Short-Course RA Therapy May Offer Long-Term Relief

Rheumatoid arthritis responded well to short term methotrexate and adalimumab treatment

/ Author:  / Reviewed by: Joseph V. Madia, MD Beth Bolt, RPh

(RxWiki News) The goal of treating rheumatoid arthritis (RA) is to dial down disease activity and provide relief from the pain, stiffness, joint damage and functional problems. A recent study highlighted one treatment that may help.

A new trial looked at various treatment regimens for newly diagnosed RA patients.

The researchers found that combining Humira (adalimumab) with standard therapy methotrexate for six months achieved long-term relief for RA patients.

The findings of this study suggest that a short-course combination therapy may be a good strategy for newly diagnosed RA patients to maintain low disease activity or remission.

"Visit your doctor if you’re feeling stiffness in your joints."

Led by Josef S. Smolen, MD, of the Division of Rheumatology at the University of Vienna in Vienna, Austria, the OPTIMA (Optimal Protocol for Treatment Initiation with Methotrexate and Adalimumab) evaluated the outcomes of several therapeutic approaches for patients with early RA.

Rheumatoid arthritis occurs when the body’s normally protective immune system attacks the joints. This process causes inflammation that can damage the joints and other organs.

RA is treated most commonly with disease-modifying antirheumatic drugs (DMARDs). Methotrexate is one of the most commonly prescribed DMARDs.

Dr. Smolen and team wanted to look at the impact of combining methotrexate with Humira, a prescription medication that treats RA.

The trial involved 1,032 newly diagnosed RA patients who were randomly assigned to receive either a combination of Humira and methotrexate or placebo (sugar pill) plus methotrexate for 26 weeks.

Those in the combination group received 40 mg of Humira every other week, along with 7.5 mg of methotrexate, which increased to 20 mg weekly by the eighth week. Patients in the placebo group were given a placebo and the methotrexate.

Patients in the combination group who achieved low disease activity at weeks 22 and 26 were randomly assigned to either continue to receive Humira in addition to methotrexate for an additional 52 weeks or were withdrawn from Humira for that period.

Folks in the placebo group continued methotrexate only, and individuals who didn’t respond to either regimen were offered Humira plus methotrexate.

Disease activity was assessed at week 78 and compared with baseline (beginning) disease status using the DAS28 (measure of joint pain and stiffness, as well as function) and X-ray studies to illustrate joint damage.

Among the 466 patients in the combination group, 207 achieved low disease activity in the first period of the trial, and 105 were randomly selected to continue taking Humira along with methotrexate.

A total of 112 patients of the 460 patients in the placebo group achieved stable low disease activity and continued taking methotrexate only.

A total of 70 percent of those who continued taking Humira and 54 percent of those who continued to take methotrexate reached the low disease activity endpoint.

Patients who had achieved target disease activity in the combination group, but who were withdrawn from Humira, mostly maintained their good responses, according to the researchers.

Most of the patients (706) of the 926 patients in period 2 of the trial experienced an adverse event. The most common serious adverse events involved infection.

The researchers wrote, “The results of our double-blind, randomised, placebo-controlled trial suggest that in most patients with early (<1 year disease duration) rheumatoid arthritis who have achieved a stable low disease activity with a 6 month course of therapy with adalimumab plus methotrexate, the good response will be maintained clinically, functionally, and structurally even when adalimumab is withdrawn. This finding suggests that a short course of an induction therapy using a biological agent in combination with methotrexate might be sufficient to allow maintenance of low disease activity or remission upon continuation of methotrexate only."

The amount of Humira taken in this trial costs about $5,300 for a month’s supply of the medication.

This study was published in the January issue of The Lancet.

AbbVie, the maker of Humira, sponsored the research.

A number of the authors reported financial relationships with AbbVie and other pharmaceutical companies.

Review Date: 
January 30, 2014
Last Updated:
January 31, 2014