Home Medizin Die Ergebnisse bleiben bis zu 3 Jahre stabil

Die Ergebnisse bleiben bis zu 3 Jahre stabil

von NFI Redaktion

STOCKHOLM, Sweden – Long-term data on Risankizumab (Skyrizi) in moderate to severe Crohn’s disease (CD) show that clinical remission and endoscopic response rates remain stable for up to three years, according to the results of the FORTIFY extension study.

„The most striking aspect for me are the endoscopic endpoints,“ said Marc Ferrante, MD, PhD, Medical News from Medscape. „In the most conservative analysis, you see a benefit the longer you observe the patients… We have never seen this with many – if any – other compounds.“

Ferrante from University Hospitals Leuven, Leuven, Belgium, added that patients responding to Risankizumab, an anti-interleukin (IL)-23 p19 inhibitor, showed lower antibody formation compared to anti-tumor necrosis factor agents.

„Most patients seemed to continue treatment without antibody formation against Risankizumab becoming a problem,“ he said. Even in patients who responded well to Risankizumab, the effects were the same whether they „received this biological first-line therapy or only after other agents had failed.“

Overall, „I think we all have the impression that IL-23 inhibitors have good efficacy, probably even better than other available compounds,“ Ferrante said. „And more importantly, this is without increased side effects.“

Ferrante presented the data (Abstract DOP 53) on February 23 at the 19th Congress of the European Crohn’s and Colitis Organization (ECCO).

Open-Label Extension up to 152 Weeks

The ongoing open-label extension study FORTIFY, which investigates the long-term efficacy and safety of Risankizumab in patients with moderate to severe CD.

These data follow the initial 52-week study published in 2022, which showed that subcutaneous Risankizumab is a safe and effective treatment for maintaining remission in patients with moderate to severe active CD. Ferrante also led this study.

Participants in this open-label extension study, who had already received a 52-week maintenance dose, received 180 mg subcutaneous Risankizumab every 8 weeks in week 56 (n = 872). Those who had previously received rescue therapy received a single 1200 mg intravenous dose of Risankizumab followed by 360 mg subcutaneous every 8 weeks, and were continued on this regime (n = 275). Data from both treatment groups (Risankizumab 180 mg and 360 mg) were pooled for analysis, with clinical outcomes evaluated every 6 months.

Population data showed clinical response on the Clinical Disease Activity Index (CDAI) of 84.9% at week 56 and 52.7% at week 152 after patients who received rescue treatment were classified as non-responders. Clinical remission of CDAI was 66.7% at week 56 and 47.2% at week 152 for this population.

Additional benefit was observed over time in the endoscopic outcomes. Endoscopic response, considered the best available predictor of long-term outcomes, was 50.8% at week 56 and 52.5% at week 152. Endoscopic remission was 35.8% at week 56 and 41.8% at week 152, and ulcer-free endoscopy was observed in 28.6% of patients at week 56 and 35.5% at week 152.

The safety profile of Risankizumab was consistent and supported long-term treatment, Ferrante said.

Treatment-emergent adverse events included serious cardiovascular adverse events in five patients on Risankizumab and 50 severe infections.

„Effective and Long-lasting Option“

Tim Raine, MD, Consulting Gastroenterologist and IBD Lead at Cambridge University Hospitals, UK, commented on the value of long-term extension studies in understanding the effects of continued drug administration beyond the typical one-year timeframe to approval clinical studies, as CD is currently incurable.

„However, there are limitations to long-term extension studies,“ he said Medical News from Medscape. In particular, patients who continue to participate in the study are those „who have had good experiences with the drug and remain motivated to participate in ongoing monitoring.“

„Patients drop out of a long-term extension study for reasons that may be related to the loss of benefit from the drug or not, and this can be problematic when dealing with missing data,“ he explained.

Considering this issue, „researchers have taken the strictest approach in handling these patients and considered all dropouts as examples of drug failure. This provides the most robust assessment of the durability of response, which may slightly underestimate the actual duration,“ said Raine.

„However, the response and remission rates for clinical endpoints suggest good durability of effect over a period of up to three years. The endoscopic data is also encouraging,“ he claimed.

„Taken together, these data suggest that Risankizumab may be an effective and durable option for some patients with Crohn’s disease and is associated with a favorable safety profile.“

Dr. Ferrante has disclosed research grants from: AbbVie, Amgen, Biogen, Gilead, Janssen, Pfizer, Takeda, and Viatris;
Consulting fees from: AbbVie, Agomab Therapeutics, Boehringer Ingelheim, Celgene, Celltrion, Eli Lilly, Janssen-Cilag, Medtronic, MRM, MSD, Pfizer, Regeneron, Samsung Bioepis, Sandoz, Takeda, and ThermoFisher;
Speaker honoraria from: AbbVie, Amgen, Biogen, Boehringer Ingelheim, Falk, Ferring, Janssen-Cilag, Lamepro, MSD, Pfizer, Sandoz, Takeda, Truvion Healthcare, and Viatris.

Dr. Raine has financial relationships with industry, including receiving research/educational grants and/or speaker/consultant fees from AbbVie, Arena, Aslan, AstraZeneca, Boehringer-Ingelheim, BMS, Celgene, Ferring, Galapagos, Gilead, GSK, Heptares, LabGenius, Janssen, Mylan, MSD, Novartis, Pfizer, Sandoz, Takeda, and UCB.

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