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

P088 Janus kinase inhibitor treatment in coexisting atopic dermatitis and irritable bowel disease: real-world experience and therapeutic outcomes. (PubMed, Br J Dermatol) - "Despite the apparent efficacy treating IBD in this series, only two of seven patients (29%) achieved satisfactory cutaneous response to JAKi monotherapy, contrasting with established efficacy data in isolated AD. These findings raise questions about underlying disease mechanisms in this phenotype, warranting further investigation.TableTreatment of seven patients with atopic dermatitis (AD) and irritable bowel disease (IBD) with Janus kinase inhibitors (JAKis)Age (years)Primary indicationBefore JAKi treatmentOn JAKi treatmentDisease statusAD treatmentIBD treatmentJAKi therapyOutcomes50ADEASI 54; UC controlledNoneGuselkumab (stopped)Upadacitinib 24 months (ongoing)EASI 75 achieved (5.1); UC remission22AD, CDEASI 41; CD activeMethotrexate (stopped)Infliximab (stopped)Upadacitinib 4 months (ongoing)EASI 75 achieved (7.4); CD remission29ADEASI 13; UC controlledNoneAZA, allopurinol (stopped)Upadacitinib 8 months (ongoing)EASI 10.3; added methotrexate (6 months), switched to..."

Journal • Real-world evidence • Alopecia • Atopic Dermatitis • Crohn's disease • Dermatitis • Dermatology • Gastroenterology • Gastrointestinal Disorder • Genetic Disorders • Herpes Zoster • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis • Varicella Zoster

O07 Serious infection risk with systemic treatments for psoriasis: a cohort study from the British Association of Dermatologists Biologics and Immunomodulators Register (BADBIR). (PubMed, Br J Dermatol) - "Inclusion criteria were adults who received at least one of the biologics, apremilast or conventional nonbiologics (acitretin, ciclosporin and methotrexate) for ≥ 6 months. All biologics licensed for psoriasis were analysed except for infliximab, which had higher prescription criteria...The certolizumab group had a low mean age of 37.4 years (SD 10.3), the ustekinumab group had a significantly longer median treatment duration of over 4 years (IQR 1.83-6.73), and more patients in the ixekizumab (42.6%) and certolizumab (40.6%) groups had concomitant psoriatic arthritis...IRs (95% CIs) of other tumour necrosis factor-α inhibitors were 15.7 (14.5-17.1) for adalimumab and 16.7 (13.8-20.0) for etanercept. For interleukin-17 inhibitors the IRs (95% CIs) were 18.4 (15.9-21.2) for secukinumab, 7.63 (0.92-27.6) for bimekizumab, 14.5 (7.73-24.8) for brodalumab and 18.5 (14.0-24.0) for ixekizumab. For interleukin-23 inhibitors the IRs (95% CIs) were 13.5 (9.97-17.8) for guselkumab,..."

Journal • Observational data • Dermatology • Immunology • Infectious Disease • Inflammatory Arthritis • Oncology • Psoriasis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies • IL12A • IL17A

BI28 A rare case of cutaneous leishmaniasis associated with guselkumab. (PubMed, Br J Dermatol) - "Our case highlights the importance of early diagnosis and prompt management of cutaneous leishmaniasis to prevent disease progression, particularly in immunocompromised patients. Travel advice to endemic regions should also be considered in patients receiving biologics such as interleukin-23 inhibitors."

Journal • Dermatology • Immunology • Infectious Disease • Inflammatory Bowel Disease • Oncology • Psoriasis • Squamous Cell Carcinoma

O05 A retrospective review of cases of psoriasis requiring discontinuation of biologic therapy from 2007 to 2024 in a multisite NHS trust. (PubMed, Br J Dermatol) - "Concurrent systemic immunosuppression (methotrexate or ciclosporin) was prescribed in 21% (n = 31)...The biologics with most interventions were adalimumab or biosimilars (n = 102: Humira n = 39, Idacio n = 30, Hyrimoz n = 23, Amgevita n = 10), ustekinumab (n = 39), secukinumab (n = 35), guselkumab (n = 13) and certolizumab (n = 11)...The main blood abnormality was positive tuberculosis ELISpot assay (interferon-γ release assay) (n = 6: Humira n = 2; and Idacio, ustekinumab, etanercept and risankizumab n = 1 each). Other abnormalities included leucocytosis in sepsis (n = 2; ustekinumab, secukinumab), neutropenia (n = 1; Hyrimoz), raised alanine aminotransferase (n = 1; Humira) and raised fetal calprotectin (n = 1; Ixekizumab)...Blood abnormalities requiring treatment intervention were infrequent, most commonly positive tuberculosis testing. Our findings support reducing blood monitoring of..."

