The two studies were to be carried out for five years, but both were stopped prematurely at Week 90 and Week 89, respectively. Patients who received OKZ for six or more months in the open-label extension were considered to have completed the studies. Measures of efficacy improved in the open-label extension for patients who switched from placebo to OKZ. Disease activity in each treatment group decreased.
Treatment-emergent adverse events occurred in 88–95% of patients in both studies. Reactions included upper respiratory and other infections, arthralgia, diarrhea, stomatitis, cough and injection site pain. OKZ was tolerated well with an expected safety profile, and reductions in disease activity were sustained to Week 48.
Canada Approves Adalimumab for 2–4 Year-Olds
In December 2015, Health Canada approved the use of adalimumab (Humira) to treat moderate to severe active polyarticular juvenile idiopathic arthritis (JIA), reducing signs and symptoms in patients aged 2–4 years old.3 In 2012, adalimumab was approved in Canada for polyarticular JIA to treat patients aged 4–17 years old. Adalimumab is already approved for use in this patient group in the U.S.
Michele B. Kaufman, PharmD, CGP, RPh, is a freelance medical writer based in New York City and a pharmacist at New York Presbyterian Lower Manhattan Hospital.
References
- Barber J. Cara Therapeutics reports positive mid-stage data for CR845 in osteoarthritis. FirstWord Pharma. 2016 Dec 9.
- Genovese MC, Fleischmann R, Tanaka Y, et al. Long-term safety and efficacy of olokizumab in patients with moderate-to-severe rheumatoid arthritis who have previously failed anti-TNF treatment. Arthritis Rheumatol. 2015 Oct; 67(suppl 10).
- AbbVie. News release: AbbVie’s HUMIRA (adalimumab) receives Health Canada approval for the extension of the polyarticular juvenile idiopathic arthritis indication for patients between 2 and 4 years. FirstWord Pharma. 2015 Dec 9.
