Background/Purpose: Injection Site Reaction (ISRs) are associated with the subcutaneous (SC) route of administration of all biologic agents, and 3% to 15% of patients reports it. ISRs include pain, itching, redness, swelling or a combination of any of those. Rhumadata® has collected the intensity of pain associated with SC injections. We report here the results and compare levels of pain across agents.

Methods: As part of the patient reported outcomes (PROs), one question on pain intensity was asked to patients exposed to SC methotrexate or a biologic agent administered with a device or a syringe. The same question was asked at all visits making multiple answers available for the same patient. The intensity of pain was described using the following scale: 1- none, 2- negligible, 3- mild, 4- moderate, 5- severe, 6- extremely severe and 7- intolerable. Pain levels associated with adalimumab (ADA), etanercept (ETA), certolizumab (CERTO), golimumab (GOLI), denosumab (DEN), abatacept (ABA), tocilizumab (TOCI) and methotrexate (MTX) are presented.

Results: A total of 12,843 injection pain assessments were extracted. 7,347, 2,117 and 3,319 were performed on patients with rheumatoid arthritis (RA), ankylosing spondylitis (AS) and psoriatic arthritis (PsA) respectively. Women represented 76%, 44% and 50% of these cohorts. Mean ages at treatment initiation were 53.0(SD=12.1), 41.6(12.4) and 48.7(11.6). Severe, very severe or intolerable pain was reported for 3.12%, 9.23% and 6.21% of SC injections performed on patients with RA, AS and PsA respectively. Multivariate logistic regression showed that women (OR=2.09, 95% CI=[1.42, 3.08]) were more likely to report severe, very severe or intolerable pain than men, as were patients with longer disease duration (OR=1.04, 95% CI=[1.02, 1.06]). Patients diagnosed later (Age at diagnosis OR=0.98, 95% CI=[0.97, 1.00]) were less likely to report high levels of pain. Subjects treated with ADA (OR=6.31, 95% CI=[3.13, 12.72]) and ETA (OR=4.37, 95% CI=[2.42, 7.90]) were more likely to report more pain than patients using MTX. Patients using CERTO (OR=0.26, 95% CI=[0.12, 0.54]) and GOLI (OR=0.11, 95% CI=[0.06, 0.23]) were less likely to report severe, very severe and intolerable pain than patients injected with ADA. Primary diagnosis (RA, AS and PsA) are similarly associated with reported pain levels. Stopping MTX or bDMARD treatment for an ISR-pain is extremely rare.

Conclusion: The intensity of pain associated with subcutaneous route of administration varies with gender, age (age at diagnosis and disease duration at injection) and administered medication.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/injection-site-reaction-associated-with-subcutaneous-biologic-agents-and-methotrexate-analysis-from-the-rhumadata-clinical-database-and-registry/