Background/Purpose:  Golimumab (GLM) has shown its efficacy and safety in various randomized clinical trials with patients eligible for clinical studies. Data from patient-reported outcomes (PROs) and socio- and health-economic parameters in daily clinical practice in Germany are still lacking.

Methods:  Patients were enrolled in the non-interventional prospective study GO-NICE at 158 German sites to explore the disease activity by DAS28, PsARC and BASDAI, the quality of life, fatigue, days of sick leave, quality of work, as well as safety.

Results: 1,613 patients were enrolled. A total of 1,458 (90.4%) patients had a baseline assessment and at least one additional visit and were thus eligible for final analysis. Proportions of patients who completed the study and were still on treatment with GLM at the end of month 24 were as follows: RA (44.9%), PsA (54.6%), and AS (59.2%). At baseline (BL): RA: n=474, mean age 54.9 yrs, 72.8% female, 64.7% biologic-naïve, PsA: n=501, mean age 50.5 yrs, 54.1% female, 56.5% biologic-naïve AS: n=483, mean age 43.6 yrs, 66.5% male, 61.0% biologic-naïve. An improvement of quality of life (EQ-5D-3L) was seen after 6 months and was maintained over 24 months. The patients’ health state today (EQ VAS) improved from 51.0 (BL) to 63.4 (RA-), from 48.4 to 64.3 (PsA-) and from 46.8 to 66.5 (AS-patients), the functional ability (FFbH) improved significantly (p<0.0001 vs. BL) from baseline 68.2 to 76.1 points (RA-), from 69.0 to 76.8 (PsA-) and from 69.0 to 78.5 (AS-patients), and the mean FACIT-Fatigue score increased significantly (p<0.0001 vs. BL) from baseline 32.4 to 38.3 points (RA), from 30.0 to 35.9 points (PsA), and from 29.9 to 37.9 points (AS) over the time until month 24. Days of absenteeism from work due to the underlying disease in the last 6 months were evaluated at BL and after 2 years of treatment. These dropped from 16.2 to 4.1 (RA), from 10.6 to 2.0 (PsA) and from 14.7 to 3.9 days (AS). Days with reduced productivity dropped in patients with RA from 64.5 days (BL) to 29.9 days (month 12) to 23.1 days (month 24), in patients with PsA from 66.6 to 26.6 to 19.8 days, and in patients with AS from 66.3 to 26.1 to 17.3 days within the past six months. The disease impact on quality of work, determined by 0 (no impact) to 10 (very severe impact) decreased within 24 months of treatment from 4.8 to 2.4 (RA-), from 4.8 to 2.2 (PsA-) and from 4.8 to 2.0 (AS-patients) referred to the past 6 months. The proportion of patients who required hospitalization decreased from 10.6% to 1.6%, physiotherapy from 28.8% to 16.6%, and massage treatment from 10.9% to 6.4% within the two years of treatment. The safety profile of GLM was consistent with that observed in other studies of GLM. 4 deaths occurred: 1 patient unlikely related and 3 patients not drug-related to the treatment of GLM

Conclusion: GLM SC once monthly was an effective treatment in patients with RA, PsA and AS in a real-life setting in Germany. Treatment with GLM showed remarkable improvements in clinical effectiveness, patient-reported quality of life parameters and socio- and health economic and. No new safety signals were detected.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/golimumab-improves-patient-reported-outcomes-and-socio-and-health-economic-parameters-in-patients-with-rheumatoid-arthritis-ra-psoriatic-arthritis-psa-and-ankylosing-spondylitis-as-results-f/