Research ArticleArticle
Open Access
Effect of Glucocorticoids on the Clinical and Radiographic Efficacy of Tofacitinib in Patients with Rheumatoid Arthritis: A Posthoc Analysis of Data from 6 Phase III Studies
Christina Charles-Schoeman, Désirée van der Heijde, Gerd R. Burmester, Peter Nash, Cristiano A.F. Zerbini, Carol A. Connell, Haiyun Fan, Kenneth Kwok, Eustratios Bananis and Roy Fleischmann
The Journal of Rheumatology November 2017, jrheum.170486; DOI: https://doi.org/10.3899/jrheum.170486
Christina Charles-Schoeman
From the University of California at Los Angeles (UCLA), Los Angeles, California, USA; Leiden University Medical Center, Leiden, the Netherlands; Charité-University Medicine Berlin Free University and Humboldt University of Berlin, Berlin, Germany; Department of Medicine, University of Queensland, Queensland, Australia; Centro Paulista de Investigação Clinica, São Paulo, Brazil; Pfizer Inc., Groton, Connecticut; Pfizer Inc., Collegeville, Pennsylvania; Pfizer Inc., New York, New York; Metroplex Clinical Research Center and University of Texas Southwestern Medical Center, Dallas, Texas, USA. Funded by Pfizer Inc. Medical writing support under direction from the authors was provided by Christina Viegelmann, PhD, on behalf of Complete Medical Communications, and was funded by Pfizer Inc. C. Charles-Schoeman has received research grants and consulting fees from Pfizer Inc. D. van der Heijde has received consulting fees from Pfizer Inc., and is the Director of Imaging Rheumatology BV. G.R. Burmester has received consulting fees from, and is on the speakers’ bureau for, Pfizer Inc. P. Nash has received research grants and honoraria for advice and lectures from AbbVie, Lilly, Novartis, Pfizer Inc., Sanofi, Roche, and UCB. C.A. Zerbini has received research grants from, and is on the speakers’ bureau for, Pfizer Inc. R. Fleischmann has received research grants and consulting fees from Pfizer Inc. C. Charles-Schoeman, MD, MS, Associate Professor of Medicine, UCLA; D. van der Heijde, MD, PhD, Professor of Rheumatology, Leiden University Medical Center; G.R. Burmester, MD, Professor of Medicine and Director, Department of Rheumatology and Clinical Immunology, Charité-University Medicine Berlin Free University and Humboldt University of Berlin; P. Nash, MBBS, FRACP, Director, Rheumatology Research Unit, Nambour Hospital, and Associate Professor, Department of Medicine, University of Queensland; C.A. Zerbini, MD, Director, Centro Paulista de Investigação Clinica; C.A. Connell, PhD, Senior Director of Clinical Research, Pfizer Inc., Groton; H. Fan, MS, Statistician/Director, Pfizer Inc., Collegeville; K. Kwok, MS, Director of Biostatistics, Pfizer Inc., New York; E. Bananis, PhD, Medical Director, Pfizer Inc., New York; R. Fleischmann, MD, Co-medical Director, Metroplex Clinical Research Center, and Clinical Professor, Department of Internal Medicine, University of Texas Southwestern Medical Center. Address correspondence to Dr. E. Bananis, 235 E. 42nd St., New York, New York 10017, USA. E-mail: stratis.bananis@pfizer.com.Full Release Article. For details see Reprints and Permissions at jrheum.org Accepted for publication September 8, 2017.
