Tofacitinib in Combination With Methotrexate in Patients With Rheumatoid Arthritis: Clinical Efficacy, Radiographic, and Safety Outcomes From a Twenty‐Four–Month, Phase III Study. Issue 6 (24th April 2019)

• Record Type: Journal Article
• Authors: van der Heijde, Désirée; Strand, Vibeke; Tanaka, Yoshiya; Keystone, Edward; Kremer, Joel; Zerbini, Cristiano A. F.; Cardiel, Mario H.; Cohen, Stanley; Nash, Peter; Song, Yeong‐Wook; Tegzová, Dana; Gruben, David; Wallenstein, Gene; Connell, Carol A.; Fleischmann, Roy
• Other Names: Hall Stephen investigator.; Nicholls David investigator.; Rischmueller Maureen investigator.; Baker Milton F. investigator.; Bessette Louis investigator.; Cividino Alfred A investigator.; Haraoui Boulos investigator.; Niall Jones Henry investigator.; Keystone Edward C. investigator.; Khraishi Majed investigator.; Thorne J. investigator.; Birbara Charles Allen investigator.; Baraf Herbert Stuart Block investigator.; Bathon Joan Marie investigator.; Brodsky Alan Lawrence investigator.; Cush John Joseph investigator.; Dikranian Ara Hagop investigator.; Diri Erdal investigator.; Dura Paul Andrew investigator.; Lohr Kristine Marie investigator.; Fleischmann Roy Mitchell investigator.; Griffin Robert Michael investigator.; Halter Dale George investigator.; Hargrove Jody Kay investigator.; Bouda David William investigator.; Reddy Pasya Suresh Kumar investigator.; Hill Geneva Louise investigator.; Jackson Raymond Edward investigator.; Kafka Shelly Pearl investigator.; Kaine Jeffrey Louis investigator.; Katzenstein Paul L. investigator.; Kempf Kevin James investigator.; Kolba Karen Sue investigator.; Kremer Joel Marc investigator.; Longley Selden investigator.; Mathews Steven D. investigator.; Milton Ami Charise investigator.; Misischia Richard James investigator.; Moorman Haydon Anthony investigator.; Moreland Larry Wayne investigator.; Niemer Mark William investigator.; Palmer William Rodney investigator.; Sayers Michael Eugene investigator.; Schuette Patrick Thomas investigator.; Shamim Talha investigator.; Shergy William Julius investigator.; Sikes David Hilton investigator.; Silverfield Joel Charles investigator.; Siva Chokkalingam investigator.; Taborn James D. investigator.; Walsh Bridget Tyrell investigator.; Wells Alvin Francis investigator.; Wolfe Sanford Mayer investigator.; Adhikari Prabha investigator.; Amano Kouichi investigator.; Bae Sang‐Cheol investigator.; Chandrashekara Srikantiah investigator.; Chopra Arvind K. investigator.; Hsu Ping‐Ning investigator.; Iwahashi Mitsuhiro investigator.; Kadel Jugal Kishore investigator.; Kawabe Yojiro investigator.; Koh Eun‐Mi investigator.; Lan Joung‐liang investigator.; Lee Soo‐Kon investigator.; Lin Hsiao‐Yi investigator.; Liou Lieh‐bang investigator.; Liu Ming‐Fei investigator.; Migita Kiyoshi investigator.; Miyamoto Toshiaki investigator.; Miyasaka Nobuyuki investigator.; Mori Shunsuke investigator.; Munakata Yasuhiko investigator.; Ohta Shuji investigator.; Park Won investigator.; Park Sung‐Hwan investigator.; Rao Uppuluri Ramakrishna investigator.; Shim Seung Cheol investigator.; Shobha Vineeta investigator.; Takasaki Yoshinari investigator.; Takeuchi Tsutomu investigator.; Tanaka Yoshiya investigator.; Tohma Shigeto investigator.; Tsai Wen‐Chan investigator.; Ueki Yukitaka investigator.; Veeravalli Sarath Chandra Mouli investigator.; Wagh Shrikant investigator.; Yamanaka Hisashi investigator.; Yoo Bin investigator.; Batalov Anastas investigator.; Bichoversuska Daniela investigator.; Dvorak Zdenek investigator.; Goranov Ivan investigator.; Hrytsenko Halyna M. investigator.; Kopackova Jana investigator.; Mosterova Zdenka investigator.; Oparanov Boycho investigator.; Petrov Andriy investigator.; Pokrzywnicka‐Gajek Ines investigator.; Povoroznyuk Vladyslav V. investigator.; Rosa Jan investigator.; Ruzga Zofia investigator.; Settas Loukas investigator.; Stanislavchuk Mykola A. investigator.; Tseluyko Vira Iosypivna investigator.; Vitek Petr investigator.; de Freitas Zerbini Cristiano Augusto investigator.; Brenol Joao Carlos Tavares investigator.; Cardiel‐Rios Mario H. investigator.; Escalante William Jose Otero investigator.; Maldonado‐Lopez Maria Concepcion investigator.; Jaller Raad Juan Jose investigator.; Hernandez Javier Dario Marquez investigator.; Jauregui Edwin Antonio investigator.; Keiserman Mauro W. investigator.; Melazzi Ana Claudia Cauceglia investigator.; Pascual‐Ramos Virginia investigator.; Pinto Luciana Teixeira investigator.; Radominski Sebastiao C. investigator.; Ximenes Antonio Carlos investigator.; de Morales Sol Villegas investigator.;
• Is Part Of: Arthritis & rheumatology. Volume 71:Issue 6(2019)
• Page Start: 878
• Page End: 891
• Publication Date: 2019-04-24
• Subjects: Arthritis -- Periodicals; Rheumatism -- Periodicals; 616.72
• DOI: 10.1002/art.40803
• Languages: English
• ISSNs: 2326-5191

