Ferring demonstrates effectiveness of a treat-to-target approach in mild-to-moderate ulcerative colitis in first major study
Natalia Elliot | October 3, 2024 | News story | Research and Development | Ferring Pharmaceuticals, Gastrointestinal tract, ulcerative colitis
1 October 2024 – Saint-Prex, Switzerland – Ferring Pharmaceuticals today announces results from the OPTIMISE study showing the first real-world evidence of the effectiveness of a treat-to-target (T2T) approach based on faecal calprotectin (FC) in patients with mild-to-moderate ulcerative colitis (M2M UC). These results have been published in the Journal of Clinical Medicine.1
UC is a chronic, inflammatory bowel condition which can cause recurring bloody diarrhoea, stomach pain and extreme tiredness.4 Of those living with UC, over 85% have mild-to-moderate disease.5,6,7 Usually 5-ASA compounds are the first-line therapy for people with M2M UC, followed by a stepwise treatment approach in case of non-response or intolerance. There is currently limited guidance on timely escalation and de-escalation of therapies.
OPTIMISE was the first major study to investigate whether a T2T approach based on monitoring of non-invasive parameters, such as clinical symptoms and FC, can provide a significantly higher benefit for patients with M2M UC versus an entirely symptom-based approach. “The OPTIMISE study represents another milestone in the management of M2M UC and demonstrates Ferring’s continued commitment to science and improving the lives of people with inflammatory bowel disease (IBD),” said Pierre-Yves Berclaz, Chief Science & Medical Officer, Ferring Pharmaceuticals.
Results from OPTIMISE, a pragmatic, randomised controlled study, showed that people who had their 5-ASA/mesalazine treatment optimised (with or without steroids) by following the T2T approach had a 17–22% advantage at achieving combined endoscopic and clinical remission over a symptoms-only based approach. For the primary endpoint of Mayo Endoscopic Score (MES)=0 at 12 months, no significant difference was found, however it was noted by the investigators that the COVID-19 pandemic negatively impacted the amount of evaluable data.1
“OPTIMISE has provided the first real-world evidence that a T2T approach can help people living with IBD to achieve long-lasting remission and have a greater quality of life,” said Kristine Paridaens, Senior Medical Director, Gastroenterology, Ferring Pharmaceuticals.
A T2T approach has been advocated by the International Organisation for the Study of IBD (IOIBD).In their Selecting Therapeutic Targets in Inflammatory Bowel Disease (STRIDE) Consensus they recommended resolution of clinical signs of disease activity and endoscopic remission as the optimal targets.2 This was further refined in STRIDE-II to include symptomatic relief and normalisation of serum and faecal markers as short-term targets for all therapies.3
The OPTIMISE results coincide with an international expert consensus focusing on the practical management of M2M UC, which was published in Expert Review of Gastroenterology and Hepatology.8 Professor Silvio Danese, a co-author of the Consensus and Principle Investigator of the OPTIMISE study, said, “The OPTIMISE study provides real-world evidence of the effectiveness of a T2T approach based on FC monitoring and how its implementation in clinical practice will allow clinicians to tightly monitor disease activity and promptly adapt treatment, helping to avoid complications and disease progression and enabling patients to achieve better disease control.”
References: [1] Danese S, Fiorino G, Vicaut E, et al. Pragmatic Randomised Controlled Study to Assess the Effectiveness of Two Patient Management Strategies in Mild to Moderate Ulcerative Colitis – the OPTIMISE study. J Clin Med 2024;13:5147.
2 Peyrin-Biroulet L, Sandborn W, Sands BE, et al. Selecting Therapeutic Targets in Inflammatory Bowel Disease (STRIDE): Determining Therapeutic Goals for Treat-to-Target. Am J Gastroenterol 2015;110:1324–38.
3 Turner D, Ricciuto A, Lewis A, et al. STRIDE-II: An Update on the Selecting Therapeutic Targets in Inflammatory Bowel Disease (STRIDE) Initiative of the International Organization for the Study of IBD (IOIBD): Determining Therapeutic Goals for Treat-to-Target strategies in IBD. Gastroenterology 2021;160:1570–83.
4 NHS. Ulcerative colitis. Available at: https://www.nhs.uk/conditions/ulcerative-colitis/. Last accessed: September 2024.
5 Raine T, Bonovas S, Kucharzik T, et al. ECCO Guidelines on Therapeutics in Ulcerative Colitis: Medical Treatment. J Crohns Colitis. 2022;16(1):2-17.
6 Fumery M, Singh S, Dulai PS, et al. Natural History of Adult Ulcerative Colitis in Population-based Cohorts: A Systematic Review. 2018;16(3):343-356.e3.
7 CCDS Pentasa All formulations. Version 18. 10 December 2022.
8 D’Amico F, Magro F, Dignass A, et al. Practical management of mild-to-moderate ulcerative colitis: an international expert consensus. Expert Rev Gastroenterol Hepatol 2024;18:421–30.
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