Tremfya (guselkumab) / J&J, Otsuka, Novartis - LARVOL DELTA

EBV-positive Hodgkin lymphoma with immunosuppressive microenvironment during IL-23 inhibitor therapy for psoriasis. (PubMed, medRxiv) - "We report the initial case of EBV-positive classic Hodgkin lymphoma (cHL) after guselkumab therapy for psoriasis. High-plex spatial proteomic analysis showed a Th2-polarized immunosuppressive tumor microenvironment, indicating immune reprogramming from IL-23 inhibition might have triggered the onset of EBV-positive cHL."

Journal • Classical Hodgkin Lymphoma • Dermatology • Hematological Malignancies • Hodgkin Lymphoma • Immunology • Lymphoma • Oncology • Psoriasis • IL23A

Novel Small-Molecule Treatment and Emerging Biological Therapy for Psoriasis. (PubMed, Biomedicines) - "There are many types of drugs to treat psoriasis: small-molecule drugs, including corticosteroids; retinoids; vitamin D analogs; and immunosuppressants, such as glucocorticoid ointment, tretinoin cream, methotrexate tablets, etc. Macromolecular biological drugs, such as Certolizumab, Secukinumab, Guselkumab, etc., include monoclonal antibodies that target various inflammatory signaling pathways...Spesolimab is the latest biological agent used to target the interleukin-36 receptor (IL-36R) to be approved for market use, which significantly reduces the risk of general pustular psoriasis (GPP) flare by 84%...In this review, we analyze the current status of psoriasis therapeutics and discuss novel delivery systems for diverse psoriasis drugs, as well as emerging cell-based therapies. We also summarize the therapeutic effectiveness of different delivery strategies."

Journal • Review • Dermatology • Immunology • Psoriasis • Pustular Psoriasis

Real-World Treatment Patterns Among Patients With Scalp Psoriasis in Canada (ISPOR 2025) - "More than half of the patients with scalp psoriasis were treated with an advanced systemic therapy; the three most common were risankizumab (26%), guselkumab (18%), and apremilast (10%). Scalp psoriasis was present in a substantial proportion of patients with plaque psoriasis in Canada, identified in more than one-third of patients in the DERMAID database. Patients with scalp psoriasis are likely to receive advanced systemic therapy, with more than half of the patients having received this treatment. Even when BSA <10% is present, indicative of mild-to-moderate psoriasis that can be managed topically, a sizable proportion of patients (20%) received advanced therapy."

Clinical • HEOR • Real-world • Real-world evidence • Dermatology • Immunology • Psoriasis

Cost per Response Analysis of Deucravacitinib and Biologic Treatments for Moderate to Severe Plaque Psoriasis From the Perspective of the Brazilian Private Healthcare System (ISPOR 2025) - "Deucravacitinib presented the lowest cost-per-response ratio amongst all treatments available for moderate to severe plaque psoriasis in the Brazilian private"

Dermatology • Immunology • Inflammation • Psoriasis

Long-term Health Outcomes in Patients With Moderate-to-Severe Ulcerative Colitis Treated With Guselkumab: a Model-based Projection (ISPOR 2025) - "The model predicts that guselkumab-treated patients with ADT non-failure will spend a greater proportion of time in remission and response and less time in active UC over 1-, 3-, and 5-years versus patients with ADT failure. This reduction in active disease state time may lead to lower healthcare resource utilization and improved quality of life."

Clinical • HEOR • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis • IL23A

Effectiveness and Safety of Guselkumab in Patients With Moderate-to-Severe Plaque Psoriasis in Real-World Practice in Korea: A Prospective, Multicenter, Observational, Postmarketing Surveillance Study. (PubMed, J Dermatol) - "Adverse events (AEs) occurred in 22.5% of patients, with an incidence rate of 42.1 per 100 patient years (PY); 14 serious AEs occurred in 13 (1.8%) patients, with an incidence rate (95% confidence interval) of 2.4 (1.2-3.7) per 100 PY. Guselkumab administered under approved label conditions was effective and well-tolerated in Korean patients with moderate-to-severe plaque psoriasis in a real-world clinical setting."

