At Week 24, TREMFYA ® demonstrated two and a half times greater ability to inhibit joint structural damage versus placebo with results consistent for patients with active PsA receiving TREMFYA® every four weeks (Q4W)a or every eight weeks (Q8W), as assessed by the PsA-modified van der Heijde-Sharp (vdH-S) score.2 The inhibition of structural joint damage was sustained through Week 48.1 The 24 Week data from the APEX study was recently published in the Annals of the Rheumatic Diseases.3
Additionally, for patients in the study's placebo group, who switched to TREMFYA® at Week 24, the rate of radiographic progression from baseline to Week 24 (0.96) was reduced by 57% (to 0.41) from Week 24 through Week 48, as measured by mean change in the PsA-modified vdH-S score.b
"Psoriatic arthritis is a chronic condition where joint damage can begin early and progress quickly if left untreated," said Christopher Ritchlin, MD, MPH of the University of Rochester Medical Center and APEX study investigator.c "The APEX study results show that guselkumab can inhibit this process, even once it has begun, making it a valuable treatment option for both initiating treatment early and for patients who already show signs of joint damage."
TREMFYA® also showed continued clinically meaningful improvement in American College of Rheumatology response criteria (ACR50d) rates. ACR50 response rates increased from Week 24 to Week 48 in both the Q4W and Q8W dose groups. Nearly half of patients in the placebo group that transitioned to TREMFYA® at Week 24 achieved ACR50 by Week 48. The data from the APEX study were consistent with the well-established safety profile of TREMFYA®, with no new safety signals identified.1
"These long-term data show that TREMFYA has set a new benchmark as the only IL-23 inhibitor proven to inhibit structural damage in active psoriatic arthritis, which can develop in up to 30% of people living with psoriasis," said Leonard Dragone, MD, PhD, Vice President, Rheumatology and Autoantibody Disease Area Leader, Johnson & Johnson Innovative Medicine. "It's durable efficacy and established safety make TREMFYA an attractive first-line treatment option for patients with psoriatic disease."
TREMFYA® is the first and only fully-human, dual-acting monoclonal antibody approved to treat PsA that blocks IL-23 while also binding to CD64, a receptor on cells that produce IL-23. 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. Findings are based on in vitro studies.4,5,6,7,8
These results support Johnson & Johnson's recent submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for approval to include new evidence in the TREMFYA® label for the inhibition of progression of structural damage in adults with active PsA.
ABOUT THE APEX STUDY (NCT04882098)
APEX is a multicenter, randomized, double-blind, placebo-controlled study in 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.10
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).11 12 13 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.14 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.15 In patients with PsA, comorbidities such as obesity, cardiovascular disease, anxiety and depression are often present.16 Studies show up to 30% of people with plaque PsO also develop PsA.10
ABOUT TREMFYA® (guselkumab)
Developed by Johnson & Johnson, TREMFYA® is the first approved fully-human, dual-acting monoclonal antibody designed to neutralize inflammation at the cellular source by blocking IL-23 and binding to CD64 (a receptor on cells that produce IL-23). 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. The clinical significance of this finding is not known.
What are the possible side effects of TREMFYA®?
TREMFYA® may cause serious side effects. See "What is the most important information I should know about TREMFYA®?"
The most common side effects of TREMFYA® include: respiratory tract infections, headache, injection site reactions, joint pain (arthralgia), diarrhea, stomach flu (gastroenteritis), fungal skin infections, herpes simplex infections, stomach pain, bronchitis feeling very tired (fatigue), fever (pyrexia), and skin rash.
Dosage Forms and Strengths: TREMFYA® is available as 100 mg/mL and 200 mg/2mL for subcutaneous injection and as a 200 mg/20 mL (10 mg/mL) single dose vial for intravenous infusion.
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.
For more information please visit, https://www.jnj.com/
