Pfizer’s Xeljanz approved in psoriatic arthritis
Pfizer’s Xeljanz pill has been approved in the US in psoriatic arthritis, for people who have not responded to, or cannot take, other disease-modifying drugs.
Xeljanz has been FDA-approved since 2012 for rheumatoid arthritis as a twice-daily pill, and since last year in a daily formulation.
Now it has been approved in the related disease psoriatic arthritis, where patients whose immune system is already overactive and causing psoriasis, begins to attack the joints, causing swelling and difficulty with movement.
Xeljanz is the first janus kinase (JAK) inhibitor class drug approved in psoriatic arthritis, although there are competitors from other classes approved in the indication.
These include Celgene’s Otezla (apremilast), which like Xeljanz offers a convenient oral alternative to injected drugs such as AbbVie’s Humira (adalimumab).
Xeljanz has been approved in psoriatic arthritis in either the daily extended release, or twice daily form.
In both formulations Xeljanz is to be taken in combination with nonbiologic disease-modifying antirheumatic drugs (DMARDs), and use in combination with biologic DMARDs or with potent immunosuppressants such as azathioprine and cyclosporine is not recommended.
The FDA approval of Xeljanz for the treatment of adult patients with active PsA was based on data from the phase 3 OPAL clinical development programme, which consisted of two pivotal studies, OPAL Broaden and OPAL Beyond, as well as available data from an ongoing long-term extension trial, OPAL Balance.
Both pivotal studies met their two primary efficacy endpoints, demonstrating statistically significant improvements in American College of Rheumatology 20 (ACR20) response and change from baseline in the Health Assessment Questionnaire –Disability Index (HAQ-DI) score at three months in patients receiving Xeljanz 5 mg twice daily treatment in combination with a nonbiologic DMARD, compared to those treated with placebo.
Randy Beranek, president and CEO of the US-based National Psoriasis Foundation, said: “Psoriatic arthritis is a serious and debilitating chronic illness that should be diagnosed and treated early.
“As an organisation that advocates for people living with psoriatic arthritis, we welcome the availability of new therapies for treating this disease.”
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