BEERSE, Belgium. (June 11, 2025) – Johnson & Johnson today announced findings from the Phase 3b APEX study showing that guselkumab significantly reduced both signs and symptoms of active psoriatic arthritis (PsA) and inhibited progression of joint structural damage at 24 weeks compared to placebo.1 These data are among the 30 accepted abstracts and presentations Johnson & Johnson is highlighting at the European Alliance of Associations for Rheumatology (EULAR) 2025 Congress.
In the Phase 3b APEX study, guselkumab significantly inhibited progression of joint structural damage, including joint erosions and space narrowing, in patients with active PsA at Week 24 as assessed by the PsA modified van der Heijde-Sharp (vdH-S) score.1,a The mean change from baseline to Week 24 in the modified van der Heijde-Sharp (vdH-S) score was 0.55 and 0.54 for patients receiving guselkumab every four weeks (Q4W) and every eight weeks (Q8W) respectively, compared with 1.35 in the placebo group (p=0.002 for Q4W and p<0.001 for Q8W dosing versus placebo, respectively).1,a In the two guselkumab dose groups, 67% (Q4W) and 63% (Q8W) of 644 patients experienced no radiographic progression, versus 53% of 376 patients in the placebo group.1
“In psoriatic arthritis, joint damage can begin early and progress quickly if left untreated, significantly impacting a patient’s ability to move, work and maintain independence,” said Philip J. Mease, MD, Director of Rheumatology Research at the Swedish Medical Center and study investigator.b “The results of the APEX study are promising as the data show guselkumab inhibited the progression of structural damage in patients, providing new clinical insights for the psoriatic community and underscoring the need for well-tolerated, effective options that address the full burden of disease.”
Guselkumab also improved both joint and skin symptoms in patients with active PsA.
- Significantly greater proportions of guselkumab-treated patients (67% for Q4W and 68% for Q8W) achieved American College of Rheumatology response criteria (ACR20c) at Week 24 versus 47% receiving placebo (p<0.001)
- More than twice as many patients treated with guselkumab achieved ACR50b (41% for Q4W and 42% for Q8W) versus 20% receiving placebo at Week 24.1
- In assessing skin clearance, greater proportions of guselkumab-treated patients (73% for Q4W and 68% for Q8W) achieved an Investigator’s Global Assessment (IGA) score of 0/1d (clear or almost clear skin) at Week 24 versus 31% receiving placebo.1
“With these results from the APEX study, guselkumab has set a new bar for joint preservation as the only IL-23 inhibitor proven to significantly inhibit structural damage,” said Terence Rooney, Vice President, Rheumatology Disease Area Leader, Johnson & Johnson Innovative Medicine. “The efficacy and safety profile of guselkumab offers psoriatic healthcare providers and patients an innovative option for disease control.”
“Psoriatic arthritis is a chronic disease that causes pain, stiffness and swelling of joints, and has a negative impact on patients’ quality of life.”1 stated Mark Graham, Senior Director, Therapeutic Area Head, Immunology, Johnson & Johnson Innovative Medicine EMEA. “The results from the APEX study reinforce our commitment to delivering for patients and healthcare professionals, with the goal of achieving long-term relief for patients.”
Through Week 24, adverse events (AEs) occurred in 38%, 42%, and 37% of pts (most commonly respiratory infections, headache, diarrhea, and psoriatic arthropathy), and serious AEs occurred in 2%, 3%, and 3% of patients, in the guselkumab Q4W, Q8W, and placebo groups respectively.1 No new safety signals were identified.1
Guselkumab is the first approved fully-human, dual-acting IL-23p19 subunit inhibitor that blocks IL-23 and binds to CD64, a receptor on cells that produce IL-23.e,2,3,4,5,6,7 IL-23 is a cytokine secreted by activated monocyte/macrophages and dendritic cells that is known to be a driver of immune-mediated diseases including active psoriatic arthritis.4
Editor’s notes:
a. The PsA-modified Sharp method typically assesses joints of the hands, wrists, and feet, (total score range, 0–470); a separate evaluation of erosions and joint space narrowing is also performed. Erosion is measured on a scale of 0 to 5 (total range, 0–270) and accounts for both the number of discrete erosions and percentage of joint involvement, with 0 defined as no erosion and 5 defined as extensive destruction involving > 80% of the joint.8
b. Dr. Philip J. Mease is a paid consultant for Johnson & Johnson. He has not been compensated for any media work.