Journal • P4 data • Real-world evidence • Dermatology • Immunology • Psoriasis

Efficacy and Safety of IL-17 and IL-23 Inhibitors in Elderly Patients With Plaque Psoriasis: A Real-World Study. (PubMed, J Dermatol) - "In this retrospective study, 121 patients with moderate-to-severe plaque psoriasis treated with secukinumab, ixekizumab, guselkumab, or risankizumab were analyzed. Drug survival is similarly excellent across age groups and biologic classes. These findings support the successful use of modern biologics in elderly psoriasis patients."

Journal • Real-world evidence • Dermatology • Immunology • Psoriasis • IL17A • IL23A

New Interleukin-23 Antagonists' Use in Crohn's Disease. (PubMed, Pharmaceuticals (Basel)) - "Selective new IL-23 inhibitors, including risankizumab, guselkumab, and mirikizumab, block the IL-23p19 subunit to inhibit the Il-23 action and alleviate inflammation in CD. Selective new IL-23 inhibitors represent a targeted and effective therapeutic class for moderately to severely active CD, offering high clinical and endoscopic remission rates, and favorable safety outcomes. Continued research, particularly on long-term efficacy and the selection of patients based on inflammatory biomarkers, will help optimize their role in personalized treatment strategies for refractory CD."

Journal • Review • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Infectious Disease • Inflammation • Inflammatory Bowel Disease • Oncology • IL23A

Targeting nail psoriasis: IL-17A inhibitors demonstrate site-specific superiority over IL-23 inhibitor in a 24-week dermoscopy-guided real-world cohort. (PubMed, Front Immunol) - "To compare the real-world clinical efficacy and safety of interleukin (IL)-17A inhibitors (secukinumab [SEC] and ixekizumab [IXE]) versus the IL-23 inhibitor guselkumab (GUS) in patients with nail psoriasis, with a focus on site-specific biologic therapeutic responses (nail matrix vs. nail bed) in a 24-week prospective observational cohort. Specifically, SEC excelled in improving dermoscopic nail matrix changes, whereas IXE was more potent for nail bed pathology. All groups significantly improved patients' life quality and exhibited good safety profiles."

Clinical • Head-to-Head • Journal • Observational data • Real-world evidence • Atopic Dermatitis • Dermatology • Immunology • Psoriasis • IL17A • IL23A

The role of interleukin inhibitors in the treatment of hidradenitis suppurativa; a systematic review of clinical trials. (PubMed, Autoimmun Rev) - "Secukinumab showed sustained hidradenitis Suppurativa Clinical Response (HiSCR) improvements, particularly in biologic-naïve patients with common adverse events (AEs). Bimekizumab was effective with biweekly dosing, while the four-week regimen had inconsistent results, with rare reports of AEs. Brodalumab and bermekimab provided rapid and sustained HiSCR responses with lesion reductions, which were well tolerated. Guselkumab and ustekinumab showed promising but statistically nonsignificant improvements with mild AEs. Risankizumab did not significantly improve HiSCR rates but showed Dermatology Life Quality Index (DLQI) benefits. Anakinra offered moderate efficacy with prolonged exacerbation-free periods but led to some treatment discontinuations. Spesolimab reduced inflammatory lesions and draining tunnels while maintaining a favorable safety profile. IL inhibitors, especially IL-17 inhibitors, have demonstrated efficacy in treating moderate-to-severe HS, while..."

Journal • Review • Dermatology • Hidradenitis Suppurativa • Immunology • Inflammation • IL17A • IL23A

Diffusion dimensionality modeling of subcutaneous/intramuscular absorption of antibodies and long-acting injectables. (PubMed, J Pharmacokinet Pharmacodyn) - "The diffusion dimensionality models were challenged with previously published subcutaneous absorption data for 13 antibody drugs and insulin lispro, and the long-acting injectable antipsychotic drugs: subcutaneous Perseris™, intramuscular Invega Sustenna®, Risperdal Consta®, and olanzapine...Three antibodies (CNTO5825, ACE910 and ustekinumab) were best described by the 2-dimensional diffusion equation. The 2- and 3-dimensional diffusion equations were equivalent for ABT981, guselkumab, adalimumab, nemolizumab, omalizumab, and secukinumab. Golimumab, DX2930, AMG139, and mepolizumab were best described by the 3-dimensional diffusion equation. All the long-acting antipsychotic dosage forms except Risperdal Consta were modeled satisfactorily. Diffusion dimensionality models are a parsimonious and effective approach for modeling drug absorption profiles of subcutaneously and intramuscularly administered small molecule and protein drugs and their dosage forms."