Désirée van der Heijde
From the University of California at Los Angeles (UCLA), Los Angeles, California, USA; Leiden University Medical Center, Leiden, the Netherlands; Charité-University Medicine Berlin Free University and Humboldt University of Berlin, Berlin, Germany; Department of Medicine, University of Queensland, Queensland, Australia; Centro Paulista de Investigação Clinica, São Paulo, Brazil; Pfizer Inc., Groton, Connecticut; Pfizer Inc., Collegeville, Pennsylvania; Pfizer Inc., New York, New York; Metroplex Clinical Research Center and University of Texas Southwestern Medical Center, Dallas, Texas, USA. Funded by Pfizer Inc. Medical writing support under direction from the authors was provided by Christina Viegelmann, PhD, on behalf of Complete Medical Communications, and was funded by Pfizer Inc. C. Charles-Schoeman has received research grants and consulting fees from Pfizer Inc. D. van der Heijde has received consulting fees from Pfizer Inc., and is the Director of Imaging Rheumatology BV. G.R. Burmester has received consulting fees from, and is on the speakers’ bureau for, Pfizer Inc. P. Nash has received research grants and honoraria for advice and lectures from AbbVie, Lilly, Novartis, Pfizer Inc., Sanofi, Roche, and UCB. C.A. Zerbini has received research grants from, and is on the speakers’ bureau for, Pfizer Inc. R. Fleischmann has received research grants and consulting fees from Pfizer Inc. C. Charles-Schoeman, MD, MS, Associate Professor of Medicine, UCLA; D. van der Heijde, MD, PhD, Professor of Rheumatology, Leiden University Medical Center; G.R. Burmester, MD, Professor of Medicine and Director, Department of Rheumatology and Clinical Immunology, Charité-University Medicine Berlin Free University and Humboldt University of Berlin; P. Nash, MBBS, FRACP, Director, Rheumatology Research Unit, Nambour Hospital, and Associate Professor, Department of Medicine, University of Queensland; C.A. Zerbini, MD, Director, Centro Paulista de Investigação Clinica; C.A. Connell, PhD, Senior Director of Clinical Research, Pfizer Inc., Groton; H. Fan, MS, Statistician/Director, Pfizer Inc., Collegeville; K. Kwok, MS, Director of Biostatistics, Pfizer Inc., New York; E. Bananis, PhD, Medical Director, Pfizer Inc., New York; R. Fleischmann, MD, Co-medical Director, Metroplex Clinical Research Center, and Clinical Professor, Department of Internal Medicine, University of Texas Southwestern Medical Center. Address correspondence to Dr. E. Bananis, 235 E. 42nd St., New York, New York 10017, USA. E-mail: stratis.bananis@pfizer.com.Full Release Article. For details see Reprints and Permissions at jrheum.org Accepted for publication September 8, 2017.
Gerd R. Burmester
From the University of California at Los Angeles (UCLA), Los Angeles, California, USA; Leiden University Medical Center, Leiden, the Netherlands; Charité-University Medicine Berlin Free University and Humboldt University of Berlin, Berlin, Germany; Department of Medicine, University of Queensland, Queensland, Australia; Centro Paulista de Investigação Clinica, São Paulo, Brazil; Pfizer Inc., Groton, Connecticut; Pfizer Inc., Collegeville, Pennsylvania; Pfizer Inc., New York, New York; Metroplex Clinical Research Center and University of Texas Southwestern Medical Center, Dallas, Texas, USA. Funded by Pfizer Inc. Medical writing support under direction from the authors was provided by Christina Viegelmann, PhD, on behalf of Complete Medical Communications, and was funded by Pfizer Inc. C. Charles-Schoeman has received research grants and consulting fees from Pfizer Inc. D. van der Heijde has received consulting fees from Pfizer Inc., and is the Director of Imaging Rheumatology BV. G.R. Burmester has received consulting fees from, and is on the speakers’ bureau for, Pfizer Inc. P. Nash has received research grants and honoraria for advice and lectures from AbbVie, Lilly, Novartis, Pfizer Inc., Sanofi, Roche, and UCB. C.A. Zerbini has received research grants from, and is on the speakers’ bureau for, Pfizer Inc. R. Fleischmann has received research grants and consulting fees from Pfizer Inc. C. Charles-Schoeman, MD, MS, Associate Professor of Medicine, UCLA; D. van der Heijde, MD, PhD, Professor of Rheumatology, Leiden University Medical Center; G.R. Burmester, MD, Professor of Medicine and Director, Department of Rheumatology and Clinical Immunology, Charité-University Medicine Berlin Free University and Humboldt University of Berlin; P. Nash, MBBS, FRACP, Director, Rheumatology Research Unit, Nambour Hospital, and Associate Professor, Department of Medicine, University of Queensland; C.A. Zerbini, MD, Director, Centro Paulista de Investigação Clinica; C.A. Connell, PhD, Senior Director of Clinical Research, Pfizer Inc., Groton; H. Fan, MS, Statistician/Director, Pfizer Inc., Collegeville; K. Kwok, MS, Director of Biostatistics, Pfizer Inc., New York; E. Bananis, PhD, Medical Director, Pfizer Inc., New York; R. Fleischmann, MD, Co-medical Director, Metroplex Clinical Research Center, and Clinical Professor, Department of Internal Medicine, University of Texas Southwestern Medical Center. Address correspondence to Dr. E. Bananis, 235 E. 42nd St., New York, New York 10017, USA. E-mail: stratis.bananis@pfizer.com.Full Release Article. For details see Reprints and Permissions at jrheum.org Accepted for publication September 8, 2017.
