Introduction: For 30 years, 5-aminosalicylic acid (5-ASA) has been the backbone of therapeutic management in patients with ulcerative colitis (UC). In the biologic era, it still remains the treatment ...of choice in mild-to-moderate UC. Positioning of this therapeutic class in moderate-to-severe UC is less clear.
Areas covered: Several studies demonstrated the ability of 5-ASA to induce endoscopic remission to a similar extent as anti-TNF therapy on the moderate segment of UC. Histologic remission is achieved after induction in up to 45% of patients treated with topical 5-ASA and 30% with oral formulations. Aminosalicylates offer a favorable safety profile compared to that of immunomodulators and biologics. High-dose 5-ASA therapy may be a valuable option for patients with moderately active disease, and physicians should weigh the pros and cons of this strategy in selected patients. Whether aminosalicylates should be continued in combination with thiopurines or biologic therapy remains under debate.
Expert opinion: In the era of biologics, aminosalicylates remain the first-line therapy in patients with mild UC, and have to be considered in case of moderate UC, given their favorable risk-benefit profile. We suggest that 5-ASA should be used in moderate patients without poor prognostic factors, while biologics should be preferred otherwise.
Subjects who had clinical benefit from the maintenance period received 300mg SC Q4W from W52 to W104. Among the W12 miri induction endoscopic improvers, IBDQ response rates at W52 were 75.6% (31/41) ...and 80.4% (37/46) and IBDQ remission rates were 65.9% (27/41) and 67.4% (31/46) in the IV-C and SC groups, respectively. At W104, the IBDQ response rates were 81.8% (27/33) and 78.0% (32/41) and IBDQ remission rates were 69.7% (23/33) and 56.1% (23/41) in the IV-C and SC groups, respectively. Week 52 and Week 104 IBDQ Outcomes in miri induction Week 12 Endoscopic Improvers Week 12 Endoscopic Improverse Week 52 Week 104 Week 52 Week 104 Miri IV-C N=41 Miri IV-C N=33 Miri SC N=46 Miri SC N=41 Total IBDQ scorea, mean (SD) 188.5 (26.6) 187.4 (21.8) 180.8 (25.4) 173.7 (32.1) IBDQ responseb, n (%) 31 (75.6) 27 (81.8) 37 (80.4) 32 (78.0) IBDQ remissionc, n (%) 27 (65.9) 23 (69.7) 31 (67.4) 23 (56.1) IBDQ score change from baseline a d mean 64.3 67.1 66.4 57.9 IBDQ Domain Scoresa, mean (SD) Bowel symptoms 58.6 (8.8) 58.8 (6.5) 57.3 (8.0) 54.3 (9.8) Systemic symptoms 27.7 (5.4) 26.8 (5.1) 25.8 (5.4) 24.7 (6.6) Emotional function 70.5 (11.1) 70.0 (9.9) 67.1 (11.0) 65.0 (13.1) Social function 31.8 (3.9) 31.8 (3.34) 30.6 (4.2) 29.7 (5.3) aMean and (SD) for scores and changes in scores do not utilize imputation and therefore are based on patients with observed data at the indicated timepoint (IV week 52 N=35; IV week 104 N=29; SC week 52 N=41; SC week 104 N=33). bIBDQ response: ≥16-point improvement in IBDQ score. cIBDQ remission: total IBDQ score ≥170. dChange from baseline. eEndoscopic improvement: ≥1 point improvement in SES-CD at Week 12.
Introduction: Mirikizumab (miri) treatment improved quality of life in patients with moderately-to-severely active Crohn’s disease (CD) through Week 52 (W52) as assessed by Medical Outcomes 36-Item ...Short Form Health Survey (SF-36) scores in the Phase 2 randomized, double-blind, parallel, placebo (PBO)-controlled study (SERENITY/NCT02891226). SF-36 Physical (PCS) and Mental (MCS) Component Summary, and 8 domain scores (physical functioning, role-physical, role-emotional, bodily pain, vitality, social functioning, mental and general health) were evaluated up to W104 and summarized by randomized treatment (i.e. pooled all IV and all SC) from W12-52 among endoscopic improvers at W12 who were rerandomized into maintenance and went onto the extension period. Conclusion: Treatment with miri is associated with a sustained improvement in quality of life as measured by SF-36 from W52 to W104 in patients with moderately-to-severely active CD.Table 1 Observed mean CFBL, (SD) Week 12 Endoscopic Improvers a Week 52 Week 104 Week 52 Week 104 Miri IV-C N=35 Miri IV-C N=29 Miri SC N=41 Miri SC N=38 PCS 10.47 (8.72) 11.68 (6.60) 10.70 (7.88) 9.96 (8.17) MCS 8.49 (11.30) 9.32 (12.35) 11.45 (11.42) 10.43 (11.59) Domain Scores Physical functioning 17.29 (18.48) 19.14 (17.17) 22.93 (22.30) 22.37 (22.83) Role-physical 30.89 (24.95) 32.33 (20.87) 32.01 (28.24) 26.64 (29.27) Role-emotional 13.10 (25.59) 16.95 (26.12) 22.36 (21.36) 19.96 (22.39) Bodily pain 27.20 (29.04) 35.28 (23.86) 34.61 (25.30) 31.00 (27.87) Vitality 28.04 (27.39) 26.72 (29.41) 30.79 (26.16) 29.11 (26.17) Social functioning 29.29 (29.85) 31.90 (24.91) 31.10 (24.71) 25.99 (30.26) Mental health 15.57 (20.39) 17.76 (23.59) 21.83 (23.63) 20.79 (22.74) General health 23.91 (20.38) 26.28 (21.70) 21.02 (18.31) 22.55 (18.38) aEndoscopic improvement: ≥1 point improvement in SES-CD at Week 12.
