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

Safety of guselkumab and ustekinumab treatment in patients with moderate-to-severe plaque psoriasis combined with latent tuberculosis or inactive hepatitis B virus infection: A retrospective multicenter observational study. (PubMed, J Am Acad Dermatol) - No abstract available

Journal • Observational data • Retrospective data • Dermatology • Hepatitis B • Immunology • Infectious Disease • Inflammation • Psoriasis • Pulmonary Disease • Respiratory Diseases • Tuberculosis

Understanding Psoriasis Patient Preferences for Biologic Dosing Frequencies: Insights From a Patient Survey. (PubMed, J Psoriasis Psoriatic Arthritis) - "This study evaluates patient dosing preferences for IL-17 and IL-23 inhibitors, risankizumab (RZB) every 12 weeks, guselkumab (GUS) every 8 weeks, and ixekizumab (IXE) every 4 weeks, in managing PsO. No statistically significant differences were observed in dosing frequency preference between treatment groups, suggesting dosing schedule is not a primary concern for most patients. This aligns with previous research demonstrating effective disease control is the most important factor for patient satisfaction; however, tailoring dosing regimens to individual patient needs can also strengthen long-term adherence, as demonstrated in recent studies."

Journal • Dermatology • Immunology • Psoriasis • IL17A • IL23A

Guselkumab Is Effective for the Management of Scalp Psoriasis in Both Biologic-Naïve and Biologic-Experienced Patients: Results From a Real-World, Retrospective Study. (PubMed, Int J Dermatol) - No abstract available

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

Positioning Guselkumab in The Treatment Algorithm of Patients with Crohn's Disease. (PubMed, Biologics) - "Moreover, guselkumab has been approved for other immunomediated inflammatory disease moderate to severe plaque psoriasis, psoriatic arthritis and ulcerative colitis. This review summarizes the available evidence on efficacy and safety of guselkumab in patients with moderate to severe CD, focusing on its positioning in the treatment algorithm."

Journal • Review • Crohn's disease • Dermatology • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Arthritis • Inflammatory Bowel Disease • Psoriasis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies • Ulcerative Colitis • IL23A

Comparative Efficacy of Different Targeted Therapies in Patients With Moderate-to-Severe Ulcerative Colitis: Systematic Review/Network Meta-Analysis and Mechanistic Overview. (PubMed, Pharmacol Res Perspect) - "Cobitolimod 250 mg was the first-ranked treatment (SUCRA, 92.67%) in Endoscopic remission. Vedolizumab 108 mg was the best dosage in reducing Adverse Events (AEs). The optimal dosage for reducing Serious Adverse Events (SAEs) was found to be Tulisokibart 1000/500 mg. During the maintenance phase, Etrasimod 2 mg/kg ranked first in clinical remission (OR 9.58; 95% CI, 2.82-32.59), and Upadacitinib 45 mg was superior in endoscopic remission. Additionally, the most effective medication for raising quality of life was Guselkumab 200 mg (OR 3.04; 95% CI, 1.70-5.40). Consequently, there is a need for further high-quality research to conclusively determine the best therapeutic option."

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

Commentary: Guselkumab binding to CD64+ IL-23-producing myeloid cells enhances potency for neutralizing IL-23 signaling. (PubMed, Front Immunol) - No abstract available

Journal • Inflammation • Pain • IL23A

Interleukin-23 Inhibitors for Inflammatory Bowel Disease: Pivotal Trials and Practical Considerations. (PubMed, Curr Gastroenterol Rep) - "IL-23 inhibitors are safe and effective for treatment of moderate-to-severe inflammatory bowel disease and appear more effective than ustekinumab for Crohn's disease. The currently available IL-23 inhibitors likely have similar efficacy, but practical considerations may influence preferences."

