Background/Purpose: Intra-articular triamcinolone hexacetonide (TH) historically provided longer-lasting control of chronic arthritis in children than comparator intra-articular glucocorticoid preparations such as triamcinolone acetonide (TA) (J Rheumatol. 2012; 39:374). Prior to 2015, pediatric rheumatologists in the U.S. commonly injected joints with TH to control oligoarticular disease or to provide adjunctive therapy to systemic treatment with methotrexate and/or biologics for polyarticular disease. Since 2015, however, TH is no longer produced or marketed in the U.S. The lack of availability of TH in the past 3 years has required use of the less-effective TA or escalation of systemic therapy. In May 2017, we were able to identify a compounding pharmacist (DB) who could produce compounded TH (cTH). We sought to determine if there was a difference in time to recurrence of swelling in joints injected with cTH versus TA.

Methods: cTH 20mg/ml is prepared with TH, USP powder, sorbitol solution 70% USP, polysorbate 80 NF, benzyl alcohol NF and sterile water for injection, USP. Testing is done as per USP 797 guidelines for sterility, potency and fungal testing. Stability testing done by Compounder’s International Analytical Laboratory, and a 90 day beyond use date is established. cTH is ordered as a patient specific prescription and requires lead time for preparation and quality testing. Use of cTH caused some unique barriers. Our Pharmacy had to vet the compounding pharmacy to assure it met FDA rules and USP 797 standards for compounding sterile products. Insurance reimbursement is not consistently approved for compounded products, and reimbursement strategies had to be established. Our pharmacy created a memo to ensure injections of cTH could be performed throughout our organization. We report results of one year of using cTH in children. Demographic information, diagnoses, and prior injection data are summarized. Side effects, including steroid atrophy, are reported.

Results: 82 joints with chronic arthritis were injected with cTH from 5/2017 to 5/2018. 39 joints were injected with TA from 2/2016 to 5/2018. Flares occurred in 16 of 82 cTH joints (20%) versus 28 of 39 TA joints (72%) (p<0.001). There was no difference in time to flare from injection date with either cTH or TA for those individuals who had recurrence of joint swelling. There were no injection site reactions, bleeding, or infections with either cTH or TA. Atrophy was rare in each group.

Conclusion: cTH was effective in managing arthritis in children. Results were similar to that reported in the literature with fewer flares using cTH. We conclude that use of cTH is a viable approach to counter the lack of commercially available TH intra-articular glucocorticoid in the USA for pediatric arthritis patients.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/resurrecting-triamcinolone-hexacetonide-the-steroid-formerly-known-as-aristospan-efficacy-and-safety-of-a-compounded-preparation-of-triamcinolone-hexacetonide-for-intra-articular-injection-in/