Ilumya (tildrakizumab-asmn) / Sun Pharma, Almirall, Merck (MSD), Hikma, China Medical System - LARVOL DELTA

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

Tildrakizumab 200 mg. Is double dosing really a window of opportunity? (PubMed, Actas Dermosifiliogr) - No abstract available

Journal • Dermatology • Immunology • Psoriasis

Sustained Safety Tildrakizumab for Psoriatic Arthritis (AJMC) - "A primary finding from the phase 2b open-label extension study is the confirmation of a favorable safety profile maintained over an extended period of 208 weeks—more than four years. The data, encompassing 281 participants, reported no new safety signals emerged and showed adverse events consistent with prior findings. The safety profile is a major advantage of IL-23 inhibition in psoriatic arthritis, as these agents are not associated with the same significant risk of infections often seen with other biologic treatments."

P2b data • Psoriatic Arthritis

Real-World Effectiveness and Safety of Tildrakizumab in Moderate-to-Severe Psoriasis: A Multicenter Experience in the Basque Country. (PubMed, Dermatol Ther (Heidelb)) - "Tildrakizumab demonstrated high effectiveness and a favorable safety profile in this large, real-world multicenter cohort. These findings support its role as a reliable therapeutic option for patients with moderate-to-severe plaque psoriasis in clinical practice."

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

Sun Pharmaceutical Industries launches its global innovative drug, Ilumya (Tildrakizumab) in India for moderate-to-severe plaque psoriasis. (Indian Pharma Post)

Launch non-US • Psoriasis

MINIMA: MIcrovascular dysfuNction In Moderate-severe Psoriasis (clinicaltrials.gov) - P4 | N=36 | Completed | Sponsor: Marcelo F. Di Carli, MD, FACC | Active, not recruiting ➔ Completed

Trial completion • Cardiovascular • Dermatology • Immunology • Psoriasis • CRP

Tilrdakizumab Almirall (clinicaltrials.gov) - P=N/A | N=3 | Active, not recruiting | Sponsor: University Hospital Schleswig-Holstein

New trial • Dermatology • Immunology • Psoriasis

Tildrakizumab as a Potential Option for Early Psoriatic Arthritis in Patients with Metabolic Comorbidities and Psoriasis: a Case Series. (PubMed, Dermatol Pract Concept) - "Tildrakizumab confirmed its efficacy in reducing signs and symptoms of early PsA, with high safety profile in our psoriasis patients also affected by multiple metabolic comorbidities."

Journal • Dermatology • Immunology • Inflammation • Inflammatory Arthritis • Pain • Psoriasis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies • IL23A

Switching within the class of IL-23 inhibitors for the treatment of psoriasis: A systematic review. (PubMed, J Eur Acad Dermatol Venereol) - No abstract available

Journal • Dermatology • Immunology • Psoriasis • IL23A

Real-World Costs per Treatment Sequence and per Responder for Biologic Therapies in Moderate-to-Severe Plaque Psoriasis: Evidence From Three Italian Centers (ISPOR-EU 2025) - "Sensitivity analyses varied the second-line agents in Sequences 1 and 2. The base sequence (adalimumab, brodalumab, guselkumab, ixekizumab) resulted in the lowest cumulative cost per patient at the third year (€17,426), compared to €18,184 in sequence 1 (adalimumab, risankizumab, guselkumab, ixekizumab) and €19,087 in sequence 2 (adalimumab, secukinumab, guselkumab, ixekizumab)...In the sensitivity analysis, the base sequence remained the most cost favorable compared to Sequence 1 (tildrakizumab) and Sequence 2 (ustekinumab) in second line. The results indicate that sequencing strategies have a substantial impact on the cost effectiveness of biologic treatments for psoriasis. The results indicate that sequencing strategies have a substantial impact on the cost effectiveness of biologic treatments for psoriasis. The primary objective confirmed brodalumab as the most economically sustainable strategy across the simulations conducted. These findings may support evidence..."

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

Comparison of Persistence Rates: Tildrakizumab vs. Adalimumab/Ustekinumab Based on a German Longitudinal Prescription Database (LRx) of Social Health Insurance Patients in Outpatient Care (ISPOR-EU 2025) - "After a four-year follow-up, PsO patients treated with Tildrakizumab showed higher persistence compared to those treated with Adalimumab/Ustekinumab, particularly among bio-naïve patients. This underscores the long-term sustained efficacy of Tildrakizumab for PsO patients in the German outpatient setting."

