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Psoriatic Arthritis in 2025: Year in Review

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The asthma year in review highlights FDA approvals, data, and advances in 2025.

2025 marked a year of meaningful expansion and maturation in psoriatic arthritis (PsA) care, as advances in immunology translated into broader treatment options, earlier intervention strategies, and clearer regulatory momentum. The field continued to move beyond symptom control alone, with growing emphasis on disease modification, functional outcomes, and addressing long-standing gaps in diagnosis and access—particularly for younger patients and those with prior treatment failure.

Regulatory developments underscored this progress, highlighted by the FDA approval of guselkumab for pediatric plaque psoriasis and PsA, extending IL-23 inhibition into younger populations for the first time. At the same time, oral targeted therapies gained traction, with deucravacitinib advancing toward FDA review following strong phase 3 data demonstrating improvements across joint, skin, and radiographic outcomes. Together, these milestones signaled a broadening PsA armamentarium that spans age groups, mechanisms of action, and routes of administration.

Clinically, 2025 delivered a wave of pivotal and late-stage data reinforcing both established and emerging pathways. IL-23 inhibition continued to solidify its role with positive phase 3 tildrakizumab trials, while TYK2 inhibition emerged as a major theme through encouraging results from deucravacitinib and zasocitinib. Head-to-head evidence favoring secukinumab in post-TNFi disease and early promise from next-generation agents like the IL-17A/IL-17F nanobody sonelokimab further defined treatment sequencing. These advances, combined with expert discussions emphasizing the urgency of coordinated dermatology–rheumatology care, framed 2025 as a year that not only advanced PsA therapeutics, but also sharpened the clinical strategy around using them.

FDA News

FDA Approves Guselkumab (Tremfya) for Pediatric Plaque Psoriasis, Psoriatic Arthritis

On September 29, 2025, the FDA approved guselkumab (Tremfya) for children aged ≥6 years and weighing ≥40 kg with moderate to severe plaque psoriasis or active psoriatic arthritis, making it the first IL-23 inhibitor approved for these pediatric indications. The decision was supported by the phase 3 PROTOSTAR trial, where guselkumab significantly improved skin clearance compared with placebo, and by extrapolated data from adult PsO and PsA studies. This expands guselkumab’s use beyond its prior adult approvals and provides a new treatment option for children with these immune-mediated diseases.

TYK2 Inhibitor Deucravacitinib up for FDA Review for Psoriatic Arthritis

The FDA accepted Bristol Myers Squibb’s sNDA for deucravacitinib in active psoriatic arthritis with a PDUFA date of March 6, 2026, based on phase 3 POETYK PsA trials showing 54.2% of patients achieved ACR20 at week 16 versus 34.1% with placebo (P <.0001). The TYK2 inhibitor also significantly improved PASI 75 response, physical function, fatigue, and radiographic progression, with no new safety signals and a low rate of serious adverse events.

Data Readouts

Pivotal Tildrakizumab Trials Meet Endpoint for Psoriatic Arthritis

Tildrakizumab 100 mg met its primary endpoint in both INSPIRE-1 and INSPIRE-2 phase 3 trials by significantly improving ACR20 response rates at week 24 versus placebo (P <.05) in patients with active psoriatic arthritis. The IL-23 inhibitor also showed improvements in ACR50, ACR70, and PASI75 with a safety profile consistent with previous psoriasis trials, reinforcing its potential as a PsA treatment option.

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.

Zasocitinib Data Demonstrates Efficacy of TYK2 Inhibition for Psoriatic Arthritis

In a phase 2b trial, zasocitinib 30 mg and 15 mg significantly improved ACR20 responses at week 12 in patients with active psoriatic arthritis (54.2% and 53.3%, respectively, vs. 29.2% with placebo; P = .002), with additional numeric gains seen in ACR50, ACR70, PASI 75, and MDA rates. The drug’s safety profile remained manageable with no new safety signals, supporting TYK2 inhibition as a promising, targeted, and potentially safer oral treatment pathway for PsA; phase 3 trials are currently underway.