Journal • CNS Disorders

Discovery and development of SIM0709 a novel bi-specific antibody targeting TL1A and IL23p19 for the treatment of IBD and beyond (IMMUNOLOGY 2025) - "In vitro , SIM0709 demonstrated superior functional activities under various functional assays on both TL1A and IL23 axes compared to that of benchmark anti-TL1A mAb RG6631 and Guselkumab, respectively. High solubility of SIM709 also supports patient-friendly formulation suitable for subcutaneous administration . Taken together, these data support the further development of SIM0709 as a potential FIC therapeutic agent for the treatment of IBD with expected first-in-human study in H1 2026."

Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • IL23A

TREMFYA (guselkumab) receives European Commission approval for adults with moderately to severely active ulcerative colitis, strengthening Johnson & Johnson’s leadership in inflammatory bowel disease (GlobeNewswire) - "Johnson & Johnson today announced that the European Commission (EC) has approved a Marketing Authorisation (MA) for TREMFYA (guselkumab) for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic treatment....The EC approval is supported by data from the QUASAR programme...The EC Decision is expected later this year."

EMA approval • Inflammatory Bowel Disease • Ulcerative Colitis

Guselkumab: a safe treatment option for patients with comorbid psoriasis and multiple sclerosis. (PubMed, Ital J Dermatol Venerol) - No abstract available

Journal • CNS Disorders • Dermatology • Immunology • Multiple Sclerosis • Psoriasis

A Long-Term Real-Life Safety Study of Guselkumab in Psoriasis Patients with Infectious Comorbidities, Malignancies or Heart Disease: The EARLY Study. (PubMed, Clin Exp Dermatol) - "This longitudinal real-life study demonstrates the long-term safety of guselkumab in psoriasis patients with chronic infection, cancer or heart disease. Stratification by oncological risk provided valuable insights for therapeutic management."

Journal • Cardiovascular • Dermatology • Heart Failure • Hepatitis B • Hepatology • Human Immunodeficiency Virus • Immunology • Infectious Disease • Oncology • Psoriasis • Pulmonary Disease • Respiratory Diseases • Tuberculosis

Effects of Guselkumab on the FIB-4 Index in Psoriasis Patients (EGIPT): A Three-Year Study. (PubMed, J Dermatol) - "These findings suggest guselkumab does not contribute to liver fibrosis progression in psoriasis patients. Further research with advanced methods like imaging or biopsy is needed to confirm the long-term hepatic safety of IL-23 inhibitors like guselkumab."

Journal • Dermatology • Fibrosis • Hepatology • Immunology • Liver Cirrhosis • Metabolic Disorders • Metabolic Dysfunction-Associated Steatotic Liver Disease • Psoriasis • IL23A

Predictive Factors for Super Responder Status and Long-Term Effectiveness of Guselkumab in Psoriasis: A Multicenter Retrospective Study. (PubMed, Dermatol Ther (Heidelb)) - "Our study highlights the importance of identifying patients most likely to achieve PASI 100 early in treatment. Factors such as obesity, prior biologic experience, and baseline PASI contribute to predicting complete skin clearance, which can guide clinical decision-making and enable personalized treatment strategies."

Biomarker • Journal • Retrospective data • Cardiovascular • Dermatology • Diabetes • Genetic Disorders • Hypertension • Immunology • Inflammation • Metabolic Disorders • Obesity • Psoriasis • IL23A

Emirates Drug Establishment approves new indications for 'Guselkumab' for treating patients with Crohn’s disease (MSN News) - "The Emirates Drug Establishment (EDE) has approved new indications for Guselkumab, making the UAE the second country globally to authorise the treatment for Crohn’s disease."

Approval • Crohn's disease

Unveiling the effectiveness and safety spectrum of biologic therapies in psoriasis: a three-year real-world analysis. (PubMed, Postgrad Med) - "Guselkumab and Secukinumab demonstrated the highest drug survival rates, whereas Ixekizumab had the lowest. Early improvements in PASI and DLQI scores were strong predictors of drug survival. Personalized treatment approaches are crucial, given the varied effectiveness, safety profiles, and drug survival among biologic therapies."

