Letter: effectiveness of golimumab to induce remission in outpatient ulcerative colitis in Italy

Rutgeerts et al. found recently that intravenous (IV) golimumab induction therapy achieved combined clinical remission and clinical response in 13% and 28% of ulcerative colitis (UC) patients respectively,1 lower than that reached in the subcutaneous (SC) induction study.2 While controlled trials are investigating the best route of administration to induce UC remission, no data are currently available about the use of SC golimumab to inducing UC remission in real life. Subcutaneous golimumab has recently becomes available also in Italy (January 2015).3 We reviewed therefore the effectiveness and safety of SC golimumab in a cohort of UC out-patients, refractory to standard treatments, enrolled in primary gastroenterology centres located in Apulia, Southern Italy. Twenty-three patients (11 males and 12 females, median age 44 years, range 21–65 years) were enrolled from April to September 2015, four of them previously treated with infliximab. Clinical activity severity was scored according to the Mayo score.4 Patients were clinically assessed at entry, after 2, 6 and 8 weeks. The primary endpoint was clinical remission, defined as a partial Mayo score ≤2, at week 8. Secondary endpoints included clinical response to treatment, defined as a partial Mayo score reduction in at least two points, and safety of the drug, defined as occurrence of adverse events during induction. The induction dose of golimumab used was 200 mg at week 0, 100 mg at week 2, and then 100 or 50 mg at week 6 according to body weight. Logistic regression analysis identified factors associated with clinical remission, including age at the time of enrolment, disease duration, Mayo score, Mayo subscore for endoscopy, and CRP and faecal calprotectin values. Clinical remission was obtained in eight (34.8%) patients. Clinical response to treatment was obtained in all patients. At univariate analysis, female sex and Mayo score ≤8 at entry were significantly related with clinical remission. After logistic regression only Mayo score ≤8 was significantly associated with clinical remission (Table 1). No side-effects were recorded during the induction course. These real-life results coming from primary gastroenterology centres confirm that the SC route is an effective route of administration for golimumab, obtaining good rates of remission, even after 8 weeks of treatment. It is noteworthy that the Mayo score was the single independent factor influencing the outcome in those patients. Declaration of personal and funding interests: None.