Guselkumab

First-line treatment with TREMFYA® shows significant inhibition of radiographic progression at Week 24, which was sustained through Week 48, preserving joint health with a well-established safety profile More than half of TREMFYA®-treated patients across both dose groups achieved a 50% improvement in signs and symptoms of psoriatic arthritis by Week 48 in the Phase 3b APEX study NEW YORK, Nov. 17, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today announced new data from the Phase 3b APEX study showing that TREMFYA® continued to reduce both signs and symptoms of active psoriatic arthritis (PsA) and inhibit progression of structural damage at 48 weeks.1 These data were presented at the Inflammatory Skin Disease Summit (ISDS) 2025. 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. Editor's notes: a. TREMFYA® is not approved for Q4W dosing in the U.S. b. VdH-S scores are from the Week 48 x-ray read. c. Dr. Christopher Ritchlin is a paid consultant for Johnson & Johnson. He has not been compensated for any media work. d. ACR50 response is defined as both at least 50% improvement from baseline in the number of tender and number of swollen joints, and a 50% 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 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. TREMFYA® is a prescription medicine approved in the U.S. to treat: adults and children 6 years and older who also weigh at least 88 pounds (40 kg) with moderate to severe plaque psoriasis who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet or UV light). adults and children 6 years and older who also weigh at least 88 pounds (40 kg) with active psoriatic arthritis. adults with moderately to severely active ulcerative colitis. adults with moderately to severely active Crohn's disease. TREMFYA® is approved in Europe, Canada, Japan, and a number of other countries for the treatment of adults with moderate-to-severe plaque psoriasis, adults with active psoriatic arthritis, adults with moderate-to-severe Crohn's disease and adults with moderate-to-severe ulcerative colitis. The legal manufacturer for TREMFYA® is Janssen Biotech, Inc. Johnson & Johnson maintains exclusive worldwide marketing rights to TREMFYA®. For more information, visit: www.tremfya.com. IMPORTANT SAFETY INFORMATION What is the most important information I should know about TREMFYA®? TREMFYA® is a prescription medicine that may cause serious side effects, including: Serious Allergic Reactions. Stop using TREMFYA® and get emergency medical help right away if you develop any of the following symptoms of a serious allergic reaction: o fainting, dizziness, feeling lightheaded (low blood pressure) o swelling of your face, eyelids, lips, mouth, tongue or throat o trouble breathing or throat tightness o chest tightness o skin rash, hives o itching Infections. TREMFYA® may lower the ability of your immune system to fight infections and may increase your risk of infections. Your healthcare provider should check you for infections and tuberculosis (TB) before starting treatment with TREMFYA® and may treat you for TB before you begin treatment with TREMFYA® if you have a history of TB or have active TB. Your healthcare provider should watch you closely for signs and symptoms of TB during and after treatment with TREMFYA®. Tell your healthcare provider right away if you have an infection or have symptoms of an infection, including: o fever, sweats, or chills o muscle aches o weight loss o cough o warm, red, or painful skin or sores on your body different from your psoriasis o diarrhea or stomach pain o shortness of breath o blood in your phlegm (mucus) o burning when you urinate or urinating more often than normal Liver problems. With the treatment of Crohn's disease or ulcerative colitis, your healthcare provider will do blood tests to check your liver before and during treatment with TREMFYA®. With the treatment of plaque psoriasis or psoriatic arthritis, your healthcare provider may do blood tests to check your liver before and as necessary during treatment with TREMFYA®.Your healthcare provider may stop treatment with TREMFYA® if you develop liver problems. Tell your healthcare provider right away if you notice any of the following symptoms: o unexplained rash o vomiting o tiredness (fatigue) o yellowing of the skin or the whites of your eyes o nausea o stomach pain (abdominal) o loss of appetite o dark urine Do not use TREMFYA® if you have had a serious allergic reaction to guselkumab or any of the ingredients in TREMFYA®. Before using TREMFYA®, tell your healthcare provider about all of your medical conditions, including if you: have any of the conditions or symptoms listed in the section "What is the most important information I should know about TREMFYA®?" have an infection