AgAIN: Secukinumab Outperforms Ustekinumab in Post-TNFi Psoriatic Arthritis, With Frank Behrens, MD

Secukinumab demonstrated superior efficacy to ustekinumab in TNFi-experienced patients with psoriatic arthritis in the phase 3b AgAIN trial. At week 28, 57.1% of patients receiving secukinumab achieved HAQ-DI response versus 27.0% with ustekinumab (P = .002), with greater improvements across joint, skin, and pain outcomes, and fewer discontinuations due to loss of efficacy.

Sonelokimab Demonstrates Psoriatic Arthritis Improvements Over Placebo

Sonelokimab met its primary endpoint in a phase 2 trial, significantly improving psoriatic arthritis signs and symptoms with higher ACR50 response rates at week 12 versus placebo. As a dual IL-17A/IL-17F–targeting nanobody, the therapy demonstrated robust joint and skin efficacy with a favorable safety profile, supporting its continued evaluation in ongoing phase 3 PsA studies.

Features/Podcasts

Closing the Gap: Collaborating Care to Improve Outcomes in Psoriasis and Psoriatic Arthritis

Experts are calling for earlier, more coordinated detection of psoriatic arthritis, which develops in up to 30% of patients with psoriasis and is often diagnosed years too late. In this HCPLive feature, leading dermatology and rheumatology voices discuss how routine screening, shared treatment strategies, and cross-specialty collaboration can help close diagnostic gaps and prevent irreversible joint damage.

References
1. Brooks A. FDA Approves Guselkumab (Tremfya) for Pediatric Plaque Psoriasis, Psoriatic Arthritis. Article. HCPLive. September 29, 2025. https://www.hcplive.com/view/fda-approves-guselkumab-tremfya-for-pediatric-plaque-psoriasis-psoriatic-arthritis
2. Johnson V. TYK2 Inhibitor Deucravacitinib up for FDA Review for Psoriatic Arthritis. Article. HCPLive. July 21, 2025. https://www.hcplive.com/view/tyk2-inhibitor-deucravacitinib-up-for-fda-review-for-psoriatic-arthritis
3. Johnson V. Pivotal Tildrakizumab Trials Meet Endpoint for Psoriatic Arthritis. Article. HCPLive. July 25, 2025. https://www.hcplive.com/view/pivotal-tildrakizumab-trials-meet-endpoint-for-psoriatic-arthritis
4. Johnson V. Phase 3 Deucravacitinib Trial Meets ACR20 End Point in PsA. Article. HCPLive. June 11, 2025. https://www.hcplive.com/view/phase-3-deucravacitinib-trial-meets-acr20-end-point-in-psa
5. Johnson V. Zasocitinib Data Demonstrates Efficacy of TYK2 Inhibition for Psoriatic Arthritis. Article. HCPLive. July 16, 2025. https://www.hcplive.com/view/zasocitinib-data-demonstrates-efficacy-of-tyk2-inhibition-for-psoriatic-arthritis
6. Behrens F. AgAIN: Secukinumab Outperforms Ustekinumab in Post-TNFi Psoriatic Arthritis, With Frank Behrens, MD. Video. HCPLive. October 28, 2025. https://www.hcplive.com/view/again-secukinumab-outperforms-ustekinumab-post-tnfi-psoriatic-arthritis-behrens
7. Johnson V. Sonelokimab Demonstrates Psoriatic Arthritis Improvements Over Placebo. Article. HCPLive. October 10, 2025. https://www.hcplive.com/view/sonelokimab-demonstrates-psoriatic-arthritis-improvements-over-placebo
8. Johnson V, Smith T. Closing the Gap: Collaborating Care to Improve Outcomes in Psoriasis and Psoriatic Arthritis. Article. HCPLive. August 25, 2025. https://www.hcplive.com/view/closing-gap-collaborating-care-improve-outcomes-psoriasis-psa

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