PMID- 37728695 OWN - NLM STAT- MEDLINE DCOM- 20231127 LR - 20240429 IS - 1865-8652 (Electronic) IS - 0741-238X (Print) IS - 0741-238X (Linking) VI - 40 IP - 11 DP - 2023 Nov TI - Corticosteroid Use and Adherence in Patients Treated with Acthar Gel for Advanced Sarcoidosis. PG - 4999-5015 LID - 10.1007/s12325-023-02630-x [doi] AB - INTRODUCTION: Long-term corticosteroid use in immune-mediated diseases is associated with increased risk of adverse events (AEs) and worsened health-related quality of life (HRQoL). Previous studies report chronic high-dose corticosteroid therapy results in higher rates of healthcare resource use and AE-related medical costs. Recent studies suggest Acthar((R)) Gel (repository corticotropin injection) is an effective steroid-sparing therapy for sarcoidosis. This study compares the corticosteroid-sparing effect between Acthar Gel and comparators and evaluates the impact of Acthar Gel adherence on reduction of corticosteroid burden. METHODS: A retrospective analysis of a large administrative pharmacy and medical claims database (Symphony Health Solutions) was conducted. Patients were included with confirmed ICD-9/10 diagnosis for sarcoidosis in the study period (2014-2020), followed by >/= 2 Acthar Gel claims or comparators (janus kinase inhibitor (JAKi)/rituximab), >/= 18 years old, with 12 months coverage pre/post index. Outcomes were compared as change from baseline. Acthar Gel adherence was determined by proportion of days covered in the follow-up period. RESULTS: The Acthar Gel (n = 735) and comparator (n = 626) cohorts were mostly female (68-72%) between 55 and 58 years old. Compared to the comparator cohort at baseline, Acthar Gel patients had greater any corticosteroid use (80% vs. 56%, p < 0.001), extended use (61% vs. 32%, p < 0.001), and mean average daily dose (6.72 vs. 3.03, p < 0.001). After treatment, Acthar Gel patients had greater reduction from baseline in any corticosteroid use (- 9.0% vs. - 3.2%) and extended use (- 10.0% vs. - 3.0%). In the Acthar Gel adherence cohorts, patients with above average adherence had greater reduction in both measures (- 11.2% vs. - 6.1%; - 11.6% vs. - 7.6%, respectively) than patients with below average adherence. Acthar Gel patients had greater reduction of extended use at all dose levels. CONCLUSION: Acthar Gel is associated with reductions in corticosteroid use compared to alternatives. Better adherence is associated with greater reduction in corticosteroid exposure. Key Summary Points. CI - (c) 2023. The Author(s). FAU - Hayes, Kyle AU - Hayes K AUID- ORCID: 0000-0001-8203-4738 AD - Mallinckrodt Pharmaceuticals, Bridgewater, NJ, USA. FAU - Niewoehner, John AU - Niewoehner J AUID- ORCID: 0000-0001-7989-3187 AD - Mallinckrodt Pharmaceuticals, Bridgewater, NJ, USA. FAU - Rice, J Bradford AU - Rice JB AUID- ORCID: 0009-0004-9276-9710 AD - Analysis Group Inc., 111 Huntington Avenue, 14th Floor, Boston, MA, 02199, USA. FAU - Downes, Nathaniel AU - Downes N AUID- ORCID: 0009-0003-4846-5229 AD - Analysis Group Inc., 111 Huntington Avenue, 14th Floor, Boston, MA, 02199, USA. nathaniel.downes@analysisgroup.com. FAU - Hagopian, Ella AU - Hagopian E AUID- ORCID: 0000-0003-0506-7004 AD - Analysis Group Inc., 111 Huntington Avenue, 14th Floor, Boston, MA, 02199, USA. FAU - Ma, Izzy AU - Ma I AUID- ORCID: 0009-0009-6179-8494 AD - Analysis Group Inc., 111 Huntington Avenue, 14th Floor, Boston, MA, 02199, USA. FAU - Wan, George J AU - Wan GJ AUID- ORCID: 0000-0002-1140-740X AD - Mallinckrodt Pharmaceuticals, Bridgewater, NJ, USA. LA - eng PT - Journal Article PT - Research Support, Non-U.S. Gov't DEP - 20230920 PL - United States TA - Adv Ther JT - Advances in therapy JID - 8611864 RN - 9002-60-2 (Adrenocorticotropic Hormone) RN - 0 (Adrenal Cortex Hormones) MH - Humans MH - Female MH - Adolescent MH - Middle Aged MH - Male MH - Retrospective Studies MH - *Quality of Life MH - *Sarcoidosis/drug therapy MH - Adrenocorticotropic Hormone MH - Adrenal Cortex Hormones/therapeutic use PMC - PMC10567815 OAB - Patients who use corticosteroids long term for advanced sarcoidosis often suffer from negative health effects. This project aimed to evaluate whether Acthar((R)) Gel (repository corticotropin injection) use led to reduced corticosteroid use and whether higher adherence to Acthar Gel led to further reduction in corticosteroid use. Pharmacy and medical claims data were used to identify patients who fit certain criteria: the Acthar Gel cohort included patients with sarcoidosis who used Acthar Gel and the comparator cohort included patients with sarcoidosis who used janus kinase (JAK) inhibitors or rituximab. The Acthar Gel cohort was split into high adherence and low adherence. The Acthar Gel cohort was found to have higher corticosteroid use than the comparator group in the baseline period before initiating Acthar Gel or a comparator therapy. After initiating treatment, Acthar Gel patients had a larger reduction in corticosteroid use according to a variety of metrics including number of corticosteroid fills and extended use fills. Furthermore, when comparing those with high Acthar Gel adherence and those with low Acthar Gel adherence, the patients with above average adherence had a larger reduction in the number of corticosteroid fills and extended use fills than patients with below average adherence to Acthar Gel. Patients who use Acthar Gel and more regularly tended to use corticosteroids less, which may allow them to avoid the negative health effects from long-term, high-dosage corticosteroid use. This finding may help providers and health plans evaluate situations in which Acthar Gel treatment may be beneficial to improve patient outcomes. OABL- eng OTO - NOTNLM OT - Acthar(R) Gel OT - Corticosteroid burden OT - Repository corticotropin injection OT - Sarcoidosis COIS- Kyle Hayes, John Niewoehner, and George J. Wan are employees of Mallinckrodt Pharmaceuticals, which provided research funding to Analysis Group (employer of J. Bradford Rice, Nathaniel Downes, Ella Hagopian, and Izzy Ma). EDAT- 2023/09/20 12:52 MHDA- 2023/11/27 12:44 PMCR- 2023/09/20 CRDT- 2023/09/20 11:14 PHST- 2023/06/02 00:00 [received] PHST- 2023/07/27 00:00 [accepted] PHST- 2023/11/27 12:44 [medline] PHST- 2023/09/20 12:52 [pubmed] PHST- 2023/09/20 11:14 [entrez] PHST- 2023/09/20 00:00 [pmc-release] AID - 10.1007/s12325-023-02630-x [pii] AID - 2630 [pii] AID - 10.1007/s12325-023-02630-x [doi] PST - ppublish SO - Adv Ther. 2023 Nov;40(11):4999-5015. doi: 10.1007/s12325-023-02630-x. Epub 2023 Sep 20.