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

“Extension application to add a new strength of 45 mg (100 mg/ml) in a pre-filled syringe (glass) in pre-filled pen (VarioJect) grouped with an extension of indication to include treatment of moderate to severe plaque psoriasis in children and adolescents from the age of 6 years…based on CNTO1959PSO3011. As a consequence, sections 4.1, 4.2, 4.8, 5.1 and 5.2 of the SmPC are updated.” (European Medicines Agency) - Pharmacovigilance Risk Assessment Committee (PRAC)-Draft agenda for the meeting on 2 - 5 Jun 2025

PRAC • Immunology • Psoriasis

GUSELKUMAB SHOWS SIMILAR DOMAIN-SPECIFIC EFFICACY IN FEMALES AND MALES WITH ACTIVE PSORIATIC ARTHRITIS: POST HOC ANALYSES OF THREE PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDIES (EULAR 2025) - P3 | "In a large, pooled cohort of PsA pts from 3 RCTs, sex has no significant impact on GUS efficacy as measured by ACR20 and across PsA domains, after adjusting for the sex differences in baseline characteristics."

Clinical • P3 data • Retrospective data • Dermatology • Fatigue • Immunology • Inflammatory Arthritis • Psoriasis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies

IXEKIZUMAB OR INTERLEUKIN-23 INHIBITORS IN PATIENTS WITH PSORIATIC ARTHRITIS: KEY REAL-WORLD OUTCOMES FROM THE PROSPECTIVE OBSERVATIONAL PARTUS STUDY IN THE US (EULAR 2025) - "IXE or an IL-23i (guselkumab [GUS] or risankizumab [RZB]) was initiated in accordance with the Food and Drug Administration (FDA) labelling in a US clinical setting. The results from the prospective observational RW study PARTUS showed that patients with active PsA treated with IXE achieved meaningful early improvements by W4 in both disease activity and patient-reported outcomes. Disease outcomes continued to improve up to W12. Patients treated with IXE reached disease activity remission and low disease activity rapidly and through W12."

Clinical • Observational data • Real-world • Real-world evidence • Dermatology • Fatigue • Immunology • Inflammatory Arthritis • Musculoskeletal Diseases • Oncology • Pain • Psoriasis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies

SEX-RELATED DIFFERENCES IN BASELINE PATIENT AND DISEASE CHARACTERISTICS: POST HOC ANALYSES OF THREE PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDIES IN PATIENTS WITH ACTIVE PSORIATIC ARTHRITIS (EULAR 2025) - P3 | " Post hoc analyses included PsA pts from 3 Phase 3 RCTs for guselkumab (GUS): 381 pts from DISCOVER-1 (NCT03162796), 739 from DISCOVER-2 (NCT03158285), and 285 from COSMOS (NCT03796858)... Sex differences in pts with highly active PsA from 3 Phase 3 trials were consistent with findings from RWE cohorts. Female PsA pts exhibited less severe PsO, higher BMI, longer PsA duration, and reported a greater impact of PsA on quality of life. These findings highlight the importance of considering biological sex and associated clinical features in the management of PsA, including the evaluation of response to treatment [7]."

Clinical • P3 data • Retrospective data • Dermatology • Fatigue • Immunology • Inflammatory Arthritis • Pain • Psoriasis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies • CRP

BASELINE DETERMINANTS OF MINIMAL DISEASE ACTIVITY (MDA) AT 12 MONTHS IN PATIENTS WITH PSORIATIC ARTHRITIS TREATED WITH GUSELKUMAB: AN ITALIAN MULTICENTER REAL-WORLD STUDY (EULAR 2025) - "A good overall GUS effectiveness was observed. MDA at 12-month follow-up appears to be more achievable in patients who have a higher perceived PsA disease activity at baseline. Furthermore, GUS used as first-line treatment appears to give a better performance towards reaching MDA."

