Golimumab induction and maintenance for moderate to severe ulcerative colitis: results from GO-COLITIS (Golimumab: a Phase 4, UK, open label, single arm study on its utilization and impact in ulcerative Colitis)

Abstract

ObjectiveGO-COLITIS aimed to measure the effectiveness of subcutaneous golimumab in tumour necrosis factor-α antagonist–naive patients with moderate to severe ulcerative colitis (UC) despite conventional treatment.DesignGO-COLITIS was an open label, single arm, phase 4 study with a pragmatic design which reflected UK clinical practice. Adult patients were eligible if diagnosed with UC ≥3 months, partial Mayo score (PMS) 4–9. Patients received subcutaneous golimumab induction (200 mg initially and 100 mg at week 2) followed at week 6 by 50 mg or 100 mg (depending on weight) every 4 weeks until week 54 with a 12-week follow-up. Efficacy was measured by PMS at baseline, week 6, 30, 54 and 66. Health-related quality of life (HRQoL; Inflammatory Bowel Disease Questionnaire (IBDQ) and EuroQol Group 5 Dimensions Health Questionnaire (EQ-5D)) was assessed at baseline, week 6 and week 54. All safety adverse events (AEs) were recorded.Results207 patients were enrolled and 205 received golimumab (full analysis set (FAS)205). At week 6, 68.8% (95% CI 62.0% to 75.1%) and 38.5% (95% CI 31.8% to 45.6%) of patients were in response and remission, respectively, using PMS. At the end of the induction phase, 140/141 patients in clinical response continued into the maintenance phase (Maintenance FAS). Sustained clinical response through week 54 was achieved in 51/205 (24.9%) of the FAS205 population and 51/140 (36.4%) of the Maintenance FAS population. Statistically significant improvements from baseline to week 6 were observed for the IBDQ total score and for each IBDQ domain score (bowel symptoms, emotional function, systemic symptoms and social function), as well as the EQ-5D index score and associated visual analogue scale score (p<0.0001). Improvement of HRQoL was sustained through week 54. Serious AEs leading to treatment discontinuation occurred in 8.8% of patients.ConclusionIn this study measuring patient-reported outcomes in patients with moderate to severe UC, golimumab induced and maintained response as measured by PMS and significantly improved quality of life measures.Trial registration numberNCT02092285; 2013-004583-56.

Fatigue in Inflammatory Bowel Diseases: Etiologies and Management

“…IBD therapy and control of inflammation is consistently associated with improvement in fatigue. In post hoc analyses of various randomized trials, treatment of CD with infliximab, adalimumab, certolizumab, or ustekimumab over placebo is associated with improvement in fatigue, as measured by the IBDQ, SF-36, EQ-5D, and FACIT [41][42][43][44] and similarly in patients with UC, upon treatment with infliximab, adalimumab, golimumab, vedolizumab, or tofacitinib [45][46][47][48][49]. Improvement in fatigue has also been seen in patients with UC who were treated with non-biologic therapies, such as immunomodulators and 5-aminosalicylates (ASA) [50].…”

Quality of life in patients with moderate to severe ulcerative colitis and the impact of treatment: A narrative review

“…A Phase 4 open label, single arm study has examined the effectiveness of golimumab in 205 patients with moderate to severe ulcerative colitis [53] . At the end of the induction phase, 140 patients achieved clinical response and continued into the maintenance phase.…”

Oral Delivery of Biologics in Inflammatory Bowel Disease Treatment

“…Tofacitinib (Agrawal et al, 2020) Non-selective Janus kinase (JAK) inhibitor Oral 0 followed by a dose of 100 mg after 2 weeks and after week 6 at a dose of 50 or 100 mg, depending on body weight, every 4 weeks (Probert et al, 2018).…”

“…Adalimumab is administered at a dose of 160 mg in the week 0, followed by 80 mg after 2 weeks and then 40 mg every 2 weeks. Certolizumab pegol is administered at a dose of 400 mg in the 0, 2, and 4 weeks followed by the same dose every 4 weeks ( Bernstein, 2015 ; National Institute for Health and Care Excellence, 2019b ) and finally, golimumab is administered at a dose of 200 mg in week 0 followed by a dose of 100 mg after 2 weeks and after week 6 at a dose of 50 or 100 mg, depending on body weight, every 4 weeks ( Probert et al, 2018 ).…”