Latest news with #guselkumab
Associated Press
2 days ago
- Health
- Associated Press
New data show TREMFYA® (guselkumab) is the only IL-23 inhibitor proven to significantly inhibit progression of joint structural damage in active psoriatic arthritis
TREMFYA ® demonstrated two and a half times greater ability to inhibit joint structural damage versus placebo in the Phase 3b APEX study More than 40% of TREMFYA®-treated patients across both dose groups achieved ACR50 at Week 24 Improvement in both joint and skin symptoms reinforce TREMFYA® as a first-line treatment option with a proven safety profile for adults with active psoriatic arthritis BARCELONA, June 11, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today announced findings from the Phase 3b APEX study showing that TREMFYA® (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 from a late-breaking abstract are among the 30 oral and poster presentations Johnson & Johnson is highlighting at the European Alliance of Associations for Rheumatology (EULAR) 2025 Congress. In the Phase 3b APEX study, TREMFYA® 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. 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 TREMFYA® 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). In the two TREMFYA® dose groups, 67% (Q4W) and 63% (Q8W) of patients experienced no radiographic progression, versus 53% in the placebo group.a,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 to be the only IL-23 inhibitor in its class that has inhibited the progression of structural damage in patients, providing new clinical insights for the psoriatic community and underscoring the need for safe, effective options that address the full burden of disease.' TREMFYA® also improved both joint and skin symptoms in patients with active PsA. The data from the APEX study were consistent with the well-established safety profile of TREMFYA®, with no new safety signals identified.1 'With these results from the APEX study, TREMFYA has set a new bar for joint preservation as the only IL-23 inhibitor proven to significantly inhibit structural damage in active psoriatic arthritis, an inflammatory arthritis that can develop in up to 30% of people living with psoriasis,' said Terence Rooney, Vice President, Rheumatology Disease Area Leader, Johnson & Johnson Innovative Medicine. 'The efficacy and safety profile of TREMFYA offers psoriatic healthcare providers and patients an innovative option for disease control.' 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.2,3,4,5,6 Editor's notes: a. TREMFYA is not approved for Q4W dosing in the U.S. 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.7 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.8 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.9 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).10,11,12 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.13 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.14 In patients with PsA, comorbidities such as obesity, cardiovascular disease, anxiety and depression are often present.15 Studies show up to 30% of people with plaque PsO also develop PsA.11 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: TREMFYA® is approved in Europe, Canada, Japan, and a number of other countries for the treatment of adults with moderate-to-severe plaque psoriasis and for the treatment of adults with active psoriatic arthritis. Johnson & Johnson maintains exclusive worldwide marketing rights to TREMFYA®. For more information, visit: 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: Tell your healthcare provider right away if you have an infection or have symptoms of an infection, including: 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: 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, and bronchitis. 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 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 & 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 or at Follow us at @JNJInnovMed. Janssen Research & Development, LLC and Janssen Biotech, Inc. are Johnson & Johnson companies. CAUTIONS CONCERNING FORWARD-LOOKING STATEMENTS This press release contains 'forward-looking statements' as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of nipocalimab. 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: 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 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. REFERENCES 1 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. 2 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. 3 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. 4 TREMFYA® [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc. 5 Skyrizi® [Prescribing Information]. North Chicago, IL: AbbVie, Inc. 6 Omvoh™ [Prescribing Information]. Indianapolis, IN: Eli Lilly and Company. 7 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. 8 Simpson E, Bissonnette R, Eichenfield LF, et al. The validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD™): The development and reliability testing of a novel clinical outcome measurement instrument for the severity of atopic dermatitis [published online April 25, 2020]. J Am Acad Dermatol. doi: 10.1016/ Accessed April 2025. 