Peter Nash
From the University of California at Los Angeles (UCLA), Los Angeles, California, USA; Leiden University Medical Center, Leiden, the Netherlands; Charité-University Medicine Berlin Free University and Humboldt University of Berlin, Berlin, Germany; Department of Medicine, University of Queensland, Queensland, Australia; Centro Paulista de Investigação Clinica, São Paulo, Brazil; Pfizer Inc., Groton, Connecticut; Pfizer Inc., Collegeville, Pennsylvania; Pfizer Inc., New York, New York; Metroplex Clinical Research Center and University of Texas Southwestern Medical Center, Dallas, Texas, USA. Funded by Pfizer Inc. Medical writing support under direction from the authors was provided by Christina Viegelmann, PhD, on behalf of Complete Medical Communications, and was funded by Pfizer Inc. C. Charles-Schoeman has received research grants and consulting fees from Pfizer Inc. D. van der Heijde has received consulting fees from Pfizer Inc., and is the Director of Imaging Rheumatology BV. G.R. Burmester has received consulting fees from, and is on the speakers’ bureau for, Pfizer Inc. P. Nash has received research grants and honoraria for advice and lectures from AbbVie, Lilly, Novartis, Pfizer Inc., Sanofi, Roche, and UCB. C.A. Zerbini has received research grants from, and is on the speakers’ bureau for, Pfizer Inc. R. Fleischmann has received research grants and consulting fees from Pfizer Inc. C. Charles-Schoeman, MD, MS, Associate Professor of Medicine, UCLA; D. van der Heijde, MD, PhD, Professor of Rheumatology, Leiden University Medical Center; G.R. Burmester, MD, Professor of Medicine and Director, Department of Rheumatology and Clinical Immunology, Charité-University Medicine Berlin Free University and Humboldt University of Berlin; P. Nash, MBBS, FRACP, Director, Rheumatology Research Unit, Nambour Hospital, and Associate Professor, Department of Medicine, University of Queensland; C.A. Zerbini, MD, Director, Centro Paulista de Investigação Clinica; C.A. Connell, PhD, Senior Director of Clinical Research, Pfizer Inc., Groton; H. Fan, MS, Statistician/Director, Pfizer Inc., Collegeville; K. Kwok, MS, Director of Biostatistics, Pfizer Inc., New York; E. Bananis, PhD, Medical Director, Pfizer Inc., New York; R. Fleischmann, MD, Co-medical Director, Metroplex Clinical Research Center, and Clinical Professor, Department of Internal Medicine, University of Texas Southwestern Medical Center. Address correspondence to Dr. E. Bananis, 235 E. 42nd St., New York, New York 10017, USA. E-mail: stratis.bananis@pfizer.com.Full Release Article. For details see Reprints and Permissions at jrheum.org Accepted for publication September 8, 2017.