Journal • Real-world evidence • Dermatology • Immunology • Infectious Disease • Inflammation • Psoriasis • Respiratory Diseases • IL12A • IL17A • IL23A

AbbVie regained TV ad spending lead amid February slowdown... (Fierce Pharma) - "The fourth- and fifth-place seats went to two other mainstays on iSpot’s monthly roundups. Sanofi and Regeneron’s Dupixent, which climbed one spot from its fifth-place finish in January, was the star of six ads throughout the month, while Johnson & Johnson’s Tremfya, runner-up for the previous two months, fell to fifth with four spots on air...Lundbeck and Otsuka’s neurology med Rexulti took sixth, thanks to just under $20 million spent on a trio of ads for the drug’s uses in treating depression and Alzheimer’s-associated agitation....Boehringer Ingelheim’s Jardiance, which held steady in eighth place..."

Commercial • Alzheimer's Disease • Asthma • Atopic Dermatitis • Chronic Kidney Disease • Chronic Obstructive Pulmonary Disease • Chronic Rhinosinusitis With Nasal Polyps • Chronic Spontaneous Urticaria • Crohn's disease • Eosinophilic Esophagitis • Immunology • Prurigo Nodularis • Psoriatic Arthritis • Ulcerative Colitis

Roflumilast Cream 0.3% for a Patient With Genital Psoriasis Refractory to Other Topical and Systemic Treatments: A Case Report. (PubMed, J Clin Aesthet Dermatol) - "After 28 weeks of initial treatment with guselkumab, body surface area (BSA) affected had fallen from 42 to 8 percent; however, new genital lesions were noted. At 16 weeks, genital and gluteal cleft disease remained well-controlled with no evidence of active disease. Overall, roflumilast cream 0.3% was well tolerated with no pruritus, folliculitis, irritation, or contact dermatitis observed."

Journal • Contact Dermatitis • Dermatitis • Dermatology • Immunology • Pruritus • Psoriasis

Treatment of plaque psoriasis with guselkumab reduces systemic inflammatory burden as measured by neutrophil/lymphocyte ratio, platelet/lymphocyte ratio and monocyte/lymphocyte ratio: A post hoc analysis of three randomised clinical trials. (PubMed, Dermatology) - P3 | "Objectives The primary aim of this study was to evaluate changes in NLR, PLR and MLR with guselkumab compared with placebo (VOYAGE I/II), adalimumab (VOYAGE I/II) and secukinumab (ECLIPSE). Conclusions Guselkumab is a highly efficacious treatment for plaque psoriasis; the study has demonstrated the potential benefit of treatment with guselkumab in reducing systemic inflammation as measured by NLR, PLR and MLR, which appeared to be independent of psoriasis response, suggesting that reducing systemic inflammation with guselkumab may decrease CVD risk. Clinical trial registration VOYAGE I: NCT02207231; VOYAGE II: NCT02207244; ECLIPSE: NCT03090100."

Journal • Retrospective data • Cardiovascular • Dermatology • Immunology • Oncology • Psoriasis • CRP

“…to introduce a new pharmaceutical form (concentrate for solution for infusion), a new strength (200 mg) and a new route of administration (intravenous use)…new strength of 200 mg for solution for injection (in pre-filled syringe/pen)…as a consequence, sections 4.1, 4.2, 4.5, 4.8, 5.1, 5.2 and 5.3 of the SmPC of the already approved form 100 mg solution for injection are updated.” (European Medicines Agency) - Pharmacovigilance Risk Assessment Committee (PRAC) Minutes of meeting on 10 – 13 Feb 2025

PRAC • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Comparative efficacy of pharmacologic interventions in ulcerative colitis: a network meta analysis. (PubMed, Inflammopharmacology) - "Upadacitinib displayed high efficacy across multiple outcomes in both induction and maintenance therapy with Infliximab, guselkumab, and filgotinib following closely behind. For achieving steroid free remission tofacitinib has the highest probability of doing so. Overall small molecules and selective IL-23 inhibitors seems promising alternative to older biologics though additional head-to-head trial are warranted along with more real-world data."

Journal • Retrospective data • Review • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis • IL23A

PHARMACEUTICAL BENEFITS ADVISORY COMMITTEE (PBAC) MEETING AGENDA July 2025 PBAC MEETING: Tremfya for severe Crohn disease (Pharmaceutical Benefits Scheme (PBS)) - "To request General Schedule Authority Required (Written) listings for subcutaneous injection and a Section 100 (Highly Specialised Drug Program) Authority Required (Written) listing for I.V. infusion for the treatment of severe Crohn disease."

Reimbursement • Crohn's disease • Inflammatory Bowel Disease