that does not go away or that keeps coming back. have TB or have been in close contact with someone with TB. have recently received or are scheduled to receive an immunization (vaccine). You should avoid receiving live vaccines during treatment with TREMFYA®. Children should be brought up to date with all vaccines before starting TREMFYA® are pregnant or plan to become pregnant. It is not known if TREMFYA® can harm your unborn baby.Pregnancy Registry: If you become pregnant during treatment with TREMFYA®, talk to your healthcare provider about registering in the pregnancy exposure registry for TREMFYA®. You can enroll by visiting www.mothertobaby.org/ongoing-study/tremfya-guselkumab, by calling 1-877-311-8972, or emailing MotherToBaby@health.ucsd.edu. The purpose of this registry is to collect information about the safety of TREMFYA® during pregnancy. are breastfeeding or plan to breastfeed. It is not known if TREMFYA® passes into your breast milk. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. 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. These are not all the possible side effects of TREMFYA®. Call your doctor for medical advice about side effects. Use TREMFYA® exactly as your healthcare provider tells you to use it. Please read the full Prescribing Information , including Medication Guide , for TREMFYA® and discuss any questions that you have with your doctor. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch , or call 1-800-FDA-1088 . 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 & JOHNSONAt 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 https://www.jnj.com/ or at www.innovativemedicine.jnj.com Follow us at @JNJInnovMed. CAUTIONS CONCERNING FORWARD-LOOKING STATEMENTS This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 related to 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 materialize, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: competition, including technological advances, new products and patents attained by competitors; uncertainty of commercial success for new products; the ability of the company to successfully execute strategic plans; impact of business combinations and divestitures; challenges to patents; changes in behavior and spending patterns or financial distress of purchasers of health care products and services; and 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, www.investor.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: Craig Stoltz cstoltz@its.jnj.com Investor contact: Lauren Johnsoninvestor-relations@its.jnj.com References: ______________________________ 1 Ritchlin CT, et al. Durable Inhibition of Structural Damage Progression and Improvements in Joint Disease Activity With the Selective Interleukin-23 Inhibitor Guselkumab in Active and Erosive Psoriatic Arthritis: Week 48 Results From a Phase 3, Randomized, Double-Blind, Placebo-Controlled Study. Presented at ISDS 2025. November 12-15. Poster 331. 2 Mease PJ, et al. Inhibition of structural damage progression with guselkumab, a selective IL-23i, in participants with active PsA: Results through Week 24 of the phase 3b, randomized, double-blind, placebo-controlled APEX study. Presented at EULAR 2025, June 11-14. LB0010. 3 Mease, 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, randomized, double-blind, placebo-controlled APEX study. Annals of the Rheumatic Diseases 2025; doi.org/10.1016/j.ard.2025.08.006 4 Atreya R, Abreu MT, Krueger JG, et al. Guselkumab, an IL-23p19 subunit-specific monoclonal antibody, binds CD64+ myeloid cells and potentially neutralizes IL-23 produced from the same cells. Poster presented at: 18th Congress of the European Crohn's and Colitis Organization (ECCO); March 1-4, 2023; Copenhagen, Denmark. Poster P504. 5 Kreuger JG, Eyerich K, Kuchroo VK. Il-23 past, present, and future: a roadmap to advancing IL-23 science and therapy. Front Immunol. 2024; 15:1331217. doi:10.3389/fimmu.2024.1331217. 6 TREMFYA® [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc. 7 Skyrizi® [Prescribing Information]. North Chicago, IL: AbbVie, Inc. 8 Omvoh™ [Prescribing Information]. Indianapolis, IN: Eli Lilly and Company. 9 Felson, D. T., & LaValley, M. P. The ACR20 and defining a threshold for response in rheumatic diseases: too much of a good thing. Arthritis Research & Therapy, 2014:16(1), 101. https://doi-org.sutd.idm.oclc.org/10.1186/ar4428 10 ClinicalTrials.gov. A Study of Guselkumab in Participants With Active Psoriatic Arthritis (APEX). Identifier: NCT04882098. Available at: https://clinicaltrials.gov/study/NCT04882098. Accessed March 2025. 11 Donvito T., CreakyJoints: What Is Dactylitis? The 'Sausage Finger' Swelling You Should Know About. Available at: https://creakyjoints.org/symptoms/what-is-dactylitis/. Accessed March 2025. 