c. ACR20/50 response is defined as both at least 20/50 percent improvement from baseline in the number of tender and number of swollen joints, and a 20/50 percent improvement from baseline in three of the following five criteria: patient GA, physician GA, functional ability measure (HAQ-DI), patient-reported pain using a visual analog scale, and erythrocyte sedimentation rate or C-reactive protein.9
d. The IGA is a five-point scale with a severity score ranging from 0 to 4, where 0 indicates clear, 1 is minimal, 2 is mild, 3 is moderate and 4 indicates severe disease.10
e. Findings for dual-acting are limited to vitro studies and the clinical significance of this finding is not known.11
ABOUT APEX STUDY (EudraCT 2020-004981-20)
APEX is a multicenter, randomized, double-blind, placebo-controlled study in 1020 patients with active PsA who are biologic naïve and have had an inadequate response to standard therapies (e.g., csDMARDs, apremilast, and/or NSAIDs). The treatment duration includes a 24-week, double-blind, placebo-controlled period, followed by a 24-week active treatment period, followed by a 12-week safety follow-up period. For patients who agree to enter the long-term extension, an additional 2 years of active treatment period is scheduled prior to the final safety follow-up.12
ABOUT PSORIATIC ARTHRITIS
Psoriatic arthritis (PsA) is a chronic, immune-mediated, inflammatory disease characterized by peripheral joint inflammation, enthesitis (pain where the bone, tendon and ligament meet), dactylitis (a type of inflammation in the fingers and toes that can result in a swollen, sausage-like appearance), axial disease and the skin lesions associated with plaque psoriasis (Pso).13,14,15,16 The disease causes pain, stiffness and swelling in and around the joints; it commonly appears between the ages of 30 and 50, but can develop at any age.16 Nearly half of patients with PsA experience moderate fatigue and about one-third suffer from severe fatigue as measured by the modified fatigue severity scale.17 In patients with PsA, comorbidities such as obesity, cardiovascular disease, anxiety and depression are often present.18 Studies show up to 30% of people with plaque Pso also develop PsA.14,16 Although the exact cause of PsA is unknown, genes, the immune system and environmental factors are all believed to play a role in disease onset.19
ABOUT GUSELKUMAB
Developed by Johnson & Johnson, guselkumab is the first approved fully-human, dual-acting IL-23p19 subunit inhibitor that blocks IL-23 and binds to CD64, a receptor on cells that produce IL-23.4 Findings for dual-acting are limited to in vitro studies that demonstrate guselkumab binds to CD64, which is expressed on the surface of IL-23 producing cells in an inflammatory monocyte model.11 The clinical significance of this finding is not known.11
Guselkumab is approved in the EU for the treatment of moderate to severe plaque psoriasis (Pso) in adults who are candidates for systemic therapy and for the treatment of active psoriatic arthritis (PsA) in adult patients who have had an inadequate response or who have been intolerant to a prior disease-modifying anti-rheumatic drug therapy.4 It is also approved for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response, lost response, or were intolerant to either conventional therapy, or a biologic treatment4 and for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic treatment.4 It is also approved in the U.S.,20 Canada,21 Japan,22 and a number of other countries for the treatment of adults with moderate-to-severe Pso who are candidates for injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet light) and for the treatment of adult patients with active PsA.4
Johnson & Johnson maintains exclusive worldwide marketing rights to guselkumab.
GUSELKUMAB IMPORTANT SAFETY INFORMATION
In controlled periods of clinical studies with guselkumab, adverse drug reactions (ADRs) that consisted of respiratory tract infections were very common (≥10 percent); increased transaminases, headache, diarrhoea, arthralgia, rash were common (≥1 to <10 percent); and herpes simplex infections, tinea infections, gastroenteritis, decreased neutrophil count, urticaria, and injection site reactions were uncommon ADRs (≥0.1 percent to <1 percent). Hypersensitivity, anaphylaxis were rare (≥ 1/10 000 to < 1/1 000).4
Please refer to the Summary of Product Characteristics for full prescribing information for guselkumab: https://www.ema.europa.eu/en/documents/product-information/tremfya-epar-product-information_en.pdf
ABOUT JOHNSON & JOHNSON
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity. Learn more at www.innovativemedicine.jnj.com/emea. Follow us at J&J Innovative Medicine Europe, Middle East & Africa (EMEA).
CAUTIONS CONCERNING FORWARD-LOOKING STATEMENTS
This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding TREMFYA®. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialise, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson’s most recent Annual Report on Form 10-K, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in Johnson & Johnson’s subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments.
Media contact:
Lenny Peeters
[email protected]
Investor contact:
Lauren Johnson
[email protected]
CP-522813
May 2025