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The American Journal of Managed Care October 2019
Inflammatory Bowel Disease Readmissions Are Associated With Utilization and Comorbidity
Shirley Cohen-Mekelburg, MD, MS; Russell Rosenblatt, MD, MS; Beth Wallace, MD, MS; Nicole Shen, MD, MS; Brett Fortune, MD, MSc; Akbar K. Waljee, MD, MSc; Sameer Saini, MD, MS; Ellen Scherl, MD; Robert Burakoff, MD; and Mark Unruh, PhD
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Michael E. Chernew, PhD
The Long-term Social Value of Granulocyte Colony-Stimulating Factors
Alison Sexton Ward, PhD; Mina Kabiri, PhD; Aylin Yucel, PhD, MSc, MBA, MHSA, PharmD; Alison R. Silverstein, MPH; Emma van Eijndhoven, MS, MA; Charles Bowers, MD; Mark Bensink, PhD, MSc, MEd; and Dana Goldman, PhD
Physician Clinical Knowledge, Practice Infrastructure, and Quality of Care
Jonathan L. Vandergrift, MS; and Bradley M. Gray, PhD
Variation in US Private Health Plans’ Coverage of Orphan Drugs
James D. Chambers, PhD; Ari D. Panzer, BS; David D. Kim, PhD; Nikoletta M. Margaretos, BA; and Peter J. Neumann, ScD
Ease of Ordering High- and Low-Value Services in Various Electronic Health Records
Eric Schwartz, MD; Allison Ruff, MD; Michael Kinning, DO; and A. Mark Fendrick, MD
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Real-World Outcomes Among Patients With Early Rapidly Progressive Rheumatoid Arthritis
Andrew J. Klink, PhD, MPH; Tammy G. Curtice, PharmD, MBA, MS; Kiran Gupta, PhD, MPharm; Kenneth W. Tuell, RPh, BCGP; A. Richard Szymialis, RPh; Damion Nero, PhD; and Bruce A. Feinberg, DO
Patients’ Expectations of Their Anesthesiologists
Charlie Lin, MD; Jansie Prozesky, MBChB; Donald E. Martin, MD; and Verghese T. Cherian, MD
A Deep Learning Model for Pediatric Patient Risk Stratification
En-Ju D. Lin, PhD, MPH; Jennifer L. Hefner, PhD, MPH; Xianlong Zeng, MS; Soheil Moosavinasab, MS; Thomas Huber, PhD, MS; Jennifer Klima, PhD; Chang Liu, PhD; and Simon M. Lin, MD, MBA
Low Screening and Follow-up for Unhealthy Alcohol Use Among Health Plan Beneficiaries
Junqing Liu, PhD; Fern McCree, MPH; Doug Kanovsky, BA; Patricia Santora, PhD; Kazi Ahmed, PhD; Chirag Bhatt, MBA; and Sarah H. Scholle, DrPH

Real-World Outcomes Among Patients With Early Rapidly Progressive Rheumatoid Arthritis

Andrew J. Klink, PhD, MPH; Tammy G. Curtice, PharmD, MBA, MS; Kiran Gupta, PhD, MPharm; Kenneth W. Tuell, RPh, BCGP; A. Richard Szymialis, RPh; Damion Nero, PhD; and Bruce A. Feinberg, DO
This study suggests that lower healthcare resource use and achieving low disease activity are associated with first-line abatacept compared with a first-line tumor necrosis factor-α inhibitor for patients with early rapidly progressive rheumatoid arthritis.
ABSTRACT

Objectives: To characterize treatment patterns, healthcare resource utilization (HRU), and disease activity among patients with early rapidly progressive rheumatoid arthritis (eRPRA) in the United States when treated with a first-line biologic disease-modifying antirheumatic drug (bDMARD) tumor necrosis factor-α (TNF) inhibitor or first-line abatacept.

Study Design: Observational, multicenter, retrospective, longitudinal, medical records–based, cohort study.

