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Subcutaneous monotherapy with Actemra demonstrates efficacy during 108-week RA trial
Subcutaneous administration of Actemra was shown to be efficacious for the treatment of rheumatoid arthritis compared with intravenous administration of Actemra, according to the recently published results of an open-label trial.
Researchers studied 346 patients with rheumatoid arthritis (RA) enrolled in a 24-week trial followed by an 84-week open-label extension trial in which 319 patients continued and 278 completed. Patients received either 162 mg subcutaneous Actemra (tocilizumab, Genentech) every 2 weeks or 8 mg/kg body weight intravenous (IV) tocilizumab every 4 weeks. Mean disease duration was 7.7 years, and 63.3% of patients used steroids at baseline.The incidence of adverse events was 498.3 per 100 patient-years, and serious adverse events occurred at 16.9 per 100 patient years and were stable over time. Common adverse events included nasopharyngitis, pharyngitis, upper-respiratory infection, hypercholesterolemia and injection-site erythema. Serious adverse events included infection, shingles, gastroenteritis and cellulitis. Four malignancies, 30 serious infections and one death due to gastric cancer were reported during the study.
Rates of adverse and serious adverse events were stable throughout the trial period, according to the researchers. Nine patients withdrew due to adverse events in the 173 patients taking IV tocilizumab and three patients withdrew due to adverse events from the subcutaneous group.
In seven patients, anti-tocilizumab antibodies were detected, but no lack of efficacy or decrease in serum tocilizumab was observed, the researchers reported.
Efficacy was similar between the IV and subcutaneous groups, and 79.2% achieved American College of Rheumatology (ACR) 20%, 50% or 70% improvement in disease activity at week 24, 80.6% at week 48 and 74.6% at week 108. The mean Disease Activity Score based on 28-joint count and erythrocyte sedimentation rate (DAS28-ESR) at baseline was 6.21 and was reduced to 2.76 at week 24, 2.61 at week 48 and 2.35 at week 108.
Dosing intervals were changed to every 3 weeks for 26 patients who achieved remission through subcutaneous administration, and 24 patients of higher weight than the group mean and insufficient response received weekly doses for 24 weeks.
The researchers concluded that the overall safety and efficacy profile of subcutaneous tocilizumab was similar to and consistent with the known profile of its IV counterpart. - by Shirley Pulawski
Disclosure: Ogata reports having received consulting fees, speaking fees and/or honoraria from Chugai Pharmaceutical. Please see the full study for a complete list of all other authors’ disclosures.