Changes in Patient Reported Pain Measures With the Citrate-free Adalimumab Formulation in Pediatric Inflammatory...

Area of Science:

• Pediatric Gastroenterology
• Immunology
• Pain Management

Background:

• Inflammatory bowel diseases (IBD) involve chronic gastrointestinal inflammation.
• Pain perception in children is multifactorial, influenced by psychological and developmental factors.
• Pain and injection-site reactions are key predictors of nonadherence to antitumor necrosis factor (TNF) therapies, with injection-site reactions being a common adalimumab adverse event.

Purpose of the Study:

• To compare injection-site pain in pediatric IBD patients treated with original versus citrate-free adalimumab formulations.
• To test the hypothesis that the citrate-free formulation results in significantly less injection-site pain.

Main Methods:

• A comparative study involving pediatric IBD patients aged 6–17 years.
• Utilized the Faces Pain Scale-Revised (FPS-R) to assess injection-site pain.
• Statistical analysis included the McNemar's test to compare pain scores between formulations.

Main Results:

• Ninety-five percent of patients reported pain scores greater than 3 with the original adalimumab formulation.
• Only 5% of patients reported pain scores greater than 3 with the citrate-free formulation.
• The McNemar's test indicated a statistically significant difference in pain scores (P < 0.0001) between the two formulations.

Conclusions:

• The citrate-free adalimumab formulation significantly reduces injection-site pain compared to the original formulation in pediatric IBD patients.
• This reduction in pain may enhance patient comfort and potentially improve treatment adherence.
• The findings support the use of citrate-free formulations to mitigate adverse events in pediatric IBD management.