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1. Fenebrutinib versus Placebo or Adalimumab in Rheumatoid Arthritis: A Randomized, Double-Blind, Phase II Trial (ANDES Study)

Author

Stanley Cohen, Katie Tuckwell, Tamiko R. Katsumoto, Rui Zhao, Joshua Galanter, Chin Lee, Julie Rae, Balazs Toth, Nandhini Ramamoorthi, Jason A. Hackney, Alberto Berman, Nemanja Damjanov, Dmytro Fedkov, Slawomir Jeka, Leslie W. Chinn, Michael J. Townsend, Alyssa M. Morimoto, Mark C. Genovese, Alejandro Porto, Amelia Granel, Cecilia Asnal, Eduardo Fabian Mysler, Gladys Alicia Testa, Jose Luis Velasco Zamora, Jose Luis Cristian Moreno, Juan Pablo Gulin, Julio Hofman, Maria Rosa Ulla, Mirtha Sabelli, Pablo Alejandro Mannucci, Pablo Jorge Maid, Ana Cláudia Cauceglia Melazzi, Antônio Scafuto Scotton, Antônio Carlos Ximenes, Elisete Funes, Emerson Alves Gimenez, Flora Maria D’Andrea Marcolino, João Francisco Marques Neto, Mauro Waldemar Keiserman, Sebastião Cézar Radominski, Sônia Maria Alvarenga Anti Loduca Lima, Thaís Rohde Pavan, Valderílio Feijó Azevedo, Aneliya Koleva, Antoaneta Toncheva, Daniela Bichovska, Delina Ivanova, Dimitar Penev, Emil Dimitrov, Mariyana Mihaylova, Nadezhda Kapandjieva, Natalia Marinova, Tanya Aleksieva, Tanya Tsvetanova, Tsvetanka Petranova, Valentina Popova, Yuliy Spasov, Carlos Enrique Toro, Carlos Ernesto Arteaga Unigarro, Edwin Jauregui, Javier Dario Marquez Hernandez, Juan Jose Jaller Raad, Patricia Julieta Velez Sanchez, Chang Keun Lee, Chang‐Hee Suh, Eun Young Lee, Sang‐Heon Lee, Seong Wook Kang, Shin‐Seok Lee, Yun Jong Lee, Beatriz Elena Zazueta Montiel, Blanca Irma Pinzon de la O, Daniel Xibille Friedmann, Francisco Rosas Lopez, Isaura Rodriguez Torres, Luis Jara Quezada, Marco Maradiaga Ceceña, Miguel Cortes Hernandez, Miguel Saavedra Salinas, Agnieszka Rapa, Agnieszka Pawtel, Agnieszka Zielinska, Anna Dudek, Anna Rychlewska‐Hanczewska, Anna Strzelecka, Artur Racewicz, Barbara Stasiuk, Katarzyna Gruszecka, Krystyna Dworak, Tomasz Lowenhoff, Alexey Maslyanskiy, Andrey Rebrov, Diana Krechikova, Elena Zhugrova, Evgeniya Shmidt, Galina Matsievskaya, Irina Vinogradova, Irina Ler, Larisa Eliseeva, Ludmila Savina, Marina Stanislav, Mikhail Sandin, Natalia Zyablova, Nikolay Korshunov, Nino Mosesova, Oksana Polovnikova, Olga Nesmeyanova, Ruzana Samigullina, Sergey Moiseev, Sergey Noskov, Tatiana Raskina, Tatiana Popova, Valeriy Marchenko, Aleksandar Jovanovski, Bojana Stamenkovic, Gorica Ristic, Milijanka Lazarevic, Mirjana Veselinovic, Nada Vujasinovic‐Stupar, Predrag Ostojic, Andriy Yagensky, Andriy Gnylorybov, Dmytro Rekalov, Dmytroo Reshotko, Georgiy Dzyak, Iurii Gasanov, Ludmila Khimion, Mykola Stanislavchuk, Natalya Prykhodko, Oleg Nadashkevych, Oleg Bortkevych, Orest Abrahamovych, Roman Yatsyshyn, Samvel Turyanytsya, Svitlana Smiyan, Vadym Vizir, Victoria Kachur, Vira Tseluyko, Vladyslav Povoroznyuk, Volodymyr Koshlia, Vyacheslav Zhdan, Yurii Lymar, Yuriy Mostovoy, Angela Hawkes, Arthur Mabaquiao, Cong‐Qiu Chu, Craig Scoville, David Wyatt, Debra Weinstein, Harris McIlwain, Jacqueline Vo, Jeffrey Poiley, Joseph Forstot, Kathryn Dao, Mark Turner, Mark Genovese, Michael Borofsky, Paul Caldron, Philip Waller, Robert Levin, Samy Metyas, Scott Stein, Sharukh Shroff, Shirley Pang, Tauseef Syed, and Vishala Chindalore

Subjects
0301 basic medicine, medicine.medical_specialty, Immunology, Rheumatoid Arthritis, Placebo, Gastroenterology, 03 medical and health sciences, 0302 clinical medicine, Rheumatology, Internal medicine, medicine, Adalimumab, Immunology and Allergy, Rheumatoid factor, Adverse effect, business.industry, medicine.disease, 3. Good health, 030104 developmental biology, 030220 oncology & carcinogenesis, Rheumatoid arthritis, Cohort, Original Article, Methotrexate, business, medicine.drug
Abstract

Objective To evaluate fenebrutinib, an oral and highly selective noncovalent inhibitor of Bruton's tyrosine kinase (BTK), in patients with active rheumatoid arthritis (RA). Methods Patients with RA and an inadequate response to methotrexate (MTX) (cohort 1; n = 480) were randomized to receive fenebrutinib (50 mg once daily, 150 mg once daily, or 200 mg twice daily), adalimumab (40 mg every other week), or placebo. Patients with RA and an inadequate response to tumor necrosis factor inhibitors (cohort 2; n = 98) received fenebrutinib (200 mg twice daily) or placebo. Both cohorts continued MTX therapy. Results In cohort 1, the percentages of patients in whom American College of Rheumatology 50% improvement criteria (ACR50) was achieved at week 12 were similar in the fenebrutinib 50 mg once daily and placebo groups, and were higher in the fenebrutinib 150 mg once daily group (28%) and 200 mg twice daily group (35%) than in the placebo group (15%) (P = 0.016 and P = 0.0003, respectively). Fenebrutinib 200 mg twice daily and adalimumab (36%) were comparable (P = 0.81). In cohort 2, ACR50 was achieved in more patients receiving fenebrutinib 200 mg twice daily (25%) than placebo (12%) (P = 0.072). The most common adverse events in the fenebrutinib groups included nausea, headache, anemia, and upper respiratory tract infections. Fenebrutinib had significant effects on myeloid and B cell biomarkers (CCL4 and rheumatoid factor). Fenebrutinib and adalimumab caused overlapping as well as distinct changes in B cell and myeloid biomarkers. Conclusion Fenebrutinib demonstrates efficacy comparable to adalimumab in patients with an inadequate response to MTX, and safety consistent with existing immunomodulatory therapies for RA. These data support targeting both B and myeloid cells via this novel mechanism for potential efficacy in the treatment of RA.

Published
2020

2. Three Multicenter, Randomized, Double-Blind, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Ustekinumab in Axial Spondyloarthritis

Author

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

Subjects
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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