Effectiveness of golimumab in patients with ulcerative colitis: results of a real-life study in Switzerland

Abstract

Background: Tumor necrosis factor (TNF) inhibitors have improved treatment of ulcerative colitis (UC), but loss of response remains a frequent problem. The anti-TNF agent, golimumab, was approved in Switzerland for the treatment of UC in 2014. This study aims to summarize the experience of golimumab in a real-world setting in Switzerland. Methods: We analyzed real-world data from 1769 UC patients from the Swiss Inflammatory Bowel Disease Cohort (SIBDC) study and performed a chart review of golimumab-treated patients. We extracted the partial Mayo score at t0 (baseline), t1 (2–16 weeks), t2 (17–35 weeks), and t3 (36–89 weeks). The primary endpoint was clinical response at t1, defined as marked improvement in partial Mayo score and objective parameters. Clinical remission was defined as resolution of symptoms and normalization of objective parameters. Results: Our chart review included 103 UC patients with golimumab treatment (5.8% of all SIBDC UC patients); only 16 (15.5%) were anti-TNF naïve. Sixty-three patients remained on golimumab (61.2%) after 180 days, 51 (44.7%) after 365 days, and 34 (33%) after 630 days after the start of treatment. Upon golimumab treatment, the partial Mayo score decreased from 4 [interquartile range (IQR): 2–6] at t0 to 2 (IQR: 0–4) at t1, 1 (IQR: 0–3.5) at t2, and 1 (IQR: 0–3) at t3 ( p < 0.001 for all comparisons with t0). The primary endpoint, clinical response at t1, could be evaluated in 52 patients and was met in 15 individuals (28.8%). Clinical remission at t1 was observed in 8 out of 52 patients (15.4%). Golimumab was generally well tolerated, one patient developed meningitis. The most frequent reasons to stop treatment were primary and secondary non-response. Conclusion: Golimumab was used in 5.8% of Swiss UC patients, mainly in biologic-experienced individuals. Golimumab treatment was associated with a sustained reduction of symptoms and clinical response in approximately 30% of patients. [ClinicalTrials.gov identifier: NCT00488631]

Patient-reported continuous clinical response to golimumab in adults with moderately to severely active ulcerative colitis: results from GO OBSERVE, a real-world European observational study

“…This patient population difference may explain, at least in part, the higher induction response rate in PURSUIT-SC compared with GO OBSERVE, as it is well established that UC patients with previous exposure to biological therapy have been shown to be less responsive to biological therapy. The induction response rate observed in the present study was within the range of induction response rates reported in previous real-world studies with GLM in UC [9–13].…”

“…within the range of induction response rates reported in previous real-world studies with GLM in UC [9][10][11][12][13].…”

Effectiveness and Factors Associated with Response to Golimumab in Japanese Patients with Ulcerative Colitis in Real Clinical Practice: The Phoenix Study

“…In addition, GLM persistence rates at 1 and 2 years after initiation were 54.5% and 45.4%, respectively. Other real-world cohort studies of GLM reported that the treatment persistence rates ranged from 44.7% to 63% at 1 year [ 8 , 11 , 15 – 17 , 20 , 23 ] and 22.5–46% at 2 years [ 15 , 16 ]. Thus, the persistence rates of GLM in Japanese patients with UC have a similar tendency to that reported in a previous study.…”

“…GLM is a subcutaneously administered fully human anti-tumor necrosis factor-α (TNF-α) antibody. Several clinical trials [2,3] and real-world data [4][5][6][7][8][9][10][11][12][13][14][15][16][17][18][19][20][21] outside Japan have demonstrated the clinical efficacy and safety of GLM in induction and maintenance therapy in patients with moderate-to-severe active UC. In addition, the PURSUIT-J study showed that GLM treatment for 54 weeks maintained clinical efficacy and safety through week 54 among induction responders in biologic-naïve Japanese patients with moderate-to-severe active UC [22].…”

Effectiveness and Safety Profiles of Biological Therapies in Inflammatory Bowel Disease: Real Life Data from an Active Pharmacovigilance Project

“…Furthermore, switchers/swappers and those who experienced ADRs were associated with a higher risk of non-persistence: 33% of patients switched to another biologic at least once, especially patients treated with anti-TNFα, as observed in other studies [ 28 , 42 , 43 ]. The treatment failures were mainly reported for GOL, which consistently remained the least frequently used anti-TNFα drug in UC and was used more frequently as a second- and third-line therapy [ 44 ]. Recent studies confirm that UC patients treated with GOL after previous failure of other anti-TNFα drugs had significantly worse outcomes [ 45 , 46 ], whereas the use of the i.v.…”