Ferring Pharmaceuticals has announced promising findings from the OPTIMISE study, which provides groundbreaking evidence for a treat-to-target (T2T) management strategy in patients with mild-to-moderate ulcerative colitis (M2M UC). The study highlights the effectiveness of using faecal calprotectin (FC) home monitoring in achieving significantly higher rates of endoscopic and clinical remission over a 12-month period compared to traditional symptom-based approaches.
Ulcerative colitis is a chronic inflammatory bowel disease that can lead to recurring symptoms such as bloody diarrhoea, abdominal pain, and fatigue. Current treatment protocols typically begin with 5-aminosalicylic acid (5-ASA; mesalazine) as a first-line therapy, followed by a stepwise treatment approach for patients who do not respond or experience intolerances. However, timely escalation and de-escalation of therapies have been poorly defined in existing guidelines.
The OPTIMISE study, published in the Journal of Clinical Medicine, represents the first major investigation into whether a T2T approach—incorporating non-invasive monitoring of clinical symptoms and FC—provides a substantial advantage for patients with M2M UC. The results indicated that patients whose 5-ASA treatment was optimised through the T2T strategy had a 17% to 22% higher chance of achieving combined endoscopic and clinical remission compared to those managed solely based on symptoms.
“OPTIMISE represents another milestone in the management of M2M UC and reflects Ferring’s ongoing commitment to enhancing the lives of individuals living with inflammatory bowel disease,” said Pierre-Yves Berclaz, Chief Science & Medical Officer at Ferring Pharmaceuticals.
While the primary endpoint of achieving a Mayo Endoscopic Score (MES) of 0 at 12 months did not show significant differences, researchers noted that the COVID-19 pandemic had a detrimental impact on the availability of evaluable data, potentially affecting outcomes.
Senior Medical Director for Gastroenterology at Ferring, Kristine Paridaens, stated, “The OPTIMISE study provides the first real-world evidence that a T2T approach can help individuals with IBD achieve long-lasting remission and enhance their quality of life.”
The findings from the OPTIMISE study are consistent with recommendations from the International Organisation for the Study of IBD (IOIBD), which advocates for the resolution of clinical signs and endoscopic remission as optimal treatment targets. The latest STRIDE-II Consensus further refines these goals to include symptomatic relief and normalisation of serum and faecal markers as immediate objectives for all therapies.
Professor Silvio Danese, co-author of the expert consensus and Principal Investigator of the OPTIMISE study, remarked, “This study offers real-world evidence supporting a T2T approach based on FC monitoring. It allows clinicians to closely monitor disease activity and promptly adjust treatment to prevent complications and disease progression, ultimately helping patients achieve better control of their condition.”
Healthcare professionals can register for a free webinar titled ‘New Avenues in Mild-to-Moderate UC Treatment Optimisation,’ scheduled for 8th October 2024. The Principal Investigators, Prof Danese and Prof Laurent Peyrin-Biroulet, will provide an in-depth overview of the study’s results and their implications for clinical practice.
