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Combination Therapy for Rheumatoid Arthritis FREE

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The summary below is from the full report titled “Concomitant Leflunomide Therapy in Patients with Active Rheumatoid Arthritis despite Stable Doses of Methotrexate. A Randomized, Double-Blind, Placebo-Controlled Trial.” It is in the 5 November 2002 issue of Annals of Internal Medicine (volume 137, pages 726-733). The authors are JM Kremer, MC Genovese, GW Cannon, JR Caldwell, JJ Cush, DE Furst, ME Luggen, E Keystone, MH Weisman, WM Bensen, JL Kaine, EM Ruderman, P Coleman, DL Curtis, EJ Kopp, SM Kantor, J Waltuck, HB Lindsley, JA Markenson, V Strand, B Crawford, I Fernando, K Simpson, and JM Bathon.


Ann Intern Med. 2002;137(9):I-42. doi:10.7326/0003-4819-137-9-200211050-00003
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What is the problem and what is known about it so far?

Rheumatoid arthritis (RA) is a chronic disease that causes painful, swollen, and deformed joints. It is caused by inflammation of the tissue linings (membranes) of joints. It usually affects the small joints of the hands and feet but may develop in any joint. People with RA usually have flares of joint pain and stiffness that last weeks to months. Between flares, people with RA are relatively symptom free.

There is no cure for RA. Repeated attacks are painful and destroy joints. About 1 in 10 persons with RA eventually becomes severely disabled from joint destruction. Treatment reduces symptoms and joint damage. Several powerful drugs, known as disease-modifying antirheumatic drugs (DMARDs), reduce the risk for permanent joint damage. But is treatment with two DMARDs better than treatment with one for some patients?

Why did the researchers do this particular study?

To see whether adding a second DMARD to ongoing therapy with methotrexate (the most commonly used DMARD) improves outcomes in adults with active RA.

Who was studied?

263 adults who had persistent symptoms and signs of RA despite treatment with methotrexate for at least 6 months. Most (78%) were women. Average age was about 56 years.

How was the study done?

Patients were randomly assigned to either continue methotrexate with placebo (dummy pill) or combine methotrexate with a second DMARD (leflunomide). Dosages of methotrexate were 10 to 20 mg weekly. Dosages of leflunomide were usually 10 to 20 mg daily. Neither the patients nor their physicians were told who got leflunomide or dummy pills. At 6 months, the researchers asked about joint symptoms, pain intensity, ability to function, and various side effects. They also did blood tests to monitor levels of joint inflammation and check for possible liver toxicity from the DMARDs.

What did the researchers find?

At 6 months, more patients who took combined therapy (about 46%) improved compared with those who took methotrexate and dummy pills (about 20%). Nearly 90% of patients in both groups reported some side effects (such as nausea or headache). Diarrhea and abnormal results on liver tests were more common among patients who took combined therapy. There were fewer infections in the combined group (about 41%) than in the single-therapy group (about 52%).

What were the limitations of the study?

The study lasted 6 months. Many patients with active RA require lifelong therapy; longer studies are needed to better establish the benefits and harms of combined DMARD therapy. All patients in this study had active RA despite methotrexate therapy, so this study's results don't necessarily apply to patients whose RA gets better with one DMARD.

What are the implications of the study?

Combination therapy with leflunomide and methotrexate improves outcomes in patients whose rheumatoid arthritis has remained active despite taking methotrexate alone. Side effects are common with DMARDs whether they are given singly or in combination. Diarrhea and abnormal results on liver tests are more common with combined leflunomide and methotrexate therapy than with methotrexate alone.

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