Journal • Retrospective data • Atopic Dermatitis • Dermatology • Diabetes • Gastroenterology • Gastrointestinal Disorder • Hematological Disorders • Hepatology • Hidradenitis Suppurativa • Immunology • Infectious Disease • Inflammatory Arthritis • Inflammatory Bowel Disease • Metabolic Disorders • Metabolic Dysfunction-Associated Steatotic Liver Disease • Neutropenia • Pain • Psoriasis • Psoriatic Arthritis • Pulmonary Disease • Respiratory Diseases • Rheumatology • Septic Shock • Seronegative Spondyloarthropathies • Tuberculosis • Type 2 Diabetes Mellitus • Ulcerative Colitis • Urticaria • IFNG

What is the optimal sequential therapy after secondary IL-17A inhibitor failure in psoriasis: switching to an IL-23 inhibitor or to another IL-17A inhibitor? (PubMed, J Dermatolog Treat) - "This single-center, retrospective analysis included psoriatic patients who experienced secondary failure to either ixekizumab or secukinumab and subsequently switched to another IL-17A inhibitor (ixekizumab or secukinumab; intraclass switching group) or to an IL-23 inhibitor (guselkumab; interclass switching group). Previous exposure to ≥2 biologics working on different pathways was identified as a risk factor for treatment failure in the interclass switching group. An intraclass switch following IL-17A inhibitors failure yielded better treatment outcomes than a switch to guselkumab."

Journal • Retrospective data • Dermatology • Immunology • Psoriasis • IL17A • IL23A

An evaluation of guselkumab for the treatment of ulcerative colitis. (PubMed, Expert Opin Biol Ther) - "No direct comparisons are available between individual IL-23 antagonists or with ustekinumab, the IL-12/23 antagonist, which limits decision-making in clinical practice. Combining two biologics as advanced combination treatment is an attractive strategy to break the therapeutic efficacy ceiling in UC - a proof-of-concept phase 2 trial combining guselkumab and golimumab has shown promise, the combination is currently undergoing evaluation in a larger ongoing trial."

Journal • Review • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis • IL12A • IL23A

Efficacy and safety of IL-23p19 and IL-12/23p40 inhibitors in moderate-to-severe Crohn's disease: a systematic review and network meta-analysis. (PubMed, Ann Med) - "Interleukin (IL)-23 inhibitors-including IL-23p19 inhibitors (guselkumab, mirikizumab, risankizumab) and the IL-12/23p40 inhibitor ustekinumab-are emerging treatments for Crohn's disease (CD), but comparative data among them remain limited. This is the first NMA comparing IL-23 inhibitors using contemporary evidence. The results offer practical insights for personalized CD treatment: guselkumab may be preferred for rapid response, mirikizumab for safety, and risankizumab for balanced efficacy."

Clinical • Journal • Retrospective data • Review • Crohn's disease • Gastroenterology • Immunology • Inflammatory Bowel Disease • IL12A • IL23A

Time to lift the moratorium on IL-23 inhibitors for axial psoriatic arthritis. (PubMed, Lancet Rheumatol) - "However, post-hoc analyses of clinical trials show clinical improvements in axial psoriatic arthritis following treatment with ustekinumab, guselkumab, and risankizumab...Furthermore, inadequate response to biological therapies in axial spondyloarthritis was associated with absence of MRI-determined bone marrow oedema, whereas responses to secukinumab in axial spondyloarthritis were independent of bone marrow oedema, pointing to divergent pathophysiological processes. The growing recognition of clinical, microanatomical, and immunological differences between axial spondyloarthritis and axial psoriatic arthritis suggests differential IL-23 pathway dependence. This Personal View aims to provide a deeper examination of these distinctions as a basis to propose reconsidering the current moratorium on IL-23 inhibitors-particularly in phenotypes not linked to HLA-B27-and to potentially expand therapeutic options."