Clinical • Reimbursement • US reimbursement • Dermatology • Immunology • Psoriasis • IL12A

Comprehensive assessment of 5 interleukin inhibitors for the treatment of psoriasis: scientific guidance based on drug selection recommendations for Chinese medical institutions. (PubMed, J Pharm Policy Pract) - "The rankings of composite scores, from highest to lowest, were as follows: ixekizumab with 68.8 points, secukinumab with 65.47 points, ustekinumab with 65.41 points, tildrakizumab with 62.6 points, and guselkumab with 61.64 points, taking into account the results from the 5 dimensions. Until the guideline recommendations, the National Essential Drug List, clinical studies, and many other dimensions of this assessment are updated, ixekizumab, secukinumab, and ustekinumab, which have the top 3 scores, can be used as a priority recommendation for Chinese medical institutions to select interleukin inhibitors and optimise the use of the drug catalog based on the scoring results of this assessment."

Journal • Dermatology • Immunology • Psoriasis

Almirall continues its sustained growth trajectory in 9M 2025 - delivering 12.8% net sales growth, strong dermatology performance, solid commercial execution in Europe, and further pipeline progress (PharmiWeb) - "Ebglyss, for the treatment of moderate to severe atopic dermatitis, generated €75.5 MM of sales during 9M 2025 – representing more than a 3x increase YoY, as European markets are ramping up after launch...Ilumetri, for the treatment of psoriasis, grew steadily in 9M 2025, with net sales increasing 12% YoY, to a total of €170.9 MM and remaining on track to meet the €300 MM peak sales target....Almirall’s broad dermatology product portfolio continues to show strong performance, further enhancing the company´s relevance to patients and dermatologists. In 9M 2025 Wynzora grew 32.3% YoY to a total of €25.4 MM, and Klisyri grew 22.6% YoY to a total of €20.1 MM."

Sales • Actinic Keratosis • Atopic Dermatitis • Psoriasis

Real-world effectiveness and predictors of complete skin clearance (pasi 100) with anti-IL-23 monoclonal antibodies in moderate-to-severe psoriasis: a retrospective cohort study. (PubMed, Expert Opin Biol Ther) - "We performed a monocentric retrospective study on 243 adults with moderate-to-severe psoriasis treated with guselkumab, risankizumab, or tildrakizumab at the University of Pisa...Prior cyclosporine use (HR 0.644) and higher baseline PASI (HR 0.973) were negative predictors...Outcomes are influenced by disease localization, duration, prior treatments, and baseline severity. Limitations include retrospective design, single-center setting, and absence of comparators."

Journal • Real-world evidence • Retrospective data • Dermatology • Immunology • Psoriasis • IL23A

Intraclass Switching of IL-23 Inhibitors in Psoriasis: Effectiveness, Patterns, and Predictors of Response - A Retrospective Multicenter Study in Italy. (PubMed, Clin Exp Dermatol) - "Intraclass switching among IL-23 inhibitors is an effective strategy, with risankizumab emerging as the most favorable option."

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

Super Responders in Plaque Psoriasis: A Real-World, Multi-Agent Analysis Showing Bimekizumab Associated with the Highest Odds of PASI = 0 at Week 12. (PubMed, J Clin Med) - " We performed a retrospective, single-center study of 116 adults with moderate-to-severe plaque psoriasis initiating their first biologic (adalimumab, tildrakizumab, guselkumab, risankizumab, bimekizumab, or secukinumab)...Multivariable logistic regression estimated adjusted associations between biologic and SR, controlling for age, sex, disease duration, BMI, baseline PASI, and prior cyclosporine/acitretin... In this real-world cohort, biologic selection-particularly bimekizumab-was the main determinant of early complete clearance. These findings highlight mechanistic class as a key driver of rapid, deep responses and support prospective validation with harmonized SR definitions and extended follow-up."

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

Cumulative clinical benefits of biologic treatments in patients with moderate-to-severe psoriasis: an Italian real-life experience - IL PSO (Italian Landscape Psoriasis). (PubMed, Clin Exp Dermatol) - "In this multicenter real-life study, bimekizumab provides exploratory evidence on the cumulative clinical benefit of biologics in moderate-to-severe psoriasis. These findings highlight the importance of cumulative endpoints and individualized treatment strategies in daily practice."

