Effectiveness and Safety of Golimumab in Treating Outpatient Ulcerative Colitis: A Real-Life Prospective, Multicentre, Observational Study in Primary Inflammatory Bowel Diseases Centers

Abstract


 
 
 
 
 
 Background & Aims: Golimumab (GOL) has been recently approved in Italy for the treatment of ulcerative colitis (UC) unresponsive to standard treatments. Our aims were to assess the real-life efficacy and safety of GOL in managing UC outpatients in Italian primary Inflammatory Bowel Diseases (IBD) centres.Methods: Consecutive UC outpatients with at least 3-months follow-up were enrolled. Primary end-point was the induction and maintenance of remission in UC, defined as Mayo score ≤2, at 6-month follow-up.Results: Ninety-three patients were enrolled. At 6-month follow-up, remission was obtained in 34 (36.5%) patients. Shorter duration of disease was the only significant predictive factor of remission. Clinical response was achieved in 60 (64.5%) patients, while mucosal healing (MH) was obtained in 18 (19.3%) patients. Sixteen (47.0%) patients under remission were still under therapy with steroids. C-reactive protein and fecal calprotectin significantly dropped during the follow-up (p<0.001 for both proteins). Adverse events occurred in 4 (4.3%) patients and 3 of them stopped treatment. Colectomy was performed in only one patient (1.1%).Conclusions: Golimumab seems to be safe and effective in inducing and maintaining remission in real life UC outpatients.Abbreviations: ADA: Adalimumab; CRP: C-reactive Protein; GOL: Golimumab; FC: Fecal calprotectin; IBD: Inflammatory Bowel Diseases; IFX: Infliximab; IQR: Interquartile range; MH: Mucosal Healing; SC: Subcutaneously; TBC: Tuberculosis; TNFα: Tumor necrosis factor α; UC: Ulcerative Colitis.
 
 
 
 
 
 
 
 
 
 
 

Clinical efficacy and safety of golimumab in biologically experienced and naive patients with active ulcerative colitis: A real‐life experience from two Italian IBD centers

“…reported a 12‐week CR rate (defined as Mayo score ≤2) of 44.1% and a 6‐month CR rate of 36.5% among 93 patients included in a multicenter study . In our study we found a 12‐week CR rate of 47%, comparable to the results of some (but not all) previously published reports. Of note, this lack of concordance may be explained by the different definitions of CR used by different authors.…”

“…Reporting adverse events in previous real‐life experiences with golimumab was not homogenous across studies. Some did not report any adverse events, while others reported rates of adverse events requiring treatment discontinuation of 0%, 2.8%, 3.2% and 9%, respectively. In our series the overall adverse event rate was 10% over the whole study period, with 8% requiring the withdrawal of golimumab (Table ).…”

“…Among the real‐life series available to date, most did not evaluate golimumab outcomes during the long‐term follow‐up . In their study of 33 patients (of whom six were experienced), Tursi et al .…”

“…As endoscopic monitoring of response was performed only in selected cases according to the treating physician's judgement, we did not include these data in formal statistical analyses. Moreover, to the best of our knowledge, among the real‐life experiences with golimumab available to date, only a few studies employed systematic endoscopic assessment of clinical response or objective laboratory markers by study protocol . Third, the decision on whether to discontinue treatment was based on the treating physician's judgment and not on standardized criteria.…”

“…Despite the increasing experiences of treatment with golimumab, only few real‐life series have been described so far, mostly including biological naive patients rather than experienced patients and with a short follow‐up period …”