Clinical • Real-world • Real-world evidence • Fibromyalgia • Genetic Disorders • Immunology • Inflammatory Arthritis • Musculoskeletal Pain • Obesity • Pain • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies • IL23A

SOCIAL MEDIA PERSPECTIVES OF BIOLOGICS AND TARGETED THERAPY IN PSORIATIC ARTHRITIS (EULAR 2025) - "We then narrowed the search to specific treatments using the term ‘psoriatic arthritis’ coupled with ‘adalimumab’, ‘baricitinib’ ‘brodalumab’, ‘certolizumab’, ‘etanercept’, ‘guselkumab’, ‘infliximab’, ‘ixekizumab’, ‘risankizumab’, ‘secukinumab’, ‘tildrakizumab’, ‘tofacitinib’, ‘upadacitinib’, and ‘ustekinumab’ and as well as their respective brand names. Social media perceptions of biologics and targeted therapies are largely positive, however there is significant commentary on downsides including local/systemic adverse effects and lack/loss of efficacy. It is important that physicians in their consultations address these common patient concerns that may be perpetuated by social media."

Immunology • Inflammatory Arthritis • Pain • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies • IL12A • IL17A

TREATMENT OUTCOME AND PERSISTENCE OF IL-23 INHIBITORS IN A REAL-WORLD COHORT OF PsA PATIENTS - A RETROSPECTIVE STUDY (EULAR 2025) - "Objectives: The primary objective was to evaluate the efficacy and drug survival of two IL-23i Guselkumab and Risankizumab, in a cohort of difficult to treat psoriatic arthritis (PsA) patients, reflecting real-world clinical practice. In this real-world cohort of difficult to treat PsA patients, IL-23i demonstrated a short drug survival time and limited effectiveness in managing joint disease."

Real-world • Real-world evidence • Retrospective data • Immunology • Inflammatory Arthritis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies • IL23A

MULTICENTER OBSERVATIONAL STUDY ON THE EFFICACY OF GUSELKUMAB IN PSORIATIC ARTHRITIS (EULAR 2025) - "PsA patients treated with GUS achieved a significant rate of disease remission or LDA in a real-world setting. The 12-month response was found to depend mainly on the baseline value of DAPSA."

Clinical • Observational data • Immunology • Inflammatory Arthritis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies • IL23A

ON-LABEL PERSISTENCE THROUGH 24 MONTHS IN PATIENTS WITH PSORIATIC ARTHRITIS USING GUSELKUMAB OR SUBCUTANEOUS INTERLEUKIN-17A INHIBITORS (EULAR 2025) - "Background: A prior study found that patients with psoriatic arthritis (PsA) treated with guselkumab (GUS; a fully human interleukin [IL]-23p19-subunit inhibitor) were ~2x more likely to maintain persistence while following prescribing guidelines at 12 months (M) versus patients treated with subcutaneous (SC) IL-17A inhibitors (IL-17Ai; secukinumab or ixekizumab). This real-world study assessing long-term treatment persistence among patients with active PsA in the US demonstrated that GUS was associated with significantly (1.5x) greater rates of on-label treatment persistence through 24M, compared to SC IL-17Ai."

Clinical • Immunology • Inflammatory Arthritis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies • IL17A

EARLY IMPROVEMENTS IN CLINICAL DISEASE ACTIVITY INDEX FOR PSORIATIC ARTHRITIS AND ITS COMPONENTS WITH GUSELKUMAB PREDICT CLINICAL RESPONSE IN TNFi-EXPERIENCED AND BIOLOGIC-NAÏVE PARTICIPANTS WITH ACTIVE PSORIATIC ARTHRITIS: POST HOC ANALYSES OF THREE PHASE 3, RANDOMIZED, CONTROLLED STUDIES (EULAR 2025) - P3 | "In a PsA population pooled across 3 RCTs, early improvements in cDAPSA total and constituent item scores with GUS Q8W were associated with higher odds of achieving long-term joint disease activity control, regardless of treatment history. The derived cutoffs suggest that TNFi-experienced pts may need to achieve lower SJCs and TJCs to attain sustained control of joint disease activity. These findings support the utility of cDAPSA, and particularly its PRO components, in assessing early improvements in joint disease activity that predict future achievement of low levels of joint disease."