Cristiano A.F. Zerbini
From the University of California at Los Angeles (UCLA), Los Angeles, California, USA; Leiden University Medical Center, Leiden, the Netherlands; Charité-University Medicine Berlin Free University and Humboldt University of Berlin, Berlin, Germany; Department of Medicine, University of Queensland, Queensland, Australia; Centro Paulista de Investigação Clinica, São Paulo, Brazil; Pfizer Inc., Groton, Connecticut; Pfizer Inc., Collegeville, Pennsylvania; Pfizer Inc., New York, New York; Metroplex Clinical Research Center and University of Texas Southwestern Medical Center, Dallas, Texas, USA. Funded by Pfizer Inc. Medical writing support under direction from the authors was provided by Christina Viegelmann, PhD, on behalf of Complete Medical Communications, and was funded by Pfizer Inc. C. Charles-Schoeman has received research grants and consulting fees from Pfizer Inc. D. van der Heijde has received consulting fees from Pfizer Inc., and is the Director of Imaging Rheumatology BV. G.R. Burmester has received consulting fees from, and is on the speakers’ bureau for, Pfizer Inc. P. Nash has received research grants and honoraria for advice and lectures from AbbVie, Lilly, Novartis, Pfizer Inc., Sanofi, Roche, and UCB. C.A. Zerbini has received research grants from, and is on the speakers’ bureau for, Pfizer Inc. R. Fleischmann has received research grants and consulting fees from Pfizer Inc. C. Charles-Schoeman, MD, MS, Associate Professor of Medicine, UCLA; D. van der Heijde, MD, PhD, Professor of Rheumatology, Leiden University Medical Center; G.R. Burmester, MD, Professor of Medicine and Director, Department of Rheumatology and Clinical Immunology, Charité-University Medicine Berlin Free University and Humboldt University of Berlin; P. Nash, MBBS, FRACP, Director, Rheumatology Research Unit, Nambour Hospital, and Associate Professor, Department of Medicine, University of Queensland; C.A. Zerbini, MD, Director, Centro Paulista de Investigação Clinica; C.A. Connell, PhD, Senior Director of Clinical Research, Pfizer Inc., Groton; H. Fan, MS, Statistician/Director, Pfizer Inc., Collegeville; K. Kwok, MS, Director of Biostatistics, Pfizer Inc., New York; E. Bananis, PhD, Medical Director, Pfizer Inc., New York; R. Fleischmann, MD, Co-medical Director, Metroplex Clinical Research Center, and Clinical Professor, Department of Internal Medicine, University of Texas Southwestern Medical Center. Address correspondence to Dr. E. Bananis, 235 E. 42nd St., New York, New York 10017, USA. E-mail: stratis.bananis@pfizer.com.Full Release Article. For details see Reprints and Permissions at jrheum.org Accepted for publication September 8, 2017.
Carol A. Connell
From the University of California at Los Angeles (UCLA), Los Angeles, California, USA; Leiden University Medical Center, Leiden, the Netherlands; Charité-University Medicine Berlin Free University and Humboldt University of Berlin, Berlin, Germany; Department of Medicine, University of Queensland, Queensland, Australia; Centro Paulista de Investigação Clinica, São Paulo, Brazil; Pfizer Inc., Groton, Connecticut; Pfizer Inc., Collegeville, Pennsylvania; Pfizer Inc., New York, New York; Metroplex Clinical Research Center and University of Texas Southwestern Medical Center, Dallas, Texas, USA. Funded by Pfizer Inc. Medical writing support under direction from the authors was provided by Christina Viegelmann, PhD, on behalf of Complete Medical Communications, and was funded by Pfizer Inc. C. Charles-Schoeman has received research grants and consulting fees from Pfizer Inc. D. van der Heijde has received consulting fees from Pfizer Inc., and is the Director of Imaging Rheumatology BV. G.R. Burmester has received consulting fees from, and is on the speakers’ bureau for, Pfizer Inc. P. Nash has received research grants and honoraria for advice and lectures from AbbVie, Lilly, Novartis, Pfizer Inc., Sanofi, Roche, and UCB. C.A. Zerbini has received research grants from, and is on the speakers’ bureau for, Pfizer