Journal • Dermatology • Immunology • Inflammation • Pain • Psoriasis

Biologic Therapies and Major Cardiovascular Events in Psoriasis: Updated Systematic Review and Meta-analysis. (PubMed, Dermatol Ther (Heidelb)) - "Anti-psoriatic biologics were not associated with an increased risk of MACE in psoriasis patients. Given that most included RCTs were of relatively short duration, longer-term studies and post-marketing surveillance are needed to clarify the cardiovascular safety profile of biologic therapies. Further large-scale studies with extended follow-up are warranted."

Journal • Retrospective data • Review • Cardiovascular • Dermatology • Immunology • Oncology • Psoriasis • IL12A • IL23A

Dual control of Chronic Plaque Psoriasis and Pouchitis with Tildrakizumab. (PubMed, Clin Exp Dermatol) - No abstract available

Journal • Dermatology • Gastrointestinal Disorder • Immunology • Inflammation • Psoriasis

Long-Term Safety of Tildrakizumab Through Week 208 in Patients With Psoriatic Arthritis: Results From the Phase 2b Open-Label Extension Study (ACR Convergence 2025) - P2b | "The safety of TIL was maintained through W208 of treatment in patients with PsA, with no new safety signals. These data support continued development of TIL to treat patients with active PsA."

Clinical • P2b data • Cardiovascular • Dermatology • Immunology • Infectious Disease • Inflammatory Arthritis • Myocardial Infarction • Psoriasis • Psoriatic Arthritis • Respiratory Diseases • Rheumatology • Seronegative Spondyloarthropathies • IL23A

A Study to Evaluate the Efficacy and Safety of Subcutaneous Tildrakizumab in Subjects With Moderate to Severe Genital Psoriasis. (clinicaltrials.gov) - P3 | N=206 | Active, not recruiting | Sponsor: Sun Pharmaceutical Industries Limited | Recruiting ➔ Active, not recruiting | Trial completion date: Jan 2028 ➔ Feb 2027

Enrollment closed • Trial completion date • Dermatology • Immunology • Psoriasis

Phase II trial of tildrakizumab in treatment-refractory bone and soft tissue sarcomas (ESMO 2025) - P, P2 | "Conclusions Tildrakizumab was safe and well tolerated but showed no objective activity. Immune and metabolic signals warrant exploration of potential combination strategies in pts with advanced sarcomas."

IO biomarker • P2 data • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor • EGR1 • ICOSLG • IL23A • STAT3

Single cell RNA-seq immune profiling of blood samples from a psoriatic disease clinical trial reveals a CD4 T cell population associated with response to IL-23 blockade (ACR Convergence 2025) - P4 | "Here, we applied single cell RNA-seq immune profiling to blood samples from 27 PsO/A patients to identify cellular features associated with response to IL-23 blockade by tildrakizumab in the setting of a clinical trial. PBMCs from psoriasis (n = 21) and psoriatic arthritis (n=6) patients were collected as part of the MINIMA study (NCT04271540) at Brigham and Women's Hospital before (following washout) and after 24 weeks of treatment with tildrakizumab... We have identified a subset of CD4+ T cells whose abundance in circulation before treatment is associated with response to IL-23i in skin disease severity. This T cell population demonstrates transcriptomic features that correspond to those expanded in psoriasis lesional skin. These results suggest that cellular features detectable in blood may be informative in predicting clinical response to IL-23 blockade."

Clinical • Dermatology • Immunology • Inflammatory Arthritis • Psoriasis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies • CCL5 • CCR6 • CD4 • CXCR3 • IFNG • IL17A • IL23A • STAT1

Efficacy of Biologics for the Treatment of Moderate-To-Severe Plaque Psoriasis in the Asian Population: A Systematic Review and Network Meta-Analysis. (PubMed, Int J Dermatol) - "The efficacy of tildrakizumab improved over time, which underscores the importance of evaluating the sustained efficacy of tildrakizumab over the long term. Combined with low dosing frequency, tildrakizumab offers an effective treatment option for patients with moderate-to-severe plaque psoriasis."

Journal • Retrospective data • Review • Dermatology • Immunology • Oncology • Psoriasis • IL12A • IL17A • IL23A • TNFA

Psoriatic arthritis risk in psoriasis patients receiving anti-IL-23 vs anti-IL-17: comparison of drug classes and individual agents. (PubMed, Rheumatology (Oxford)) - "PsO patients treated with IL23i had a lower subsequent PsA risk compared with those treated with IL17i."

Journal • Dermatology • Genetic Disorders • Immunology • Inflammatory Arthritis • Obesity • Oncology • Psoriasis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies • IL12A • IL17A • IL23A • TNFA