christyakov Valery investigator.; Gorbunov Vladimir investigator.; Ilivanova Elena investigator.; Zemerova Elena investigator.; Kamalova Rima investigator.; Kameneva Tatyana investigator.; Macievskaya Galina investigator.; Marusenko Irina investigator.; Maslyansky Alexey investigator.; Myasoedova Svetlana investigator.; Myasoutova Leisan investigator.; Nemtsov Boris investigator.; Nesmeyanova Olga investigator.; Plaksina Tatyana investigator.; Pokrovskaya Tatyana investigator.; Polyakova Svetlana investigator.; Rebrov Andrey investigator.; Savina Liudmila investigator.; Smakotina Svetlana investigator.; Stanislav Marina investigator.; Ukhanova Olga investigator.; Vinogradova Irina investigator.; Zonova Elena investigator.; Baek Han Joo investigator.; Kim Tae‐Hwan investigator.; Lee ChangKeun investigator.; Lee SangHeon investigator.; Lee Sang‐Hoon investigator.; Lee Shin‐Seok investigator.; Park Sung‐Hwan investigator.; Song YeongWook investigator.; Suh Chang‐Hee investigator.; Ramos Juan Amarelo investigator.; Blanco Franciso Javier investigator.; Collantes Eduardo investigator.; Diaz Miguel Consuelo investigator.; Vivar Maria Luz Garcia investigator.; Gratacos Jordi investigator.; Juanola Xavier investigator.; Chen Der‐Yuan investigator.; Chen Hsiang‐Cheng investigator.; Chen Kun‐Hung investigator.; Chen Ying‐Chou investigator.; Chiu Ying‐Ming investigator.; Luo Shue‐Fen investigator.; Tsai Shih‐Tzu investigator.; Tseng Jui‐Cheng investigator.; Wei Cheng‐Chung investigator.; Weng Meng‐Yu investigator.; Abrahamovych Orest investigator.; Reshotko Dmytro investigator.; Golovchenko Oleksandr investigator.; Hospodarsky Ihor investigator.; Iaremenko Oleg investigator.; Levchenko Olena investigator.; Dudnyk Oleksandr investigator.; Garmish Olena investigator.; Grishyna Olena investigator.; Protsenko Galyna investigator.; Rekalov Dmytro investigator.; Smiyan Svitlana investigator.; Stanislavchuk Mykola investigator.; Trypilka Svitlana investigator.; Tseluyko Vira investigator.; Turianytsia Samvel investigator.; Vasylets Viktoriya investigator.; Virstyuk Nataliya investigator.; Kleban Yaroslav investigator.; Ciurtin Coziana investigator.; Gaffney Karl investigator.; Gunasekera Wiranthi investigator.; Mackay Kirsten investigator.; Packham Jon investigator.; Sengupta Raj investigator.; Tahir Hasan investigator.; Aelion Jacob investigator.; Bennett Ralph investigator.; Deodhar Atul investigator.; Gonzalez‐Paoli Julio investigator.; Griffin Robert M. investigator.; Grisanti Michael investigator.; Mallepalli Jyothi investigator.; Peters Eric investigator.; Schechtman Joy investigator.; Singhal Atul investigator.;
• Is Part Of: Arthritis & rheumatology. Volume 71:Issue 2(2019)
• Page Start: 258
• Page End: 270
• Publication Date: 2018-12-29
• Subjects: Arthritis -- Periodicals; Rheumatism -- Periodicals; 616.72
• DOI: 10.1002/art.40728
• Languages: English
• ISSNs: 2326-5191

Abstract

Abstract : Objective: To evaluate the efficacy and safety of ustekinumab in 3 randomized, placebo‐controlled studies in patients with axial spondyloarthritis (SpA). Studies 1 and 2 included patients with radiographic axial SpA (anti–tumor necrosis factor [anti‐TNF]–naive patients and patients with inadequate response or intolerance to anti‐TNF, respectively); study 3 patients had nonradiographic axial SpA. Methods: In all 3 studies, patients were randomly assigned (1:1:1) to receive subcutaneous ustekinumab at 45 mg or 90 mg or placebo up to 24 weeks, after which placebo‐treated patients were rerandomized to receive ustekinumab at 45 mg or 90 mg. The primary end point in studies 1 and 2 was the proportion of patients who met the Assessment of SpondyloArthritis international Society criteria for 40% improvement in disease activity (achieved an ASAS40 response). The primary end point in study 3 was the proportion of patients who achieved an ASAS20 response. Other disease activity and safety measures were also evaluated. A week 24 analysis of study 1 was preplanned to determine continuation of studies 2 and 3. Results: For study 1, the primary and major secondary end points were not met, and the study was discontinued. As a result, studies 2 and 3 were prematurely discontinued before they were fully enrolled. For all 3 studies, neither ustekinumab dose group demonstrated clinically meaningful improvement over placebo on key efficacy end points. The proportion of patients experiencing adverse events in the ustekinumab groups was consistent with that in previous studies. Conclusion: In these 3 placebo‐controlled trials, efficacy of ustekinumab in the treatment of axial SpA was not demonstrated. The safety profile was consistent with that of studies in other indications.