A treat-to-target (T2T) strategy in daily clinical practice for patients with early rheumatoid arthritis proved successful in maintaining good disease- and patient-related outcomes over a 5-year period at two rheumatology clinics in the Netherlands.
The observational study builds on previous research on the long-term results of continuous application of T2T strategies in rheumatoid arthritis, for which there have been few published studies. “Long-term data from more recent randomized controlled clinical trials, using a T2T approach and biologicals, have shown good clinical outcomes. However, the generalizability of these results is hampered by the selection of specific patient groups in clinical trials and strict exclusion criteria. Patients seen in real-life practice may differ substantially from those in randomized clinical trials,” first authorof Medisch Spectrum Twente, Enschede, the Netherlands, and her colleagues wrote in .
The investigators examined outcomes for 229 patients with very early RA who enrolled in the Dutch Rheumatoid Arthritis Monitoring (DREAM) remission induction cohort during 2006-2009, which included 5 years of follow-up for 171 of the patients. These patients underwent a protocoled T2T strategy aimed at remission, defined as a 28-joint Disease Activity Score (DAS28) of less than 2.6.
“In previous publications on the [DREAM] remission induction cohort, successful implementation of T2T in daily clinical practice was demonstrated. Achieving remission within the first year of treatment was shown to be a realistic goal for an important proportion of patients,” the authors wrote.
All patients started methotrexate monotherapy at an initial dosage of 15 mg/week that could be increased to a maximum dosage of 25 mg/week in week 8. Patients took folic acid on the second day after methotrexate. By week 12, those with persistent disease activity added sulfasalazine, starting at 2,000 mg/day and increasing if necessary to a maximum of 3,000 mg/day at week 20. Patients whose DAS28 remained at 3.2 or greater at week 24 received a tumor necrosis factor inhibitor. Those who reached remission had no change in medication, and when remission lasted for at least 6 months, medication was gradually tapered and eventually discontinued. Patients who had flares in which disease activity increased to a DAS28 of 2.6 and higher restarted their last effective medication or dosage, which could subsequently be intensified if necessary. Patients with comorbidities and contraindications for medication were not excluded because deviations from the protocol were allowed. The protocol also allowed concomitant treatment with NSAIDs, prednisolone at a dosage of less than 10 mg/day, and intra-articular corticosteroid injections.
The rate of DAS28-defined remission rose to 63% (126 of 199 patients) by the end of the first year, and only 5% had high disease activity at 24 weeks. The rate of remission remained stable over the next 4 years. This rate of remission was reflected as a drop from an overall mean DAS28 of 4.93 at baseline to 2.49 at 5 years. The majority of the drop in DAS28 occurred during the first 3 months (–1.63 points), and by the end of the first year of treatment, mean disease activity stayed below 2.6 on the DAS28.
The investigators saw a sustained remission at least once in 144 of the 171 patients with 5-year outcome data available, including sustained remission for 1 year or longer in 115. Median time to the first sustained remission proved to be 50 weeks, and half had this last less than 97 weeks and half more than 97 weeks.
During the 5-year follow-up, 17% of patients received treatment with biologics, with a median start of their first biologic at about 54 weeks after baseline. This first biologic was used continuously for a median of 29 weeks, and close to one-third of patients who started a biologic switched to a second biologic after a median duration of 41 weeks on the first. About two-thirds did not need a second biologic. A total of 66% of patients who took a biologic had at least one period of sustained remission.
Functional disability improved overall at 5 years as determined by Health Assessment Questionnaire (HAQ) scores that were available for 107 patients. HAQ scores decreased from a median of 1.125 at baseline to 0.375 after 24 weeks (P less than .001), where they remained stable throughout the rest of follow-up. Overall, nearly 70% of the patients with available 5-year data had a change in their individual HAQ score that was clinically meaningful from baseline to 24 weeks.
“Our study describes long-term outcome of implementation and continuous application of T2T to RA patients in daily clinical practice. The outcomes are similar to or even better than the results of T2T randomized clinical trials, in which strict selection of patients and controlled conditions were followed. These ‘real-life data’ are of important additional value in the evidence for the effectiveness of a T2T approach in RA patients,” the investigators concluded.
They had no disclosures to report.
SOURCE: Versteeg G et al. Clin Rheumatol. 2018 Feb 1. .