Clinical • P3 data • Retrospective data • Immunology • Inflammatory Arthritis • Pain • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies

GUSELKUMAB EFFICACY IN PSORIATIC ARTHRITIS: A REAL-WORLD EVIDENCE COMPARISON STUDY WITH ADALIMUMAB AND IL-17A INHIBITORS FROM THE MULTICENTER PROSPECTIVE BIOlogic aPUlian REgistry (BIOPURE) (EULAR 2025) - "In particular, ADA group included pts treated with both originator or biosimilar ADA and in IL-17A-i group treated with secukinumab or ixekizumab...All patients were comparable in terms of inflammation reactants, tender and swollen joint count, mean DAPSA score, corticosteroids use (percentage of patients and prednisone-equivalent daily dose), combination therapy with methotrexate (MTX), and the presence of comorbidities, particularly fibromyalgia, at baseline... In the context of an excellent performance in 24 months of follow-up of all the drugs under study, GUS seems to guarantee a faster response in terms of reaching DAPSA remission, MDA and steroid-sparing at 6 months, regardless of the treatment line."

Clinical • HEOR • Real-world • Real-world evidence • Fibromyalgia • Immunology • Inflammation • Inflammatory Arthritis • Musculoskeletal Pain • Pain • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies • IL17A • IL23A

SPANISH COHORT OF PSORIATIC ARTHRTIS PATIENTS TREATED WITH GUSELKUMAB (EULAR 2025) - "All 112 patients were previously treated with conventional systemic disease-modifying antirheumatic drugs (csDMARDs), being methotrexate (81.3%), leflunomide (41.1%) and sulfasalazine (19,6%) the most frequent treatments used respectively. A mean of 1.4 csDMARDs and 3.0 bDMARDs and tsDMARDs were used in these patients, being adalimumab (67.9%), etanercept (23.2%), golimumab (24.1%), infliximab (15.2%), certolizumab (20.5%), secukinumab (48.2%), ixekizumab (32.1%) and ustekinumab (19.2%) the most frequent therapeutic agents used. Regarding tsDMARDs JAK-i and apremilast were used in 23.2% and 20.5% of patients respectively (Figure 1B-C-D)... In this study, we present a cohort of patients from the northern of Spain treated with guselkumab under real-world clinical practice conditions with long-term effectiveness data. The drug showed high persistence (84.31% in the first year) in a more complex patient profile than those examined in clinical trials. There were no notable..."

Clinical • Dermatology • Immunology • Inflammatory Arthritis • Oncology • Psoriasis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies • CRP

REAL-WORLD GUSELKUMAB USE IN FINNISH PATIENTS WITH PSORIATIC ARTHRITIS: ADHERENCE, PERSISTENCE, AND PATIENT-REPORTED OUTCOMES (EULAR 2025) - "The nationwide FINGUS-PsA study highlights the real-world use of GUS for psoriatic arthritis in Finland. Most patients had long-standing disease and prior exposure to multiple bDMARDs or JAKis. High adherence to the GUS Q8 week dosing and alignment with the defined daily dose were observed."

Adherence • Clinical • Patient reported outcomes • Real-world • Real-world evidence • Fatigue • Immunology • Inflammation • Inflammatory Arthritis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies

GENE EXPRESSION PROFILE IS DIFFERENT BETWEEN MEN AND WOMEN IN PSORIATIC DISEASE (EULAR 2025) - P=N/A | "Objectives: Our aim was to assess the molecular effects of specific bDMARDs (adalimumab-ADA, guselkumab-GUS, ustekinumab-UST) in the synovium and blood with specific attention to gender differences. In the TIGERS study, differences in blood and synovium transcriptomic profile between men and women, even before a bDMARD initiation, were observed. Additional analyses are ongoing to better characterize the pathways involved in this gender difference and further inform tailoring our therapeutic strategy."

