Dose Escalation With Remicade® and Orencia®

Study Overview
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Brief Summary
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The purpose of this study is to describe infliximab and abatacept dosing patterns (i.e., dosing amount and frequency) and costs among a population of managed care enrollees with RA. This study will also identify changes in infliximab and abatacept dosing over time and the implication these changes may have on the costs of medication administration.

Detailed Description
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This study will be conducted in two parts. The primary analysis is a longitudinal analysis, where patients' health care claims from a period during which the patient was continuously enrolled in the health plan will be used to evaluate the primary outcome (i.e., dose escalation). The second analysis will be cross-sectional, where patients' health care claims from a fixed period of time (i.e., 2008) will be used to examine health care cost. The final enrollment for the longitudinal portion of the study was 2,001 (1,306 infliximab and 695 abatacept patients). Final enrollment for the cross-sectional portion was 3,450 (2,646 infliximab and 806 abatacept patients). There may be some overlap in these numbers.

Official Title
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Comparison of Dosing and Costs Between Rheumatoid Arthritis Patients Treated With Remicade® Versus Orencia®

Conditions
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Rheumatoid Arthritis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Commercial health plan enrollees with medical and pharmacy coverage At least 3 claims on separate days for infliximab (HCPCS J1745) or abatacept (HCPCS C9230, J0129, J3590) administration during the subject identification period The 3 initial claims for abatacept occurred within a 6-week period inclusive of the index date and the three initial claims for infliximab occur within a 9-week period inclusive of the index date Presence of a diagnosis of RA (ICD-9-CM 714.xx) Continuous enrollment during the baseline and follow-up periods At least 18 years of age or older on the index date Exclusion Criteria: Prior exposure to the index medication during the baseline period Diagnosis of psoriasis (ICD-9-CM 696.1), psoriatic arthritis (696.0), ankylosing spondylitis (720.0), Crohn's disease (555.x), or ulcerative colitis (556.x) in any position at any time during the study period Exposure to alefacept (HCPCS J0215, C9211, C9212) or efalizumab (HCPCS S0162) at any time during the study period

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| RA patients using Remicade®<br> | |
| RA patients using Orencia®<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Escalation in dosing amount or frequency |  | Throughout follow-up period (variable, between 6 weeks and 39 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Switch/discontinuation of index therapy |  | Throughout follow-up period (variable, between 6 weeks and 39 months) | 
| Number of infusions |  | Throughout follow-up period (variable, between 6 weeks and 39 months) | 
| Average dose per infusion |  | Throughout follow-up period (variable, between 6 weeks and 39 months) | 
| Frequency of infusions |  | Throughout follow-up period (variable, between 6 weeks and 39 months) | 
| Average costs per infusion |  | Throughout follow-up period (variable, between 6 weeks and 39 months) | 
| Health care resource utilization |  | Throughout follow-up period (variable, between 6 weeks and 39 months) | 
| Health care costs |  | Throughout follow-up period (variable, between 6 weeks and 39 months) | 
| Concurrent medication use |  | Throughout follow-up period (variable, between 6 weeks and 39 months) | 
| Time to maximum dose |  | Throughout follow-up period (variable, between 6 weeks and 39 months) | 
| Time to dose escalation |  | Throughout follow-up period (variable, between 6 weeks and 39 months) |