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 three phase III studies

Background: To summarize changes from baseline in health-related quality of life (HRQOL), impact of disease on work productivity, employability, and healthcare resource utilization (HRU) among patients with RA, PsA and 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 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 week 24, with follow-up through week 256. HRQOL was measured using 36-item short-form health survey (SF-36); impact of disease on work productivity was measured using 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. HRU included number of physician visits in the past 4 weeks, ER visit in the past 3 months, and hospitalizations in the past 12months. Changes from baseline through week 256 in SF-36 PCS and MCS, work productivity, employability, and HRU 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 combined GLM group for RA, PsA and AS, respectively were below the US norm, indicating impaired HRQOL. Baseline percentage of RA, PsA and AS patients unemployable before retirement were 13.7%, 12.1% and 14.1%. At week 24, 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 GLMtreated patients vs PBO (-1.987, -2.242, -2.805, all P<0.001) in RA, PsA and AS. At week 256, 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), while mean change in impact of disease on work productivity for RA, PsA, and AS was -2.71, -3.0 and -3.9. 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 week 256. 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 HRQoL, reduced impact of disease on work productivity, improved employability, and less HRU through 5 years.