Of the W12 endoscopic improvers, 74 finished W52 maintenance and entered the extension period (W52-W104) where 68 completed treatment through W104. CDAI and PRO remission were sustained through W104, ...with no differences observed in pts who received either IV-C and SC miri treatments during maintenance and continued into the extension period.Table 1. Abbreviations: CD = Crohn’s disease; SF = stool frequency; AP = abdominal pain; CDAI = Crohn’s Disease Activity Index; PRO = patient-reported outcomes.
Introduction: We explored the potential relationship between early histologic and endoscopic responses on long term clinical outcomes after 2 years of mirikizumab (miri) treatment in a Phase 2 trial ...in patients with moderately-to-severely active Crohn’s disease (CD). Among patients receiving miri with active histological disease at baseline, we determined the relationship between histologic and/or endoscopic response or remission at W12 and W52 with clinical remission based on the Crohn’s Disease Activity Index (CDAI), patient-reported outcomes (PRO), and hospitalization rates at W104. AP= abdominal pain; CDAI= Crohn’s Disease Activity Index; GHAS= Global Histologic Disease Activity Score; PRO= patient-reported outcomes; N=number of patients in the histologic/endoscopic response group; n = number of patients in the specified category; RHI= Robarts Histologic Index; SES-CD=Simple Endoscopic Score for Crohn’s Disease; SF= stool frequency. aPatients with Active histologic disease at Baseline and with both Endoscopic and Histologic measures at Week 12. bDefined as serious adverse event due to hospitalization.
Introduction
Real-world data are used to inform decision-makers and optimise therapeutic management for patients with ulcerative colitis (UC) and Crohn’s disease (CD). We analysed data on the ...epidemiology (by using proxies of prevalence and incidence), patient characteristics, treatment patterns and associated healthcare direct costs for the management of patients with UC and patients with CD in Italy.
Methods
This retrospective observational study used administrative databases from eight Local Health Units geographically distributed across Italy. Adult patients with a hospitalisation and/or an exemption for UC or CD were included. Study outcomes were summarised descriptively, and limited statistical tests were performed.
Results
At baseline, 9255 adults with UC and 4747 adults with CD were included. Mean (standard deviation) age at inclusion was 54.0 (18.4)/48.6 (18.1) years, for UC/CD. The estimated average incidence of UC and CD for the period 2013–2020 was 36.5 and 18.7 per 100,000, respectively. The most frequently prescribed drug category for patients with UC/CD was conventional treatment mesalazine and topical corticosteroids (67.4%/61.1%), immunomodulators and systemic corticosteroids (43.2%/47.7%), followed by biologic treatments (2.1%/5.1%). The mean annual total direct cost per patient was 7678 euro (€), for UC and €6925 for CD.
Conclusion
This analysis, carried-out in an Italian clinical setting, may help to optimise therapy for patients with UC and CD and provide relevant clinical practice data to inform decision-makers.
Plain Language Summary
Data from clinical practice can be used to guide healthcare decisions and optimise treatment for patients with ulcerative colitis and Crohn’s disease. This study used anonymised patient information from almost four million individuals across Italy to describe the epidemiology, patient characteristics, treatment patterns and healthcare costs of patients with ulcerative colitis and Crohn’s disease. Adults with an Italian National Health System code in their records associated with the diagnosis of ulcerative colitis or Crohn’s disease were included. Baseline characteristics were balanced between groups and rates of perceived incidence were numerically similar to the results reported in similar Italian studies. This study found that patients with ulcerative colitis and Crohn’s disease were most often prescribed conventional treatments, and biological treatments were least-commonly prescribed. More than half of patients with ulcerative colitis and nearly half of those with Crohn’s disease were persistent with first (index) treatment of mesalazine and topical corticosteroids and with biologic index treatment during the follow-up period. Switch occurred in up to approximately a quarter of patients with ulcerative colitis and Crohn’s disease. The main factors that predicted switch were index biologic for ulcerative colitis and baseline comorbidities for Crohn’s disease. The average direct cost per patient in 1 year was 7678 euro (€) for ulcerative colitis and €6925 for Crohn’s disease. The results of this analysis may help to optimise therapy for patients with ulcerative colitis and Crohn’s disease, and to inform decision-makers in healthcare systems on which treatment options provide value for money and benefit patients.
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