Methods: Patients with eRPRA were identified by anti–citrullinated protein antibody positivity, 28-joint Disease Activity Score–C-reactive protein of 3.2 or greater, symptomatic synovitis in 2 or more joints for at least 8 weeks prior to the index date, and onset of symptoms within 2 years or less of the index date. Patients received abatacept or a TNF inhibitor as first-line treatment. Patient characteristics, treatment patterns, HRU, and disease activity following bDMARD initiation were compared across the 2 groups. Odds ratios (ORs) of HRU in the first 6 months of bDMARD treatment were estimated using multivariable logistic regression to adjust for patient mix.

Results: There were 60 patients treated with abatacept and 192 treated with a TNF inhibitor in the first line. Those treated with first-line abatacept had lower adjusted odds of hospitalization (OR, 0.42; 95% CI, 0.18-0.95), emergency department (ED) visits (OR, 0.39; 95% CI, 0.16-0.93), and magnetic resonance imaging (MRI) (OR, 0.45; 95% CI, 0.21-0.97) than those treated with a first-line TNF inhibitor (all P <.05). Adjusted odds of achieving low disease activity as measured by clinical disease activity index within 100 days of bDMARD initiation favored first-line abatacept versus a first-line TNF inhibitor (OR, 4.37; 95% CI, 1.34-13.94; P = .01).

Conclusions: Adjusting for disease severity, patients with eRPRA who were treated with first-line abatacept were less likely to have hospitalizations, ED visits, and MRI use during the first 6 months of bDMARD treatment and more likely to achieve low disease activity within 100 days of bDMARD start compared with those who received a first-line TNF inhibitor.

Am J Manag Care. 2019;25(10):e288-e295
Takeaway Points
  • Current management of rheumatoid arthritis (RA) in the United States is often directed by payer medical policy, typically requiring a tumor necrosis factor-α (TNF) inhibitor as a first- and second-line biologic disease-modifying antirheumatic drug (bDMARD).
  • The paradigm of this one-size-fits-all approach to the treatment of RA, which then results in prescribers’ formulary constraints, is now challenged by defined clinical subsets of patients who may be better served by alternative treatment sequences.
  • This study challenges this paradigm by demonstrating benefit observed among patients with early rapidly progressive RA (eRPRA) treated with a non–TNF inhibitor bDMARD.
  • Patients with eRPRA treated with first-line abatacept were less likely to have hospitalizations, emergency department visits, and magnetic resonance imaging during the first 6 months of bDMARD treatment compared with those who received a first-line TNF inhibitor.
The systemic treatment of rheumatoid arthritis (RA) has evolved from nonsteroidal anti-inflammatory drugs (NSAIDs) to corticosteroids (CSs) to conventional disease-modifying antirheumatic drugs (cDMARDs) to biologic DMARDs (bDMARDs) and Janus kinase (JAK) inhibitors.1 bDMARDs plus JAK inhibitors represent 4 different mechanism of action (MOA) drug classes; one such drug class, the tumor necrosis factor-α (TNF) inhibitor class, dominates current treatment as both the initial and subsequent bDMARD in patients with progressive RA. Whether the result of clinical trial design or the lack of pathobiologic differentiation, patients with RA have, for the past decade, been treated in a restrictive one-size-fits-all paradigm. This treatment paradigm has been codified into payer medical policy that is usually implemented through a pharmacy benefit manager in which formulary restrictions limit symptomatic disease management to the drug sequence of cDMARDs until failure, followed by a TNF inhibitor until failure, and then an alternative TNF inhibitor upon failure. Although traditional medicine challenges the strategy of salvaging the failure of a drug of a specific MOA with another drug of the same MOA (eg, penicillin failure is not followed by alternative penicillin), there has been limited research comparing alternative treatment sequences.

