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Abstract Number: 392

Safety and Clinical Response of Weekly Adalimumab in the Treatment of Juvenile Idiopathic Arthritis, Pediatric Chronic Uveitis and Other Childhood Rheumatic Diseases

Colleen K. Correll1, Danielle R. Bullock1, Rachel Cafferty1 and Richard K Vehe2, 1Pediatrics, University of Minnesota, Minneapolis, MN, 2University of Minnesota Masonic Children’s Hospital, Minneapolis, MN

Meeting: 2016 ACR/ARHP Annual Meeting

Date of first publication: September 28, 2016

Keywords: Adalimumab, juvenile idiopathic arthritis (JIA), Pediatric rheumatology, safety and uveitis

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Session Information

Date: Sunday, November 13, 2016

Title: Pediatric Rheumatology – Clinical and Therapeutic Aspects - Poster I: Juvenile Idiopathic Arthritis, Uveitis

Session Type: ACR Poster Session A

Session Time: 9:00AM-11:00AM

Background/Purpose: Every other week adalimumab is used to treat juvenile idiopathic arthritis (JIA) and other pediatric rheumatic diseases. It is common for pediatric rheumatologists to escalate to weekly dosing to achieve better disease control when needed. Weekly adalimumab has been demonstrated to be safe and effective in several autoimmune diseases in adults; however, to our knowledge, there have been no studies demonstrating the safety and effectiveness of weekly adalimumab in children with rheumatic diseases. We conducted a retrospective chart review of pediatric patients on weekly adalimumab to assess safety and clinical responsiveness.

Methods: Sixty-nine patients at the University of Minnesota or Gillette Children’s Hospital were identified as treated with weekly adalimumab. Sixty (87%) were eligible for the chart review. Demographic and clinical data were collected. Basic descriptive analysis was performed to assess for adverse events and clinical response to weekly adalimumab.

Results: Sixty-three percent (38/60) of patients on weekly adalimumab were females, and the mean age at initiation of weekly dosing was ~14 years. Weekly adalimumab was used most commonly to treat uveitis and rheumatoid factor-negative polyarticular JIA. Most of the patients were also on a nonsteroidal anti-inflammatory drug (NSAID) and methotrexate (Table 1). Only three patients (5%) had an infection requiring hospitalization. One patient with sepsis was concurrently taking an NSAID, methotrexate, and cyclosporine for treatment of chronic uveitis with JIA. Two patients (3%) developed autoimmune disease (Table 2). Most children dislike the pain associated with adalimumab injections, and, thus, the common practice at our clinics is to stop weekly dosing by three months if it is not helpful in treating the disease. Therefore, for this chart review, if the patient continued the weekly dosing for at least three months we determined they had a positive clinical response. Ninety-percent (53/59) of patients were determined to have a positive clinical response. One patient was lost to follow-up prior to the three month point.

Conclusion: The use of weekly adalimumab in children in our centers was determined to be safe and effective. Ninety-percent of patients had a positive clinical response. Minor infections were common, but serious infections requiring hospitalization were uncommon. 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.

Table 1. Characteristics of patients on weekly adalimumab
Characteristics N (%)
   Male 22 (36.7)
   Age (in years) at diagnosis (mean ±SD) 7.7 (5.3)
   Age (in years) at start of adalimumab (mean ±SD) 13.28 (4.9)
   Age (in years) at start of weekly adalimumab (mean ±SD) 13.93 (4.78)
   Positive clinical response to weekly adalimumab* 53 (90)
Diagnosis
   Oligoarticular JIA, persistent 10 (16.7)
   Oligoarticular JIA, extended 0 (0)
   RF-positive polyarticular JIA 2 (3.3)
   RF-negative polyarticular JIA 15 (25.0)
   Enthesitis-related JIA 9 (15.0)
   Arthritis associated with IBD 1 (1.7)
   Psoriatic arthritis 9 (15.0)
   Systemic JIA 3 (5.0)
   Uveitis 17 (28.3)
   Other 9 (15.0)
Concurrent Medications
   NSAID 40 (66.7)
   Methotrexate 50 (83.3)
   Oral prednisone 28 (46.7)
   Hydroxychloroquine 8 (13.3)
   Leflunomide 7 (11.7)
   Sulfasalazine 6 (10.0)
   Mycophenolate 4 (6.7)
   Cyclosporine 3 (5.0)
   Azathioprine 2 (3.3)
   Intravenous methylprednisolone 2 (3.3)
   Rituximab 2 (3.3)
   Abatacept 1 (1.7)
   Intravenous immunoglobulin 1 (1.7)

*Positive clinical response defined as being on weekly dosing for at least three months JIA=juvenile idiopathic arthritis, RF=rheumatoid factor, IBD=inflammatory bowel disease, NSAID=nonsteroidal anti-inflammatory drug  

Table 2. Adverse events while patient was on weekly adalimumab
Adverse event N (%)
Infection not requiring antimicrobials 24 (40.0)
Infection requiring antimicrobials* 24 (40.0)
       Sinusitis 11 (18.3)
       Pharyngitis/tonsillitis 9 (15.0)
       Ear infection 8 (13.3)
       Respiratory infection/pneumonia 4 (6.7)
       Cellulitis 1 (1.7)
       Abscess 1 (1.7)
       Shingles 1 (1.7)
       Other 7 (11.7)
Infection requiring hospitalization 3 (5)
       Viral pharyngitis and Behcet’s flare 1 (1.7)
       Sepsis 1 (1.7)
       Acute appendicitis 1 (1.7)
Injection site reaction 4 (6.7)
Transaminitis† 2 (3.3)
Leukopenia‡ 1 (1.7)
Anemia‡ 3 (5)
Thrombocytopenia 0 (0)
Other autoimmune disease 2 (3.3)
     Multiple sclerosis 1 (1.7)
     Autoimmune hepatitis 1 (1.7)
Malignancy 0 (0)
Death 0 (0)

*Some patients had more than one type of infection, †One case thought to be secondary to adalimumab, ‡Not thought to be secondary to adalimumab  


Disclosure: C. K. Correll, None; D. R. Bullock, None; R. Cafferty, None; R. K. Vehe, Pfizer Inc, 2,BMS, 3.

To cite this abstract in AMA style:

Correll CK, Bullock DR, Cafferty R, Vehe RK. Safety and Clinical Response of Weekly Adalimumab in the Treatment of Juvenile Idiopathic Arthritis, Pediatric Chronic Uveitis and Other Childhood Rheumatic Diseases [abstract]. Arthritis Rheumatol. 2016; 68 (suppl 10). https://acrabstracts.org/abstract/safety-and-clinical-response-of-weekly-adalimumab-in-the-treatment-of-juvenile-idiopathic-arthritis-pediatric-chronic-uveitis-and-other-childhood-rheumatic-diseases/. Accessed .
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