Attainment Of Remission, Functional, and Quality Of Life Improvements With Golimumab Treatment In Rheumatoid Arthritis Are Associated With Patient Expectations

B Dasgupta¹, B Combe², I Louw³, J Wollenhaupt⁴, C Zerbini⁵, A Beaulieu⁶, H Schulze-Koops⁷, P Durez⁸, V Wolff⁹, R Yao¹⁰, HH Weng¹⁰, M Govoni¹¹ and N Vastesaeger¹², ¹Southend University Hospital, Westcliff-on-Sea, United Kingdom, ²Hôpital Lapeyronie, Montpellier, France, ³Panorama Medical Centre, Cape Town, South Africa, ⁴Schön-Klinik, Hamburg, Germany, ⁵Hospital Heliópolis, Serviço de Reumatologia, São Paulo, Brazil, ⁶Centre de Rhumatologie, St-Louis, QC, Canada, ⁷University of Munich, Munich, Germany, ⁸Université Catholique de Louvain and Cliniques Universitaires Saint-Luc, Brussels, Belgium, ⁹Hospital del Salvador, Santiago, Chile, ¹⁰Merck & Co., Inc., Whitehouse Station, NJ, ¹¹MSD Italy, Rome, Italy, ¹²Merck Sharp & Dohme, Brussels, Belgium

Meeting: 2013 ACR/ARHP Annual Meeting

Keywords: anti-TNF therapy, Biologics, Disease-modifying antirheumatic drugs, patient-reported outcome measures and quality of life

Session Information

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

Session Type: Abstract Submissions (ACR)

Background/Purpose: Golimumab (GLM) and other tumor necrosis factor antagonists are used as add-on therapy for patients with rheumatoid arthritis (RA) who have not responded to disease-modifying antirheumatic drugs (DMARDs). Comprehensive management of RA involves clinical goals such as remission and outcomes important to patients such as daily functioning and improvement in quality of life (QoL). After DMARD failure, patients may have low treatment expectations, which could affect outcomes. This subanalysis of the GO-MORE study investigated relationships between patient expectations and GLM treatment outcomes.

Methods: GO-MORE was an open-label, multinational, prospective study in biologic-naïve patients with active RA despite DMARD treatment. Patients received 50-mg subcutaneous GLM once monthly for 6 months. At baseline and month 3, patients rated their expectation of how well their treatment would control RA symptoms and improve QoL 3 months later using 5-point Likert scales (1=good outcome, 5=poor outcome). Patients were divided into tertiles of expectation scores: most positive (≤1.5), intermediate (>1.5 to <1.86), or least positive (≥1.86). Efficacy outcomes were compared among tertiles using ANCOVA; Pvalues were calculated for pairwise differences from the comparator group.

Results: At baseline, 3280 efficacy-evaluable patients had moderate (21.3%) or high disease activity (78.7%), mean age 52.3 (SD=12.8) years, mean disease duration 7.6 (SD=7.9) years, mean Health Assessment Questionnaire Disability Index (HAQ-DI) 1.44 (SD=0.67), and mean EQ-5D 0.42 (SD=0.33). Overall, patients had high expectations, with a mean expectation score of 1.4 (1=good expectation, 5=poor expectation) at baseline. Higher expectations were observed in patients who had failed fewer DMARDs (1 vs 2 failures, P=.0039; 1 vs ≥3 failures, P<.0001) and patients who had high baseline disease activity (moderate vs high disease activity, P=.0014). Patients expected improvement in physical (pain, joint swelling, fatigue) and functional (ability to participate in activities) outcomes. After 6 months of GLM, patients with the most positive expectations had higher remission rates (P<.0001). More positive expectations were also associated with greater improvements in functional impairment and EuroQoL Questionnaire (EQ-5D) scores (table).

Table. Relationship Between Patient Expectations and GLM Treatment Outcomes

Treatment Outcome at Month 6	Patient Expectations at Baseline
Treatment Outcome at Month 6	Most Positive n=1212	Intermediate n=1009	Least Positive n=1054
Remission 28-joint Disease Activity Score (DAS28-ESR)<2.6, n (%)	339 (28.0)	236 (23.4)	209 (19.8) P < .0001^a
Minimal Functional Impairment HAQ-DI ≤0.5, n (%)	562 (46.4)	368 (36.5) P < .0001^a	294 (27.9) P < .0001^a
Change in EQ-5D Score Mean (SD)	0.28 (0.35)	0.25 (0.33)	0.21 (0.34) P < .0001^a

^aP values for comparison with most positive expectation group. Pvalues >.001 not reported.

Conclusion: Patients had high expectations for add-on GLM treatment despite previous treatment failures. Patients with more positive expectations had better outcomes and better comprehensive control of their RA than those with less positive expectations, as evidenced by higher DAS28 remission rates and improvement in patient-reported measures, such as physical function and QoL.

Disclosure:

B. Dasgupta,

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

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

B. Combe,

Pfizer, Roche-Chugai ,

Merck, Pfizer, Roche-Chugai, and UCB,

I. Louw,

Merck, BMS, Pfizer, Roche, Janssen, and Lilly,

Abbott, BMS, and Janssen in South Africa, and the Merck Investigator Consulting Network,

J. Wollenhaupt,

AbbVie, Biotest, BMS, Chugai, MSD, Medac, Merck, MSD, Pfizer, Roche, UCB, Astra Zeneca, and Sanofi,

C. Zerbini,

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

Pfizer, Bristol, Lilly, and MSD,

Pfizer and Bristol,

A. 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,

P. Durez,
None;

V. Wolff,
None;

R. Yao,

Merck Sharp & Dohme,

H. Weng,

Merck Sharp & Dohme,

M. Govoni,

Merck Sharp & Dohme,

N. Vastesaeger,

Merck Sharp & Dohme,

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