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

A Study of Tildrakizumab in Pediatric Subjects With Chronic Plaque Psoriasis (clinicaltrials.gov) - P2/3 | N=135 | Active, not recruiting | Sponsor: Sun Pharmaceutical Industries Limited | Recruiting ➔ Active, not recruiting | Trial completion date: Dec 2031 ➔ Aug 2031 | Trial primary completion date: Jul 2025 ➔ Apr 2025

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

Beyond skin clearance: Tildrakizumab improves high burdensome symptoms and psychological well-being in moderate-to-severe psoriasis patients – 2-year POSITIVE study results (AAD 2026) - "Patients treated with tildrakizumab in a real-world setting achieved significant reductions in burdensome symptoms of psoriasis after 16 weeks, which were maintained over 2 years. Tildrakizumab significantly improved psychological well-being in patients with moderate-to-severe psoriasis, matching general population levels at week 16 and improving further by year 2."

Clinical • CNS Disorders • Depression • Dermatology • Immunology • Musculoskeletal Diseases • Musculoskeletal Pain • Orthopedics • Psoriasis

Sustained Three-Year Effectiveness of Tildrakizumab in Moderate-to-Severe Psoriasis: Real-World Data from a Single-Center Cohort (AAD 2026) - "Conclusion Tildrakizumab provided substantial and durable improvements in objective and patient-reported outcomes over three years in routine care. Significant clinical benefit was also achieved in patients discontinuing early, supporting its effectiveness across different treatment durations."

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

Stable Laboratory Parameters Over Three Years Support Minimal Monitoring During Tildrakizumab Therapy (AAD 2026) - "Discontinuations due to AEs were rare. These findings support the long-term safety of tildrakizumab and suggest that routine laboratory monitoring during therapy may not be necessary."

Immunology • Infectious Disease • Inflammation • Psoriasis • Respiratory Diseases

Tildrakizumab in Real-World Chinese Psoriasis: Efficacy-Safety Profiles from a 28-Week Prospective Cohort with Geriatric and Metabolic Syndrome Stratification (AAD 2026) - "Tildrakizumab demonstrated sustained efficacy in real-world management of moderate-to-severe psoriasis and supported broad applicability across diverse psoriasis subtypes."

Clinical • Real-world • Real-world evidence • Dermatology • Geriatric Disorders • Immunology • Metabolic Disorders • Psoriasis

Effects of interleukin-23 inhibitors on carotid intima-media thickness in patients with psoriasis (AAD 2026) - "Twelve patients were recruited (7 on risankizumab, 3 on guselkumab, and 2 on tildrakizumab), with a mean age of 53 ± 7.1 years, a mean PASI of 7 ± 5.2, a mean BMI of 29.9 ± 4, an average of 1.6 ± 1 prior biologic therapies, and a mean baseline cIMT of 0.78 ± 0.19 mm. These results suggest that IL-23 inhibitors may reduce cIMT and total cholesterol in patients with psoriasis, potentially lowering CVR. Larger studies with longer follow-up are required to validate these results."

Clinical • Cardiovascular • Dermatology • Immunology • Inflammation • Psoriasis • IL23A

Risk of infections in patients with psoriasis treated with biologic agents and new oral small molecules. BIOBADADERM Registry. (AAD 2026) - " We analyzed crude incidence rates of overall, serious, recurrent, and infections of special interest in patients treated with etanercept, infliximab, certolizumab, adalimumab, ustekinumab, secukinumab, ixekizumab, brodalumab, bimekizumab, guselkumab, risankizumab, tildrakizumab, apremilast, and dimethyl fumarate. Modern systemic therapies for psoriasis show a favorable infection safety profile in real-world settings. IL-17 inhibitors appear to increase the risk of Candida infections, while some biologics may reduce the incidence of respiratory and viral infections."

Clinical • Candidiasis • Dermatology • Human Papillomavirus Infection • Immunology • Infectious Disease • Nephrology • Novel Coronavirus Disease • Psoriasis • Respiratory Diseases • IL17A

Beyond Trial-and-Error: Mechanism-Guided Use of Biologics in Scalp Psoriasis (AAD 2026) - "Ustekinumab offered modest scalp improvement but lacked dedicated trials. IL-17 inhibitors (secukinumab, ixekizumab, brodalumab, bimekizumab) consistently produced the most rapid clearance, with several maintaining high rates of complete response in long-term follow-up. IL-23 inhibitors (guselkumab, risankizumab, tildrakizumab) provided excellent durability, with real-world evidence confirming sustained clearance. No scalp-specific outcomes were reported for certolizumab... Biologic selection in scalp psoriasis can move beyond trial-and-error toward mechanism-guided therapy. IL-17 inhibitors are best suited for rapid scalp clearance, while IL-23 inhibitors may optimize long-term durability. These findings support the development of a practical, scalp-specific treatment algorithm to address one of the most visible and burdensome manifestations of psoriasis."

