TY - JOUR
T1 - Impact of Tofacitinib on Components of the ACR Response Criteria
T2 - Post Hoc Analysis of Phase III and Phase IIIb/IV Trials
AU - Bessette, Louis
AU - Mysler, Eduardo
AU - Kinch, Cassandra D.
AU - Kwok, Kenneth
AU - Lukic, Tatjana
AU - On, Phu Vinh
AU - van Vollenhoven, Ronald F.
N1 - Funding Information: The authors would like to acknowledge Tanya Girard, PhD, a former employee and stockholder of Pfizer Canada ULC, for her significant intellectual and scientific contributions to this work. Medical writing support, under the guidance of the authors, was provided by Jennifer Arnold, PhD, CMC Connect, McCann Health Medical Communications and was funded by Pfizer Inc, New York, New York, USA, in accordance with Good Publication Practice (GPP3) guidelines. Some data reported in this manuscript were previously presented at the American College of Rheumatology Annual Scientific Meeting, Atlanta, Georgia, USA, November 8–13, 2019: Bessette L, Dougados M, Mysler E, et al. Impact of tofacitinib on the individual components of the ACR composite score in patients with rheumatoid arthritis: a post hoc analysis of phase 3 trials [abstract]. Arthritis Rheumatol 2019;71 Suppl 10:1348. Funding Information: This study was sponsored by Pfizer Inc. 1L. Bessette, MD, MSc, Department of Medicine, Laval University, Quebec, Quebec, Canada; 2E. Mysler, MD, Organización Médica de Investigación, Buenos Aires, Argentina; 3C.D. Kinch, PhD, P.V. On, MSc, Pfizer Canada ULC, Kirkland, Quebec, Canada; 4K. Kwok, MS, T. Lukic, MD, MSc, Pfizer Inc, New York, New York, USA; 5R.F. van Vollenhoven, MD, PhD, Amsterdam Rheumatology and Immunology Center, and Department of Rheumatology and Clinical Immunology, Amsterdam University Medical Centers, Amsterdam, The Netherlands. LB has received grants and/or research support from AbbVie, Amgen, BMS, Celgene, Janssen, Eli Lilly, Gilead Sciences, Novartis, Pfizer Inc, Roche, Sanofi, and UCB; and has acted as a consultant or speaker for AbbVie, Celgene, Eli Lilly, Fresenius Kabi, Gilead Sciences, Novartis, Pfizer Inc, and Sandoz. EM has received research grants from Eli Lilly, Pfizer Inc, and Roche; and serves on speakers’ bureaus for AbbVie, Amgen, AstraZeneca, BMS, Eli Lilly, Janssen, Pfizer Inc, Roche, and Sanofi. CDK, KK, TL, and PVO are employees and stockholders of Pfizer Inc. RFvV has received grants and/or research support from AbbVie, Amgen, BMS, GSK, Pfizer Inc, Roche, and UCB; and has acted as a consultant for AbbVie, AstraZeneca, Biotest, BMS, Celgene, Crescendo, Eli Lilly, GSK, Janssen, Merck, Novartis, Pfizer Inc, Roche, UCB, and Vertex. Address correspondence to Dr. C.D. Kinch, Pfizer Canada ULC, 17300 Trans-Canada Hwy, Kirkland, QC H9J 2M5, Canada. Email: Cassandra.Kinch@pfizer.com. Accepted for publication February 9, 2022. Publisher Copyright: © 2022 The Journal of Rheumatology.
PY - 2022/6/1
Y1 - 2022/6/1
N2 - Objective. To evaluate the effect of tofacitinib (TOF) on American College of Rheumatology (ACR) response criteria components in patients with rheumatoid arthritis (RA). Methods. This post hoc analysis pooled data from RA phase III randomized controlled trials (RCTs) assessing TOF 5 or 10 mg BID, adalimumab (ADA), or placebo, with conventional synthetic disease-modifying antirheumatic drugs, and a phase IIIb/IV RCT assessing TOF 5 mg BID monotherapy, TOF 5 mg BID with methotrexate (MTX), or ADA with MTX. Outcomes included proportions of patients achieving ACR20/50/70 responses and ≥ 20/50/70% improvement rates in ACR components at week 2 and months 1, 3, and 6; and mean percent improvement in ACR components and Clinical or Simplified Disease Activity Index (CDAI or SDAI) low disease activity or remission rates, at month 3, for ACR20/50/70 responders. Results. Across treatment groups, ≥ 20/50/70% improvement rates were numerically higher for most physician- vs patient-reported measures. In phase III RCTs, at earlier timepoints, ≥ 50/70% improvements in patient global assessment of disease activity, pain, and physician global assessment were similar. Among ACR20 responders receiving TOF, mean percent improvements for tender and swollen joint counts were > 70% at month 3. CDAI/SDAI remission was achieved at month 3 by 27.8-45.0% of ACR70 responders receiving TOF. Conclusion. Among ACR20 responders treated with TOF, physician-reported components particularly exceeded 20% response improvement. At month 3, disease state generally did not corroborate ACR70 response criteria. Divergences between physician- and patient-reported measures highlight the importance of identifying appropriate patient-reported outcome targets to manage RA symptoms in clinical practice.
AB - Objective. To evaluate the effect of tofacitinib (TOF) on American College of Rheumatology (ACR) response criteria components in patients with rheumatoid arthritis (RA). Methods. This post hoc analysis pooled data from RA phase III randomized controlled trials (RCTs) assessing TOF 5 or 10 mg BID, adalimumab (ADA), or placebo, with conventional synthetic disease-modifying antirheumatic drugs, and a phase IIIb/IV RCT assessing TOF 5 mg BID monotherapy, TOF 5 mg BID with methotrexate (MTX), or ADA with MTX. Outcomes included proportions of patients achieving ACR20/50/70 responses and ≥ 20/50/70% improvement rates in ACR components at week 2 and months 1, 3, and 6; and mean percent improvement in ACR components and Clinical or Simplified Disease Activity Index (CDAI or SDAI) low disease activity or remission rates, at month 3, for ACR20/50/70 responders. Results. Across treatment groups, ≥ 20/50/70% improvement rates were numerically higher for most physician- vs patient-reported measures. In phase III RCTs, at earlier timepoints, ≥ 50/70% improvements in patient global assessment of disease activity, pain, and physician global assessment were similar. Among ACR20 responders receiving TOF, mean percent improvements for tender and swollen joint counts were > 70% at month 3. CDAI/SDAI remission was achieved at month 3 by 27.8-45.0% of ACR70 responders receiving TOF. Conclusion. Among ACR20 responders treated with TOF, physician-reported components particularly exceeded 20% response improvement. At month 3, disease state generally did not corroborate ACR70 response criteria. Divergences between physician- and patient-reported measures highlight the importance of identifying appropriate patient-reported outcome targets to manage RA symptoms in clinical practice.
KW - ACR improvement criteria
KW - clinical trials
KW - rheumatoid arthritis
UR - http://www.scopus.com/inward/record.url?scp=85131271202&partnerID=8YFLogxK
U2 - https://doi.org/10.3899/jrheum.210707
DO - https://doi.org/10.3899/jrheum.210707
M3 - Article
C2 - 35232809
SN - 0315-162X
VL - 49
SP - 566
EP - 576
JO - Journal of rheumatology
JF - Journal of rheumatology
IS - 6
ER -