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

MINIMA: MIcrovascular DysfuNction in Moderate-severe Psoriasis (clinicaltrials.gov) - P4 | N=36 | Active, not recruiting | Sponsor: Marcelo F. Di Carli, MD, FACC | Trial completion date: Jan 2025 ➔ Jun 2025

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

Frontal Fibrosing Alopecia: A Comprehensive Review with Recent Updates. (PubMed, Indian J Dermatol) - "Many topical and systemic treatment options are available, but none have shown satisfactory results. Recently, many biological agents have been tried including tofacitinib and tildrakizumab."

Journal • Review • Alopecia • Dermatology • Fibrosis • Immunology • Lichen Planus

Tildrakizumab Effective for Psoriasis, Yet Patients Note Specific Points of Dissatisfaction (HCPLive) - "These data represent the conclusion of an analysis conducted by a team of investigators...from the Department of Dermatology at the Polyclinique Courlancy in Reims-Bezannes, France. Reguiai et al. highlighted that prior real-world data on tildrakizumab use for psoriasis had been primarily from clinicians’ perspectives....An overall evaluation was also provided by subjects regarding how psoriasis impacts daily life, with selections including a complete lack of impact, minor life impairment, moderate impairment, or a severe level of impairment that prevents typical daily activities....Overall, psoriasis at baseline was shown in the team's findings to have significantly impaired the lives of study subjects. Specifically, they noted that 42% showed signs of clinical depression and added that 34.6% reported disease involvement in the genital region that led to negative impacts in their sexual well-being."

Real-world • Psoriasis

A Study to Evaluate the Efficacy and Safety of Subcutaneous Tildrakizumab in Subjects With Moderate to Severe Genital Psoriasis. (clinicaltrials.gov) - P3 | N=192 | Not yet recruiting | Sponsor: Sun Pharmaceutical Industries Limited | Trial completion date: Jan 2027 ➔ Jan 2028 | Initiation date: Nov 2024 ➔ Mar 2025 | Trial primary completion date: Dec 2025 ➔ Mar 2026

Trial completion date • Trial initiation date • Trial primary completion date • Dermatology • Immunology • Psoriasis

Efficacy and Safety of Tildrakizumab Compared to Placebo in Anti-TNF naïve Subjects With Active Psoriatic Arthritis II (INSPIRE 2) (clinicaltrials.gov) - P3 | N=296 | Active, not recruiting | Sponsor: Sun Pharmaceutical Industries Limited | Trial completion date: Dec 2024 ➔ Nov 2025 | Trial primary completion date: Sep 2024 ➔ Jun 2025

Trial completion date • Trial primary completion date • Immunology • Inflammatory Arthritis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies • CRP

Treatment patterns, drug survival, and effectiveness of tildrakizumab among patients with prior interleukin-17 experience in the CorEvitas Psoriasis Registry (AAD 2025) - "As measured by clinician- and patient-reported outcomes, tildrakizumab was effective in real-world patients with prior IL-17i experience. The majority of IL-17i–experienced initiators persisted on treatment for at least 1 year."

Clinical • Dermatology • Fatigue • Immunology • Pain • Psoriasis • IL17A

Efficacy and Safety of Tildrakizumab Compared to Placebo in Subjects With Active Psoriatic Arthritis I (INSPIRE 1) (clinicaltrials.gov) - P3 | N=510 | Active, not recruiting | Sponsor: Sun Pharmaceutical Industries Limited | Recruiting ➔ Active, not recruiting | Trial primary completion date: May 2025 ➔ Sep 2025

Enrollment closed • Trial primary completion date • Immunology • Inflammatory Arthritis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies • CRP

Efficacy and safety of tildrakizumab for the treatment of obese patients with moderate-to-severe plaque psoriasis affecting the scalp: Post hoc analysis of a Phase 3b trial (AAD 2025) - "Tildrakizumab treatment resulted in consistent efficacy with no safety signals in obese patients relative to nonobese patients with moderate-to-severe plaque psoriasis affecting the scalp."

Clinical • P3 data • Retrospective data • Dermatology • Genetic Disorders • Immunology • Obesity • Psoriasis

The Clinical and Molecular Response of Pyoderma Gangrenosum to Interleukin 23 Blockade: Result from a proof-of-concept open-label clinical trial (AAD 2025) - "We present the results of a proof-of-concept open label clinical trial of IL-23p19 antagonism with Tildrakizumab in Pyoderma Gangrenosum...Differential clinical and molecular response was seen when peristomal and pretibial PG lesions were compared, suggesting that IL-23 antagonism is less effective in the setting of peristomal disease. This novel data provides insights into the clinical relevance of alterations in molecular markers in pyoderma gangrenosum and the potential for the identification of clinically relevant biomarkers of disease activity."

