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Rheumatology Year in Review: 2024

Key Takeaways

  • Bimekizumab received FDA approval for PsA, nr-axSpA, and AS, expanding its therapeutic indications in rheumatology.
  • The FDA accepted an NDA for TNX-102 SL for fibromyalgia, supported by successful phase 3 trials demonstrating pain reduction.
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This year in review spotlights top rheumatology FDA news from 2024 and new research out of the ACR 2024 Convergence.

HCPLive Rheumatology Year in Review: 2024

HCPLive Rheumatology Year in Review: 2024

2024 has been a landmark period for rheumatology, including a new approval of bimekizumab for treating active psoriatic arthritis (PsA), active non-radiographic axial spondyloarthritis (nr-axSpA, and active ankylosing spondylitis (AS), as well as a new drug application (NDA) for what could potentially be the first new drug approved for fibromyalgia treatment in 15 years.

Collectively, these developments underscore the momentum in the field, as rheumatologists leverage cutting-edge science to improve patient outcomes in both common and rarer diseases.

Check out HCPLive’s coverage of the top rheumatological news from 2024 in this rheumatology year in review!

FDA Actions

Bimekizumab Approved for Psoriatic Arthritis, Ankylosing Spondylitis, AxSpA

On September 23, the FDA spproved bimekizumab-bkzx under the name BIMZELX for treating active PsA, active nr-axSpA with objective signs of inflammation, and active AS in adults.

The approval adds to BIMZELX’s previously approved indication for adults with moderate-to-severe plaque psoriasis in October 2023 and follows the approval for PsA and AxSpA in Canada in March 2024.

FDA Accepts New Drug Application for TNX-102 SL in Fibromyalgia

On December 14, the FDA accepted Tonix Pharmaceuticals' 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.

The NDA is supported by data from the phase 3 RELIEF trial, completed in December 2020, and the phase 3 RESILIENT trial, completed in December 2023, both of which met their primary endpoints by demonstrating a significant reduction of daily pain compared with placebo (P = .010 and P = .00005, respectively).

Upadacitinib Expands Indication to Pediatric Patients with pJIA, PsA

On June 4, the FDA expanded Upadacitinib's (Rinvoq) approved indications in the United States to include the treatment of pediatric patients aged ≥ 2 years with active polyarticular juvenile idiopathic arthritis (pJIA) and patients aged 2 to < 18 years with PsA who have had inadequate response or intolerance to ≥ 1 tumor necrosis factor (TNF) blockers. A weight-based oral solution (Rinvoq LQ) is also offered as a treatment option for younger patients.

The expanded indications were supported by data on the drug in adult patients with PsA and rheumatoid arthritis (RA), incorporating pharmacokinetic data, as well as 51 pediatric patients with JIA and active polyarthritis, and safety data from 83 pediatric patients with JIA and active polyarthritis.

Reexamining Pain Management

Study Finds Benefits and Risks in Cannabis Use for Rheumatoid Arthritis

Recent research elucidated characteristics of people with RA using cannabis and found benefits on mortality, depression, chronic pain, and anxiety, but an increased risk of opioid use, nicotine dependence, and alcohol use.

They also found that mortality was significantly lower among cannabis users (0.98% vs. 2.71%), who also incurred lower total hospital charges ($57,773 vs. $63,681) than non-users, but there weas no significant difference in the length of hospital stay.

Long-term Opioids for Fibromyalgia Linked to Depression, Sleep Issues

Retrospective research found that patients with fibromyalgia who continue opioid use beyond 90 days are at significantly greater risk of developing depression or a sleep disorder.

The findings support clinical guidelines recommending against the prescription of opioids to treat fibromyalgia in the first place, and emphasize the need for clinicians to gauge and continuously monitor patients’ self-treatment of their fibromyalgia symptoms.

Opioid Use Trends Down in Last Decade for Rheumatic Diseases

Over the last decade, the use of non-opioid pain management modalities has increased or stabilized while opioid and nonsteroidal anti-inflammatory drugs (NSAID) use has declined in patients with autoimmune rheumatic diseases, including PsA, RA, AsSpA, systemic sclerosis, and Sjogren disease.

Additionally, physical therapy usage and anticonvulsant usage have risen slightly since 2014, highlighting a shift towards increased use of non-opioid pain management modalities and a decline in opioid and NSAID prescription.

New Research in Fibromyalgia

Post-COVID-19 Musculoskeletal Pain Often Fulfills Fibromyalgia Criteria

Fibromyalgia developed in most people surveyed with post-COVID-19 syndrome (PCS), new-onset musculoskeletal (MSK) pain, underscoring the syndrome’s potential as a long-term sequalae of viral infections.

Out of the assessed participants, 13 (72.2%) met fibromyalgia criteria, with an average WPI score of 8.8 and an average SS score of 8.2, which indicate a high level of pain and a significant impact on quality of life. Five participants (27.8%) did not meet the ACR criteria for FMS, 4 of which were male.

Self-Guided Digital Behavioral Therapy Improved Fibromyalgia Management and Pain

Digital acceptance and commitment therapy (ACT), a form of cognitive behavioral therapy (CBT), was safe and helped manage fibromyalgia in adult patients when compared with digital symptom tracking.

At 12 weeks, 99 (71%) ACT participants reported improvement on PGIC compared with 30 (22%) active control participants, a 48·4% proportional difference (95% CI, 37·9–58·9; P<·0001). Participants in the digital ACT group were also more likely to be “much improved” or “better” (between-group difference in proportions, 21%; P<.0001), and a much smaller proportion of participants in this group reported worsening on PGIC (5% vs 24%; P <.0001).

Vitamin D, Magnesium Deficiency Linked to Worse Fibromyalgia Symptoms

An exploratory study evaluating the link between specific micronutrients and the symptoms of fibromyalgia revealed vitamin D and magnesium played a role in physical function and stiffness among patients.

Among the patients with fibromyalgia, there was a moderate negative correlation between vitamin D and physical functioning (r = -.561, P = .008) as well as between magnesium and stiffness (r = -.518, P = .016).

New Research in Gout

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.

Patients prescribed colchicine prophylaxis had a significantly lower risk of cardiovascular events compared with those without, with weighted rates of cardiovascular events of 28.8 per 1000 person-years (95% CI, 25.2-33.2) and 35.3 per 1000 person-years (95% CI, 33.0-37.9), respectively. These rates translate to a weighted rate difference of –6·5 [95% CI, –9·4 to –3·6] per 1000 person-years and a weighted hazard ratio of 0.82 [95% CI, 0.69–0.94] in patients with prophylactic colchicine in the intent-to-treat analysis. These findings were supported by further, stratified analyses, and for secondary outcomes.

Beer, Cider Consumption Increases Risk of Gout in Both Sexes

Overall, current drinkers had a higher risk of gout than never drinkers among men (HR, 1.69 [95% CI, 1.30-2.18]) but not among women (HR, 0.83; 95% CI, 0.67-1.03). Among current drinkers, higher total alcohol consumption was associated with a higher risk of gout among both sexes and more strongly among men (HR, 2.05 [95% CI, 1.84-2.30) than women (HR, 1.34 [95% CI, 1.12-1.61]). Beer or cider had the strongest association per 1 pint a day, with an HR of 1.60 (95% CI, 1.53-1.67) in men and 1.62 in women (95% CI, 1.02-2.57).

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