Inc. R. Fleischmann has received research grants and consulting fees from Pfizer Inc. C. Charles-Schoeman, MD, MS, Associate Professor of Medicine, UCLA; D. van der Heijde, MD, PhD, Professor of Rheumatology, Leiden University Medical Center; G.R. Burmester, MD, Professor of Medicine and Director, Department of Rheumatology and Clinical Immunology, Charité-University Medicine Berlin Free University and Humboldt University of Berlin; P. Nash, MBBS, FRACP, Director, Rheumatology Research Unit, Nambour Hospital, and Associate Professor, Department of Medicine, University of Queensland; C.A. Zerbini, MD, Director, Centro Paulista de Investigação Clinica; C.A. Connell, PhD, Senior Director of Clinical Research, Pfizer Inc., Groton; H. Fan, MS, Statistician/Director, Pfizer Inc., Collegeville; K. Kwok, MS, Director of Biostatistics, Pfizer Inc., New York; E. Bananis, PhD, Medical Director, Pfizer Inc., New York; R. Fleischmann, MD, Co-medical Director, Metroplex Clinical Research Center, and Clinical Professor, Department of Internal Medicine, University of Texas Southwestern Medical Center. Address correspondence to Dr. E. Bananis, 235 E. 42nd St., New York, New York 10017, USA. E-mail: stratis.bananis@pfizer.com.Full Release Article. For details see Reprints and Permissions at jrheum.org Accepted for publication September 8, 2017.
Haiyun Fan
From the University of California at Los Angeles (UCLA), Los Angeles, California, USA; Leiden University Medical Center, Leiden, the Netherlands; Charité-University Medicine Berlin Free University and Humboldt University of Berlin, Berlin, Germany; Department of Medicine, University of Queensland, Queensland, Australia; Centro Paulista de Investigação Clinica, São Paulo, Brazil; Pfizer Inc., Groton, Connecticut; Pfizer Inc., Collegeville, Pennsylvania; Pfizer Inc., New York, New York; Metroplex Clinical Research Center and University of Texas Southwestern Medical Center, Dallas, Texas, USA. Funded by Pfizer Inc. Medical writing support under direction from the authors was provided by Christina Viegelmann, PhD, on behalf of Complete Medical Communications, and was funded by Pfizer Inc. C. Charles-Schoeman has received research grants and consulting fees from Pfizer Inc. D. van der Heijde has received consulting fees from Pfizer Inc., and is the Director of Imaging Rheumatology BV. G.R. Burmester has received consulting fees from, and is on the speakers’ bureau for, Pfizer Inc. P. Nash has received research grants and honoraria for advice and lectures from AbbVie, Lilly, Novartis, Pfizer Inc., Sanofi, Roche, and UCB. C.A. Zerbini has received research grants from, and is on the speakers’ bureau for, Pfizer Inc. R. Fleischmann has received research grants and consulting fees from Pfizer Inc. C. Charles-Schoeman, MD, MS, Associate Professor of Medicine, UCLA; D. van der Heijde, MD, PhD, Professor of Rheumatology, Leiden University Medical Center; G.R. Burmester, MD, Professor of Medicine and Director, Department of Rheumatology and Clinical Immunology, Charité-University Medicine Berlin Free University and Humboldt University of Berlin; P. Nash, MBBS, FRACP, Director, Rheumatology Research Unit, Nambour Hospital, and Associate Professor, Department of Medicine, University of Queensland; C.A. Zerbini, MD, Director, Centro Paulista de Investigação Clinica; C.A. Connell, PhD, Senior Director of Clinical Research, Pfizer Inc., Groton; H. Fan, MS, Statistician/Director, Pfizer Inc., Collegeville; K. Kwok, MS, Director of Biostatistics, Pfizer Inc., New York; E. Bananis, PhD, Medical Director, Pfizer Inc., New York; R. Fleischmann, MD, Co-medical Director, Metroplex Clinical Research Center, and Clinical Professor, Department of Internal Medicine, University of Texas Southwestern Medical Center. Address correspondence to Dr. E. Bananis, 235 E. 42nd St., New York, New York 10017, USA. E-mail: stratis.bananis@pfizer.com.Full Release Article. For details see Reprints and Permissions at jrheum.org Accepted for publication September 8, 2017.
