Rheumatology Month in Review: December 2024

This rheumatology month in review highlights new research across rheumatological diseases, including psoriatic arthritis (PsA) and cardiovascular event risk.

New Psoriatic Arthritis Research

Deucravacitinib Meets ACR20 Endpoint for Psoriatic Arthritis in Phase 3 Trial

Deucravacitinib (Bristol Myers Squibb) was superior to placebo in achieving American College of Rheumatology 20 (ACR20) response in people with PsA after 16 weeks of treatment, leading 2 pivotal phase 3 trials, POETYK PsA-1 (IM011-054) and POETYK PsA-2 (IM011-055), to achieve their primary endpoints.
Roland Chen, MD, senior vice president and head, Immunology, Cardiovascular and Neuroscience development, Bristol Myers Squibb, said in a statement that "these POETYK PsA-1 and POETYK PsA-2 findings demonstrate that oral Sotyktu has the potential to be the first TYK2 inhibitor for people living with psoriatic arthritis and reinforce the established efficacy and safety profile of Sotyktu. We are encouraged by the positive data across both Phase 3 trials and look forward to discussing the results with health authorities."

CASPAR Criteria May Identify More Patients With Juvenile PsA Than ILAR Criteria

ClASsification criteria for PsA (CASPAR) identified more patients with PsA than International League of Associations for Rheumatology (ILAR) criteria in people with juvenile idiopathic arthritis (JIA), demonstrating its potential utility.

“Classifying patients with JPsA is often challenging because, in contrast to adult PsA, psoriasis may manifest up to 10 years after arthritis onset in children and may be prevented by the use of disease-modifying antirheumatic drugs,” investigators wrote.

Nearly 65% of Patients with RA, PsA Had Asymptomatic Pulmonary Involvement
A recent study showed the prevalence of asymptomatic pulmonary involvement in patients with newly diagnosed rheumatoid arthritis (RA) and PsA. The research also revealed a lack of correlation between pulmonary function, disease function, and medication during the disease progression.

“The lack of correlation…suggests that reducing arthritic disease activity does not necessarily mitigate the risk or severity of pulmonary involvement,” wrote investigators, led by Lone Winter and Simon M. Petzinna, both from the department of rheumatology and clinical immunology at the Clinic of Internal Medicine III, University Hospital Bonn in Germany.

Cardiovascular Event Risk and Rheumatic Disease

Rheumatoid Arthritis Heart Failure Risk Driven by Increased HFpEF Risk

People with RA had a higher risk of heart failure (HF) overall than people without RA, even adjusting for cardiovascular risk factors, with the elevated risk driven by HF with preserved (HFpEF) ejection fraction.

"Patients with RA are at increased risk of cardiovascular disease (CVD) including HF. However, little is known regarding the relative risks of heart failure subtypes such as HFpEF or reduced ejection fraction (HFrEF) in RA compared to non-RA,” lead investigator Yumeko Kawano, MD, Brigham and Women's Hospital, and Harvard Medical School, and colleagues wrote.

Colchicine Prophylaxis for Gout Flares Linked to Lower Cardiovascular Events
Prophylactic colchicine reduced the risk of cardiovascular events in patients with gout initiating urate-lowering therapy compared to those not prescribed prophylactic colchicine.

“Cipolletta and colleagues propose the prevention of gout flare as an additional cause of the beneficial effect of colchicine on cardiovascular event risk. Gout flares have been associated with an increase in cardiovascular events, albeit transient, following flare. One can speculate whether this effect is additional to or part of a more general colchicine effect on the chronic inflammatory state that is supposedly present in all patients with gout, also between flares,” Hein Janssens, MD, PhD, Department of Primary and Community Care, Radboudumc Research Institute for Medical Innovation, Radboud University Medical Centre, Nijmegen 6500, Netherlands, and Matthijs Janssen, MD, PhD, Department of Rheumatology, VieCuri Medical Centre, Venlo, Netherlands, wrote in a related editorial.

New Drug Prospects for Fibromyalgia

FDA Accepts New Drug Application for TNX-102 SL in Fibromyalgia
Tonix Pharmaceuticals announced on December 17, 2024, that the US Food and Drug Administration (FDA) accepted the New Drug Application (NDA) for TNX-102 SL (cyclobenzaprine HCl sublingual tablets) to treat fibromyalgia. The FDA is expected to assign the NDA a Prescription Drug User Fee Act (PDUFA) target action date in a Day 74 Letter.

Seth Lederman, MD, Chief Executive Officer of Tonix Pharmaceuticals, said in a statement that "the fibromyalgia community, comprised of patients and their families and support groups, has been waiting for a new drug for over 15 years.”