Clinical trial NCT01692899: Retention Rates of Adalimumab, Etanercept and Infliximab as First and Second-Line Biotherapy in Patients With Rheumatoid Arthritis in Daily Practice
Official title: Retention Rates of Adalimumab, Etanercept and Infliximab as First and Second-Line Biotherapy in Patients With Rheumatoid Arthritis in Daily Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Keywords: Retention Rates
of Adalimumab
Etanercept and Infliximab
as First and Second-Line Biotherapy
in Patients with Rheumatoid Arthritis
in Daily Practice.
TNF inhibitors
biotherapy
retrospective study
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: scientific steering committee of KOL in rheumatology
First posted: 2012-09-25
Enrollment: 780
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: RA defined by the 1987 ACR criteria \[18\]; first TNFα inhibitor prescribed in the previously mentioned period; TNFα inhibitor prescribed as first-line biotherapy; and patients had undergone at least one evaluation in the center after treatment initiation. Patients were excluded if: they had previously received another biotherapy; the TNFα inhibitor was prescribed in an RCT; or they refused to participate.

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

Eligibility criteria: 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

Primary outcomes:
measure: Compare retention rates of adalimumab, etanercept and infliximab administered as first-line biologic therapy in RA
timeFrame: 2 years
Secondary outcomes:
measure: Compare retention rates of TNFα inhibitor monoclonal antibodies (adalimumab and infliximab) and the soluble receptor (etanercept)
timeFrame: 4 years
measure: Causes of discontinuing these treatments
timeFrame: 4 years
measure: Determine the factors associated with better retention of the first TNFα inhibitors
timeFrame: 4 years
measure: Compare retention rates of possible second-line TNFα inhibitors
timeFrame: 4 years
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Frazier-Mironer A, Dougados M, Mariette X, Cantagrel A, Deschamps V, Flipo RM, Logeart I, Schaeverbeke T, Sibilia J, Le Loet X, Combe B. Retention rates of adalimumab, etanercept and infliximab as first and second-line biotherapy in patients with rheumatoid arthritis in daily practice. Joint Bone Spine. 2014 Jul;81(4):352-9. doi: 10.1016/j.jbspin.2014.02.014. Epub 2014 Apr 8.