Guidelines recommend that disease activity should be assessed every 1 to 3 months in patients with high or moderate disease activity, and every 6 to 12 months in those with low disease activity or remission, but implementation of these principles has not been well evaluated in the United States.
In treating patients with rheumatoid arthritis (RA), the primary aim is disease remission, though low disease activity is also considered an acceptable goal. American College of Rheumatology (ACR) and European League Against Rheumatism (EULAR) guidelines recommend starting treatment with a conventional disease-modifying anti-rheumatic drug (DMARD), and if the patient does not respond adequately, a biologic (such as an anti—tumor necrosis factor [anti-TNF] agent), a Janus kinase (JAK) inhibitor, or a targeted synthetic DMARD, all with or without methotrexate.
Guidelines recommend that disease activity should be assessed every 1 to 3 months in patients with high or moderate disease activity, and every 6 to 12 months in those with low disease activity or remission, but implementation of these principles has been varied in Europe and has not been well evaluated in the United States. A newly published analysis sought to evaluate the prevalence of inadequate response to anti-TNF agents and delays in adjustments to treatment.
Using the Corrona registry, which includes data on 44,532 US patients with RA and 152,215 patient-years of follow-up, the researchers considered 2282 biologic-naïve patients who started an anti-TNF drug between 2001 and 2014.
Within 6 months of initiating treatment, 9.8% of patients had switched to a different biologic, and 14.3% discontinued their first anti-TNF agent without immediately switching to another therapy. At 6 months, 75.9% of patients continued on their first anti-TNF drug. In total, 46.4% of patients did not have an adequate response at 6 months; the remaining 53.6% of patients had either low disease activity or remission. The greatest improvements in patient-reported outcome measures (PROs) were present in patients who had an adequate response.
Those patients who continued to use their first anti-TNF drug for at least 6 months and had an inadequate response were followed for another 6 months, and of the evaluable patients, 5.9% had discontinued their first drug and had not started another biologic, and 5.6% had switched to another biologic at 12 months. In total, 64.5% of patients continued to receive the same drug at 12 months and still had no response. However, 35.5% achieved a response at 12 months.
According to the authors, “It is possible that the small improvements among those with an inadequate response seen in this study were deemed by the physician and/or the patient to be “satisfactory” or “sufficient” to continue treatment with the same TNF inhibitor for an additional 6 months,” but even if this were the case, it does not sufficiently explain why treatment was not accelerated in patients who did not attain a minimally clinically important improvement.
Physicians, write the authors, must focus on patients who continue to receive ineffective therapies in order to improve awareness and aid patients in making the best decisions about their care.
Reference
Pappas DA, Gerber RA, Litman HJ, et al. Delayed treatment acceleration in patients with rheumatoid arthritis who had inadequate response to initial tumor necrosis factor inhibitors: data from the Corrona registry. Am Health Drug Benefits. 2018;11(3):148-158. PMCID: PMC5973251.
Eye on Pharma: EU Aflibercept Approvals; Biosimilars Canada Campaign; Celltrion Data
November 19th 2024The European Commission grants marketing authorization to 2 aflibercept biosimilars; Biosimilars Canada launches new campaign to provide sustainable solutions to employers; Celltrion shares positive data for 2 biosimilars.
Breaking Barriers in Osteoporosis Care: New Denosumab Biosimilars Wyost, Jubbonti Approved
June 16th 2024In this episode, The Center for Biosimilars® delves into the FDA approval of the first denosumab biosimilars, Wyost and Jubbonti (denosumab-bbdz), and discuss their potential to revolutionize osteoporosis treatment with expert insights from 2 rheumatologists.
Insights from Festival of Biologics: Dracey Poore Discusses Cardinal Health’s 2024 Biosimilar Report
May 19th 2024The discussion highlights key emerging trends from the Festival of Biologics conference and the annual Cardinal Health Biosimilars Report, including the importance of sustainability in the health care landscape and the challenges and successes in biosimilar adoption and affordability.
Phase 3 Study Reports Similar Efficacy Between SB17, Stelara in Psoriasis
October 19th 2024A phase 3, 28-week comparative clinical trial in patients with moderate to severe plaque psoriasis confirmed similarity of the proposed ustekinumab biosimilar SB17 (Samsung Bioepis) to the reference product (Stelara) in efficacy, safety, pharmacokinetics, and immunogenicity.