Dermatology • Immunology • Psoriasis • CD8 • IL22 • IL23A

Real-world tildrakizumab persistence in the US by biologic experience and insurance coverage in the PPD CorEvitas Psoriasis Registry (AAD 2026) - "Tildrakizumab initiators remained on drug more than 2 years on average; fewer than half of discontinuations were due to safety or effectiveness. Drug survival and persistence varied by insurance coverage, with nearly three-quarters of patients on Medicare persistent at 1 year and an average time on drug of nearly 3 years. These real-world findings support the safety and effectiveness of tildrakizumab for patients with plaque psoriasis, including those on Medicare."

Clinical • Real-world • Real-world evidence • Reimbursement • US reimbursement • Dermatology • Immunology • Psoriasis • IL12A • IL23A • TNFA

Efficacy and safety of tildrakizumab in patients with moderate-to-severe psoriasis affecting the nails: A multicenter, randomized, double-blind, placebo-controlled, Phase 3b trial (AAD 2026) - P3 | "Efficacy and safety of tildrakizumab in patients with moderate-to-severe plaque psoriasis affecting the nails were maintained through W52."

Clinical • P3 data • Dermatology • Immunology • Pruritus • Psoriasis

Vulvovaginal Lichen Planus Treatment Outcomes: A Systematic Review of Novel and Established Therapies (AAD 2026) - "Among monotherapies, systemic corticosteroids showed highest complete resolution (CR) rates at 88.9%, followed by biologics with tildrakizumab achieving 88% CR, and JAK inhibitors with tofacitinib showing 75% CR. Notably, intravaginal hydrocortisone suppositories achieved 54.6% CR compared to only 14.8% with topical clobetasol propionate, demonstrating superior efficacy of mucosal delivery methods...Recurrence rates varied significantly: 84% for topical corticosteroids alone, 11.9% for methotrexate, and only 3.2% for tildrakizumab, suggesting potential disease-modifying effects of certain biologics...Our findings suggest that intravaginal delivery methods outperform topical application, newer targeted therapies show promise even in treatment-refractory cases, and combination approaches are frequently necessary for adequate disease control. The superior efficacy of JAK inhibitors and biologics, combined with lower recurrence rates, offers new hope for patients with..."

Clinical • Review • Dermatology • Dermatopathology • Lichen Planus

Comparative risk of psoriatic arthritis in psoriasis patients on immunomodulators (AAD 2026) - "The immunomodulatory agents assessed included Adalimumab, Infliximab, Ixekizumab, Secukinumab, Tildrakizumab, Certolizumab pegol, Risankizumab, Etanercept, Guselkumab, and Ustekinumab. Inhibition of this inflammation by immunomodulators could impede PsA progression. Physicians can consider Risankizumab, Guselkumab, and Ustekinumab as treatment options for PsO patients with PsA risk factors to mitigate disease progression and improve patients’ quality of life."

Clinical • Immunomodulating • Cardiovascular • Dermatology • Diabetes • Dyslipidemia • Gastroenterology • Gastrointestinal Disorder • Genetic Disorders • Gout • Hypertension • Immunology • Inflammation • Inflammatory Arthritis • Inflammatory Bowel Disease • Metabolic Disorders • Obesity • Psoriasis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies • IL12A • IL23A • JAK1 • JAK3 • TNFA

Biologic treatment in Psoriasis and Hidradenitis Suppurativa patients with active malignancy: Experience from a Tertiary Care Hospital. (AAD 2026) - "Three patients were on adalimumab at cancer diagnosis; all switched to a different biologic class afterward. Biologic agents used included ustekinumab (n=1), tildrakizumab (n=4), guselkumab (n=1), and risankizumab (n=3)...This patient was not eligible for curative treatment, received palliative care, and died during follow-up. To sum up, biologic therapy may be feasible in selected patients with recent malignancy under close monitoring, preferring IL-23 inhibitors due to their safety profile."

