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Abstract Number: 320

Sustained Improvement In Health-Related Quality Of Life, Work Productivity, Employability, and Reduced Healthcare Resource Utilization Of Patients With Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis Treated With Golimumab: 5-Year Results From 3 Phase III Studies

Chenglong Han1, Arthur Kavanaugh2, Mark C. Genovese3, Benjamin Hsu4, Atul A. Deodhar5 and Elizabeth C. Hsia4, 1Janssen Global Services, LLC., Malvern, PA, 2University of California, San Diego, La Jolla, CA, 3Division of Rheumatology, Stanford University, Palo Alto, CA, 4Janssen Research & Development, LLC., Spring House, PA, 5Div of Arthritis & Rheum OP-09, Oregon Health & Science University, Portland, OR

Meeting: 2013 ACR/ARHP Annual Meeting

Keywords: anti-TNF therapy and quality of life, Biologics, Employment

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Session Information

Title: Spondylarthropathies and Psoriatic Arthritis: Clinical Aspects and Treatment: Psoriatic Arthritis: Clinical Aspects and Treatment I

Session Type: Abstract Submissions (ACR)

Background/Purpose:

To summarize changes from baseline in health-related quality of life (HRQOL), impact of disease on work productivity, employability, and healthcare resource utilization among patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA), and ankylosing spondylitis (AS) treated with golimumab (GLM) through 5 years.

Methods:

Patients with active RA despite MTX (GO-FORWARD), active PsA (GO-REVEAL), and active AS (GO-RAISE) were randomized to placebo (PBO) or GLM (50mg or 100mg Q4w). In GO-FORWARD, treatment also included concomitant MTX (GLM monotherapy in GO-FORWARD was not included in this analysis).  Patients randomized to PBO crossed over to GLM at wk 24, with follow-up through wk256.  HRQOL was measured using 36-item short -form of health survey (SF-36); impact of disease on work productivity was measured using a VAS scale (0=no impact, 10=impact very much); Employable was defined as being actively employed or to be able to work if a job was available. Healthcare resource utilization included the number of physician visits in the past 4 wks, ER visit in the past 3 months, and hospitalizations in the past 12 months. Changes from baseline through wk 256 in SF-36 PCS and MCS, work productivity, employability, and healthcare resource utilization were summarized from observed patients.

Results:

At baseline, both mean SF-36 PCS (30.19, 32.91, and 30.00) and MCS (43.65, 45.19, and 44.03) scores in the combined GLM group for RA, PsA, and AS, respectively were below the US norm, indicating impaired HRQOL.  Baseline percent of RA, PsA, and AS patients unemployable before retirement were 13.7%, 12.1%, and 14.1%, respectively.  At wk24, RA, PsA, and AS GLM-treated pts had statistically significant greater improvement in both mean SF-36 PCS (7.65, 7.83, and 9.36, p<0.001) and MCS (3.07, 3.84, and 4.01, p <0.05) and had a statistically significant greater mean change from baseline in reduction in impact of disease on work productivity in the combined GLM-treated patients vs PBO (−1.987, −2.242, −2.805, all p<0.001) in RA, PsA and AS, respectively.  At wk256, sustained improvement in SF-36 PCS and MCS was observed in the RA, PsA, and AS GLM-treated patients (mean change from baseline: PCS 9.3, 9.8, and 13.0 and MCS 4.5, 4.7, and 5.1, respectively), while mean change in impact of disease on work productivity for RA, PsA, and AS was −2.71, −3.0, and, −3.9, respectively.  In addition, RA, PsA, and AS patients employable at baseline remained employable (all >95%), while those unemployable at baseline became more likely to be employable (RA 33.3%, PsA 64.3%, and AS 76.5%) at Wk256.  A reduction in physician visits (RA −84%, PsA −89%, and AS −88%) was observed, as well as a reduction in the number of hospitalizations, ER visits, and days hospitalized, although these events were rare.  Patients randomized to PBO at baseline and crossed-over to active treatment achieved similar outcomes overtime as those patients who were randomized to active treatment at baseline.

Conclusion:

Golimumab-treated patients showed sustained improvement in HR QoL, reduced impact of disease on work productivity, improved employability, and less healthcare resource utilization through 5yrs.


Disclosure:

C. Han,

Janssen Global Services, LLC.,

3;

A. Kavanaugh,

Janssen Research & Development, LLC.,

9;

M. C. Genovese,

Janssen Research & Development, LLC.,

2,

Janssen Research & Development, LLC.,

5;

B. Hsu,

Janssen Research & Development, LLC.,

3;

A. A. Deodhar,

Abbvie, Amgen, Novartis, UCB, Pfizer, Janssen,

2,

UCB, Merck Sharp & Dohme, Pfizer, Abbvie, Novartis,

9;

E. C. Hsia,

Janssen Research & Develpment, LLC.,

3.

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