9 A Study of Guselkumab in Participants With Active Psoriatic Arthritis (APEX). Identifier: NCT04882098. Available at: Accessed March 2025. 10 Donvito T., CreakyJoints: What Is Dactylitis? The 'Sausage Finger' Swelling You Should Know About. Available at: Accessed March 2025. 11 Belasco J., Wei N. Psoriatic Arthritis: What is Happening at the Joint? Rheumatol Ther. 2019 Sep;6(3):305-315. Available at: Accessed March 2025. 12 Gower, T. Enthesitis and PsA. Arthritis Foundation. Available at: Accessed March 2025. 13 National Psoriasis Foundation. About Psoriatic Arthritis. Available at: Accessed March 2025. 14 Husted J.A., et al. Occurrence and correlates of fatigue in psoriatic arthritis. Ann Rheum Dis, 2008:68(10), 1553–1558. Available at: Accessed March 2025. 15 Haddad A., Zisman D. Comorbidities in Patients with Psoriatic Arthritis. Rambam Maimonides Med J 2017 Jan 30;8(1):e0004. Available at: Accessed March 2025. 16 TREMFYA® Prescribing Information. Available at: Accessed March 2025. View original content to download multimedia: SOURCE Johnson & Johnson
Medical News Today
3 days ago
- Health
- Medical News Today
How Tremfya works: Mechanism of action explained
How it works How long it takes to work Tremfya (guselkumab) is a prescription drug that treats psoriatic arthritis, plaque psoriasis, and ulcerative colitis. Its mechanism of action is binding to interleukin-23 that's overactive. Tremfya belongs to a class of medications called interleukin-23 blockers. It's a type of biologic called a monoclonal antibody, which is a protein that attaches to substances in the body. Tremfya works by binding to interleukin-23 (a protein in the body) that's overactive. By binding to this protein, Tremfya decreases how active your immune system is to ease inflammation and decrease symptoms of your condition. The way a drug works is known medically as its mechanism of action. The mechanism of action for Tremfya may vary depending on the condition it's being used to treat. Tremfya is approved by the Food and Drug Administration (FDA) to treat certain conditions, including psoriatic arthritis. When you have psoriatic arthritis, your immune system (your body's defense against infections) is overactive. It attacks healthy tissues and cells, causing joint pain and inflammation. It also causes your body to make too many skin cells, leading to a buildup of cells and areas called plaques. These plaques are flushed, itchy patches on your skin. Tremfya is FDA-approved to treat moderate to severe plaque psoriasis. This condition is one of many types of psoriasis. When you have plaque psoriasis, your immune system is overactive. It causes your body to make too many skin cells, leading to a buildup of cells and areas called plaques. These plaques are itchy patches on your skin. They may look pink or be darker than your skin color. Sometimes, they may look white and scaly. Tremfya may be an option for plaque psoriasis treatment if you can receive either: systemic therapy (treatment that affects your whole body), or phototherapy (treatment with light) Tremfya is FDA approved to treat moderate to severely active ulcerative colitis (UC) in adults. When UC is active, it's causing symptoms. Tremfya is prescribed to help put UC in remission and keep it there. With remission, you have few or no symptoms of the condition. Ulcerative colitis is a type of inflammatory bowel disease (IBD) that affects the colon and rectum. It's thought to result from overactivity in a person's immune system. With UC, you have inflammation in your colon, rectum, or both. In severe cases, ulcers can also form in these areas. Symptoms of this condition include blood in your stool, diarrhea, abdominal pain or cramps, and weight loss. For this condition, Tremfya is typically prescribed alone. Your doctor may also prescribe nonbiologics to treat an ulcerative colitis flare-up. Tremfya is FDA approved to treat Crohn's disease. Like UC, Crohn's disease is a type of IBD. Unlike UC, which affects the colon and rectum, Crohn's disease can affect your entire digestive system, including your stomach, intestines, and colon. To find out more about Crohn's disease, visit our IBD hub. In clinical trials, people with plaque psoriasis often experienced a reduction in symptoms after receiving three doses of Tremfya over 16 weeks. Also, more than half of the people receiving Tremfya for psoriatic arthritis in clinical trials experienced a decrease in symptoms after 16 weeks of treatment. In a clinical trial of Tremfya for UC, more than half of the people receiving the drug experienced a decrease in symptoms after 12 weeks. Some people also experienced remission (few or no symptoms of UC). If you have more questions about how long it takes for Tremfya to work, talk with your doctor or pharmacist. Disclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses. Medical News Today has strict sourcing guidelines and relies on peer-reviewed studies, academic research institutions, and medical journals and associations. We only use quality, credible sources to ensure content accuracy and integrity. You can learn more about how we ensure our content is accurate and current by reading our editorial policy.