Clinical • Colorectal Adenocarcinoma • Colorectal Cancer • Dermatology • Hidradenitis Suppurativa • Immunology • Lung Adenocarcinoma • Lung Cancer • Oncology • Palliative care • Prostate Adenocarcinoma • Prostate Cancer • Psoriasis • Solid Tumor • Squamous Cell Carcinoma • Supraglottic Laryngeal Cancer • IL23A

Sustained effectiveness of tildrakizumab in patients with moderate-to-severe psoriasis overall and in high-impact areas: 2-year results from the POSITIVE study (AAD 2026) - "In a real-world setting, tildrakizumab significantly improved skin clearance in patients with moderate-to-severe plaque psoriasis after 16 weeks, with further improvement observed over the 2-year period. In addition, tildrakizumab showed marked and sustained improvement in high-impact areas such as the scalp, palms or soles, and nails throughout 2 years."

Clinical • Dermatology • Immunology • Inflammation • Psoriasis

Real-world tildrakizumab effectiveness in the US by biologic experience and geographic region in the PPD CorEvitas Psoriasis Registry (AAD 2026) - "Most tildrakizumab initiators had high skin clearance and improved quality of life at 12 months. The magnitude of the positive responses varied by biologic experience and geographic region, suggesting that differences in patient and treatment characteristics may contribute to variability in the real-world effectiveness of tildrakizumab."

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

Safety Outcomes of IL-23 Versus IL-17 Inhibitors in Psoriasis: A Multicenter Real-World Study (AAD 2026) - "Adults (≥18 years) with psoriasis initiating an IL-23 inhibitor (guselkumab, risankizumab, tildrakizumab) were compared to those commencing an IL-17 inhibitor (secukinumab, ixekizumab, brodalumab). This first multicenter, real-world head-to-head comparison of IL-23 and IL-17 inhibitors in psoriasis demonstrates a therapeutic trade-off: IL-23 agents reduce infection and mortality risks but increase malignancy and NMSC risks relative to IL-17 inhibitors. These findings offer pivotal evidence to inform individualized, long-term biologic selection in psoriasis, addressing a major gap in dermatologic care."

Clinical • Real-world • Real-world evidence • Dermatology • Genetic Disorders • Herpes Zoster • Immunology • Infectious Disease • Non-melanoma Skin Cancer • Pneumonia • Psoriasis • Respiratory Diseases • Septic Shock • Skin Cancer • Solid Tumor • Varicella Zoster • IL17A • IL23A

BeNeBio: Dose Reduction of IL17 and IL23 Inhibitors in Psoriasis (clinicaltrials.gov) - P4 | N=244 | Completed | Sponsor: Radboud University Medical Center | Active, not recruiting ➔ Completed

Head-to-Head • Trial completion • Dermatology • Immunology • Psoriasis • IL17A

Efficacy and Safety of Tildrakizumab for Moderate-to-Severe Plaque Psoriasis with Diabetes: Pooled Subgroup Analysis of reSURFACE 1 and reSURFACE 2. (PubMed, Dermatol Ther (Heidelb)) - P3 | "Short-term efficacy of tildrakizumab was maintained in patients with and without diabetes mellitus. A higher frequency of AEs in patients with diabetes and obesity may be attributable to underlying disease and associated higher inflammation."

Journal • Dermatology • Diabetes • Genetic Disorders • Immunology • Inflammation • Metabolic Disorders • Obesity • Psoriasis

Comparative risk of psoriatic arthritis in psoriasis patients on immunomodulators. (PubMed, Proc (Bayl Univ Med Cent)) - "The immunomodulatory agents assessed included adalimumab, infliximab, ixekizumab, secukinumab, tildrakizumab, certolizumab pegol, risankizumab, etanercept, guselkumab, and ustekinumab. Overall, IL-23 inhibitors risankizumab, guselkumab, and ustekinumab had the greatest decreased risk of PsA. Physicians can consider risankizumab, guselkumab, and ustekinumab as treatment options for psoriasis patients with PsA risk factors to mitigate disease progression and improve patients' quality of life."