Journal • Review • Ankylosing Spondylitis • Immunology • Inflammation • Inflammatory Arthritis • Pain • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies • Spondylarthritis • CRP • IL23A

The complex interplay between psoriasis and depression: from molecular mechanisms to holistic treatment approaches. (PubMed, Front Immunol) - "Biologics (e.g., adalimumab, secukinumab, and guselkumab) can simultaneously ameliorate skin lesions and depressive symptoms. When combined with psychological interventions-including cognitive behavioral therapy and mindfulness therapy-a multidisciplinary collaboration involving dermatology, rheumatology, and psychology is essential to formulate a tailored treatment plan. This review systematically outlines the core mechanisms underlying comorbidity of these two diseases, as well as multidimensional treatment strategies."

Journal • Review • CNS Disorders • Depression • Dermatology • Immunology • Inflammation • Mood Disorders • Psoriasis • Psychiatry • Rheumatology • CXCL8 • IL6

Development of Descending Thoracic Aortic Aneurysm in a Psoriasis Patient Under Guselkumab Treatment. (PubMed, J Dermatol) - No abstract available

Journal • Cardiovascular • Dermatology • Immunology • Psoriasis

Long-term real-world persistence of guselkumab in patients with moderate-to-severe psoriasis. (PubMed, Actas Dermosifiliogr) - No abstract available

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

Efficacy of Guselkumab in Treating Hailey Hailey Disease (clinicaltrials.gov) - P2 | N=10 | Recruiting | Sponsor: Yale University | Trial completion date: Nov 2025 ➔ Apr 2026 | Trial primary completion date: Nov 2025 ➔ Apr 2026

Trial completion date • Trial primary completion date • Genetic Disorders

Accuracy of Budget Impact Projections in Bulgarian Health Technology Assessment: A Five-Year Validation Study (2020-2025). (PubMed, Healthcare (Basel)) - "Large overshoots were observed for Avelumab, Risankizumab, and Guselkumab; Cobimetinib and Abemaciclib remained below forecast. Health Technology Assessment Budget Impact Analyses captured broad cost scaling but systematically missed product-specific uptake, with deviations largely volume-driven. Strengthening national registries and real-world data pipelines, and adopting dynamic, indication-responsive contracting and forecasting, could materially improve budget predictability while preserving access to innovation."

HEOR • Journal • Oncology

Validity and Psychometric Properties of 3 and 4 Visual Analog Scale in Participants With Psoriatic Arthritis Treated With Guselkumab. (PubMed, J Rheumatol) - "These analyses support the validity of 3VAS/4VAS as multidimensional measures of PsA disease activity. 4VAS may be preferred owing to its greater face validity and separate measurements of the two cardinal aspects of PsA (joint/skin disease) and pain."

Clinical • Journal • Dermatology • Immunology • Inflammatory Arthritis • Pain • Psoriasis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies

EMERGE: Shared Pathways Between Non-Alcoholic Fatty Liver Disease and Psoriatic Disease With Guselekumab Therapy (clinicaltrials.gov) - P=N/A | N=20 | Not yet recruiting | Sponsor: University of California, San Diego

New trial • Dermatology • Hepatology • Immunology • Inflammatory Arthritis • Metabolic Dysfunction-Associated Steatotic Liver Disease • Psoriasis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies

Inhibition of Structural Damage Progression With Guselkumab, a Selective IL-23i, in Participants With Active PsA: Results Through Week 24 of the Phase 3b APEX Study (ISDS 2025) - P3 | "APEX enrolled biologic-naïve adults with active PsA and ≥2 erosive joints on hand/foot radiographs, despite previous non-biologic DMARDs/apremilast/NSAIDs. No new safety signals were identified. APEX showed significant inhibition of structural damage progression with both dosing regimens of GUS The GUS safety profile in these biologic-naïve pts with active PsA is consistent with that previously established for GUS across a broad range of patients with PsA, psoriasis, and/or inflammatory bowel disease."

P3 data • Dermatology • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Arthritis • Inflammatory Bowel Disease • Psoriasis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies

Multi-omics profiling reveals shared molecular signatures in psoriasis target plaques across disease severities during guselkumab induction therapy (ISDS 2025) - "Although the number of moderate-to-severe patients is limited and the inclusion of additional participants is warranted, the results indicate that comparable plaques on mild and moderate-to-severe patients are also comparable on a molecular level. Similar treatment responses highlight the applicability of IL-23 blockade to mild psoriasis patients."

