Among 409 patients enrolled in the Corrona registry from 2014 to 2018 with moderate-to-high disease activity at baseline, and who had disease activity assessments after 6 months of DMARD monotherapy, 54% still had moderate-to-high disease, yet only 29% had any escalation in treatment, as has been recommended in international guidelines, according to Leslie R. Harrold, MD, of the University of Massachusetts in Worcester, and colleagues.
These findings suggest that a majority of patients were not being managed with a treat-to-target approach, “despite its value being widely accepted and despite advanced therapies being readily available to treat patients after an inadequate response to conventional synthetic DMARD monotherapy,” the authors wrote.
Although the treat-to-target approach of close disease monitoring and prompt dose escalation when targets are not met after 3 to 6 months is advocated by groups such as the American College of Rheumatology, it is unclear how broadly implemented these strategies have been adopted in real-world clinical practice.
Harrold and colleagues retrospectively analyzed data from the observational Corrona RA registry, which has enrolled more than 50,000 patients since 2001.
Moderate-to-high disease activity was defined as a Clinical Disease Activity Index (CDAI) >10, and treatment escalation or advancement was defined as an increase in the dose of the original DMARD or the addition of another conventional DMARD, biologic, or targeted synthetic agent from the index visit to the 6 month follow-up visit.
Among patients who had achieved remission/low disease activity by 6 months, improvements were seen on a wide range of specific measures, including pain, fatigue, and duration of morning stiffness.
For patients who received treatment escalation by 6 months, the change involved increase in the dose of the initial DMARD in 13%, addition of another DMARD in 8%, and initiation of a biologic in 10%.
The researchers also sought to identify patient and clinical factors that were associated with treatment escalation, finding that escalation was more common in patients who were younger (63.5 vs 66.9, P=0.007), had shorter disease duration (8.9 vs 11.9 years, P<0.001), had higher baseline CDAI (20.4 vs 17.7, P=0.008), and had daily doses of prednisone >10 mg (7% vs 1%, P=0.023).
Multiple clinical factors also were associated with treatment escalation, including:
- Higher tender joint counts, 7.3 vs 5.5 (P<0.001)
- Higher scores on patient global assessment, 46.7 vs 40.4 (P=0.021)
- Higher scores on patient pain assessment, 47.9 vs 40.3 (P=0.009)
- Fatigue, 47.8 vs 38.2 (P=0.002)
- DAS28 joint counts, 4.5 vs 4.2 (P<0.001)
- HAQ score, 0.5 vs 0.4 (P=0.035)
- Duration of morning stiffness, 114.1 vs 65.5 minutes (P=0.012)
- EuroQol 5 dimensions score, 0.69 vs 0.74 (P=0.007)
Potential reasons for the insufficient use of treatment escalation in RA include inadequate training of healthcare providers in disease assessment and patient hesitation, they suggested.
“There is considerable need for a treat-to-target approach to care to prevent joint damage and physical disability and maximize long-term health-related quality of life for patients with RA,” they concluded, adding that further work is needed to more fully examine factors that could interfere with optimization of treatment.
A study limitation was the lack of information on financial factors that may have influenced treatment decisions.
The study was supported by Corrona. Harrold and some co-authors are company employees.
The authors disclosed relevant relationships with Corrona, AbbVie, Bristol-Myers Squibb, Roche, Pfizer, Amgen, Genentech, Eli Lilly, Regeneron, and Sanofi.
The authors disclosed relevant relationships with Corrona, AbbVie, Bristol-Myers Squibb, Roche, Pfizer, Amgen, Genentech, Eli Lilly, Regeneron, and Sanofi.
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Primary Source
Clinical Rheumatology
Source Reference: Harrold L, et al “Assessing disease severity in bio-naive patients with RA on treatment with csDMARDs: insights from the Corrona Registry” Clin Rheumatol 2019; DOI: 10.1007/s10067-019-04727-7.
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