Secukinumab (Cosentyx) was approved by the U.S. Food and Drug Administration (FDA) earlier this week for the treatment of adults with active ankylosing spondylitis (AS) and active psoriatic arthritis (PsA).1
Secukinumab was initially FDA approved in 2015 to treat adult patients with moderate to severe plaque psoriasis. Secukinumab is a human IgG1 monoclonal antibody that selectively binds to the interleukin-17A (IL-17A) cytokine and inhibits its interaction with the IL-17 receptor. It is administered as a subcutaneous injection.
These two new approvals are based on the safety and efficacy outcomes from four placebo-controlled Phase 3 trials in more than 1,500 adults with AS or PsA. Patients were either biologic treatment-naive or had an inadequate response or were intolerant to anti-tumor necrosis factor alpha (TNF-α) therapies. Primary study endpoints in these trials were achieving statistically significant improvements (vs. placebo) in the signs and symptoms of PsA and AS, measured by a 20% reduction in the American College of Rheumatology (ACR 20) response criteria at Week 24, and by at least a 20% improvement in the Assessment of Spondyloarthritis International Society criteria (ASAS 20) at Week 16, respectively.
More than 9,600 patients used secukinumab in the clinical trial programs for many uses, with more than 15,000 psoriasis patients treated post-marketing. No new safety signals have been identified. The most common adverse reactions in clinical trials were diarrhea, nasopharyngitis and upper respiratory tract infection.2
Cosentyx is available as a 150 mg/mL solution for injection in a single-use Sensoready pen, as 150 mg/mL solution for injection in a single-use prefilled syringe and as 150 mg in a lyophilized powder for injection in a single-use vial for reconstitution for healthcare professional use only.
Dosing Recommendations
AS: With a loading dose, administer 150 mg SC at Weeks 0, 1, 2, 3 and 4, and every four weeks thereafter. Without a loading dose, administer 150 mg subcutaneously every four weeks.
PsA: With concomitant moderate to severe plaque psoriasis, administer 300 mg subcutaneously at Weeks 0, 1, 2, 3 and 4, and then 300 mg every four weeks thereafter (the plaque psoriasis dosing). For some patients, a lower dose of 150 mg may be acceptable.
PsA (other): Secukinumab may be administered with or without a loading dosage. With a loading dose, administer 150 mg subcutaneously at Weeks 0, 1, 2, 3 and 4, and every four weeks thereafter. Without a loading dose, administer 150 mg subcutaneously every four weeks. If PsA persists, consider using the higher dosage of 300 mg.
Secukinumab (Cosentyx) is to be used under the guidance and supervision of a physician. When deemed appropriate after proper training in subcutaneously injection technique, patients may self-administer using the Sensoready pen or prefilled syringe. The lyophilized powder is for healthcare provider use only. The drug should be administered at a different anatomic location (such as upper arms, thighs or any quadrant of the abdomen) than the previous injection and not into areas where the skin is tender, bruised, erythematous, indurated or affected by psoriasis.
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
- Novartis receives two new FDA approvals for Cosentyx to treat patients with ankylosing spondylitis and psoriatic arthritis in the US. Novartis press release. 2016 Jan 15.
- Cosentyx (secukinumab) product labeling. Novartis. Updated January 2016.