Dermatology • Immunology • Psoriasis • IL23A

Systemic Biologic Treatment for Psoriasis in Elderly Patients (ISDS 2025) - "Drug survival of adalimumab as first-line treatment, and of guselkumab in any treatment sequence, was significantly better in the elderly-start group (p=0.029 and p=0.032, respectively). Biologic treatments for psoriasis demonstrate both efficacy and safety in elderly patients. Some agents exhibited better drug survival when initiated after age 65 years."

Clinical • Dermatology • Immunology • Infectious Disease • Psoriasis

Common Psoriasis Therapeutics and Ocular Symptoms: Analysis of the FAERS Database (ISDS 2025) - "OAE for adalimumab, apremilast, etanercept, infliximab, ustekinumab, guselkumab, and secukinumab were queried from the FAERS Database with disproportionality analysis (DA) conducted for top 25 OAEs. Apremilast, however, was only associated with increased risk of blepharospasm (16.43); all other adverse events studied displayed no increased risk. Our findings support the necessity of physician guidance and the research needed in elucidating ocular adverse events."

Age-related Macular Degeneration • Cataract • CNS Disorders • Dermatology • Dry Eye Disease • Glaucoma • Immunology • Keratitis • Macular Degeneration • Ocular Inflammation • Ophthalmology • Psoriasis • Retinal Disorders • Uveitis • ROR1

SPECTREM: Guselkumab Demonstrates Consistent Significant Clearance Across the Full Range of Low Body Surface Area, Moderate Psoriasis With Special Sites Involvement (ISDS 2025) - "Guselkumab is highly effective in low BSA, moderate plaque psoriasis with special sites involvement. Consistent, significant improvements across multiple clearance measures irrespective of baseline BSA substantiate the effectiveness of guselkumab across a broad range of patients."

Dermatology • Immunology • Psoriasis

Durable Inhibition of Structural Damage Progression and Improvements in Joint Disease Activity With Guselkumab in Active and Erosive Psoriatic Arthritis: Week 48 Results From APEX (ISDS 2025) - P3 | "Incidence rates did not increase with continued GUS (W0-48: 147 [132-163]/148 [136-162]), or after PBO-to-GUS transition (W24-48: 156 [138-176]). In biologic-naïve adults with active and erosive PsA, inhibition of radiographic progression and joint disease activity improvements with GUS were durable through W48 without increased AE incidence, further substantiating GUS benefit for preserving joint health."

Immunology • Inflammatory Arthritis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies

Guselkumab Pharmacokinetics and Immunogenicity in Pediatric Psoriasis: Phase 3 PROTOSTAR Study (ISDS 2025) - P3 | "In Part 1 (Weeks [W] 0–16), participants were randomized to GUS, placebo, or open-label etanercept. The development and titers of Ab to GUS did not impact PK or clinical response. The observed PK for GUS in pediatric PsO participants receiving WB dosing was generally comparable with PK in adults with PsO."

Clinical • P3 data • PK/PD data • Dermatology • Immunology • Pediatrics • Psoriasis

Guselkumab Demonstrates Effectiveness Regardless of Disease Duration: Week 76 Results from the Real-world G-EPOSS Study (ISDS 2025) - "Radtke MA et al. J Dtsch Dermatol Ges 2015; 13:674–90."

Clinical • Real-world • Real-world evidence • Cardiovascular • CNS Disorders • Depression • Dermatology • Diabetes • Hypertension • Immunology • Inflammation • Inflammatory Arthritis • Metabolic Disorders • Psoriasis • Psoriatic Arthritis • Psychiatry • Rheumatology • Seronegative Spondyloarthropathies

Pharmacokinetics of Guselkumab in Super-Responders and Long-Term Psoriasis Disease Control: Insights from the Phase 3b GUIDE Trial (ISDS 2025) - "Presented at EADV Congress 2023; Berlin, Germany; October 11–14, 2023. P2042."

P3 data • PK/PD data • Dermatology • Immunology • Psoriasis

EFFECT-1LAT: Describing Treatment Patterns and Creating an Updated Treatment Flow in an Ulcerative Colitis Population (clinicaltrials.gov) - P=N/A | N=4000 | Not yet recruiting | Sponsor: Pfizer | Trial completion date: Oct 2025 ➔ Mar 2026 | Initiation date: Sep 2025 ➔ Dec 2025 | Trial primary completion date: Oct 2025 ➔ Mar 2026

Trial completion date • Trial initiation date • Trial primary completion date • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis