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Abstract Number: 446

Remission Rates During Golimumab Treatment For Rheumatoid Arthritis Are Associated With Differences In Baseline Disease States Across Geographic Regions

P Durez1, K Pavelka2, M Lazaro3, A Garcia Kutzbach4, R Moots5, H Amital6, R Yao7, M Govoni8,9, N Vastesaeger10 and HH Weng7, 1Université Catholique de Louvain and Cliniques Universitaires Saint-Luc, Brussels, Belgium, 2Revmatologicky Ustav, Praha, Czech Republic, 3IARI Instituto de Asistencia Reumatologica Integral, Buenos Aires, Argentina, 4AGAR Francisco Marroquin University, Guatemala City, Guatemala, 5University Hospital Aintree, Liverpool, United Kingdom, 6Sheba Medical Center, Tel-Hashomer, Israel, 7Merck & Co., Inc., Whitehouse Station, NJ, 8MSD Italy, Rome, Italy, 9Merck Sharp & Dohme, Rome, Italy, 10Merck Sharp & Dohme, Brussels, Belgium

Meeting: 2013 ACR/ARHP Annual Meeting

Keywords: anti-TNF therapy, Biologics, Disease-modifying antirheumatic drugs, methotrexate (MTX) and rheumatoid arthritis (RA)

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Session Information

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

Session Type: Abstract Submissions (ACR)

Background/Purpose: Regional differences in practice patterns and access to biologic treatment for rheumatoid arthritis (RA) may lead to regional differences in baseline disease characteristics, which could influence response to biologic treatments. The purpose of this analysis of the GO-MORE study was to compare across geographic regions the baseline disease levels and remission rates among biologic-naïve RA patients during 6 months of add-on golimumab (GLM) treatment.

Methods: GO-MORE was an open-label, multinational, prospective study in biologic-naïve patients with active RA (DAS28-ESR ≥3.2) despite nonbiologic disease-modifying antirheumatic drug treatment. Patients received 50-mg SC GLM once monthly for 6 months. In planned and post hoc analyses, baseline disease activity, disease duration, and DAS28-ESR remission rates were evaluated across geographic regions. 

Results:

Baseline disease activity varied across regions (table), with high EULAR disease activity most prevalent in South Africa, Asia, and Latin America. Disease duration was longest in Latin America and South Africa. Overall, after 6 months of GLM treatment, DAS28-ESR remission rate was approximately 25%. Remission rates varied substantially by region, with lower remission rates generally found in the regions with the greatest initial disease activity and disease duration, with the exception of South Africa. Within the European region, the largest population in the study, the countries with the lowest remission rates were Russia and Romania (6.8% and 7.8% at month 6, respectively), also had high rates of baseline disease activity (96.6% and 86.3% of patients had high disease activity, respectively; mean DAS28-ESR 6.4 and 6.2, respectively). In the European countries with the highest remission rates, Belgium and Austria (43.1% and 40.2% at month 6, respectively), much lower baseline disease activity was observed (40.2% and 59.8% of patients had high disease activity, respectively; mean DAS28-ESR 5.0 and 5.2, respectively). Regardless of geographic region, patients with moderate baseline disease activity were more likely to achieve remission than those with high baseline disease activity (43.4% and 18.5%, respectively, P<.0001).

 

Table. Patient Baseline Disease Activity and Remission Rates at Month 6

Geographic Region

Baseline EULAR Disease Activitya
n (%)

Baseline Disease Duration, y
 Mean (SD)

Baseline DAS28-ESR
 Mean (SD) 

Month 6 DAS28-ESR Remissionb
n (%) 

Moderate

High

South Africa, N=117

10 (8.5)

107 (91.5)

7.6 (7.9)

6.7 (1.1)

34 (29.1)

Asia, N=133

10 (7.5)

123 (92.5)

5.4 (4.8)

6.2 (0.8)

20 (15.0)

Europe, N=1818

525 (29.0)

1286 (71.0)

7.4 (7.8)

5.7 (1.0)

507 (27.9)

Latin America, N=906

84 (9.3)

821 (90.7)

8.6 (8.2)

6.4 (1.0)

156 (17.2)

Middle East, N=88

19 (21.8)

68 (78.2)

6.9 (7.0)

6.0 (1.0)

24 (27.3)

Canada, N=218

50 (23.0)

167 (77.0)

6.6 (8.4)

5.9 (1.1)

43 (19.7)

aModerate disease activity: DAS28-ESR 3.2–5.1; high disease activity: DAS28-ESR >5.1.

bRemission: DAS28-ESR <2.6. 

Conclusion: After 6 months of GLM treatment, patients in South Africa, Europe, and the Middle East had higher remission rates than those in Latin America and Asia. This pattern may be due to differences in baseline disease activity and duration, which may reflect differences in practice patterns and access to biologic treatments. Overall, patients with moderate baseline disease activity were more likely to achieve remission than those with high baseline disease activity.


Disclosure:

P. Durez,
None;

K. Pavelka,

Amgen, Roche, BMS, MSD, UCB, and Pfizer,

8;

M. Lazaro,

Bristol Myers Squibb Argentina ,

2,

Abbott Laboratories,

8;

A. Garcia Kutzbach,
None;

R. Moots,
None;

H. Amital,
None;

R. Yao,

Merck Sharp & Dohme,

3;

M. Govoni,

Merck Sharp & Dohme,

3;

N. Vastesaeger,

Merck Sharp & Dohme,

3;

H. Weng,

Merck Sharp & Dohme,

3.

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