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Long-term subcutaneous tocilizumab seen as safe, effective in phase 3b trial of adults with RA
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Subcutaneously administered tocilizumab was safe and effective for 84 weeks in adults with rheumatoid arthritis who completed the 96-week SUMMACTA and BREVACTA global trials, according to phase 3b study results.
“Rheumatologists can be reassured that in this tocilizumab [subcutaneous] sc extension study, efficacy was maintained with no new safety signals,” Alan Kivitz, MD, rheumatologist at Altoona Arthritis and Osteoporosis Center, told Healio Rheumatology.
In this U.S. study, 217 patients continued to receive 162 mg of subcutaneous or intravenous tocilizumab (Actemra, Genentech) each week or every other week for up to 84 weeks. Of the patients, 76.5% were female and the mean age was 58.4 years. The primary endpoint was the percentage of patients with serious adverse events, and secondary endpoints included efficacy, lab abnormalities and immunogenicity.
The researchers found 10.6% of patients had serious adverse events, the most common of which were infections (3.7%). The rate of serious adverse events was 14.7 per 100 patient-years, compared with 11.2 and 14.6 for BREVACTA and SUMMACTA, respectively, while the rate of serious infections (4.38 per 100 patient-years) was also similar to BREVACTA (3.92) and SUMMACTA (3.95). Alanine aminotransferase elevations, which occurred in 38.2% of patients, did not increase the risk for liver injury. In addition, immunogenicity, which occurred in 1% of patients, did not increase the risk for serious adverse events. Similarly, the SUMMACTA trial had between 0.5% and 1.6% of patients who developed immunogenicity.
Grade three and four neutropenia, which occurred in 3% of patients, was transient and did not increase the risk for serious infection. No anaphylaxis or deaths occurred. However, 6% of patients withdrew from the study for safety reasons. The mean Clinical Disease Activity Index and DAS28 each remained stable throughout the 84 weeks.
The researchers concluded these results showed the durability of safety and efficacy for this therapy. – by Will Offit
Disclosures: Kivitz reports research grants or consulting fees from AbbVie, Pfizer, Genentech, UCB, Amgen, Celgene, Bristol-Myers Squibb, AstraZeneca and Janssen. Please see the full study for a list of all other researchers’ relevant financial disclosures.
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