Background: Golimumab is an anti-TNF-alpha antibody approved for the treatment of Ulcerative Colitis (UC) patients. Its efficacy and safety were studied in randomized, double blind trials, but its effectiveness and safety in daily clinical practice are still little known.
The aim of the study was to assess the effectiveness and safety of Golimumab in daily clinical practice.
Methods: All UC patients from 14 centers treated with Golimumab, were consecutively enrolled starting from June 2015. Demographic information's (age, gender, smoking status) and clinical data (extension and duration of UC, previous therapies, comorbidities) at time of enrollment were collected. Clinical, laboratory and endoscopic data during the treatment with Golimumab were collected every three months.
Results: A total of 104 patients (39 males) were enrolled. The mean age at diagnosis and mean duration of disease were respectively 38.9±14.6 years, and 9.1±7.0 years. Sixty-four patients had a pancolitis (62%), 36 a distal colitis (35%) and 4 (4%) a proctitis. At enrollement, the median total and endoscopic Mayo score, ESR, C Reactive Protein and faecal calprotectine were respectively 8 (IQR 4–10), 2 (IQR 2–3), 25 (IQR 16.5–40), and 1 (IQR 0.3–2.35). Eighty-eight patients (87%) were never or ex smokers. Fifty-six patients (54%) were naïve to anti-TNF-alpha. Fifty-six patients (54%) were naïve to anti-TNF-alpha. The indications for Golimumab were: steroid-resistance in 17 pts (16%), steroid-dependence in 64 pts (62%), extraintestinal manifestations in 7 pts (7%), and anti-TNF-alpha failure in 16 pts (15%). Twenty patients (19%) were treated with concomitant immunosuppressants. After 3 months of therapy, a total of 48 patients (46%) were responder (reduction of at least 3 points of partial Mayo score), and 37 of them were in clinical remission (total Mayo score ≤2). After 3 months of therapy a significant reduction of the median values of the total Mayo score (5; IQR 2–7, p<0.0001), endoscopic Mayo score (1.5; IQR 2–2.25, p<0.0001), ESR (18; IQR 12.5–30, p<0.01), and CRP (median value 0.5, IQR 0.3–1.2, p<0.01) was observed. At univariate analysis for predictive factors of response (gender, duration of disease, smoking status, previous therapies with anti-TNF, and combo therapy), only the naïve status to anti-TNF-alpha was associated with a better outcome (p=0.01). A total of 7 adverse events (no serious) were observed. Six non-responder patients underwent to colectomy. All of them were refractory to other anti-TNF-alpha.
Conclusions: Golimumab is effective and safe in induction of response in UC patients in daily clinical practice.