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Two drugs combined better for RA than methotrexate alone
At six months, 43% of patients receiving adalimumab and methotrexate had a 50% improvement in RA symptoms.
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Combined treatment with adalimumab and methotrexate effectively treats long-standing rheumatoid arthritis about five times better than methotrexate alone, a new Cochrane review shows.
Federico Navarro-Sarabia, MD, chair of rheumatology at the Hospital Universitario Virgen Macarena in Seville, Spain, and colleagues reviewed data from six randomized controlled trials involving 2381 patients with rheumatoid arthritis (RA) for at least 10 years. They found that adalimumab (Humira, Abbott Laboratories) plus methotrexate decreased pain and swelling in patients who had failed standard treatment.
At six months, 43% of patients treated with biweekly 40 mg adalimumab injections and methotrexate experienced a 50% improvement in RA symptoms. In contrast, only 9% of patients treated with methotrexate and placebo injections showed such an improvement.
At one year, radiographic analysis showed both biweekly 40 mg adalimumab injections and weekly 20 mg adalimumab injections significantly slowed RA progression, including Sharp modified index and erosion score. Biweekly 40 mg adalimumab injections also had significantly improved joint space score, according to the study.
Adalimumab “is even more active when used combined with methotrexate,” Navarro-Sarabia said in a press release. “More people had improved symptoms with adalimumab alone than with [placebo] injections, but the improvement was not as much as when adalimumab was taken in combination with methotrexate,” he said.
At six months, patients treated with biweekly 40 mg adalimumab injections and methotrexate had a relative risk ranging from 1.52 to 4.63 for achieving a 20% improvement in symptoms, measured using the American College of Rheumatology criteria (ACR20).
For these same patients, the relative risk for achieving an ACR50 (50% improvement) averaged 4.63 and averaged 5.14 for achieving an ACR70 (70% improvement).
At one year, adalimumab and methotrexate-treated patients had a 2.46 relative risk for achieving an ACR20, a 4.37 relative risk for achieving an ACR50 and a 5.15 relative risk for achieving an ACR70, according to the study.
Patients treated with biweekly 40 mg adalimumab injections as monotherapy had a 1.91 relative risk for achieving an ACR20, a 2.48 relative risk for achieving an ACR50, and a 7.33 relative risk for achieving an ACR70 at six months follow-up, according to the study.
COURTESY: ABBOTT LABORATORIES |
Adalimumab is a recombinant human IgG1 monoclonal antibody, which binds to tumor necrosis factor (TNF), specifically TNF-alpha. The researchers found that patients treated with the drug more frequently developed positive antinuclear antibodies than control patients. Additionally, most studies showed no significant differences in safety between adalimumab and control patients. Only one study found a significantly higher rate of serious infections among adalimumab-treated patients, the authors noted.
“The available clinical trials with adalimumab are short-term studies (six-months duration) and there is only one 12-month study. Long-term efficacy and safety studies are needed,” the authors said in the press release.
For more information:
- Navarro-Sarabia F, Arizia-Arizia R, Hernandez-Cruz B, Villanueva I. Adalimumab for treating rheumatoid arthritis. Cochrane Database Syst Rev. 2005; Issue 3.