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Abstract Number: 472

More Positive Expectations of Treatment with Golimumab for Rheumatoid Arthritis Are Associated with Greater Improvement in Clinical Outcomes

Bhaskar Dasgupta1, Bernard Combe2, Ingrid Louw3, Sarvajeet Pal4, Jürgen Wollenhaupt5, Cristiano Zerbini6, Andre D. Beaulieu7, Hendrik Schulze-Koops8, Patrick Durez9, W. Bensen10, V. Wolff11, Ruji Yao12, Holly Weng12 and Nathan Vastesaeger13, 1Southend University Hospital, Westcliff-on-Sea, United Kingdom, 2Hôpital Lapeyronie-Service d'Immuno-rhumatologie, Montpellier, France, 3Panorama Medical Centre, Cape Town, South Africa, 4Advance Rheumatology Clinic, Hyderabad, India, 5Schön-Klinik, Hamburg, Germany, 6Centro Paulista de Investigações, Sao Paulo, Brazil, 7Bureau 140, Centre de Rhumatologie, St. Louis, QC, Canada, 8University of Munich, Munich, Germany, 9UCL Saint-Luc, Brussels, Belgium, 10St. Joseph's Hospital and McMaster University, Hamilton, ON, Canada, 11Hospital del Salvador, Santiago, Chile, 12Merck Sharp & Dohme, Kenilworth, NJ, 13Merck Sharp & Dohme, Brussels, Belgium

Meeting: 2012 ACR/ARHP Annual Meeting

Keywords: Tumor necrosis factor (TNF)

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Session Information

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

Session Type: Abstract Submissions (ACR)

Background/Purpose: Little is known about how patient and physician expectations relate to clinical outcomes. This study investigated the expectations that patients and physicians have at the start and after 3 months of treatment with golimumab (GLM) for RA and evaluated the relationship between these expectations and treatment outcomes.

Methods: GO-MORE was an open-label, multinational, prospective study in biologic-naïve patients who had active RA despite DMARD treatment. All patients received 50-mg subcutaneous GLM once monthly for 6 months. At baseline and after 3 months of treatment, patients rated their overall expectation of how well their treatment would control RA symptoms. They also rated the ability of the treatment to relieve specific symptoms and improve quality of life 3 months later using 5-point Likert scales (1=good outcome, 5=poor outcome). Patients were then divided into tertiles of expectation scores: high (≤1.5), medium (>1.5 to <1.86), or low (≥1.86). Patients indicated which attribute they wanted to improve most. Physicians were asked to predict patient disease state 3 months later and selected (from the same list used by patients), the attribute they thought patients most wanted to improve.

Results: At baseline, 3280 patients had mean age of 52.3 (SD=12.8) years, median disease duration of 4.9 years, mean HAQ-DI of 1.44 (SD=0.67) and had moderate (21.3%) or high disease activity (78.7%). Prior to starting treatment, 95.9% of patients expected GLM to be better than their current DMARD treatment. After 3 months of treatment, 85.1% expected the treatment to be more effective still by month 6. The attributes patients wanted to improve most were pain and quality of life, with pain selected by most patients at baseline and quality of life selected by most following 3 months of treatment. Patients with more positive expectations about treatment had greater improvement in DAS28-ESR and HAQ scores and were more likely to show good EULAR response at month 6 than patients with less positive expectations (Table 1).

Table 1. Relationship Between Patients’ Baseline Treatment Expectations and Improvement in Outcomes

Baseline Treatment
Expectation

DAS28-ESR

HAQ

DAS28-CRP

Baseline, Mean (N)

Change at Month 6, Mean (SD)

P Valuea

Baseline, Mean (N)

Change at Month 6, Mean (SD)

P Valuea

Achieved EULAR Response, n/N (%)

P Valuea

High(≤1.5)

6.03 (1212)

–2.43 (1.377)

 

1.40 (1211)

–0.65 (0.691)

 

1030/1212 (84.98)

 

Medium
(>1.5 to<1.86)

6.00 (1009)

–2.28 (1.386)

NSb

1.43 (1009)

–0.55 (0.610)

<0.0001

827/1009 (81.96)

NSb

Low (≥1.86)

5.86 (1054)

–2.04 (1.344)

<0.0001

1.48 (1053)

–0.44 (0.583)

<0.0001

805/1054 (76.38)

<0.0001

aP values are for pairwise comparison with high expectation group.

bP values >0.001 are considered to be nonsignificant.

At baseline, physicians expected 29.6% of patients to attain remission and 59.2% to attain low disease activity after 3 months of treatment. At the end of month 3, they expected 38.8% to attain remission and 53.1% to attain low disease activity by the end of month 6. Physicians identified pain and tender and swollen joints as the issues they thought their patients most wanted to improve.

Conclusion: Despite similar baseline scores, patients with more positive expectations about outcomes of GLM treatment demonstrated better outcomes than patients with less positive expectations.


Disclosure:

B. Dasgupta,

EULAR, ACR, Health Technology Assessment, British Heart Foundation, Research for Patient benefits UK, Napp ,

2,

Schering Plough, Merck, Roche, Mundipharma, Astra Zeneca,

9,

Schering Plough, Merck, Roche, Mundipharma, Astra Zeneca,

5;

B. Combe,

Merck Pharmaceuticals,

5;

I. Louw,
None;

S. Pal,
None;

J. Wollenhaupt,

MSD,

5,

MSD,

8;

C. Zerbini,

Novartis, Pfizer, Bristol, Lilly, Amgen, and MSD,

2,

Pfizer, Bristol, Lilly, and MSD,

5,

Pfizer and Bristol,

6;

A. D. Beaulieu,

Merck, Servier, Amgen, Abbott, Pfizer, and Roche,

;

H. Schulze-Koops,

Abbott, Actelion, Biotest, BMS, Chugai, Essex, GSK, MSD, Medac, Merck, Mundai Pharma, Novartis, Nycomed, Pfizer, Roche, UCB,

5,

Abbott, Actelion, Biotest, BMS, Chugai, Essex, GSK, MSD, Medac, Merck, Mundai Pharma, Novartis, Nycomed, Pfizer, Roche, UCB,

8,

Merck Pharmaceuticals,

9;

P. Durez,
None;

W. Bensen,

Abbott, Amgen, BMS, Janssen, Merck, Pfizer, Roche, and Servier Warner Chilcott,

5,

Abbott, Amgen, BMS, Janssen, Merck, Pfizer, Roche, and Servier Warner Chilcott,

8;

V. Wolff,

Merck Pharmaceuticals,

9,

Merck Pharmaceuticals,

2;

R. Yao,

Merck Pharmaceuticals,

3;

H. Weng,

Merck Pharmaceuticals,

3;

N. Vastesaeger,

Merck Pharmaceuticals,

3.

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