(RxWiki News) Biologic medications are a newer form of treatment for rheumatoid arthritis. They are often prescribed in combination with other medications. But how do they work when given alone? And which one works best on its own?
These researchers found that patients who received tocilizumab alone had greater improvement of rheumatoid arthritis symptoms than patients who received adalimumab alone.
Harmful side effects, however, were slightly more common among patients taking tocilizumab.
"Ask your pharmacist about newer rheumatoid arthritis medications."
This study was conducted by Cem Gabay, MD, of University Hospitals of Geneva in Switzerland, and fellow researchers.
Biologic medications like Actemra and Humira are typically prescribed when patients did not respond well to methotrexate, one of the most effective and commonly used medications to treat rheumatoid arthritis and similar conditions.
While biologics are usually part of a combination treatment, they are also prescribed alone.
According to Dr. Gabay and colleagues, "Roughly a third of patients with rheumatoid arthritis treated with biological treatments receive them as a monotherapy [single medication]."
So, these researchers set out to study the safety and effectiveness of two biologics as monotherapies.
The researchers recruited patients from 15 countries in North and South America, Australasia and Europe. All participants were at least 18 years of age, had severe rheumatoid arthritis for at least six months and did not respond well to methotrexate or were not suited to continue methotrexate treatment.
A total of 326 patients were enrolled in the study. Of these, 163 were assigned to tocilizumab and 162 to adalimumab.
Patients assigned to tocilizumab were given 8 mg of tocilizumab per kilogram of bodyweight every four weeks plus placebo (fake medication) every two weeks. Those assigned to adalimumab were given dosages of 40 mg every two weeks plus placebo every four weeks.
After 24 weeks of treatment, patients assigned to tocilizumab had greater reductions in swollen and tender joint counts, as measured by DAS28, compared to patients assigned to adalimumab.
DAS28 stands for Disease Activity Score in 28 joints. It is a measure of rheumatoid arthritis disease activity that counts the number of tender or swollen joints out of a total 28 joints.
DAS28 scores range from 0 to 10. A score below 2.6 is considered remission (little to no disease activity), while a score over 5.1 is considered high disease activity.
In this study, patients assigned to tocilizumab had a mean decrease in DAS28 of 3.3 points. In comparison, the adalimumab group had a mean decrease of 1.8 points.
Despite the greater improvement in disease activity associated with tocilizumab, the tocilizumab group had a slightly higher rate of serious adverse events (harmful side effects).
A total of 12 percent of the tocilizumab group (19 patients) experienced a serious adverse event, compared to 10 percent of the adalimumab group (16 patients).
More tocilizumab patients than adalimumab patients had increased levels of LDL cholesterol (the "bad" cholesterol) and alanine aminotransferase (a sign of liver damage). More of the tocilizumab group also had reduced platelet counts, which affects blood clotting ability, and reduced neutrophil counts, which can reduce ability to fight off infections.
"Tocilizumab monotherapy was superior to adalimumab monotherapy for reduction of signs and symptoms of rheumatoid arthritis in patients for whom methotrexate was deemed inappropriate," the study authors concluded.
They added that the safety profiles of the two medications were consistent with past findings. Both medications are associated with a risk of serious infections.
This study appears in the May 4 issue of The Lancet. The research was funded by F. Hoffmann-La Roche, which manufactures Actemra.