Postapproval Comparative Safety Study of Tofacitinib and Biological Disease‐Modifying Antirheumatic Drugs: 5‐Year Results from a United States–Based Rheumatoid Arthritis Registry
Objective Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). We compared 5‐year adverse event (AE) incidence rates (IRs) between patients initiating tofacitinib and those initiating new biological disease‐modifying antirheumatic drugs (bDMARDs) within the U...
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| Published in | ACR open rheumatology Vol. 3; no. 3; pp. 173 - 184 |
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| Main Authors | , , , , , , , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
United States
John Wiley & Sons, Inc
01.03.2021
John Wiley and Sons Inc Wiley |
| Subjects | |
| Online Access | Get full text |
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| Summary: | Objective
Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). We compared 5‐year adverse event (AE) incidence rates (IRs) between patients initiating tofacitinib and those initiating new biological disease‐modifying antirheumatic drugs (bDMARDs) within the United States (US) Corrona RA registry.
Methods
IRs (number of first events/100 patient‐years) of major adverse cardiovascular events (MACE), serious infection events (SIEs), herpes zoster (HZ), malignancies, and death were estimated among tofacitinib and bDMARD initiators, regardless of dose/schedule, between November 6, 2012 (US Food and Drug Administration tofacitinib approval), and July 31, 2018 (follow‐up through January 31, 2019). Propensity score (PS) methods were used to control for nonrandom prescribing practices. Hazard ratios (HRs) were calculated to compare rates using multivariable‐adjusted Cox regression. Different risk windows were used for acute (MACE, SIEs, HZ, and venous thromboembolic events [VTEs]) and long‐term (malignancy and death) events. VTEs were assessed descriptively.
Results
For MACE, SIEs, and HZ, 1999 (3152.1 patient‐years) and 8358 (12 869.4 years) tofacitinib and bDMARD initiators were included, respectively; for malignancy/death, 1999 (4505.6 patient‐years) and 6354 (16 670.8 patient‐years) initiators were included, respectively. AE rates were similar across cohorts, except for HZ, which was significantly higher with tofacitinib versus bDMARDs (PS‐trimmed adjusted HR 2.32; 95% confidence interval [CI] 1.43‐3.75). There were 45 (zero serious) and 88 (five serious) HZ events with tofacitinib and bDMARDs, respectively. Sensitivity analyses demonstrated similar results. VTE IRs (95% CI) were 0.29 (0.13‐0.54) and 0.33 (0.24‐0.45) for tofacitinib and bDMARDs, respectively.
Conclusion
In this registry analysis, both cohorts had similar MACE, SIE, malignancy, death, and VTE rates; HZ rates were higher for tofacitinib initaitors than for bDMARD initiators. |
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| Bibliography: | Dimitrios A. Pappas, MD: Corrona, Waltham, Massachusetts, and Columbia University, New York, New York Supported by Pfizer. The registry is sponsored by Corrona, LLC. Corrona has been supported through contracted subscriptions in the last 2 years by AbbVie, Amgen, Boehringer Ingelheim, Bristol‐Myers Squibb, Celgene, Crescendo, Eli Lilly and Company, Genentech, Gilead, Glaxo Smith Kline, Janssen, Merck, Momenta Pharmaceuticals, Novartis, Ortho Dermatologics, Pfizer Inc, Regeneron, Roche, Sun, and UCB. Medical writing support, under the guidance of the authors, was provided by Jennifer Stewart, PhD, MBA, and Anthony G. McCluskey, PhD, CMC Connect, McCann Health Medical Communications, and was funded by Pfizer in accordance with Good Publication Practice guidelines (Ann Intern Med 2015;163:461‐4). Corrona owns the Corrona Rheumatoid Arthritis registry. Pfizer paid a subscription fee to Corrona for access to the Corrona Rheumatoid Arthritis registry. Michelle Karpman at Corrona, LLC, provided medical writing support in accordance with Good Publication Practice guidelines (Ann Intern Med 2015;163:461‐4). Joel M. Kremer has received research grants from AbbVie, Bristol‐Myers Squibb, Eli Lilly and Company, Genentech, Novartis, and Pfizer (more than $10 000 in total), and has received consulting fees or other remuneration from AbbVie, Amgen, Bristol‐Myers Squibb, Eli Lilly and Company, Genentech, Pfizer, and Regeneron/Sanofi (less than $10 000). Clifton O. Bingham III has received research grants from Bristol‐Myers Squibb (less than $10 000) and has received consulting fees or other remuneration from AbbVie, Bristol‐Myers Squibb, Eli Lilly and Company, Genentech/Roche, Gilead, Janssen, Pfizer, and Regeneron/Sanofi (less than $10 000 each). Laura C. Cappelli has received research grants from Bristol‐Myers Squibb and has received consulting fees or other remuneration from Regeneron/Sanofi Genzyme (less than $10 000). Jeffrey D. Greenberg is an employee and shareholder of Corrona. Ann M. Madsen is an employee and shareholder of Pfizer. Jamie Geier is an employee and shareholder of Pfizer. Jose L. Rivas is an employee and shareholder of Pfizer. Alina M. Onofrei is an employee of Corrona. Christine J. Barr is an employee and shareholder of Corrona. Dimitrios A. Pappas is an employee and shareholder of Corrona and has received consulting fees or other remuneration from Novartis, Roche, and Regeneron (less than $10 000). Heather J. Litman is an employee and shareholder of Corrona. Kimberly J. Dandreo is an employee of Corrona. Andrea B. Shapiro is an employee and shareholder of Pfizer. Carol A. Connell is an employee and shareholder of Pfizer. Arthur Kavanaugh has received research grants from Pfizer (less than $10 000). No other disclosures relevant to this article were reported. Carol A. Connell, RN, PhD: Pfizer, Groton, Connecticut The views and opinions expressed within this manuscript are those of all authors and do not necessarily represent those of the sponsor. 1 Alina M. Onofrei, MSc, Christine J. Barr, BSN, MPH, Heather J. Litman, PhD, Kimberly J. Dandreo, MSc: Corrona, Waltham, Massachusetts 2 3 Jeffrey D. Greenberg, MD: Corrona, Waltham, Massachusetts, and New York University School of Medicine 4 5 Jose L. Rivas, MD: Pfizer SLU, Madrid, Spain 6 Joel M. Kremer, MD: Albany Medical College, Center for Rheumatology, Albany, New York 7 8 Arthur Kavanaugh, MD: University of California, San Diego School of Medicine, La Jolla. 9 Clifton O. Bingham III, MD, Laura C. Cappelli, MD: Johns Hopkins University, Baltimore, Maryland Ann M. Madsen, PhD, Jamie Geier, PhD: Pfizer, New York, New York, USA Andrea B. Shapiro, MD, MS: Pfizer, Peapack, New Jersey 10 ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 14 content type line 23 |
| ISSN: | 2578-5745 2578-5745 |
| DOI: | 10.1002/acr2.11232 |