title: Evaluation of Real-World Experience with Tofacitinib Compared with Adalimumab, Etanercept, and Abatacept in RA Patients with 1 Previous Biologic DMARD: Data from a U.S. Administrative Claims Database.
abstract: BACKGROUND
  Real-world data comparing tofacitinib with biologic disease-modifying antirheumatic drugs (bDMARDs) are limited.
  
  
  OBJECTIVE
  To compare characteristics, treatment patterns, and costs of patients with rheumatoid arthritis (RA) receiving tofacitinib versus the most common bDMARDs (adalimumab [ADA], etanercept [ETN], and abatacept [ABA]) following a single bDMARD in a U.S. administrative claims database.
  
  
  METHODS
  This study was a retrospective cohort analysis of patients aged ≥ 18 years with an RA diagnosis (ICD-9-CM codes 714.0x-714.4x; 714.81) and 1 previous bDMARD filling ≥ 1 tofacitinib or bDMARD claim in the Truven MarketScan Commercial and Medicare Supplemental claims databases (November 1, 2012-October 31, 2014). Monotherapy was defined as absence of conventional synthetic DMARDs within 90 days post-index. Persistence was evaluated using a 60-day gap. Adherence was assessed using proportion of days covered (PDC). RA-related total, pharmacy, and medical costs were evaluated in the 12-month pre- and post-index periods. Treatment patterns and costs were adjusted using linear models including a common set of clinically relevant variables of interest (e.g., previous RA treatments), which were assessed separately using t-tests and chi-squared tests.
  
  
  RESULTS
  Overall, 392 patients initiated tofacitinib; 178 patients initiated ADA; 118 patients initiated ETN; and 191 patients initiated ABA. Tofacitinib patients were older versus ADA patients (P = 0.0153) and had a lower proportion of Medicare supplemental patients versus ABA patients (P = 0.0095). Twelve-month pre-index bDMARD use was greater in tofacitinib patients (77.6%) versus bDMARD cohorts (47.6%-59.6%). Tofacitinib patients had greater 12-month pre-index RA-related total costs versus bDMARD cohorts (all P < 0.0001) and greatest index use of monotherapy (P = 0.0080 vs. ABA). A similar (all P > 0.10) proportion of patients were persistent with tofacitinib (42.6%) versus ADA (37.6%), ETN (42.4%), and ABA (43.5%). Mean PDC was 0.55 for tofacitinib versus 0.57 (ADA), 0.59 (ETN), and 0.44 (ABA; P = 0.0003). Adjusted analyses generated similar findings to the unadjusted treatment patterns. Tofacitinib had lower adjusted 12-month post-index mean RA-related total costs ($23,568) versus ADA ($29,278; P < 0.0001), ETN ($26,885; P = 0.0248), and ABA ($30,477; P < 0.0001).
  
  
  CONCLUSIONS
  In this study, tofacitinib was more commonly used as monotherapy and yielded at least comparable persistence and adherence with lower adjusted mean RA-related total costs versus ADA, ETN, and ABA. Further analysis is warranted given the greater 12-month pre-index bDMARD use and RA-related costs for tofacitinib versus bDMARDs.
  
  
  BACKGROUND
  This study was sponsored by Pfizer. Harnett, Gerber, Gruben, Koenig, and Chen are employees and shareholders of Pfizer. Some data reported in this manuscript have been previously presented at the Academy of Managed Care Nexus 2015; Orlando, Florida; October 26-29, 2015, and was submitted in abstract form to the European League Against Rheumatism Congress; London, United Kingdom; June 8-11, 2016. All authors were involved in the conception and design of this study. Harnett and Gruben were involved in data collection and analysis. All authors interpreted the data, critically reviewed and revised the manuscript, and read and approved the final manuscript.
authors.affiliation: 1 Pfizer, New York, New York.
authors.forename: James
authors.initials: J
authors.lastname: Harnett
authors.affiliation: 2 Pfizer, Groton, Connecticut.
authors.forename: Robert
authors.initials: R
authors.lastname: Gerber
authors.affiliation: 2 Pfizer, Groton, Connecticut.
authors.forename: David
authors.initials: D
authors.lastname: Gruben
authors.affiliation: 3 Pfizer, Collegeville, Pennsylvania.
authors.forename: Andrew S
authors.initials: AS
authors.lastname: Koenig
authors.affiliation: 1 Pfizer, New York, New York.
authors.forename: Connie
authors.initials: C
authors.lastname: Chen
mesh_terms: D000069594:Abatacept / Q000008:administration & dosage* / Q000191:economics; D000068879:Adalimumab / Q000008:administration & dosage* / Q000191:economics; D000328:Adult; D000368:Aged; D018501:Antirheumatic Agents / Q000008:administration & dosage* / Q000191:economics; D001172:Arthritis, Rheumatoid / Q000188:drug therapy* / Q000191:economics / Q000453:epidemiology; D015331:Cohort Studies; D016208:Databases, Factual; D000068800:Etanercept / Q000008:administration & dosage* / Q000191:economics; D005260:Female; D006801:Humans; D007345:Insurance Claim Review; D008297:Male; D008875:Middle Aged; D010880:Piperidines / Q000008:administration & dosage* / Q000191:economics; D047428:Protein Kinase Inhibitors / Q000008:administration & dosage / Q000191:economics; D011743:Pyrimidines / Q000008:administration & dosage* / Q000191:economics; D011758:Pyrroles / Q000008:administration & dosage* / Q000191:economics; D012189:Retrospective Studies; D014481:United States / Q000453:epidemiology
chemical_list: D018501:Antirheumatic Agents; D010880:Piperidines; D047428:Protein Kinase Inhibitors; D011743:Pyrimidines; D011758:Pyrroles; D000069594:Abatacept; C479163:tofacitinib; D000068879:Adalimumab; D000068800:Etanercept