Dimitrios A Pappas1, Robert A Gerber2, Heather J Litman3, David Gruben4, Jamie Geier5, Winnie D Hua6, Connie Chen7, Youfu Li8, Joel M Kremer9, John S Andrews10, Jeffrey A Bourret11. 1. Scientific Director of International Registry and Comparative Effectiveness and Biomarkers Sub-Study, Corrona, Waltham, MA, and Assistant Professor of Medicine, Department of Medicine, Columbia University, New York City. 2. Senior Director, Health Economics and Outcomes Research, Pfizer, Groton, CT. 3. Associate Director of Biostatistics, Corrona. 4. Statistician, Pfizer, Groton, CT. 5. Director of Epidemiology, Pfizer, New York City. 6. Biostatistician, Corrona. 7. Senior Medical Director, Global Medical Affairs, Pfizer, New York City. 8. Biostatistician III, University of Massachusetts Medical School, Worcester. 9. Chief Medical Officer, Corrona, and Professor of Medicine, Albany Medical College, NY. 10. Senior Director, US Medical Affairs, Pfizer, Collegeville, PA. 11. Senior Director, North America Medical Affairs, and Medical Lead, Specialty Payer & Channel Customer Strategy, Pfizer, Collegeville, PA.
Abstract
BACKGROUND: The implementation of treat-to-target principles in rheumatoid arthritis (RA) has not been fully investigated in patients with inadequate response to tumor necrosis factor (TNF) inhibitor treatment. OBJECTIVES: To evaluate the prevalence of an inadequate response to initial TNF inhibitor treatment at 6 and 12 months among patients with RA in a real-world patient registry, as well as the delay in therapy adjustment and its impact on disease activity and patient-reported outcome (PRO) measures. METHODS: This analysis is based on data of patients with moderate or severe disease activity (Clinical Disease Activity Index [CDAI] score >10) who were included in the Consortium of Rheumatology Researchers of North America (Corrona) RA registry, a prospective, observational database. The patients had never received treatment with a biologic disease-modifying antirheumatic drug (DMARD) and had initiated treatment with a TNF inhibitor (adalimumab, certolizumab pegol, etanercept, golimumab, or infliximab) between October 2001 and December 2014. We evaluated treatment response (CDAI score ≤10), select PRO measures, and treatment changes at 6 months. Patients who had an inadequate response to TNF inhibitor therapy at 6 months and continued to use their initial TNF inhibitor were evaluated again at 12 months. RESULTS: This retrospective analysis included 2282 patients. At 6 months, 1732 (75.9%) of the patients continued to use their initial TNF inhibitor; of these, 803 (46.4%) patients had an inadequate response to treatment. Of the 803 patients who had an inadequate response at 6 months, 488 (60.8%) continued their initial treatment at 12 months. Of these 488 patients, 315 (64.5%) had an inadequate response at 12 months, and 173 (35.5%) had a response. Numerically greater improvements in all PRO measures were observed for patients who responded to therapy compared with patients with an inadequate response. CONCLUSIONS: In this real-world analysis of data from the Corrona RA registry, a considerable proportion of patients with RA had an inadequate response to the initial TNF inhibitor therapy at 6 and 12 months. Many patients continued to have moderate or high disease activity, without accelerating treatment (eg, addition or increase in the dose of concurrent conventional synthetic DMARDs or a TNF inhibitor), contrary to treat-to-target principles, thus remaining at risk for accumulating joint damage and disability.
