Pegloticase Shows Encouraging Safety Profile for Gout Treatment
A new analysis of multiple clinical trials has found that pegloticase (Krystexxa; Amgen), a medication used to treat gout, does not increase the risk of thromboembolic (TE) or cardiovascular (CV) events in patients with uncontrolled gout.
While gout flares are known to be associated with an increased risk of CV/TE events, this post-hoc analysis, led by Dr. Orrin M. Troum of the University of Southern california, examined the safety of pegloticase specifically. “In these trials, the proportion of patients experiencing gout flares increased during the first month of pegloticase therapy but rapidly and progressively declined to nearly 0% over 12 months of therapy,” Dr. Troum and his team wrote. “Although CV safety signals where not identified in pegloticase clinical trials, the demonstrated relationship between gout flares and CV/TE events has raised the meaningful question of whether or not pegloticase treatment increases these events in uncontrolled gout patients.”
The researchers combined data from four trials, including two phase 3 trials, the MIRROR open-label trial, and the MIRROR randomized controlled trial. Over 328 patients received pegloticase (8 mg) every two (all trials) or four weeks (phase 3 trials) for the first 24 weeks. Notably, some participants in the MIRROR trials received methotrexate as an additional treatment.
The analysis found that only 5 out of 328 patients experienced at least one CV/TE event during pegloticase treatment, with a rate of 35.4 events per 1000 person-years.Dr. troum explained, “treatment with pegloticase did not increase the frequency of CV/TE events and the overall incidence of CV/TE events reported in this post-hoc analysis was similar to that in the general gout population. Further, all identified CV/TE events occurred within 120 days after gout flare onset, a window of higher risk resolute by a prior study. Given that gout flare occurrence is lower in patients who maintain SU levels,”
Dr.Troum also presented findings from the phase 4 AGILE study at the American College of Rheumatology (ACR) Convergence in November 2024. AGILE investigated the effectiveness and safety of shortened, 1-hour pegloticase infusions combined with methotrexate. The study demonstrated that these shortened infusions were well-tolerated and maintained efficacy in patients with uncontrolled gout, potentially reducing the treatment burden.
“Pegloticase is currently approved to be given over a 2-hour period and this often has an impact… on [patients’] daily lives, if this is an every 2 week therapy for at least 6 to 12 months,” Dr. Troum commented during the ACR meeting.
How does E.L. Cade’s background inform the stories they tell through their fiction?
Archyde News:
Headline: In Conversation with Fic Author, E. L. cade: Unraveling the Worlds of Fiction
Subhead: Get an exclusive glimpse into the mind of popular fic author E. L. Cade, as we discuss their latest work, creative process, and the impact of fan fiction on contemporary storytelling.
Archyde: Good day, E.L. cade! Thank you for joining us today.Let’s dive right in. Your latest fic, “Echoes of yesteryear,” has been receiving rave reviews. What inspired this unique blend of ancient fiction and fantasy?
E. L. Cade: Thank you for having me, Archyde! I’m always thrilled to discuss my work. “Echoes of Yesteryear” was inspired by my interest with the Victorian era and the suffragette movement. I’ve always been drawn to stories that explore societal norms and the people who challenge them. I thought, what if there was a secret society of women in the Victorian era, using magic to fight for their rights? Hence, ”echoes of Yesteryear” was born.
Archyde: Your fics often focus on strong female leads and explores themes of feminism. How have your experiences and views shaped these narratives?
E. L. Cade: Growing up, I’ve always been surrounded by strong women – my mother, grandmothers, aunts, and later, my colleagues. I’ve seen firsthand the struggles they’ve faced and the resilience they’ve shown. I believe that stories have the power to change perceptions and inspire action. By creating strong, relatable female leads, I hope to contribute to a more inclusive narrative landscape.
archyde: Fan fiction has often been at the forefront of progressive storytelling. What do you think is the impact of fan fiction on mainstream literature and media today?
E. L. Cade: Fan fiction has democratized storytelling in many ways. It has given a platform to voices that were previously unheard, allowing them to explore and create diverse narratives. It has also pushed the boundaries of what is considered ‘acceptable’ in literature, paving the way for more inclusive and progressive storytelling in mainstream media. Moreover, it has shown that there’s a huge appetite for diverse content, which could onyl be beneficial for the industry.
Archyde: Your work often blurs the line between genres. How do you approach world-building when jumping between different narratives and styles?
E. L. Cade: World-building is one of my favourite aspects of writing. I love creating immersive,believable worlds,even when they diverge from reality. While each fic has its unique aspects, I find that there are common threads – themes of identity, love, and loss – that weave through all my work. This helps to create a sense of continuity, even when the settings and styles vary.
Archyde: what advice would you give to aspiring fic writers looking to hone their craft?
E. L. Cade: Read widely and write often. Don’t be afraid to experiment with different styles, genres, and narratives. Remember that every story has a unique voice, and it’s your job to discover and amplify that voice. Also, engage with your community. The fic community is incredibly supportive and insightful. They can provide valuable feedback and help you grow as a writer.
We thank E. L. Cade for their time and insights. Keep an eye out for their upcoming projects, and until then, keep reading, writing, and creating!
