Safety of ADA in Pediatric Polyarticular JIA, ERA

WASHINGTON, DC — There was no change in safety profile for adalimumab in pediatric patients with polyarticular juvenile idiopathic arthritis (pJIA), enthesitis-related arthritis (ERA), psoriasis (Ps), and Crohn’s disease (CD), a recent analysis showed. The research was presented at the American College of Rheumatology (ACR) 2016 Annual Meeting.

Gerd Horneff, MD, from the Asklepios Kliniken GmbH in Hamburg, Germany, and colleagues evaluated the safety data from six clinical trials as well as their open-label extension studies for patients with polyarticular juvenile idiopathic arthritis (pJIA), enthesitis-related arthritis (ERA), psoriasis (Ps), and Crohn’s disease (CD), according to the abstract. There were 577 patients included in the study with 1440.7 total patient-years (PYs).

Adverse events were recorded per 100 PY between the initial ADA dose up to 70 days after the final ADA dose. Patients with pJIA from three clinical trials (NCT00048542, NCT00775437, and NCT00690573) and patients with ERA from one clinical trial with interim 52-week data (NCT01166282) received body surface area dosing of ADA at a dose of 24 mg/m²  every other week (eow) or 20 mg eow (< 30 kg) to 40 mg eow (≥ 30 kg). 

For patients with Ps (NCT01251614), there was an initial dose of 0.4 mg/kg (up to 20 mg) or 0.8 mg/kg (up to 40 mg) at baseline followed by eow treatment.

Patients with CD received 160 mg and 80 mg open-label ADA induction therapy at baseline and 2 weeks if ≥ 40 kg, and 80 mg at baseline and 40 mg at 2 weeks if < 40 kg. After the initial therapy, CD patients received double-blind maintenance dosing at 4 weeks, which consisted of a high-dose group with a 40 mg dose eow if ≥ 40 kg or 20 mg dose eow if < 40 kg, and a high dose group with a 20 mg dose eow if ≥ 40 kg or 10 mg dose eow if < 40 kg. 

At 12 weeks, the researchers allowed dosing to control disease flare, and patients received additional weekly or eow dosing an open-label extension on the trial (NCT00686374).

Dr Horneff and colleagues found adverse events in 90% of patients across treatments, with pJIA and ERA patients reporting headaches (13.6 per 100 PY), nasopharyngitis (12.4 per 100 PY) and upper respiratory tract infections (30.2 per 100 PY). 

Patients with Ps reported a 46.9 per 100 PY for headaches, 58.4 per 100 PY rate for nasopharyngitis and 24.7 per 100 PY  for upper respiratory tract infections, while CD patients had a 23.4 per 100 PY for headaches, 15.2 per 100 PY for nasopharyngitis and 14.8 per 100 PY for upper respiratory tract infections.

Reference

Horneo G, Seyger MMB, Arikan D, Kalabic J, et al. Safety of adalimumab in pediatric patients with polyarticular juvenile idiopathic arthritis, enthesitis-related arthritis, psoriasis, and Crohn’s disease. Presented at: ACR/ARHP Annual Meeting; November 11-16, 2016; Washington D.C. Abstract #385.