This unusual paradigm in which failure of a drug class is addressed with an alternative drug from the same class persists despite a complex arsenal of alternative therapeutics. cDMARDs (including methotrexate and sulfasalazine) and TNF inhibitors (including adalimumab, certolizumab, etanercept, golimumab, and infliximab) have been widely used and studied over the past 18 years both as single agents and, more recently, in combination. Newer biologics showing favorable safety and efficacy have also steadily emerged.2,3 Some of the more recent additions to the RA armamentarium are non–TNF inhibitor drugs, including the T-cell costimulation blocker abatacept, the interleukin-6 receptor antibody tocilizumab, and the JAK inhibitor tofacitinib. Challenges to the TNF inhibitor–based paradigm, in the second-line and even the first-line setting, using drug options from this arsenal are beginning to emerge.

Recent clinical and molecular profiling have helped to further define subsets of patients who may not benefit from this uniform treatment strategy, such as patients with early rapidly progressive RA (eRPRA).4,5 Anti–citrullinated protein antibody (ACPA) positivity has been shown to indicate more severe disease progression and more erosive disease, signifying a rapidly progressive form of RA.6,7 ACPA positivity, as measured by anti–cyclic citrullinated peptide-2 (anti-CCP2) tests, has been reported among 3% to 52% of RA cohorts,8 is likely helpful in identifying patients with eRPRA, and may assist in identifying the most effective treatment sequence for a given patient. Although no definition of eRPRA has been formally established, initial work by the American College of Rheumatology (ACR) has resulted in treatment recommendations stratified by early (<6 months duration) and established (≥6 months duration) RA in the presence or absence of poor prognostic features, including an anti-CCP2 test resulting in ACPA positivity.9

The current study sought to identify the clinical subset of patients presenting with eRPRA and to subsequently examine treatment patterns, healthcare resource utilization (HRU), and disease activity following treatment with a first-line bDMARD. The primary aim was to describe HRU and clinical outcomes of patients with eRPRA treated with abatacept and compare them with those patients treated with a TNF inhibitor.

METHODS

This was an observational, multicenter, retrospective, longitudinal, medical records–based, cohort study of patients with eRPRA treated with a first-line bDMARD. Patients meeting study inclusion and exclusion criteria were identified by providers in Cardinal Health’s proprietary Rheumatology Provider Extended Network, which represents 838 practices comprising approximately 1900 physicians across the 48 contiguous US states. Data were collected by electronic case report forms (eCRFs) abstracted by healthcare providers using patient medical records. Retrospective data were collected at 1 time point, covering at least 6 months of follow-up for each patient.

Patients with eRPRA treated with abatacept as a first bDMARD or a TNF inhibitor as a first bDMARD between February 1, 2012, and January 31, 2017, were eligible for study inclusion; date of initiation of first bDMARD was set as the index date. Patients were included in the study cohort if they met the following criteria: (1) had a diagnosis of RA; (2) were 18 years or older at RA diagnosis; (3) had symptomatic synovitis in 2 or more joints for at least 8 weeks prior to index date; (4) had a 28-joint Disease Activity Score (DAS28)–C-reactive protein (CRP) of 3.2 or greater prior to index date; (5) had ACPA positivity; (6) had onset of symptoms 2 years or less prior to index date; (7) initiated first-line abatacept or a first-line TNF inhibitor between February 1, 2012, and January 31, 2017; and (8) had 6 or more months of data following initiation of abatacept or a TNF inhibitor. Patients were classified into 1 of 2 treatment groups based on their first-line bDMARD treatment: abatacept or TNF inhibitor. Patients remained in this group until discontinuation of first-line abatacept or a first-line TNF inhibitor, death, they were lost to follow-up, or the end of the study period, whichever occurred first.

Treatment patterns included dates of bDMARD initiation and discontinuation and concomitant medications received during bDMARD treatment. Numbers of rheumatology visits, emergency department (ED) visits, inpatient hospitalizations, laboratory tests (CRP, erythrocyte sedimentation rate [ESR]), radiology procedures (magnetic resonance imaging [MRI], ultrasound, x-ray), and surgeries were collected from the patient chart for the 6-month period following initiation of first-line abatacept or a first-line TNF inhibitor.


 
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