TY - JOUR
T1 - 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
AU - van Vollenhoven, Ronald F.
AU - Keystone, Edward Clark
AU - Strand, Vibeke
AU - Pacheco-Tena, Cesar
AU - Vencovský, Jiří
AU - Behrens, Frank
AU - Racewicz, Arthur
AU - Zipp, Daniela
AU - Rharbaoui, Faiza
AU - Wolter, Ralf
AU - Knierim, Luise
AU - Schmeidl, Rainer
AU - Zhou, Xuefei
AU - Aigner, Silke
AU - Dälken, Benjamin
AU - Wartenberg-Demand, Andrea
AU - AUTHOR GROUP
AU - Aelion, Jacob
AU - Arreola, Jorge Aguilar
AU - Arias, Maria Araujo
AU - Back, Johan
AU - Baranauskaite, Asta
AU - Bennett, Ralph
AU - Bookman, Arthur
AU - Brzezicki, Jan
AU - Butrimiene, Irena
AU - Churchill, Melvin
AU - Djacenko, Svetlana
AU - Dokoupilova, Eva
AU - Drescher, Edit
AU - Dudek, Anna
AU - Edwards, William
AU - Eliseeva, Larisa
AU - Ershova, Olga
AU - Fortin, Isabelle
AU - Galatikova, Dagmar
AU - de la Torre, Ignacio Garcia
AU - Garmish, Olena
AU - Gasanov, Yuriy
AU - Gnylorybov, Andriy
AU - Goldberg, Marc
AU - Golovchenko, Oleksandr
AU - Gordeev, Ivan
AU - Hiepe, Falk
AU - Sil, Gabriela Huerta
AU - Husarova, Viola
AU - Iaremenko, Oleg
AU - Jeka, Slawomir
AU - Kamburova, Daniela
AU - Kavanaugh, Arthur
AU - Keszthelyi, Peter
PY - 2018
Y1 - 2018
N2 - To evaluate the efficacy, biological activity and safety of tregalizumab in patients with active rheumatoid arthritis (RA) and an inadequate response to methotrexate (MTX). 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. 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. 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. NCT01999192; Results
AB - To evaluate the efficacy, biological activity and safety of tregalizumab in patients with active rheumatoid arthritis (RA) and an inadequate response to methotrexate (MTX). 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. 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. 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. NCT01999192; Results
U2 - https://doi.org/10.1136/annrheumdis-2017-212478
DO - https://doi.org/10.1136/annrheumdis-2017-212478
M3 - Article
C2 - 29343509
SN - 0003-4967
VL - 77
SP - 495
EP - 499
JO - Annals of the rheumatic diseases
JF - Annals of the rheumatic diseases
IS - 4
ER -