Efficacy and safety of tregalizumab in patients with rheumatoid arthritis and an inadequate response to methotrexate: results of a phase IIb, randomised, placebo-controlled trial. Issue 4 (17th January 2018)

• Record Type: Journal Article
• Authors: van Vollenhoven, Ronald F; Keystone, Edward Clark; Strand, Vibeke; Pacheco-Tena, Cesar; Vencovský, Jiří; Behrens, Frank; Racewicz, Arthur; Zipp, Daniela; Rharbaoui, Faiza; Wolter, Ralf; Knierim, Luise; Schmeidl, Rainer; Zhou, Xuefei; Aigner, Silke; Dälken, Benjamin; Wartenberg-Demand, Andrea
• Other Names: author non-byline.; Aelion Jacob author non-byline.; Arreola Jorge Aguilar author non-byline.; Arias Maria Araujo author non-byline.; Back Johan author non-byline.; Baranauskaite Asta author non-byline.; Behrens Frank author non-byline.; Bennett Ralph author non-byline.; Bookman Arthur author non-byline.; Brzezicki Jan author non-byline.; Butrimiene Irena author non-byline.; Churchill Melvin author non-byline.; Djacenko Svetlana author non-byline.; Dokoupilova Eva author non-byline.; Drescher Edit author non-byline.; Dudek Anna author non-byline.; Edwards William author non-byline.; Eliseeva Larisa author non-byline.; Ershova Olga author non-byline.; Fortin Isabelle author non-byline.; Galatikova Dagmar author non-byline.; De la Torre Ignacio Garcia author non-byline.; Garmish Olena author non-byline.; Gasanov Yuriy author non-byline.; Gnylorybov Andriy author non-byline.; Goldberg Marc author non-byline.; Golovchenko Oleksandr author non-byline.; Gordeev Ivan author non-byline.; Hiepe Falk author non-byline.; Sil Gabriela Huerta author non-byline.; Husarova Viola author non-byline.; Iaremenko Oleg author non-byline.; Jeka Slawomir author non-byline.; Kamburova Daniela author non-byline.; Kavanaugh Arthur author non-byline.; Keszthelyi Peter author non-byline.; Keystone Edward author non-byline.; Knyazeva Larisa author non-byline.; Krechikova Diana author non-byline.; Kuzmanova Stefka author non-byline.; Lapcikova Angelika author non-byline.; Levinson Dennis author non-byline.; Lopez Garcia Jesus Alberto author non-byline.; Lymar Iurii author non-byline.; Marinova Natalia author non-byline.; Moiseev Sergey author non-byline.; Musilova Lucie author non-byline.; Nagy Magdolna author non-byline.; Najam Sabeen author non-byline.; Nedovic Jovan author non-byline.; Nemeth Eleonora author non-byline.; Novosad Libor author non-byline.; Ochoa-Ortega Luis author non-byline.; Oparanov Boycho author non-byline.; Tena Cesar Pacheco author non-byline.; Penev Dimitar author non-byline.; Pesant Yves author non-byline.; Podrazilova Lucie author non-byline.; Pulka Grazyna author non-byline.; Racewicz Artur author non-byline.; Raskina Tatiana author non-byline.; Rekalov Dmytro author non-byline.; Reshetko Olga author non-byline.; Riega Torres Janett Carmen author non-byline.; Rubbert-Roth Andrea author non-byline.; Rychlewska-Hanczewska Anna author non-byline.; Savina Ludmila author non-byline.; Schulze-Koops Hendrik author non-byline.; Bukilica Mirjana Sefik author non-byline.; Shevchuk Sergii author non-byline.; Simoncsics Eszter author non-byline.; Simova Lubomira author non-byline.; Sitek-Ziolkowska Karina author non-byline.; Skublova Andrea author non-byline.; Sliwowska Beata author non-byline.; Smakotina Svetlana author non-byline.; Spieler Wolfgang author non-byline.; Stanislavchuk Mykola author non-byline.; Stefanovic Dusan author non-byline.; Stejfova Zuzana author non-byline.; Stoilov Rumen author non-byline.; Strapkova Maria author non-byline.; Stryuk Raisa author non-byline.; Sulyok Gabriella author non-byline.; Sylwestrzak Anna author non-byline.; Szombati Istvan author non-byline.; Theander Jan author non-byline.; Tomkova Sona author non-byline.; Trapp Robert author non-byline.; Tseluyko Vira author non-byline.; Tälli Jaak author non-byline.; Vencovsky Jiri author non-byline.; Vitek Petr author non-byline.; Vladeva Stoyanka author non-byline.; Vo Jacqueline author non-byline.; Vollenhoven Ronald Van author non-byline.; Vujasinovic-Stupar Nada author non-byline.; Wassenberg Siegfried author non-byline.; Wollenhaupt Juergen author non-byline.; Zielinska Agnieszka author non-byline.;
• Is Part Of: Annals of the rheumatic diseases. Volume 77:Issue 4(2018)
• Page Start: 495
• Page End: 499
• Publication Date: 2018-01-17
• Subjects: rheumatoid arthritis -- t cells -- autoimmune diseases -- Dmards (biologic); Rheumatism -- Periodicals; 616.723005
• DOI: 10.1136/annrheumdis-2017-212478
• Languages: English
• ISSNs: 0003-4967

Abstract

Abstract : Objective: To evaluate the efficacy, biological activity and safety of tregalizumab in patients with active rheumatoid arthritis (RA) and an inadequate response to methotrexate (MTX). Methods: 321 patients were randomised (1:1:1:1) to placebo or tregalizumab 25, 100 or 200 mg once-weekly subcutaneously in addition to MTX treatment. Responders at week 12 continued the same treatment, and non-responders at week 12 were escalated to the next higher tregalizumab dose level or re-randomised from placebo to active treatment. After 24 weeks, patients could continue treatment with tregalizumab for 24 weeks (extension phase). The primary endpoint was the American College of Rheumatology 20% improvement criteria (ACR20) response rate at week 12. Safety and biological activity were monitored through week 48. Results: At week 12, ACR20 response rates were not statistically significantly different between placebo and any of the tregalizumab doses. Tregalizumab injections were well tolerated; most adverse events were mild to moderate and comparable among treatment and placebo groups. Biological activity was shown by dose-dependent CD4 downmodulation. Conclusion: Treatment with tregalizumab did not show significant clinical efficacy in patients with active RA compared with placebo but resulted in the expected biological effect on CD4 modulation. Tregalizumab was generally well tolerated, and no new safety findings were identified. Trial registration number: NCT01999192; Results .