Rheumatology Month in Review: June 2025

In June, new data offered important updates in the treatment of psoriatic arthritis, uncontrolled gout, fibromyalgia, and asthma, highlighting both advances in therapeutic options and lingering gaps in care. Notably, deucravacitinib demonstrated sustained joint and skin symptom improvements in adults with psoriatic arthritis in the pivotal POETYK PsA-1 and PsA-2 trials, while monthly high-dose pegloticase infusions with methotrexate showed feasibility for uncontrolled gout, potentially reducing treatment burden. In fibromyalgia, a comprehensive Cochrane analysis underscored the limited but meaningful role of duloxetine, milnacipran, and pregabalin, and TNX-102 SL emerged as a promising candidate to become the first new FDA-approved therapy for fibromyalgia in over 15 years. Finally, a large meta-analysis reinforced guideline recommendations against SABA monotherapy, linking its overuse with increased mortality and acute exacerbations in asthma, underscoring the need for ongoing optimization of asthma management strategies.

Check out this June 2025 rheumatology month in review for a recap of HCPLive’s coverage of the top pulmonary news and research from the past few weeks:

Insights from EULAR

Phase 3 Deucravacitinib Trial Meets ACR20 End Point in PsA

The phase 3 POETYK PsA-1 trial demonstrated that deucravacitinib significantly improved joint and skin symptoms in adults with active psoriatic arthritis, meeting its primary endpoint with 54.2% of treated patients achieving ACR20 response at week 16 versus 34.1% on placebo. Key secondary endpoints were also met, including significant improvements in skin clearance, physical function, and quality of life measures, alongside evidence of inhibited radiographic progression. The safety profile of deucravacitinib was consistent with previous studies, with no new safety signals identified, supporting its potential as an oral, first-in-class TYK2 inhibitor for psoriatic arthritis management.

Higher Dose Pegloticase Q4W Feasible for Uncontrolled Gout

The phase 4 FORWARD trial suggests that once-monthly (Q4W) dosing of pegloticase at 16 mg or 30 mg, combined with methotrexate, can maintain serum urate control in most patients with uncontrolled gout, with 68-73% achieving sustained sUA responses through month 6. These findings indicate that less frequent pegloticase infusions could improve treatment logistics and adherence while maintaining comparable safety and efficacy to the established Q2W regimen. Importantly, infusion reaction rates were low and consistent with prior studies, supporting monthly pegloticase as a feasible alternative for patients struggling with the burden of biweekly therapy.

New Data Further Support Safety of Upadacitinib With 26-Week GC Taper for Giant Cell Arteritis

In the SELECT-GCA phase 3 trial, upadacitinib 15 mg daily with a 26-week glucocorticoid taper showed numerically lower rates of serious infections (7.9 events/100 patient-years) compared with placebo on a 52-week taper (12.7 E/100 PY), suggesting reduced infection risk with a shorter steroid course. Herpes zoster rates were higher with upadacitinib 15 mg but remained within expected ranges, while opportunistic infections were rare and mostly mild.

Inebilizumab Efficacy and Safety Consistent Across Demographic Subgroups of IgG4-RD

A post-hoc analysis of the phase 3 MITIGATE trial confirmed inebilizumab’s effectiveness in reducing IgG4-related disease flares across diverse demographic subgroups, including variations by age, sex, and race. The treatment consistently lowered annualized flare rates and increased rates of flare-free, corticosteroid-free remission at 52 weeks compared to placebo, regardless of baseline characteristics.

A New Fibromyalgia Therapy on the Horizon

New Data Support TNX-102 SL Efficacy Ahead of PDUFA

TNX-102 SL, a sublingual cyclobenzaprine formulation, showed significant efficacy in reducing pain and improving sleep disturbance in fibromyalgia patients in the phase 3 RESILIENT study, with benefits sustained over 14 weeks. The phase 1 PK study demonstrated that TNX-102 SL achieves higher dynamic peak cyclobenzaprine levels with reduced exposure to its active metabolite norcyclobenzaprine, which may contribute to more durable effects compared to oral formulations. If approved by its August 15, 2025 PDUFA date, TNX-102 SL could become the first new FDA-approved fibromyalgia therapy in over 15 years and a novel non-opioid analgesic option for this challenging chronic pain condition.

Other Hot Topics in Rheumatology Research

Rheumatoid Arthritis Burden Has Surged Over Last 30 Years

A large AI-driven analysis of rheumatoid arthritis (RA) trends across 953 global locations revealed a 13.2% rise in RA incidence since 1990, affecting 17.9 million people in 2021, with a shift toward younger populations. While age-standardized RA mortality dropped by 32.7% since 1980, global RA-related DALYs nearly doubled, highlighting an expanding burden despite medical advances. The study also pinpointed local hotspots—like West Berkshire, UK, with the highest incidence—and demonstrated that targeted interventions, such as smoking reduction, could substantially lower RA burden, emphasizing the importance of localized strategies beyond socioeconomic status alone.

Pharmacological Therapies Largely Ineffective Against Fibromyalgia Syndrome Pain

A comprehensive Cochrane overview of pharmacologic treatments for fibromyalgia found moderate to good evidence supporting duloxetine, milnacipran, and pregabalin for reducing moderate-to-severe pain in about 1 in 10 adults, with benefits sustained over 4-12 weeks. Among 21 included reviews, many therapies—such as NSAIDs, antipsychotics, and cannabinoids—had inadequate or no data, while amitriptyline and SSRIs showed signs of publication bias and mirtazapine had moderate evidence of no effect. Overall, while adverse events were relatively common, serious events were rare, underscoring the limited yet important role of these few agents in fibromyalgia pain management.