Background/Purpose: Up to 37% of patients prescribed adalimumab (AD) report significant injection-site pain (Registered Prescribing Information, 2016). For AD to be a stable pre-filled product, the pH is 5.2, which contributes to injection-site discomfort. Injection site pain is a major factor in patient willingness to initiate/continue AD. Literature reports less injection-site pain with older age, smaller volume, and use of autoinjectors. In 2008, we also reported that addition of lidocaine (LID) decreased discomfort by 80% and improved acceptance of AD. Incompatibility is not reported between AD and LID. AD and LID were combined at room temperature; no precipitation occurred. In our practice, when initiating AD, patients are offered the option of adding 0.2 ml of LID to AD.

To better understand the impact of LID added to AD, we evaluated two groups of JIA patients: those who used AD with LID, compared to those who did not. Our aim was to understand characteristics of the groups and to identify patients who might benefit by adding LID. We also sought to assess differences in disease control and adverse events that might occur when adding LID

Methods: Chart review of AD-treated JIA patients was performed. Age when instituting AD, sex, diagnoses, ESR, joint counts, and adverse events were reviewed. Results were compared between LID users (LID+) and non-users (LID-). Chi Square, T-Test and Z-score statistics assessed differences between groups.

Results: 98 JIA patients treated with AD from 2008 to May 2017 were included; 71 patients added LID, whereas 27 did not. JIA subtypes were: 28 ERA, 17 poly, 26 oligo, 23 psoriatic, 1 undifferentiated, 3 systemic; uveitis was present in 19 patients. No differences in LID use by diagnosis were found. Fewer males than females added LID (56% versus 78%)( p = 0.036). Mean age when AD was instituted and duration of use was similar: 12.2 years of age in LID+ group and 12.7 years in LID- group; AD taken for 16.2 mos ±14.2 in the LID- group and taken for 20.9 ± 20.6 mos in the LID+ group (both age and duration NS). JIA patients ≤ 10 yo did not add LID more often than those ≥ 11 yo. Further analysis by age showed that 91% of early adolescents aged 10-14 years added LID, compared to 59% children aged 1-9 years and 50% teens ≥15 years (p=0.002). In the LID+ group, joint counts and ESR improved significantly after taking AD (p =0.002 and p< 0.00001, respectively), but no improvement was seen in either metric in the LID- group. 11% of the total population reported mild adverse events. One patient in LID- group discontinued AD due to injection site pain.

Conclusion: In our cohort, adding LID to AD was preferred more by female and early adolescent patients. Adding LID produced no increased adverse events and did not impede response to AD, as shown by improved joint count/ESR in the LID+ group after starting AD. Interestingly, the LID- group demonstrated no such improvement. This may reflect non-adherence to AD in the latter group possibly due to painful injections and will need further study. Our previous work showed AD plus LID produced less injection-site pain; hence patients continued this treatment. We conclude that it is safe to add LID to AD and certain JIA patients prefer this addition, possibly with improved adherence and better disease control.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/adalimumab-therapy-in-juvenile-idiopathic-arthritis-addition-of-lidocaine-for-prevention-of-injection-site-pain-or-not-that-is-the-question-a-comparison-study/