Kenneth Kwok
From the University of California at Los Angeles (UCLA), Los Angeles, California, USA; Leiden University Medical Center, Leiden, the Netherlands; Charité-University Medicine Berlin Free University and Humboldt University of Berlin, Berlin, Germany; Department of Medicine, University of Queensland, Queensland, Australia; Centro Paulista de Investigação Clinica, São Paulo, Brazil; Pfizer Inc., Groton, Connecticut; Pfizer Inc., Collegeville, Pennsylvania; Pfizer Inc., New York, New York; Metroplex Clinical Research Center and University of Texas Southwestern Medical Center, Dallas, Texas, USA. Funded by Pfizer Inc. Medical writing support under direction from the authors was provided by Christina Viegelmann, PhD, on behalf of Complete Medical Communications, and was funded by Pfizer Inc. C. Charles-Schoeman has received research grants and consulting fees from Pfizer Inc. D. van der Heijde has received consulting fees from Pfizer Inc., and is the Director of Imaging Rheumatology BV. G.R. Burmester has received consulting fees from, and is on the speakers’ bureau for, Pfizer Inc. P. Nash has received research grants and honoraria for advice and lectures from AbbVie, Lilly, Novartis, Pfizer Inc., Sanofi, Roche, and UCB. C.A. Zerbini has received research grants from, and is on the speakers’ bureau for, Pfizer Inc. R. Fleischmann has received research grants and consulting fees from Pfizer Inc. C. Charles-Schoeman, MD, MS, Associate Professor of Medicine, UCLA; D. van der Heijde, MD, PhD, Professor of Rheumatology, Leiden University Medical Center; G.R. Burmester, MD, Professor of Medicine and Director, Department of Rheumatology and Clinical Immunology, Charité-University Medicine Berlin Free University and Humboldt University of Berlin; P. Nash, MBBS, FRACP, Director, Rheumatology Research Unit, Nambour Hospital, and Associate Professor, Department of Medicine, University of Queensland; C.A. Zerbini, MD, Director, Centro Paulista de Investigação Clinica; C.A. Connell, PhD, Senior Director of Clinical Research, Pfizer Inc., Groton; H. Fan, MS, Statistician/Director, Pfizer Inc., Collegeville; K. Kwok, MS, Director of Biostatistics, Pfizer Inc., New York; E. Bananis, PhD, Medical Director, Pfizer Inc., New York; R. Fleischmann, MD, Co-medical Director, Metroplex Clinical Research Center, and Clinical Professor, Department of Internal Medicine, University of Texas Southwestern Medical Center. Address correspondence to Dr. E. Bananis, 235 E. 42nd St., New York, New York 10017, USA. E-mail: stratis.bananis@pfizer.com.Full Release Article. For details see Reprints and Permissions at jrheum.org Accepted for publication September 8, 2017.