Abstract

Abstract : Objective: Tofacitinib is an oral JAK inhibitor for the treatment of rheumatoid arthritis (RA). The phase III, 24‐month, placebo‐controlled Oral Rheumatoid Arthritis (ORAL) Scan trial was undertaken to evaluate the efficacy, including inhibition of structural progression, and safety of tofacitinib in patients with active RA and an inadequate response to methotrexate (MTX). Month 24 data from the completed study are reported here. Methods: Patients were randomized 4:4:1:1 to receive tofacitinib 5 mg or 10 mg twice daily, or placebo, switched to tofacitinib 5 mg or 10 mg twice daily, with stable background MTX. Patients receiving placebo switched to tofacitinib at month 3 (nonresponders) or month 6 (remaining patients). Clinical efficacy, structural progression, and treatment‐emergent adverse events were evaluated. Analyses were performed on the full analysis set with observed data or nonresponder imputation with no advancement penalty for clinical efficacy, and imputation by linear extrapolation for structural progression. Results: Overall, 797 patients were treated; 539 (67.6%) completed 24 months of treatment. Responses according to the American College of Rheumatology criteria for 20% improvement (ACR20), ACR50, and ACR70; the proportion of patients in whom remission or low disease activity was achieved according to the 4‐variable Disease Activity Score in 28 joints using the erythrocyte sedimentation rate, Clinical Disease Activity Index, or Simplified Disease Activity Index; Boolean remission; and Health Assessment Questionnaire disability index scores were maintained from month 12 to 24 and were similar between tofacitinib dosages. Limited structural damage was observed at months 12 and 24. Safety events were similar in type and frequency for both tofacitinib dosages, and were consistent with those previously reported. Conclusion: Our findings indicate that clinical and radiographic treatment effects are sustained in months 12–24 in patients with RA receiving tofacitinib 5 mg or 10 mg twice daily plus MTX. The safety profile is consistent with that of other tofacitinib studies.