Medscape
05-06-2025
- Health
- Medscape
IL-23 Inhibitors Show Highest Drug Survival in Psoriasis
Interleukin (IL)-23p19 inhibitors guselkumab and risankizumab demonstrated the highest drug survival for effectiveness and safety comparable with ustekinumab over 2 years, exceeding that of all other biologics. IL-17 receptor inhibitor brodalumab showed comparable effectiveness and safety with adalimumab and secukinumab. METHODOLOGY: Researchers conducted a cohort study using data from the British Association of Dermatologists Biologics and Immunomodulators Register from November 2007 to June 2023 and compared the drug survival of all current commonly used biologics in patients with chronic plaque psoriasis (median age at therapy initiation, 48 years). The analysis included 19,034 treatment courses across the following biologics: Tumour necrosis factor-alpha inhibitor adalimumab (n = 6815), IL-12/23p40 inhibitor ustekinumab (n = 5639), IL-17A inhibitors secukinumab (n = 3051) and ixekizumab (n = 1072), IL-17 receptor inhibitor brodalumab (n = 367), and IL-23p19 inhibitors guselkumab (n = 1258) and risankizumab (n = 832). Multivariable flexible parametric models assessed drug survival, with discontinuation due to ineffectiveness and adverse effects reported separately. Researchers also calculated the restricted mean survival time (RMST) at 2 years for each biologic and the difference in RMST between all comparator biologics. The overall median follow-up duration was 2.3 years. TAKEAWAY: Guselkumab and risankizumab demonstrated the highest adjusted survival time for effectiveness (RMST, 1.93 years for both; 95% CI, 1.91-1.95 and 1.90-1.96 years, respectively). Risankizumab showed the highest survival for safety (1.94 years; 95% CI, 1.92-1.96 years), followed by guselkumab (1.92 years; 95% CI, 1.90-1.94 years) and ustekinumab (1.92 years; 95% CI, 1.91-1.93 years). Brodalumab exhibited a lower adjusted survival time for effectiveness (1.75 years; 95% CI, 1.69-1.81 years) than most biologics except secukinumab and adalimumab and lower drug survival for safety than all biologics except the IL-17A inhibitors and adalimumab. Among the IL-17A inhibitors, secukinumab exhibited significantly lower adjusted drug survival than ixekizumab for effectiveness but had a significantly higher safety profile. Prior exposure to biologics was associated with a decline in survival, with significantly larger reductions observed for IL-17 inhibitors. IN PRACTICE: "Drug survival is high with IL23p19 inhibitors. People with psoriasis persist with IL23p19 inhibitors up to an estimated 21 weeks more for effectiveness and 13 weeks more for safety compared with other biologics over a 2-year period on average," the authors wrote. "This evidence on the absolute difference in time persisted on biologic may help clinicians and patients make an informed decision on choosing the right biologic, including differentiating between different classes of biologics based on the patient's history of having PsA [psoriatic arthritis] or not, their treatment history, and whether they prioritize treatment longevity," they added. SOURCE: This study was led by Leila Motedayen Aval, The University of Manchester, The Dermatology Centre, Salford Royal Hospital, Northern Care Alliance NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, England. It was published online on May 29, 2025, in the Journal of the European Academy of Dermatology and Venereology . LIMITATIONS: This study was limited by missing data for newer biologics, particularly IL-17A inhibitors and IL-23p19 inhibitors, and shorter follow-up periods for newer treatments. Residual selection bias may have been present. Additionally, researchers could not evaluate dosing regimens due to missing data for over 50% of dosing frequency information for secukinumab, and results may not be generalisable beyond the UK and Republic of Ireland healthcare systems. DISCLOSURES: The British Association of Dermatologists Biologic Register Ltd receives income from AbbVie, Almirall, Eli Lilly, J&J, Leo Pharma, Novartis, Samsung Bioepis, UCB, BI, and BMS for providing pharmacovigilance services. This research was supported by the National Institute for Health and Care Research Manchester, Guy's and St Thomas' and Newcastle's Biomedical Research Centres. Several authors reported receiving grants or personal fees and having other ties with various sources.
Daily Mail
24-05-2025
- Health
- Daily Mail
New once-a-month jab can eliminate distressing symptoms for patients with severe bowel diseases like Crohn's and ulcerative colitis in only three months
Patients with severe bowel disease are set to benefit from a new drug that can eliminate their distressing symptoms in only three months. The once-a-month jab, guselkumab, treats Crohn's and ulcerative colitis, two debilitating conditions which occur when the immune system mistakenly attacks healthy tissue in the gut and other parts of the body. The medicine binds to immune cells that cause this damage, significantly reducing symptoms. Studies show that more than half of patients with Crohn's – an aggressive condition which can damage the gut as well as the mouth, stomach, and anus – were symptom-free within 12 weeks of starting guselkumab. About a quarter of patients with ulcerative colitis, where the damage is limited to the gut, experienced a similar benefit after beginning the treatment. Earlier this month, the drug safety watchdog, the Medicines and Healthcare products Regulatory Agency, gave the green light for guselkumab to be prescribed in the UK to patients who have failed to respond to other treatments. It is likely to be rolled out on the NHS within the next year. About half-a-million people in the UK suffer with Crohn's, which causes severe pain, diarrhoea, exhaustion and weight loss. It can also trigger pain in the joints, anus and eyes. About a third of patients living with the condition, where the gut lining becomes inflamed, will require surgery. Ulcerative colitis affects roughly 146,000 people in the UK. Symptoms include diarrhoea, blood in the poo, and regularly needing to go to the toilet. Both conditions can be controlled by drugs called biologics. These injections limit the damage caused by the immune system to the body. However, not all patients respond to them. The NHS spending watchdog, the National Institute for Health and Care Excellence, is currently deciding whether to fund guselkumab. Experts say the £2,250-a-month jab will be a lifeline and crucial addition to the Health Service's bowel disease treatments.
