1. Three Multicenter, Randomized, Double-Blind, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Ustekinumab in Axial Spondyloarthritis
- Author
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Atul Deodhar, Lianne S. Gensler, Joachim Sieper, Michael Clark, Cesar Calderon, Yuhua Wang, Yiying Zhou, Jocelyn H. Leu, Kim Campbell, Kristen Sweet, Diane D. Harrison, Elizabeth C. Hsia, Désirée Heijde, Frederico Ariel, Cecilia Adma Asnal, Alberto Berman, Gustavo Citera, Graciela Rodriguez, Veronica Gabriela Savio, Paul Bird, Hedley Griffiths, David Nicholls, Maureen Rischmueller, Jane Zochling, Kurt De Vlam, Michel Malaise, Adrien Nzeusseu Toukap, Filip Van den Bosch, Johan Vanhoof, Rubens Bonfiglioli, Mauro Keiserman, Antonio Scafuto Scotton, Ricardo Xavier, Antonio Carlos Ximenes, Assen Atanasov, Ivan Goranov, Ivan Kazmin, Rodina Nestorova Licheva, Nikolay Nikolov, Boycho Oparanov, Rumen Stoilov, Louis Bessette, Jude Rodrigues, Ladislav Bortilik, Eva Dokoupilova, Zdenek Dvoarak, Dagmar Galatikova, Petr Nemec, Lucie Podrazilova, Gabriela Simkova, Zuzana Stejfova, Radka Moravcova, Petr Vitek, Alain Cantagrel, Athan Baillet, Beatrice Banneville, Bernard Combe, Maxime Breban, Minh Nguyen, Philippe Goupille, Juergen Braun, Andrea Everding, Joern Kekow, Ramona Koenig, Andrea Rubbert‐Roth, Torsten Witte, Attila Bartha, Edit Drescher, Kata Kerekes, Attila Kovacs, Judit Pulai, Bernadette Rojkovich, Sandor Szanto, Edit Toth, Hilario Avila, Igancio Garcia Torre, Fedra Irazoque, Marco Maradiaga, Cesar Pacheco, Marek Brzosko, Anna Dudek, Slawomir Jeka, Marek Krogulec, Brygida Kwiatkowska, Piotr Wiland, Rafal Wojciechowski, Agnieszka Zielinska, Helena Santos, Olga Bugrova, Valery Christyakov, Vladimir Gorbunov, Elena Ilivanova, Elena Zemerova, Rima Kamalova, Tatyana Kameneva, Galina Macievskaya, Irina Marusenko, Alexey Maslyansky, Svetlana Myasoedova, Leisan Myasoutova, Boris Nemtsov, Olga Nesmeyanova, Tatyana Plaksina, Tatyana Pokrovskaya, Svetlana Polyakova, Andrey Rebrov, Liudmila Savina, Svetlana Smakotina, Marina Stanislav, Olga Ukhanova, Irina Vinogradova, Elena Zonova, Han Joo Baek, Tae‐Hwan Kim, ChangKeun Lee, SangHeon Lee, Sang‐Hoon Lee, Shin‐Seok Lee, Sung‐Hwan Park, YeongWook Song, Chang‐Hee Suh, Juan Amarelo Ramos, Franciso Javier Blanco, Eduardo Collantes, Miguel Consuelo Diaz, Maria Luz Garcia Vivar, Jordi Gratacos, Xavier Juanola, Der‐Yuan Chen, Hsiang‐Cheng Chen, Kun‐Hung Chen, Ying‐Chou Chen, Ying‐Ming Chiu, Shue‐Fen Luo, Shih‐Tzu Tsai, Jui‐Cheng Tseng, Cheng‐Chung Wei, Meng‐Yu Weng, Orest Abrahamovych, Dmytro Reshotko, Oleksandr Golovchenko, Ihor Hospodarsky, Oleg Iaremenko, Olena Levchenko, Oleksandr Dudnyk, Olena Garmish, Olena Grishyna, Galyna Protsenko, Dmytro Rekalov, Svitlana Smiyan, Mykola Stanislavchuk, Svitlana Trypilka, Vira Tseluyko, Samvel Turianytsia, Viktoriya Vasylets, Nataliya Virstyuk, Yaroslav Kleban, Coziana Ciurtin, Karl Gaffney, Wiranthi Gunasekera, Kirsten Mackay, Jon Packham, Raj Sengupta, Hasan Tahir, Jacob Aelion, Ralph Bennett, Julio Gonzalez‐Paoli, Robert M. Griffin, Michael Grisanti, Jyothi Mallepalli, Eric Peters, Joy Schechtman, and Atul Singhal
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0301 basic medicine ,Ankylosing ,Adult ,Male ,medicine.medical_specialty ,Immunology ,Placebo ,Antibodies ,law.invention ,03 medical and health sciences ,0302 clinical medicine ,Rheumatology ,Randomized controlled trial ,Double-Blind Method ,law ,Internal medicine ,Ustekinumab ,Monoclonal ,Clinical endpoint ,medicine ,Immunology and Allergy ,Humans ,Spondylitis, Ankylosing ,Adverse effect ,Spondylitis ,030203 arthritis & rheumatology ,Ankylosing spondylitis ,business.industry ,Antibodies, Monoclonal ,Middle Aged ,medicine.disease ,Injection Site Reaction ,Clinical trial ,030104 developmental biology ,Treatment Outcome ,Antirheumatic Agents ,Spondylarthropathies ,Female ,business ,medicine.drug - Abstract
Author(s): 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, Desiree | Abstract: ObjectiveTo 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.MethodsIn 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.ResultsFor 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.ConclusionIn 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.
- Published
- 2019
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