RESEARCH - Safety and efficacy of Enbrel treatment in patients with early and long-standing RA: 10 years of clinical experience

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1007 - Safety and Efficacy of Etanercept (Enbrel®) Treatment in

North American Patients With Early and Long-Standing Rheumatoid

Arthritis: 10 Years of Clinical Experience

ACR/ARHP 2008 Scientific Meeting

Pres. Time: Monday, Oct 27, 2008, 9:00 AM -11:00 AM

Location: Hall A, Poster Board: 268

Category: 17. RA: clinical aspects

Author(s): Weinblatt1, M. Genovese2, J. Bathon3, J. Kremer4,

R. Fleischmann5, M. Schiff6, Y. Chon7, H. Weng7, S. Baumgartner7.

1Brigham & Women's Hosp, Boston, MA; 2Stanford Univ Med Center, Palo

Alto, CA; 3s Hopkins Univ, Baltimore, MD; 4The Center for

Rheumatology, Albany, NY; 5Univ Texas Southwestern Med Ctr, Dallas,

TX; 6Denver Arthritis Clinic, Denver, CO; 7Amgen Inc, Thousand Oaks,

CA

Abstract:

PURPOSE: To assess the long-term safety and efficacy of etanercept

(ETN) therapy in adult patients with early rheumatoid arthritis (ERA,

duration ˜3 years) or long-standing RA (LRA) whose disease failed to

respond to ™1 DMARD.

METHODS: RA patients who participated in clinical trials of ETN were

eligible to enroll in open-label extension studies. Efficacy endpoints

were analyzed in patients who received ETN 25 mg BIW in ERA (N=207)

and LRA studies (N=644), based on a completers analysis. Safety and

persistence data were analyzed for all patients who received ETN (ERA,

N=558; LRA, N=714) for up to 10 years. Standard incidence ratios

(SIRs) were calculated using general population data (SEER).

RESULTS: Total ETN exposure was 3207 pt-yrs for ERA patients and 4021

pt-yrs for LRA patients with median exposure times of 6.9 yrs and 6.2

yrs, respectively. ETN therapy resulted in significant improvements in

measures of disease activity that were sustained for the longest time

points examined (Table). Currently, 249 (45%) ERA patients and 273

(38%) LRA patients continue to receive ETN in these studies. The most

common reasons patients discontinued ETN were adverse events (ERA 13%,

LRA 14%) or lack of efficacy (ERA 8%, LRA 13%). For up to 10 years in

ERA and LRA patients, the rates of serious adverse events and serious

infections in patients receiving ETN have remained consistent with

those seen in the original placebo groups. Few (2 ERA; 4 LRA) OIs have

been reported, including candida species (1 case), non-tuberculous

mycobacterium (1 case), and herpes zoster (4 cases). No cases of

tuberculosis were reported. Reported malignancies remained low (SIR

[95% CI] = 1.02 [0.79, 1.29]). Overall rates of lymphoma were higher

than expected in the general population (SIR [95% CI] = 4.20 [2.10,

7.51]); however, incidence did not increase over time. Forty-six

deaths were observed while 84 were expected (SEER); 5 deaths were the

result of sepsis.

CONCLUSIONS: These data show the durability of ETN response, with

improvement maintained for the longest time points available for each

dataset. Safety analyses revealed no new safety signal with continuous

ETN use up to 10 years. Lymphoma rates were higher than expected

(SEER); however, it is unknown if this finding is related to ETN or

the elevated risk of lymphoma inherent in patients with RA.

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Presentation 1007

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