WASHINGTON, DC—Use of weekly adalimumab in children with juvenile idiopathic arthritis (JIA), pediatric chronic uveitis, and other childhood rheumatic diseases is safe and effective, with 90% having a positive clinical response, a retrospective chart review presented at the 2016 ACR/ARHP Annual Meeting has found.
“Minor infections were common, but serious infections requiring hospitalization were uncommon,” stated Colleen K. Correll, MD, MPH, of the department of pediatrics at the University of Minnesota in Minneapolis, MN. “Two patients on weekly adalimumab developed autoimmune disease. Adalimumab-induced autoimmunity is a recognized issue, but further studies are needed to determine if weekly dosing increases this risk in children.”
Adalimumab, on an every-other-week basis, is used to treat JIA and other pediatric rheumatic diseases, and it is “common for pediatric rheumatologists to escalate to weekly dosing to achieve better disease control when needed,” Dr. Correll, and colleagues noted.
Although “weekly adalimumab has been demonstrated to be safe and effective in several autoimmune diseases in adults, she added, “to our knowledge, there have been no studies demonstrating the safety and effectiveness of weekly adalimumab in children with rheumatic diseases.”
To assess safety and clinical responsiveness, the investigators conducted a retrospective chart review of 60 pediatric patients treated with weekly adalimumab at the University of Minnesota or Gillette Children’s Hospital. They collected demographic and clinical data and performed a basic descriptive analysis.
Of the patients, 38 (63%) were female. Mean age at diagnosis was 7.7 years; mean age at start of adalimumab treatment was 13.28 years and, at initiation of weekly dosing, 13.93 years.
Weekly adalimumab was used most commonly to treat uveitis (17 patients, or 28.3%) and rheumatoid factor (RF)-negative polyarticular JIA (15; 25%). Other diagnoses were persistent oligoarticular JIA (10; 16.7%), enthesitis-related JIA (9; 15.0%), psoriatic arthritis (9; 15.0%), “other” (9; 15%), systemic JIA (3; 5%), RF-positive polyarticular JIA (2; 3.3%), and arthritis associated with inflammatory bowel disease (1; 1.7%).
Most of the patients were on concomitant methotrexate (50 patients; 83.3%) or a nonsteroidal anti-inflammatory drug (NSAID; 40 patients, or 66.7%). Other concurrent medications included oral prednisone (28 patients, or 46.7%), hydroxychloroquine (8; 13.3%), leflunomide (7; 11.7%), sulfasalazine (6; 10%), mycophenolate (4; 6.7%), cyclosporine (3; 5%), azathioprine (2; 3.3%), intravenous methylprednisolone (2; 3.3%), rituximab (2; 3.3%), abatacept (1; 1.7%), and intravenous immunoglobulin (1; 1.7%).
“Most children dislike the pain associated with adalimumab injections, and, thus, the common practice at our clinics is to stop weekly dosing by 3 months if it is not helpful in treating the disease,” Dr. Correll noted. “Therefore, for this chart review, if the patient continued the weekly dosing for at least 3 months, we determined they had a positive clinical response.”
Based on that criterion, 53 of 59 patients (93%) were determined to have a positive clinical response, with 1 patient lost to follow-up prior to the 3-month assessment.
A total of 3 patients (5%) had an infection requiring hospitalization: viral pharyngitis and Behcet’ s flare, acute appendicitis, and sepsis, the latter of which was concurrently taking an NSAID, methotrexate, and cyclosporine for treatment of chronic uveitis with JIA.
Adverse events noted while patients were on weekly adalimumab were infection not requiring antimicrobials (24 patients, 40%), injection site reaction (4; 6.7%), transaminitis (2; 3.3%, with 1 case thought to be secondary to adalimumab), and 1 case (1.7%) of leukopenia and 3 cases (5%) of anemia that were not thought to be secondary to adalimumab.
A total of 24 patients (40%) had infections that required antimicrobials, with some having more than one type of infection. These were sinusitis (11 patients, 18.3%), pharyngitis/tonsillitis (9; 15%), ear infection (8; 13.3%), respiratory infection/pneumonia (4; 6.7%), cellulitis (1; 1.7%), abscess (1; 1.7%), shingles (1; 1.7%), and “other” (7; 11.7%).
Two patients developed autoimmune diseases, multiple sclerosis and autoimmune hepatitis. There were no cases of thrombocytopenia or malignancies, or deaths.