BACKGROUND: The implementation of treat-to-target principles in rheumatoid arthritis (RA) has not been fully investigated in patients with inadequate response to tumor necrosis factor (TNF) inhibitor treatment. OBJECTIVES: To evaluate the prevalence of an inadequate response to initial TNF inhibitor treatment at 6 and 12 months among patients with RA in a real-world patient registry, as well as the delay in therapy adjustment and its impact on disease activity and patient-reported outcome (PRO) measures. METHODS: This analysis is based on data of patients with moderate or severe disease activity (Clinical Disease Activity Index [CDAI] score >10) who were included in the Consortium of Rheumatology Researchers of North America (Corrona) RA registry, a prospective, observational database. The patients had never received treatment with a biologic disease-modifying antirheumatic drug (DMARD) and had initiated treatment with a TNF inhibitor (adalimumab, certolizumab pegol, etanercept, golimumab, or infliximab) between October 2001 and December 2014. We evaluated treatment response (CDAI score ≤10), select PRO measures, and treatment changes at 6 months. Patients who had an inadequate response to TNF inhibitor therapy at 6 months and continued to use their initial TNF inhibitor were evaluated again at 12 months. RESULTS: This retrospective analysis included 2282 patients. At 6 months, 1732 (75.9%) of the patients continued to use their initial TNF inhibitor; of these, 803 (46.4%) patients had an inadequate response to treatment. Of the 803 patients who had an inadequate response at 6 months, 488 (60.8%) continued their initial treatment at 12 months. Of these 488 patients, 315 (64.5%) had an inadequate response at 12 months, and 173 (35.5%) had a response. Numerically greater improvements in all PRO measures were observed for patients who responded to therapy compared with patients with an inadequate response. CONCLUSIONS: In this real-world analysis of data from the Corrona RA registry, a considerable proportion of patients with RA had an inadequate response to the initial TNF inhibitor therapy at 6 and 12 months. Many patients continued to have moderate or high disease activity, without accelerating treatment (eg, addition or increase in the dose of concurrent conventional synthetic DMARDs or a TNF inhibitor), contrary to treat-to-target principles, thus remaining at risk for accumulating joint damage and disability.
Authors: Jeffrey R Curtis; Lang Chen; Aseem Bharat; Elizabeth Delzell; Jeffrey D Greenberg; Leslie Harrold; Joel Kremer; Soko Setoguchi; Daniel H Solomon; Fenglong Xie; Huifeng Yun Journal: Arthritis Care Res (Hoboken) Date: 2014-12 Impact factor: 4.794
Authors: Jasvinder A Singh; Kenneth G Saag; S Louis Bridges; Elie A Akl; Raveendhara R Bannuru; Matthew C Sullivan; Elizaveta Vaysbrot; Christine McNaughton; Mikala Osani; Robert H Shmerling; Jeffrey R Curtis; Daniel E Furst; Deborah Parks; Arthur Kavanaugh; James O'Dell; Charles King; Amye Leong; Eric L Matteson; John T Schousboe; Barbara Drevlow; Seth Ginsberg; James Grober; E William St Clair; Elizabeth Tindall; Amy S Miller; Timothy McAlindon Journal: Arthritis Rheumatol Date: 2015-11-06 Impact factor: 10.995
Authors: Elena Nikiphorou; Helga Radner; Katerina Chatzidionysiou; Carole Desthieux; Codruta Zabalan; Yvonne van Eijk-Hustings; William G Dixon; Kimme L Hyrich; Johan Askling; Laure Gossec Journal: Arthritis Res Ther Date: 2016-10-28 Impact factor: 5.156
Authors: Leslie R Harrold; George W Reed; Ani John; Christine J Barr; Kevin Soe; Robert Magner; Katherine C Saunders; Eric M Ruderman; Tmirah Haselkorn; Jeffrey D Greenberg; Allan Gibofsky; J Timothy Harrington; Joel M Kremer Journal: Arthritis Care Res (Hoboken) Date: 2018-02-06 Impact factor: 4.794
Authors: Lucie Nekvindová; Jiří Vencovský; Karel Pavelka; Pavel Horák; Zlatuše Křístková; Jakub Závada Journal: Arthritis Res Ther Date: 2021-01-06 Impact factor: 5.156
Authors: Kelly D O'Neill; Kathryne E Marks; Pamela S Sinicrope; Cynthia S Crowson; Dana Symons; Elena Myasoedova; John M Davis Journal: ACR Open Rheumatol Date: 2021-09-18