ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 489

Combining Methotrexate To Etanercept Does Not Improve Its Retention Rate In Rheumatoid Arthritis Patients When Compared To Etanercept Monotherapy. A Report From The Rhumadata® Clinical Data Base and Registry

Denis Choquette1, Louis Bessette2, Boulos Haraoui1, Diane Sauvageau3, Jean Pierre Pelletier1, Jean-Pierre Raynauld3, Edith Villeneuve3 and Louis Coupal1, 1Rheumatology, Institut de rhumatologie de Montréal (IRM), Montréal, QC, Canada, 2Centre Hospitalier Universitaire de Québec, pavillon CHUL, Sainte-Foy, QC, Canada, 3Rheumatology, Institut de Rhumatologie de Montréal, Montreal, QC, Canada

Meeting: 2013 ACR/ARHP Annual Meeting

Keywords: ,

Session Information

Title: Rheumatoid Arthritis Treatment - Small Molecules, Biologics and Gene Therapy I

Session Type: Abstract Submissions (ACR)

Background/Purpose: Etanercept (ETA) has demonstrated good retention in both mono and combination therapy in clinical trials of rheumatoid arthritis patients followed over short observation periods (less than 2 years). Studies evaluating the efficacy of anti-TNF have provided better results when it is used with methotrexate compared to monotherapy. Data from registries have also demonstrated that methotrexate significantly influence the retention on anti-TNF. The rationale of this analysis is to explore the impact of combining methotrexate with etanercept on retention vs. monotherapy usage over a prolonged observation period in the Rhumadata® clinical database and registry.

Methods: RA patients prescribed ETA as a first biologic agent after January 1st 2004 were included in the present analysis. Baseline demographics for both cohorts included age, disease duration, HAQ-DI, fatigue and pain visual analog scale evaluation (VAS), TJC, SJC, DAS 28 ESR and SDAI. The drug retention rate of subjects on ETA monotherapy (n=45) were estimated and compared to the retention rate of subjects also receiving a DMARD (n=211) using Kaplan-Meier survival estimates. Six month and yearly estimates (up to 5 years) were obtained. Statistical analysis was performed using SAS version 9.3. RHUMADATA® is a clinical database and registry used in daily clinical practice at the IRM and CORQ.

Results:

:  At six months, drug retention for ETA monotherapy and combination therapy was estimated at 87%. Yearly drug retention rates for subjects on monotherapy ranged from 64% at year 1 to 36% at year 6. Estimates for subjects on combination therapy ranged from 78% to 53%.

Therapy

6 months

Year 1

Year 2

Year 3

Year 4

Year 5

Monotherapy (n=45)

 

 

 

 

 

 

     Mean retention time in days (StdD)

166.9 (6.9)

301.2 (16.1)

520.6 (39.8)

713.6 (65.1)

897.6 (91.2)

1053.55 (115.0)

     % retention (StdE)1

87% (5%)

64% (7%)

55% (8%)

52% (8%)

49% (8%)

36% (6%)

Combination therapy (n=211)

 

 

 

 

 

 

     Mean retention time in days (StdD)

170.7 (2.3)

322.0 (6.5)

591.2 (16.5)

832.8 (27.3)

1057.6 (38.8)

1260.4 (50.32)

     % retention (StdE)

87% (2%)

78% (3%)

71% (3%)

64% (3%)

58% (4%)

53% (4%)

Log-rank p-value

0.10

0.34

0.13

0.36

0.43

0.06

1 Product-limit survival estimates

 

 Conclusion: Etanercept with and without methotrexate discloses statistically similar retention rates from 6 months up to 5 years. It is worth noting that combination therapy remains numerically superior to the monotherapy over the 5 year observation period.

Disclosure:

D. Choquette,
None;

L. Bessette,
None;

B. Haraoui,
None;

D. Sauvageau,
None;

J. P. Pelletier,
None;

J. P. Raynauld,
None;

E. Villeneuve,
None;

L. Coupal,
None.

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