12 Belasco J., Wei N. Psoriatic Arthritis: What is Happening at the Joint? Rheumatol Ther. 2019 Sep;6(3):305-315. Available at: https://pubmed.ncbi.nlm.nih.gov/31102105/. Accessed March 2025. 13 Gower, T. Enthesitis and PsA. Arthritis Foundation. Available at: https://www.arthritis.org/health-wellness/about-arthritis/related-conditions/physical-effects/enthesitis-and-psa. Accessed March 2025. 14 National Psoriasis Foundation. About Psoriatic Arthritis. Available at: https://www.psoriasis.org/about-psoriatic-arthritis/. Accessed March 2025. 15 Husted J.A., et al. Occurrence and correlates of fatigue in psoriatic arthritis. Ann Rheum Dis, 2008:68(10), 1553–1558. Available at: https://doi-org.sutd.idm.oclc.org/10.1136/ard.2008.098202. Accessed March 2025. 16 Haddad A., Zisman D. Comorbidities in Patients with Psoriatic Arthritis. Rambam Maimonides Med J 2017 Jan 30;8(1):e0004. Available at: https://doi-org.sutd.idm.oclc.org/10.5041/RMMJ.10279. Accessed March 2025. View original content to download multimedia:https://www.prnewswire.com/news-releases/new-long-term-data-reinforces-tremfya-guselkumab-as-the-only-il-23-inhibitor-proven-to-substantially-inhibit-structural-joint-damage-in-active-psoriatic-arthritis-302616074.html SOURCE Johnson & Johnson

AbbVie has boosted its 2025 revenue projection to a company record $60.9 billion. It is the third straight quarter that the Illinois drugmaker has adjusted the sales figure positively. For the third straight quarter, AbbVie has jacked up its revenue forecast for 2025. The Illinois drugmaker has raised its guidance by $400 million, now expecting sales to reach $60.9 billion.The estimate is $1.9 billion higher than AbbVie's projection from the start of the year, another indication that the company continues to be surprised by the performance of immunology stalwarts Skyrizi and Rinvoq and that it has rebounded from the 2023 loss of patent protection in the United States for Humira, the first drug ever to generate more than $20 billion in annual sales.“Clearly, the momentum is there,” AbbVie CEO Rob Michael said on a Friday conference call. “We’ve beaten and raised in every quarter in 2025.”The new forecast reflects expectations that Skyrizi sales will reach $17.3 billion in 2025, which is a $200 million increase from AbbVie's previous estimate based on the drug's market share gains in psoriasis and inflammatory bowel disease (IBD), chief financial officer Scott Reents said.In the third quarter, Skyrizi sales reached $4.7 billion, up 47% year-over-year, while Rinvoq pulled in $2.2 billion for a 35% boost. The $6.9 billion the duo generated in Q3 far exceeds the most ever racked up by Humira in a single quarter, which was $5.6 billion in Q4 of 2022 before its exclusivity lapsed.As challengers come at Skyrizi with advancements—such as Johnson & Johnson’s FDA expansion last month for Tremfya in ulcerative colitis—there remains much room for growth because of the rapid expansion in the use of drugs in the class, AbbVie’s chief commercial officer Jeff Stewart explained.“We know that Tremfya is going to gain some market share,” Stewart said. “But what’s actually happening is that the category or the class of IL-23s is expanding incredibly rapidly and we view this as a positive. We said before, this is not a zero-sum game.”Stewart added that a year ago, the market share of IL-23 penetration in ulcerative colitis was 5%. It’s now close to 40%.“This is a dramatic change in the adoption of the IL-23s,” Stewart added. “It’s just not a Skyrizi story. AbbVie has uniquely a one-two punch in this market. We got Skyrizi and Rinvoq.”Investors have been taking note of AbbVie's momentum. According to GlobalData on Friday, AbbVie posted a 25% increase in its market cap in the third quarter, which exceeded that of any other company among the top 15 in the biopharma industry. The company’s market cap did take a hit earlier this month, however, when it revealed a $2.7 billion hit tied to acquired in-process research and development (IPR&D) expenses and milestones.Still, the company's third-quarter results evidently left something to be desired, as shares slipped by about 4% by midday. Overall, in the third quarter, AbbVie’s revenues came in at $15.78 billion, a 9% year-over-year increase, topping consensus by $200 million.Michael also pointed to strong sales in the company’s neuroscience portfolio. While dropping its annual sales estimate on cosmetic Botox by $200 million, AbbVie also increased its sales projection of its neuroscience products by $200 million, spread across gains for antipsychotic treatment Vraylar, new Parkinson’s disease drug Vyalev, and Botox’s therapeutic indications. Humira sales fell to $993 million, a 55% decline, marking the first time since 2007 that its quarterly sales failed to reach $1 billion.