Long-term, Real-life, Observational Study in Treating Outpatient Ulcerative Colitis with Golimumab

Abstract

Background and Aims: Several studies have found Golimumab (GOL) effective and safe in the short-term treatment of ulcerative colitis (UC), but few long-term data are currently available from real world. Our aim was to assess the long-term real-life efficacy and safety of GOL in managing UC outpatients in Italy.
 Methods: A retrospective multicenter study assessing consecutive UC outpatients treated with GOL for at least 3-month of follow-up was made. Primary endpoints were the induction and maintenance of remission in UC, defined as Mayo score ≤2. Several secondary endpoints, including clinical response, colectomy rate, steroid free remission and mucosal healing, were also assessed during the follow-up.
 Results: One hundred and seventy-eight patients were enrolled and followed up for a median (IQR) time of 9 (3-18) months (mean time follow-up: 33.1±13 months). Clinical remission was achieved in 57 (32.1%) patients: these patients continued with GOL, but only 6 patients (3.4%) were still under clinical remission with GOL at the 42nd month of follow-up. Clinical response occurred in 64 (36.4%) patients; colectomy was performed in 8 (7.8%) patients, all of them having primary failure. Steroid-free remission occurred in 23 (12.9%) patients, and mucosal healing was achieved in 29/89 (32.6%) patients. Adverse events occurred in 14 (7.9%) patients.
 Conclusions: Golimumab does not seem able to maintain long-term remission in UC in real life. The safety profile was good.

Chronic Intestinal Disorders in Humans and Pets: Current Management and the Potential of Nutraceutical Antioxidants as Alternatives

“…Anti-TNF therapies approved for the treatment of both CD and UC, include infliximab and adalimumab. Golimumab has also been evaluated for use in UC [ 26 ]. Unfortunately, one-third of patients are primary non-responders, and dose intensification is needed in 23 to 46% of responders, with drug discontinuation occurring in 5% to 12% of patients per year [ 27 ].…”

Effectiveness and Factors Associated with Response to Golimumab in Japanese Patients with Ulcerative Colitis in Real Clinical Practice: The Phoenix 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].…”