Journal • Dermatology • Immunology • Inflammatory Arthritis • Oncology • Psoriasis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies • IL12A • IL23A • JAK1 • JAK3 • TNFA

Comparing Systemic Therapies for Scalp Psoriasis: A Literature Review (AAD 2026) - "Ixekizumab achieved >90% PSSI improvement across multiple trials, with sustained clearance to 264 weeks; brodalumab showed 94.1% improvement at 52 weeks; secukinumab displayed 95.9% improvement at 52 weeks with durability to 156 weeks. IL-23 inhibitors had lower changes in PSSI scores, with tildrakizumab (34.5→2.9), risankizumab (25→3.2), and guselkumab (17.4→1.3). Ustekinumab (IL-12/23) showed variable results (22–85.6%), with lower scalp clearance by sPGA (52.7% of patients vs. 74% in IL-17A cohort)...Conclusion This review demonstrates higher efficacy of IL-17 inhibitors compared to IL-23/IL-12/23 inhibitors, particularly ixekizumab and brodalumab, for scalp clearance and itch reduction. These findings may guide clinical decision making and highlight the need for consistent endpoint reporting in future trials."

Review • Dermatology • Immunology • Psoriasis • IL12A • IL23A

Sun Pharma Announces US FDA Acceptance of Supplemental Biologics License (sBLA) Application for ILUMYA (tildrakizumab-asmn) for the Treatment of Adults with Active Psoriatic Arthritis (PRNewswire) - "The FDA regulatory action date for this sBLA is expected by October 29, 2026....The sBLA is based on the results from the INSPIRE-1 and INSPIRE-2 Phase 3 clinical studies evaluating the efficacy and safety of ILUMYA in adult patients with active psoriatic arthritis. Top-line findings from these studies were reported in July 2025. Further details of the studies will be shared at a future congress."

FDA filing • P3 data • PDUFA • Psoriatic Arthritis

Demyelination Reported with Biologic Therapies for Rheumatologic and Inflammatory Bowel Diseases: Insights from FAERS (AAN 2026) - "Mechanistic classes included: anti–tumor necrosis factor (TNF)-α agents, anti-integrin antibodies (excluding natalizumab), anti-interleukin agents (including IL-12/23, IL-23, IL-17, IL-6, and IL-1 inhibitors), B-cell targeted therapies (excluding rituximab), and T-cell co-stimulation modulators... Safety signals for demyelination were identified with TNF-α inhibitors (infliximab, adalimumab, certolizumab pegol, golimumab, and etanercept) with a PRR of 7.34 (95% CI: 6.75–7.98), and abatacept, a selective T-cell co-stimulation modulator (PRR: 2.12; 95% CI: 1.41–3.20). No safety signals were observed for IL-12/23 inhibitors (ustekinumab), IL-17 inhibitors (secukinumab, ixekizumab, bimekizumab), IL-23 inhibitors (mirikizumab, guselkumab, tildrakizumab, risankizumab), and anti-α4β7 integrin (vedolizumab). Reporting counts were insufficient for IL-6 inhibitors (tocilizumab and sarilumab), IL-1 inhibitors (anakinra, canakinumab, and rilonacept), and B-lymphocyte stimulator..."

Gastroenterology • Gastrointestinal Disorder • Hematological Disorders • Immunology • Inflammation • Inflammatory Bowel Disease • IL12A • IL17A • IL23A

Biological Treatment of Psoriasis-Data So Far. (PubMed, Pharmaceuticals (Basel)) - "Although topical treatments, systemic treatments (methotrexate, cyclosporine, acitretin), and phototherapy play a role, biologic agents have improved the efficacy of treatment of moderate-to-severe psoriasis. The purpose of this article is to comprehensively review the clinical trial data and evaluate and compare the key features of the currently approved biologic drugs for the treatment of psoriasis."

Journal • Review • Dermatology • Immunology • Inflammation • Psoriasis

FIRST-YEAR COST PER RESPONDER FOR BRODALUMAB COMPARED WITH OTHER BIOLOGIC THERAPIES FOR MODERATE TO SEVERE PLAQUE PSORIASIS IN CANADA (ISPOR 2026) - "The treatments (originators and available SEBs) included in this analysis were adalimumab, brodalumab, bimekizumab, etanercept, guselkumab, ixekizumab, risankizumab, secukinumab, and ustekinumab. Tildrakizumab, certolizumab, and infliximab were not part of the selected NMA and were therefore excluded from this analysis... At one year, brodalumab demontrates the greatest cost-effectiveness across PASI 100 and PASI 90 compared with other studied biologic therapies (originators and SEBs), providing optimal value for patients, prescribers, and payers."

Dermatology • Immunology • Psoriasis

Utilization of a Microdevice for Psoriasis and Atopic Dermatitis (clinicaltrials.gov) - P4 | N=10 | Not yet recruiting | Sponsor: University of California, San Francisco

New P4 trial • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Psoriasis