Clinical • Gene expression profiling • Immunology • Inflammatory Arthritis • Orthopedics • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies • IL23A • TNFA

UVEITIS IN RHEUMATIC DISEASES- DATA FROM A ROMANIAN TERTIARY CENTER (EULAR 2025) - "Distribution of biological therapies were as follows: Adalimumab (ADA) – 16 (51.61%), Etanercept (ETA) - 5 (16.13%), Infliximab (INF) - 4 (12.9%), Certolizumab (CZP) – 2(6.45%), Secukinumab (SEK) – 1 (3.23%), Golimumab (GOL) – 1(3.23%), Guselkumab (GUS) – 1(3.23%) and Upadacitinib (UPA) – 1(3.23%)...Pertaining to conventional immunosupressives, 40.35% of the patients included in the study were taking csDMARDs, with the following distribtuion: Methotrexate – 12 (21,05%), Sulfasalazine – 5 (8.77%), Leflunomide – 2 (3.51%), Azathioprine – 2 (3.51%), Mycophenolate mofetil – 1(1.75%) and 2 (3.51%) patients with a combination of Azathioprine and Hydroxychloroquine... Our study revealed that spondyloarthritis was the most common rheumatic disease associated with uveitis, with the majority of cases being unilateral and anterior. Women were significantly more likely than men to experience uveitis episodes. Additionally, some patients required changes in biological therapy due to..."

ANCA Vasculitis • Ankylosing Spondylitis • Immunology • Inflammatory Arthritis • Lupus • Ocular Inflammation • Ophthalmology • Psoriatic Arthritis • Rare Diseases • Rheumatoid Arthritis • Rheumatology • Seronegative Spondyloarthropathies • Sjogren's Syndrome • Spondylarthritis • Systemic Lupus Erythematosus • Uveitis • Vasculitis

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 (EULAR 2025) - P3 | " APEX enrolled biologic-naïve adults with active PsA (≥3 tender and ≥3 swollen joints; C-reactive protein ≥0.3 mg/dL) and ≥2 joints with erosions on radiographs of hands and feet, despite previous non-biologic DMARDs, apremilast, or NSAIDs. APEX is the first study to show significant inhibition of structural damage progression with both dosing regimens (Q4W and Q8W) of GUS, a dual-acting selective IL-23i. 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 pts with PsA, psoriasis, and/or inflammatory bowel disease [2]."

Clinical • Late-breaking abstract • P3 data • Dermatology • Gastroenterology • Gastrointestinal Disorder • Immunology • Infectious Disease • Inflammation • Inflammatory Arthritis • Inflammatory Bowel Disease • Pain • Psoriasis • Psoriatic Arthritis • Respiratory Diseases • Rheumatology • Seronegative Spondyloarthropathies • CRP • IL23A

Real-World Switching Patterns for Patients with Psoriatic Arthritis on First-Line Advanced Therapies (EULAR 2025) - "Switching was evaluated for the overall population, stratified by the mechanism of action (MOA; reference IL-23i) and individual drugs (reference: risankizumab (RZB))...RZB was associated with significantly lower proportion of switchers (3.8%) than guselkumab (12.9%), followed by secukinumab (18.8%), ixekizumab (20.8%), apremilast (26.9%), etanercept (30.0%) and adalimumab (32.4%) (all P<0.05)... The proportion of PsA patients taking 1LAT who switched over 12 months was the lowest with IL-23i. At the individual drug level, RZB was associated with the lowest odds of switching."

Clinical • Metastases • Real-world • Real-world evidence • Immunology • Inflammatory Arthritis • Oncology • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies • IL12A • IL17A

On-label Persistence Through 24 Months Among Patients with Psoriatic Arthritis Initiating Guselkumab or Subcutaneous TNF Inhibitors (EULAR 2025) - " Using claims from the IQVIA PharMetrics ® Plus database (1/1/2011-6/30/2023), adults with active PsA and ≥1 claim for either GUS or SC TNFi (i.e., adalimumab, certolizumab pegol, etanercept, SC golimumab) were identified (first claim = index date; Figure 1a). GUS was associated with a significantly greater likelihood (~2x) of on-label persistence through 24M vs SC TNFi among pts with PsA, despite a higher prevalence of biologic-experienced pts in the GUS cohort."

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