Medscape
20-05-2025
- Health
- Medscape
MHRA Approves Guselkumab for Inflammatory Bowel Disease
The Medicines and Healthcare products Regulatory Agency (MHRA) has approved guselkumab (Tremfya, Janssen-Cilag Limited) for use in adults with Crohn's disease and ulcerative colitis (UC). The drug is already licensed in the UK for plaque psoriasis and psoriatic arthritis. The new indication covers patients with moderately to severely active Crohn's disease or UC who have not responded to other treatments or have experienced unacceptable side effects. Guselkumab is a monoclonal antibody (IgG1-lambda) that inhibits interleukin-23 (IL-23)—a natural cytokine associated with inflammatory and immune responses—by selectively binding to its p19 subunit. This inhibits the proinflammatory actions of IL-23, thereby decreasing cytokine and chemokine release. The European Medicines Agency extended the drug's indications in March. Crohn's Disease: Remission in More Than Half of Patients The MHRA said that clinical trials showed that guselkumab reduced symptoms such as diarrhoea and abdominal pain in patients with Crohn's disease. Three studies involving around 1400 patients found that up to 56% achieved clinical remission after 12 weeks of treatment. In comparison, 15%-22% of patients on placebo reached remission. Endoscopic response, indicating reduced intestinal inflammation, was seen in up to 41% of patients treated with guselkumab versus 11%-21% in the placebo group. A follow up study published last year showed that 57%-75% of patients maintained remission to week 48, depending on the dose. Endoscopic remission at week 48 was reported in 17%-33% of treated patients. Initial induction treatment is given by either intravenous infusion or injection every 4 weeks for three cycles. This is followed by maintenance therapy with subcutaneous injections every 4 or 8 weeks, depending on the induction phase response. Pre-filled syringes or pens are available for self-administration. Ulcerative Colitis: Long-Term Remission Achievable In UC, guselkumab helps to reduce abdominal pain and inflammation of the intestinal lining, reducing fatigue and helping patients maintain normal activities. According to the MHRA, 23% of patients receiving guselkumab achieved clinical remission after 12 weeks of induction treatment, compared with 8% on placebo. With continued treatment, remission was reported in up to 50% of patients by week 44. In the placebo group, the remission rate was 19%. A study extension, presented by the manufacturer at Digestive Disease Week this month, showed 72% of patients in clinical remission, with 99% of them remaining corticosteroid free for 8 or more weeks through to week 92. Among the 43% of trial patients in endoscopic remission at week 44, most (84%) maintained this outcome through to week 92. Induction treatment for UC involves monthly intravenous infusions. Maintenance treatment is delivered by subcutaneous injection. Treatment should be discontinued if there is no clinical response after 24 weeks. Adverse Effects and Safety Monitoring Guselkumab is associated with an increased risk of infections, particularly of the upper respiratory tract. Fungal and viral infections, such as tinea and herpes simplex, are also common. Patients should be screened for tuberculosis before initiating treatment. Live vaccines are contraindicated during therapy. Other commonly reported side effects include headache, injection site reactions, arthralgia, elevated liver enzymes, diarrhoea, and gastroenteritis. Julian Beach, interim executive director of healthcare quality and access at the MHRA, said in a press release: 'We're assured that the appropriate regulatory standards of safety, quality, and efficacy for the approval of this new formulation have been met." He added that the safety of guselkumab will be kept under close review. Healthcare professionals and patients are encouraged to report adverse reactions via the Yellow Card scheme. A full list of side effects will be included in the Patient Information Leaflet and the Summary of Product Characteristics, available on the MHRA website within 7 days of approval.
