Background/Purpose: Monotherapy accounts for approximately 30% of biologic disease-modifying anti-rheumatic drug (DMARD) use in RA (Emery P et al. Ann Rheum Dis 2013;72:1897-904). A validated algorithm can assess effectiveness of these drugs from claims data (Curtis JR et al. Arthritis Res Ther. 2011;13:R155). The objective of this study was to apply the algorithm to evaluate effectiveness of monotherapy in patients initiating TNFi and non-TNFi biologics.

Methods: Optum claims data (January 2009-February 2014) were analyzed. The index date was the date of the first claim for a biologic DMARD or tofacitinib after the patient was enrolled for ≥6 months. Inclusion criteria were age ≥18 years at index, RA diagnosis (ICD-9-CM 714.0x) pre-index or the first 30 days post-index, and monotherapy (no conventional DMARD for 120 days post-index). Key exclusion criteria were a previous claim for the index drug during the pre-index period, use of a biologic for a non-RA indication (eg, psoriasis), or <12 months of continuous enrollment with medical and pharmacy benefits after the index date (“post-index period”). Consistent with the validated algorithm, RA was considered effectively treated if the patient met all 6 criteria post-index: (1) high adherence (infusions per labeling or medication possession ratio ≥80% for other medications); (2) no increase in biologic dose; (3) no biologic switch; (4) no new non-biologic DMARD; (5) no new/increased oral glucocorticoid; and (6) <2 glucocorticoid injections >90 days after the index date.

Results: New monotherapy was initiated in 2,147 RA patients: IV TNFi (n=246), IV non-TNFi (n=266), SC TNFi (n=1,595), SC non-TNFi (n=36), or tofacitinib (n=4). Mean age was 52.9 years (SD, 13.4), 77.0% were female, and 81.0% were commercially insured. Achievement of all 6 effectiveness criteria was not different between new non-TNFi monotherapy and new TNFi monotherapy (20.9% vs 20.8%, p=0.947); patients initiating TNFi monotherapy were more likely to increase their index biologic dose (Table). Patients initiating IV non-TNFi monotherapy were more likely to achieve all 6 effectiveness criteria (21.4% vs 10.6%, p<0.001); patients initiating IV TNFi monotherapy were more likely to have high adherence and more likely to increase their biologic dose (Table). Small sample sizes for SC non‑TNFi or tofacitinib limited interpretation of their effectiveness.

Conclusion: Application of the claims-based algorithm considered non-TNFi monotherapy initiation to have similar (all non-TNFi) or better (IV non-TNFi) effectiveness compared with TNFi monotherapy initiation in RA.

Jonathan Latham of PharmaScribe, LLC provided medical writing assistance.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/effectiveness-of-monotherapy-in-rheumatoid-arthritis-ra-patients-initiating-a-tumor-necrosis-factor-inhibitor-tnfi-vs-a-non-tnfi-in-a-large-us-commercial-and-medicare-advantage-plan/