Eustratios Bananis
From the University of California at Los Angeles (UCLA), Los Angeles, California, USA; Leiden University Medical Center, Leiden, the Netherlands; Charité-University Medicine Berlin Free University and Humboldt University of Berlin, Berlin, Germany; Department of Medicine, University of Queensland, Queensland, Australia; Centro Paulista de Investigação Clinica, São Paulo, Brazil; Pfizer Inc., Groton, Connecticut; Pfizer Inc., Collegeville, Pennsylvania; Pfizer Inc., New York, New York; Metroplex Clinical Research Center and University of Texas Southwestern Medical Center, Dallas, Texas, USA. Funded by Pfizer Inc. Medical writing support under direction from the authors was provided by Christina Viegelmann, PhD, on behalf of Complete Medical Communications, and was funded by Pfizer Inc. C. Charles-Schoeman has received research grants and consulting fees from Pfizer Inc. D. van der Heijde has received consulting fees from Pfizer Inc., and is the Director of Imaging Rheumatology BV. G.R. Burmester has received consulting fees from, and is on the speakers’ bureau for, Pfizer Inc. P. Nash has received research grants and honoraria for advice and lectures from AbbVie, Lilly, Novartis, Pfizer Inc., Sanofi, Roche, and UCB. C.A. Zerbini has received research grants from, and is on the speakers’ bureau for, Pfizer Inc. R. Fleischmann has received research grants and consulting fees from Pfizer Inc. C. Charles-Schoeman, MD, MS, Associate Professor of Medicine, UCLA; D. van der Heijde, MD, PhD, Professor of Rheumatology, Leiden University Medical Center; G.R. Burmester, MD, Professor of Medicine and Director, Department of Rheumatology and Clinical Immunology, Charité-University Medicine Berlin Free University and Humboldt University of Berlin; P. Nash, MBBS, FRACP, Director, Rheumatology Research Unit, Nambour Hospital, and Associate Professor, Department of Medicine, University of Queensland; C.A. Zerbini, MD, Director, Centro Paulista de Investigação Clinica; C.A. Connell, PhD, Senior Director of Clinical Research, Pfizer Inc., Groton; H. Fan, MS, Statistician/Director, Pfizer Inc., Collegeville; K. Kwok, MS, Director of Biostatistics, Pfizer Inc., New York; E. Bananis, PhD, Medical Director, Pfizer Inc., New York; R. Fleischmann, MD, Co-medical Director, Metroplex Clinical Research Center, and Clinical Professor, Department of Internal Medicine, University of Texas Southwestern Medical Center. Address correspondence to Dr. E. Bananis, 235 E. 42nd St., New York, New York 10017, USA. E-mail: stratis.bananis@pfizer.com.Full Release Article. For details see Reprints and Permissions at jrheum.org Accepted for publication September 8, 2017.
Roy Fleischmann
From the University of California at Los Angeles (UCLA), Los Angeles, California, USA; Leiden University Medical Center, Leiden, the Netherlands; Charité-University Medicine Berlin Free University and Humboldt University of Berlin, Berlin, Germany; Department of Medicine, University of Queensland, Queensland, Australia; Centro Paulista de Investigação Clinica, São Paulo, Brazil; Pfizer Inc., Groton, Connecticut; Pfizer Inc., Collegeville, Pennsylvania; Pfizer Inc., New York, New York; Metroplex Clinical Research Center and University of Texas Southwestern Medical Center, Dallas, Texas, USA. Funded by Pfizer Inc. Medical writing support under direction from the authors was provided by Christina Viegelmann, PhD, on behalf of Complete Medical Communications, and was funded by Pfizer Inc. C. Charles-Schoeman has received research grants and consulting fees from Pfizer Inc. D. van der Heijde has received consulting fees from Pfizer Inc., and is the Director of Imaging Rheumatology BV. G.R. Burmester has received consulting fees from, and is on the speakers’ bureau for, Pfizer Inc. P. Nash has received research grants and honoraria for advice and lectures from AbbVie, Lilly, Novartis, Pfizer Inc., Sanofi, Roche, and UCB. C.A. Zerbini has received research grants from, and is on the speakers’ bureau for, Pfizer Inc. R. Fleischmann has received research grants and consulting fees from Pfizer Inc. C. Charles-Schoeman, MD, MS, Associate Professor of Medicine, UCLA; D. van der Heijde, MD, PhD, Professor of Rheumatology, Leiden University Medical Center; G.R. Burmester, MD, Professor of Medicine and Director, Department of Rheumatology and Clinical Immunology, Charité-University Medicine Berlin Free University and Humboldt University of Berlin; P. Nash, MBBS, FRACP, Director, Rheumatology Research Unit, Nambour Hospital, and Associate Professor, Department of Medicine, University of Queensland; C.A. Zerbini, MD, Director, Centro Paulista de Investigação Clinica; C.A. Connell, PhD, Senior Director of Clinical Research, Pfizer Inc., Groton; H. Fan, MS, Statistician/Director, Pfizer Inc., Collegeville; K. Kwok, MS, Director of Biostatistics, Pfizer Inc., New York; E. Bananis, PhD, Medical Director, Pfizer Inc., New York; R. Fleischmann, MD, Co-medical Director, Metroplex Clinical Research Center, and Clinical Professor, Department of Internal Medicine, University of Texas Southwestern Medical Center. Address correspondence to Dr. E. Bananis, 235 E. 42nd St., New York, New York 10017, USA. E-mail: stratis.bananis@pfizer.com.Full Release Article. For details see Reprints and Permissions at jrheum.org Accepted for publication September 8, 2017.
