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News & Trends - Pharmaceuticals

Ferring unveils first real-world evidence for faecal calprotectin approach in ulcerative colitis

Health Industry Hub | October 4, 2024 |

Pharma News: Ferring Pharmaceuticals has announced results from a new study, which provides the first real-world evidence supporting the efficacy of a treat-to-target (T2T) approach based on faecal calprotectin (FC) in managing mild-to-moderate ulcerative colitis (UC).

With over 85% of UC patients experiencing mild-to-moderate disease, current treatment practices primarily rely on a stepwise approach, often starting with 5-ASA compounds. However, there is limited guidance on when to escalate or de-escalate therapies.

The OPTIMISE study sought to evaluate whether a T2T approach – focused on monitoring non-invasive parameters like clinical symptoms and FC – offers greater benefits than solely symptom-based management.

The study revealed that patients whose 5-ASA/mesalasine treatments [Ferring’s Pentasa] were optimised using the T2T strategy, with or without steroids, showed a 17–22% improvement in achieving combined endoscopic and clinical remission compared to the symptom-based approach.

While no significant difference was found for the primary endpoint of Mayo Endoscopic Score (MES)=0 at 12 months, the investigators noted that the COVID-19 pandemic negatively affected the availability of evaluable data. Still, these findings highlight the value of tighter disease monitoring to help patients achieve sustained remission and improved quality of life.

In March 2018, MSAC considered but did not support the application which requested public funding for FC testing for monitoring disease activity in patients with known IBD. The more recent application from Gastroenterological Society of Australia (GESA) is undergoing evaluation with the rationale being that FC testing is cheaper, safer, and clinically non-inferior compared to current alternatives such as colonoscopy and biopsy.

Ferring’s Chief Science & Medical Officer, Pierre-Yves Berclaz, called the results a “milestone in the management of mild-to-moderate UC,” underscoring the company’s commitment to advancing treatment for inflammatory bowel disease (IBD).

Kristine Paridaens, Senior Medical Director, Gastroenterology, Ferring Pharmaceuticals said 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.”

The results coincide with a newly published international expert consensus, which outlines practical management strategies for mild-to-moderate UC, reinforcing the clinical value of timely adjustments in treatment to better control the disease.

Professor Silvio Danese, a co-author of the consensus and the Principal Investigator of OPTIMISE, noted “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.”

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