Retention Rates of Adalimumab, Etanercept and Infliximab as First and Second-Line Biotherapy in Patients With Rheumatoid Arthritis in Daily Practice

Completed

• Conditions: Rheumatoid Arthritis

• Registration Number: NCT01692899
• Lead Sponsor: Pfizer

Brief Summary

To compare retention rates of adalimumab, etanercept and infliximab as first-line biotherapy in rheumatoid arthritis (RA), to determine causes of discontinuation, retention-associated factors, and retention rates of possible second-line tumor necrosis factor α inhibitors (TNFi).

Detailed Description

In this retrolective, multicentric study, medical charts of RA patients starting TNFi between March 2005 and April 2009 were reviewed, with follow-up between 2 and 6 years. The retention rate was estimated using the Kaplan-Meier method. Comparison between TNFi was done after adjustment using a Cox model. Factors associated with better retention were identified by multivariate analysis. Medical charts of all patients with RA starting a first TNFα inhibitor therapy between March 1, 2005 (start of commercialization of adalimumab in France) and April 30, 2009 (allowing at least 2 years of follow-up) were systematically reviewed in detail by 2 rheumatologist investigators

Study Timeline

• Study Start: 2011-06
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Status Verified: 2012-09
• Study First Submitted: 2012-09-21
• Study First Submitted QC: 2012-09-24
• Last Update Submitted: 2012-09-24
• Study First Posted: 2012-09-25
• Last Update Posted: 2012-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 780

Inclusion Criteria

• RA defined by the 1987 ACR criteria [18]
• first TNFα inhibitor prescribed in the previously mentioned period
• TNFα inhibitor prescribed as first-line biotherapy
• undergone at least one evaluation in the center after treatment initiation

Exclusion Criteria

• previously received another biotherapy
• TNFα inhibitor was prescribed in an RCT
• refused to participate

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Compare retention rates of adalimumab, etanercept and infliximab administered as first-line biologic therapy in RA	2 years

Secondary Outcome Measures

Name	Time	Method
Compare retention rates of TNFα inhibitor monoclonal antibodies (adalimumab and infliximab) and the soluble receptor (etanercept)	4 years
Causes of discontinuing these treatments	4 years
Determine the factors associated with better retention of the first TNFα inhibitors	4 years
Compare retention rates of possible second-line TNFα inhibitors	4 years