Effect of golimumab on health-related quality of life, other patient-reported outcomes and healthcare resource utilization in patients with moderate-to-severe ulcerative colitis: a real-world multicenter, noninterventional, observational study in Greece

Abstract

Background and aims This real-world study assessed the impact of golimumab on health-related quality of life (HRQoL) and other patient-reported outcomes (PROs) in patients with ulcerative colitis over 12 months in Greece. Methods GO-LIFE was a noninterventional, prospective, multicenter, 12-month study. Patients who had moderately-to-severely active ulcerative colitis were naïve to antitumor necrosis factor (anti-TNFα) therapy and had failed previous conventional therapy. Patients received golimumab as per label. The primary endpoint was patients achieving inflammatory bowel disease questionnaire 32-item (IBDQ-32) remission at 12 months. Secondary endpoints, at 6 and 12 months, included patients achieving IBDQ-32 response; the mean change in the treatment satisfaction questionnaire for medication (TSQM) and the work productivity and activity impairment in ulcerative colitis (WPAI:UC) questionnaires; changes in healthcare utilization; patients achieving clinical response and remission; adherence rates and the percentage of patients who discontinued golimumab. Results IBDQ-32 remission was achieved by 76.9% of patients at 12 months. Mean changes in all TSQM and WPAI:UC domain scores at 12 months were statistically significant. Clinical remission was achieved by 49.4 and 50.6% of patients at 6 and 12 months, and clinical response by 59.3 and 56.8%, respectively. All patients but one (80/81) had high adherence (≥80%) to golimumab treatment over 12 months. Ulcerative colitis-related health care resource utilization was reduced during the follow-up period. Conclusions In real-world settings, treatment with golimumab resulted in meaningful improvements in HRQoL and other PROs, and in disease activity at 6 and 12 months in patients with moderately-to-severely active ulcerative colitis who were naïve to anti-TNFa therapy.

Work productivity and activity impairment in patients with chronic rhinosinusitis undergoing endoscopic sinus surgery—A prospective, multi‐institutional study

“…Although normative data are lacking, control populations of US adults identified mean productivity impairment of 6.9% to 7.1% and mean activity impairment of 14.0% to 17.3% 41,42 . Mean preoperative productivity impairment in our medically refractory CRS cohort was 34.4%, lower than that seen for Crohn disease (CD, 51.9%) but higher than that for ulcerative colitis (UC, 24.7%), chronic obstructive pulmonary disease (COPD, 24.9%), heart failure (HF, 29.1%), rheumatoid arthritis (RA, 29.1%), and asthma (15.8%‐16.8%) 43–48 . Mean activity impairment in our cohort was 36.4%, lower than that for CD (56.6%), UC (43.4%), HF (43.2%), and COPD (39.9%), but higher than for RA (33.3%) and asthma (28.1%‐28.4%) 43–48 .…”

“…41,42 Mean preoperative productivity impairment in our medically refractory CRS cohort was 34.4%, lower than that seen for Crohn disease (CD, 51.9%) but higher than that for ulcerative colitis (UC, 24.7%), chronic obstructive pulmonary disease (COPD, 24.9%), heart failure (HF, 29.1%), rheumatoid arthritis (RA, 29.1%), and asthma (15.8%-16.8%). [43][44][45][46][47][48] Mean activity impairment in our cohort was 36.4%, lower than that for CD (56.6%), UC (43.4%), HF (43.2%), and COPD (39.9%), but higher than for RA (33.3%) and asthma (28.1%-28.4%). [43][44][45][46][47][48] Evaluation among our CRS cohort identified mean 6-month productivity improvement of 20.0%, lower than posttreatment productivity improvement in RA (32.6%) and CD (21.4%), but higher than that for UC (12.6%) and asthma (2.8%).…”

“…[43][44][45][46][47][48] Mean activity impairment in our cohort was 36.4%, lower than that for CD (56.6%), UC (43.4%), HF (43.2%), and COPD (39.9%), but higher than for RA (33.3%) and asthma (28.1%-28.4%). [43][44][45][46][47][48] Evaluation among our CRS cohort identified mean 6-month productivity improvement of 20.0%, lower than posttreatment productivity improvement in RA (32.6%) and CD (21.4%), but higher than that for UC (12.6%) and asthma (2.8%). [43][44][45]49 Our cohort also identified a mean 6-month activity improvement of 20.5%, lower than the posttreatment activity improvement in RA (38.8%) and CD (25.9%), but higher than that for UC (19.5%) and asthma (4.5%).…”

“…[43][44][45][46][47][48] Evaluation among our CRS cohort identified mean 6-month productivity improvement of 20.0%, lower than posttreatment productivity improvement in RA (32.6%) and CD (21.4%), but higher than that for UC (12.6%) and asthma (2.8%). [43][44][45]49 Our cohort also identified a mean 6-month activity improvement of 20.5%, lower than the posttreatment activity improvement in RA (38.8%) and CD (25.9%), but higher than that for UC (19.5%) and asthma (4.5%). [43][44][45]49 Comparative data are still nominal and many studies reported outcomes from medical management, so future studies may benefit from utilizing the WPAI for a more standardized comparison of outcomes among patients with CRS after ESS.…”

Autoinflammatory Diseases and Cytokine Storms—Imbalances of Innate and Adaptative Immunity

“…This drug, with anti-inflammatory and immunosuppressive functions, also has important collateral effects, especially in pediatric age since it blocks growth, delays bone development, and causes weight gain and mood instability. Therefore, the identification of cytokines as therapeutic targets has great relevance: examples of this are canakinumab and anakinra, inhibitors of soluble IL-1β and its receptor, respectively; infliximab and certolizumab, which bind TNF-α; tocilizumab, which blocks IL-6 ( Table 1 ) [ 69 , 70 , 71 , 72 , 73 , 74 , 75 , 76 , 77 , 78 , 79 , 80 , 81 , 82 , 83 , 84 , 85 , 86 , 87 , 88 , 89 , 90 , 91 , 92 , 93 , 94 , 95 , 96 , 97 , 98 , 99 , 100 , 101 , 102 , 103 , 104 , 105 , 106 , 107 , 108 , 109 , 110 , 111 , 112 , 113 , 114 , 115 , 116 , 117 , …”