COPENHAGEN — Remission is a realistic therapeutic goal in rheumatoid arthritis with first, second, and even third courses of anti-tumor necrosis factor therapy.
Of the available drugs in this class, etanercept is associated with highest rates of achieving and sustaining remission, according to the findings of a single center observational study.
Although several randomized, controlled clinical trials and observational studies with tumor necrosis factor-alpha (TNF-alpha) inhibitors in RA have shown that remission is a reasonable treatment goal, “there have been no studies comparing the TNF blockers for this purpose,” Dr. Paolo Sfriso reported at the annual European Congress of Rheumatology. For this reason, he and his colleagues in the rheumatology unit at the University of Padua (Italy), sought to investigate the number of patients with active RA who achieved clinical remission while using adalimumab, etanercept, and infliximab as first, second, and third treatment-course agents in step-up, tightly controlled regimens. The investigators also evaluated patients' respective rates of remission persistence and the median remission times.
Toward this end, the investigators enrolled 570 patients from northeast Italy who had highly active RA (defined as a DAS28 greater than 5.1) and were treated with etanercept, adalimumab, or infliximab between May 2000 and May 2008 in an observational study. In all of the patients, the anti-TNF-alpha therapy was prescribed according to standard recommended dosages in combination with 7.5-10 mg methotrexate per week, Dr. Sfriso explained. In patients who did not achieve remission (defined as a DAS28 less than 2.6 for at least 3 months) after 12 weeks of therapy, 20 mg of leflunomide every other day was added, he said, noting that therapy was adjusted every 3 months based on DAS28 results, and “some patients who did not achieve remission were switched to another TNF-alpha blocker.” Patients taking NSAIDs and less than 5 mg of prednisolone per day were eligible for inclusion.
Regarding demographics, the median age of the primarily female (79%) study population was 51 years, and the median durations of disease and of anti-TNF-alpha treatment were 8 years and 204 weeks, respectively, said Dr. Sfriso. Leflunomide was added in 28% of patients, he noted.
In total, 875 treatment courses for 530 patients were considered in the analysis (treatment courses that lasted less than 8 weeks were excluded), including 210 with adalimumab, 418 with etanercept, and 247 with infliximab, Dr. Sfriso reported. “Remission was achieved in 62.6% of all of the treatments, and survival of remission with etanercept as the first treatment course was significantly higher than adalimumab or infliximab,” he said. The median period of remission for first-course etanercept was 63 months, compared with 41 months for infliximab and 36 months for adalimumab, he said.
The number of patients achieving clinical remission with second and third courses of anti-TNF-alpha treatment was 61.9% and 60.3%, respectively, with no statistically significant differences in the duration of remission among the three drugs, Dr. Sfriso said. “The only significant predictor [of remission] was age younger than 40 years, and only for the first course of anti-TNF-alpha therapy.”
The findings confirm that remission is “a realistic and achievable goal with [anti-TNF-alpha] therapy in real-world practice, and is also a reasonable goal with subsequent treatment courses,” he said.
Dr. Sfriso reported having no financial conflicts relative to his presentation.