FDA Approves Update for Tremfya in Delaying Psoriatic Arthritis Joint Damage

The FDA approved a supplemental biologics license application for guselkumab (Tremfya), officially including evidence in its label for the inhibition of structural joint damage progression in adults with active psoriatic arthritis (PsA). This expansion establishes guselkumab as the only IL-23 inhibitor proven to help stop further joint damage, marking a significant milestone for a patient population at high risk for irreversible physical impairment.¹

“Joint damage associated with active psoriatic arthritis can happen as soon as 6 months after onset of disease, so it’s important to have treatment solutions that can help provide daily symptom relief while also protecting joints from long-term structural damage,” Philip J. Mease, MD, director of rheumatology research at the Swedish Medical Center/Providence St. Joseph Health and Clinical Professor at the University of Washington School of Medicine in Seattle, Washington, said in a news release.¹ “With the inclusion of these findings in the label, we now have stronger clinical evidence that sets Tremfya apart as a treatment option for patients with active psoriatic arthritis at risk for joint damage.”

The clinical significance of this label update is rooted in the aggressive nature of PsA, a chronic inflammatory disease that affects roughly 30 percent of people with plaque psoriasis. Up to half of all patients living with active PsA develop irreversible bone damage within 2 years of their diagnosis, which can occur as early as 6 months after the onset of symptoms. This structural deterioration, which manifests as bone erosions and joint space narrowing, is directly linked to impaired physical function, reduced work productivity, and a diminished quality of life.^1,2

About the Trial

The regulatory decision was primarily supported by 24-week results from the phase 3b APEX (NCT04882098) study, which evaluated biologic-naïve adults with active and erosive disease. The trial met its primary end point of significantly improving joint symptoms, as measured by the ACR20 response, and its major secondary end point of inhibiting radiographic progression. Using the PsA-modified van der Heijde-Sharp (vdH-S) score to quantify damage, researchers found that patients treated with guselkumab—administered either every 4 weeks or every eight weeks—exhibited significantly lower rates of damage progression compared to the placebo group.³

For patients who initially received a placebo but switched to guselkumab at week 24, they saw a 57% reduction in their rate of radiographic progression through week 48. This demonstrates that the therapy can offer benefits even after initial disease progression has occurred. Furthermore, guselkumab is differentiated by its mechanism as a fully human, dual-acting monoclonal antibody that selectively inhibits the IL-23p19 subunit while also binding to CD64, a receptor on the surface of cells that produce IL-23.¹

Although other biologics, such as those targeting IL-17 or TNF, also inhibit structural damage, guselkumab remains the only IL-23 inhibitor to achieve this specific proof of efficacy to date. For instance, studies on the IL-23 inhibitor risankizumab did not show a statistically significant difference in radiographic progression compared to placebo at the 24-week mark. This distinction makes guselkumab a unique first-line treatment option for patients who require both symptom relief and long-term joint preservation.^1,2

What Pharmacists Should Know

From a clinical pharmacy perspective, the safety profile of guselkumab in the APEX study remained consistent with its established use in plaque psoriasis and other indications, with no new safety signals identified. The recommended maintenance dosage for PsA is 100 mg injected subcutaneously every 8 weeks, following starter doses at weeks 0 and 4. Pharmacists should continue to advise patients on standard precautions, including screening for tuberculosis prior to treatment and monitoring for common adverse effects such as upper respiratory infections, headaches, and injection site reactions.^3,4

This expansion of the guselkumab label reinforces the importance of early intervention and targeted therapy in preventing the cumulative damage associated with PsA. By providing a treatment that addresses both the skin manifestations and the underlying joint destruction, health care providers can better manage the multidomain nature of this complex disease. As pharmacists facilitate access to these specialty biologics, understanding these nuances in structural inhibition is essential for optimizing patient outcomes and preventing long-term disability.^1,2

“Up to half of all patients living with active psoriatic arthritis can develop early irreversible joint damage, leaving them unable to perform simple daily tasks or go to work,” Brandee Pappalardo, PhD, MPH, vice president of medical affairs, dermatology, and rheumatology at Johnson & Johnson Innovative Medicine, said in a news release.¹ “This label update reinforces our commitment to advancing innovation for these patients by offering the only IL-23 inhibitor with structural inhibition in its label, making Tremfya a differentiated treatment option for symptom relief and joint preservation that helps address the progressive nature of active psoriatic arthritis.”

READ MORE: FDA Updates Resource Center

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REFERENCES

1. FDA approves label expansion, cementing Tremfya as the only IL‑23 inhibitor proven to help stop further joint damage. News release. Johnson and Johnson. May 28, 2026. Accessed May 29, 2026. https://www.jnj.com/media-center/press-releases/fda-approves-label-expansion-cementing-tremfya-as-the-only-il-23-inhibitor-proven-to-help-stop-further-joint-damage

2. Ritchlin CT, Coates LC, Mease PJ, van der Heijde D, Rahman P. Effects of Guselkumab on Structural Damage Progression in Patients with Active Psoriatic Arthritis. Adv Ther. Published online May 5, 2026. doi:10.1007/s12325-026-03563-x

3. Mease PJ, Ritchlin CT, Coates LC, et al. Inhibition of structural damage progression with the selective interleukin-23 inhibitor guselkumab in participants with active PsA: results through week 24 of the phase 3b, randomised, double-blind, placebo-controlled APEX study. Ann Rheum Dis. 2025;84(12):1983-1994. doi:10.1016/j.ard.2025.08.006

4. Mayo Clinic. Guselkumab (subcutaneous route). February 1, 2026. Accessed May 29, 2026. https://www.mayoclinic.org/drugs-supplements/guselkumab-subcutaneous-route/description/drg-20406359