Secukinumab Approved for Pediatric Patients With ERA, PsA

The FDA has approved secukinumab (Cosentyx from Novartis) for children and adolescents with enthesitis-related arthritis (ERA) and psoriatic arthritis (PsA).

The decision is based on results of the phase 3 JUNIPERA trial, which found the treatment yielded reduced flare risk in this patient population compared with placebo. Over 2 years, researchers also observed improved disease activity in patients treated with secukinumab, while safety was consistent with the treatment’s known profile among those with plaque psoriasis, PsA, non-radiographic axial spondyloarthritis, and ankylosing spondylitis.

The 2-year randomized withdrawal trial enrolled 86 pediatric patients aged 2 to 17 diagnosed with ERA or juvenile PsA (JPsA). Both ERA and JPsA are characterized by joint swelling, while, if left untreated, the conditions can lead to high levels of pain and disability.

Secukinumab can now be administered to patients with ERA aged 4 years and older or patients with PsA who are at least 2 years old. The approved dosing, administered via a subcutaneous injection every 4 weeks following loading doses, is 75 mg (body weight: 15 kg to < 50 kg) or 150 mg (≥ 50 kg). With correct guidance from a health care provider, it can be administered outside a provider’s office by an adult caregiver.

The treatment now has a total of 5 indications, and the latest approval means it is the first biologic indicated for ERA. It is also the only treatment approved for both ERA and PsA in pediatric US patients. Earlier this year, secukinumab was approved as a first-line treatment for pediatric psoriasis.

Secukinumab, a fully human biologic, functions by inhibiting interleukin-17A.

The primary end point of JUNIPERA was time to flare in treatment period 2 (week 12 to 104). Investigators found:

• Patients with active JPsA (n = 34; mean age: 12.2 years) treated with secukinumab had a significantly longer time to flare, showing an 85% reduction in the risk of flare (P < .001) vs placebo
• Patients with active ERA (n = 52; mean age: 13.7 years) treated with secukinumab had a longer time to flare, showing a 53% reduction in the risk of flare vs placebo

“The symptoms of PsA and ERA can be debilitating for children and adolescents living with these chronic conditions, impacting their daily lives," Tiffany Westrich-Robertson, CEO, International Foundation for Autoimmune & Autoinflammatory Arthritis, said in a statement. "It is encouraging to see an additional treatment option for these underserved patient populations."

Patients taking secukinumab can experience new cases of inflammatory bowel disease and serious allergic reactions.