Background/Aims Filgotinib is an oral, once-daily, Janus kinase 1 preferential inhibitor approved for the treatment of ulcerative colitis (UC). This study aimed to assess symptomatic response with filgotinib 200 mg (FIL200) according to disease severity using baseline partial Mayo Clinic Score (pMCS).
Methods In the phase 2b/3 SELECTION study (NCT02914522), adults with moderate-to-severe UC were randomized to receive FIL200, filgotinib 100 mg, or placebo for 11 weeks in induction studies A (biologic-naive) and B (biologic-experienced). In this post hoc analysis, symptomatic remission (Mayo rectal bleeding subscore of 0 and stool frequency subscore ≤ 1) rates were assessed daily from baseline to day 15 and fortnightly from week 2 to week 10 by baseline pMCS (pMCS ≥ 7, pMCS < 7) in patients who received induction FIL200.
Results Of those who received FIL200 in induction studies A and B, 90 and 148 patients had a pMCS ≥ 7, and 155 and 114 had a pMCS < 7, respectively. Symptomatic remission rates were generally significantly higher in the pMCS < 7 than ≥ 7 group from day 2–15 (day 2: 8.4% vs. 1.1%, P= 0.009 [induction study A]; 8.8% vs. 0.7%, P= 0.004 [induction study B]). However, by week 10, there was no longer a significant difference in the rates between the pMCS ≥ 7 and < 7 groups (43.3% vs. 54.8%, P= 0.124 [induction study A]; 26.4% vs. 39.5%, P= 0.099 [induction study B]).
Conclusions Symptomatic response to FIL200 occurred more rapidly in the less severe disease groups than in the more severe disease groups; however, regardless of disease severity, both groups benefited from continued FIL200 treatment.
Antonio Tursi, Daniele Piovani, Giovanni Brandimarte, Francesco Di Mario, Walter Elisei, Marcello Picchio, Gisella Figlioli, Gabrio Bassotti, Leonardo Allegretta, Maria Laura Annunziata, Mauro Bafutto, Maria Antonia Bianco, Raffaele Colucci, Rita Conigliaro, Dan L. Dumitrascu, Ricardo Escalante, Luciano Ferrini, Giacomo Forti, Marilisa Franceschi, Maria Giovanna Graziani, Frank Lammert, Giovanni Latella, Daniele Lisi, Giovanni Maconi, Debora Compare, Gerardo Nardone, Lucia Camara de Castro Oliveira, Chaves Oliveira Enio, Savvas Papagrigoriadis, Anna Pietrzak, Stefano Pontone, Ieva Stundiene, Tomas Poškus, Giuseppe Pranzo, Matthias Christian Reichert, Stefano Rodino, Jaroslaw Regula, Giuseppe Scaccianoce, Franco Scaldaferri, Roberto Vassallo, Costantino Zampaletta, Angelo Zullo, Erasmo Spaziani, Stefanos Bonovas, Alfredo Papa, Silvio Danese, DICA International Group
Intest Res 2025;23(1):96-106. Published online August 12, 2024
Background/Aims Patients with diverticular disease (DD) frequently have abnormal bowel movements. However, it is unknown whether the entity of these alterations is associated with the severity of DD. We aimed to assess bowel habits and their relationship with the severity of DD according to Diverticular Inflammation and Complication Assessment (DICA) classification, Combined Overview on Diverticular Assessment (CODA) score, and fecal calprotectin (FC).
Methods An international, multicenter, prospective cohort study was conducted in 43 centers. A 10-point visual analog scale (VAS) was used to assess the severity of constipation and diarrhea. The association of constipation and diarrhea with DICA classification, CODA score, and basal FC was tested using non-parametric tests. Survival methods for censored observations were applied to test the association of constipation and diarrhea with the incidence of acute diverticulitis over a 3-year follow-up.
Results Of 871 patients with DD were included in the study. Of these, 208 (23.9%) and 199 (22.9%) reported a VAS score for constipation and diarrhea at least 3 at baseline, respectively. Higher constipation and diarrhea scores were associated with increasing DICA classification, CODA score and basal FC (P< 0.001). Constipation and diarrhea scores were independently associated with an increased hazard of developing acute diverticulitis (hazard ratio [HR]constipation = 1.15 per 1-VAS point increase, 95% confidence interval [CI], 1.04–1.27; P=0.004; and HRdiarrhea =1.14; 95% CI, 1.03–1.26; P=0.014, respectively).
Conclusions In newly diagnosed patients with DD, higher endoscopic and combined scores of DD severity were associated with higher scores of constipation and diarrhea at baseline. Both constipation and diarrhea were independent prognostic factors of acute diverticulitis.
Citations
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Global guidelines on diverticular disease of the colon: the Fiesole Consensus report Antonio Tursi, Giovanni Brandimarte, Francesco Di Mario, Wenjie Ma, Juozas Kupcinskas, Jaroslaw Regula, Giovanni Maconi, Peter Malfertheiner, Giovanni Barbara, Neil Stollman, Savvas Papagrigoriadis, Thomas Golda, Antonio Amato, Mauro Bafutto, Gabrio Basso Gut.2025; : gutjnl-2025-336902. CrossRef
Silvio Danese, Rupa Banerjee, JR Fraser Cummings, Iris Dotan, Paulo G Kotze, Rupert Wing Loong Leong, Kristine Paridaens, Laurent Peyrin-Biroulet, Glyn Scott, Gert Van Assche, Jan Wehkamp, Jesús K Yamamoto-Furusho
Intest Res 2018;16(4):522-528. Published online October 16, 2018
Symptomatic ulcerative colitis (UC) can be a chronic, disabling condition. Flares in disease activity are associated with many of the negative impacts of mild-to-moderate UC. Rapid resolution of flares can provide benefits to patients and healthcare systems. i Support Therapy–Access to Rapid Treatment (iSTART) introduces patient-centered care for mild-to-moderate UC. iSTART provides patients with the ability to self-assess symptomology and self-start a short course of second-line treatment when necessary. An international panel of experts produced consensus statements and recommendations. These were informed by evidence from systematic reviews on the epidemiology, mesalazine (5-ASA) treatment, and patient use criteria for second-line therapy in UC. Optimized 5-ASA is the first-line treatment in all clinical guidelines, but may not be sufficient to induce remission in all patients. Corticosteroids should be prescribed as second-line therapy when needed, with budesonide MMX® being a preferred steroid option. Active involvement of suitable patients in management of UC flares has the potential to improve therapy, with patients able to show good accuracy for flare self-assessment using validated tools. There is a place in the UC treatment pathway for an approach such as iSTART, which has the potential to provide patient, clinical and economic benefits.
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