Abstract
Objective Tofacitinib has been investigated for the treatment of rheumatoid arthritis (RA) in phase III studies in which concomitant glucocorticoids (GC) were allowed. We analyzed the effect of GC use on efficacy outcomes in patients with RA receiving tofacitinib and/or methotrexate (MTX) or conventional synthetic disease-modifying antirheumatic drugs (csDMARD) in these studies.
Methods Our posthoc analysis included data from 6 phase III studies (NCT01039688; NCT00814307; NCT00847613; NCT00853385; NCT00856544; NCT00960440). MTX-naive patients or patients with inadequate response to csDMARD or biological DMARD received tofacitinib 5 or 10 mg twice daily alone or with csDMARD, with or without concomitant GC. Patients receiving GC (≤ 10 mg/day prednisone or equivalent) before enrollment maintained a stable dose throughout. Endpoints included the American College of Rheumatology (ACR) 20/50/70 response rates, rates of Clinical Disease Activity Index (CDAI)-defined low disease activity (LDA; CDAI ≤ 10) and remission (CDAI ≤ 2.8), and changes from baseline in CDAI, 28-joint count Disease Activity Score (DAS28-4)–erythrocyte sedimentation rate (ESR), Health Assessment Questionnaire–Disability Index (HAQ-DI), pain visual analog scale (VAS), and modified total Sharp score.
Results Of 3200 tofacitinib-treated patients, 1258 (39.3%) received tofacitinib monotherapy and 1942 (60.7%) received tofacitinib plus csDMARD; 1767 (55.2%) received concomitant GC. ACR20/50/70 response rates, rates of CDAI LDA and remission, and improvements in CDAI, DAS28-4-ESR, HAQ-DI, and pain VAS with tofacitinib were generally similar with or without GC in monotherapy and combination therapy studies. GC use did not appear to affect radiographic progression in tofacitinib-treated MTX-naive patients. MTX plus GC appeared to inhibit radiographic progression to a numerically greater degree than MTX alone.
Conclusion Concomitant use of GC with tofacitinib did not appear to affect clinical or radiographic efficacy. MTX plus GC showed a trend to inhibit radiographic progression to a greater degree than MTX alone.
In this issue
The Journal of Rheumatology
Vol. 49, Issue 5
1 May 2022
Effect of Glucocorticoids on the Clinical and Radiographic Efficacy of Tofacitinib in Patients with Rheumatoid Arthritis: A Posthoc Analysis of Data from 6 Phase III Studies
Christina Charles-Schoeman, Désirée van der Heijde, Gerd R. Burmester, Peter Nash, Cristiano A.F. Zerbini, Carol A. Connell, Haiyun Fan, Kenneth Kwok, Eustratios Bananis, Roy Fleischmann
The Journal of Rheumatology Nov 2017, jrheum.170486; DOI: 10.3899/jrheum.170486
Effect of Glucocorticoids on the Clinical and Radiographic Efficacy of Tofacitinib in Patients with Rheumatoid Arthritis: A Posthoc Analysis of Data from 6 Phase III Studies
Christina Charles-Schoeman, Désirée van der Heijde, Gerd R. Burmester, Peter Nash, Cristiano A.F. Zerbini, Carol A. Connell, Haiyun Fan, Kenneth Kwok, Eustratios Bananis, Roy Fleischmann
The Journal of Rheumatology Nov 2017, jrheum.170486; DOI: 10.3899/jrheum.170486
