TNF Blocker Withdrawal Feasible After 6 Months in Early RA

Alice Goodman

May 26, 2011

May 26, 2011 (London, United Kingdom) — Withdrawal of adalimumab after 6 months of combination treatment with adalimumab plus methotrexate appears to be a feasible approach in the treatment of very early rheumatoid arthritis (RA), according to a study reported here at the European League Against Rheumatism Congress 2011.

Approximately 80% of patients who were withdrawn from adalimumab but continued on methotrexate maintained their response at 52 weeks. Another 10% who continued on combination therapy maintained their response at 52 weeks.

"For a large proportion of very early RA patients, 6 months of combination therapy followed by methotrexate monotherapy may be a viable option to achieve good outcomes," said lead author Paul Emery, MD, from Leeds Teaching Hospital in the United Kingdom. "Although patients treated with continuous combination therapy do better and have higher levels of disease control, methotrexate monotherapy is a less expensive option. This is an argument to get payers to allow up-front treatment with biologics," he stated.

Patients in the study were treated with the combination of adalimumab 40 mg every other week plus methotrexate for 26 weeks. Those who achieved disease control — reflected by a Disease Activity Score on a measure of 28 items (DAS28) below 3.2 at 6 months — were randomized to monotherapy (methotrexate for 12 months [n = 102]) or combination therapy (continuation of adalimumab plus methotrexate for 52 weeks [n = 105]).

At week 78, 94.1% of the monotherapy group and 95.2% of the combination group maintained a 20% improvement, according to American College of Rheumatology criteria (ACR20). Using a more stringent end point, at week 78, 80% of the monotherapy group and 88% of the combination group achieved at least a 50% improvement on ACR criteria (ACR50). Overall, 81.2% of patients in the monotherapy group and 91.4% of patients in the combination group (P = .001) had good disease control — reflected by a DAS28 below 3.2. Using more stringent criteria, 66.3% and 85.9%, respectively, achieved a DAS28 below 2.6 (P = .001).

"About 89% of those treated with combination therapy and 80% [of those randomized to continue on] methotrexate monotherapy had no disease progression. Over time, a similar percentage of patients in both groups achieved and maintained normal function," Dr. Emery reported.

Adverse events in this trial were similar to those seen in other trials of adalimumab, and consistent with trials of other tumor necrosis factor inhibitors.

"Our own experience is that we had the best results with a year of combination therapy, but the 6-month combination treatment [followed by methotrexate monotherapy] is a nod to health economics," Dr. Emery stated.

"It is doubtful that this single study will change practice, but the study will be noted and discussed by rheumatologists," said Joel Kremer, MD, from Albany Medical College in New York. "Doctors are creatures of habit, and the approach studied in this trial is not being done commonly. It will take time."

Dr. Emery reports receiving grant/research support from Abbott, Merck, Pfizer, Roche, and BMS; and being a consultant for Abbott, Merck, Pfizer, Roche, and BMS. Dr. Kremer reports receiving grant/research support from Pfizer and being a consultant for Pfizer.

European League Against Rheumatism (EULAR) Congress 2011: Abstract THU0251b. Presented May 26, 2011.

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