Clinical • Gastroenterology • Immunology • Inflammation • Inflammatory Bowel Disease • Pain • Pyoderma Gangrenosum • Ulcerative Colitis • CASP8 • CXCL8 • IFI27 • IL17A • IL1B • IL23A • IL6 • LGALS3 • SAA1 • STAT3 • TNFA • XBP1

Efficacy and safety of tildrakizumab for the treatment of patients with moderate-to-severe plaque psoriasis and diabetes: Post hoc analysis of reSURFACE 1 and reSURFACE 2 (AAD 2025) - "Efficacy of tildrakizumab 100 mg was maintained in patients with and without diabetes mellitus. Higher frequency of SAEs in patients with diabetes and obesity may be attributable to underlying inflammation."

Clinical • Retrospective data • Dermatology • Diabetes • Genetic Disorders • Immunology • Inflammation • Metabolic Disorders • Obesity • Psoriasis

Characteristics and treatment outcomes of patients with prior apremilast experience treated with tildrakizumab in the CorEvitas Psoriasis Registry (AAD 2025) - "Among real-world patients previously treated only with apremilast, tildrakizumab was effective for clinician- and patient-reported outcomes; >90% of patients were persistent for ≥1 year."

Clinical • Dermatology • Immunology • Pain • Psoriasis

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 2025) - P3 | "Tildrakizumab was efficacious vs placebo for the treatment of moderate-to-severe psoriasis affecting the nails, with no new safety signals."

Clinical • P3 data • Dermatology • Immunology • Psoriasis

A holistic approach to patients with moderate-to-severe plaque psoriasis in a real-world setting: improvements with tildrakizumab beyond the skin lesions (AAD 2025) - "A high proportion of patients with moderate-to-severe plaque psoriasis treated with tildrakizumab were free or almost free from skin, scalp, nail involvement and itching and they experienced an improvement in overall well-being after 28 weeks, and this improvement was maintained through W52. These data highlight the importance of evaluating other endpoints beyond skin lesions to ensure a holistic approach to psoriasis management."

Clinical • Real-world • Real-world evidence • CNS Disorders • Dermatology • Immunology • Inflammation • Pruritus • Psoriasis

Tildrakizumab improves high burdensome symptoms and overall well-being in patients with moderate-to-severe plaque psoriasis (AAD 2025) - "Patients treated with tildrakizumab in a real-world setting achieved rapid and significant reductions in burdensome symptoms of psoriasis (such as itch or skin pain) after 16 weeks, which were maintained through W52. Tildrakizumab significantly improved patients' well-being in patients with moderate-to-severe psoriasis, achieving a well-being status similar to the general population after 16 weeks, which was maintained up to W52."

Clinical • Dermatology • Fatigue • Immunology • Musculoskeletal Diseases • Musculoskeletal Pain • Orthopedics • Pain • Psoriasis

Efficacy of tildrakizumab 200 mg for treating difficult-to-treat patient populations with moderate-to-severe plaque psoriasis. (PubMed, Dermatol Reports) - "In this regard, we report a case series describing patients with psoriasis located in different DTT areas or presenting a high Psoriasis Area and Severity Index (PASI) score at baseline and treated ineffectively with prior lines of therapy. Finally, patients achieved complete remission following therapy with tildrakizumab 200 mg (anti-IL-23p19), highlighting its potential efficacy in these patient populations."

Journal • Dermatology • Immunology • Psoriasis

Off-label use of Tildrakizumab in patients with Hidradenitis Suppurativa (AAD 2025) - "70.6% (12/17) previously tried adalimumab. From this limited data, tildrakizumab may be an efficacious and safe biologic option for HS management. The average change in lesions demonstrate an improvement in disease outcomes with treatment."

Clinical • Dermatology • Hidradenitis Suppurativa • Immunology • Pain • Psoriasis • IL23A

Treatment patterns, drug survival, and effectiveness of tildrakizumab in biologic-naïve and biologic-experienced patients in the CorEvitas Psoriasis Registry (AAD 2025) - "Based on clinician- and patient-reported outcomes and mean drug survival of almost 3 years, tildrakizumab was effective among real-world US patients."

Clinical • Dermatology • Fatigue • Immunology • Pain • Psoriasis

Real-world effectiveness and quality of life outcomes of tildrakizumab for moderate-to-severe plaque psoriasis in the United States: A systematic literature review and meta-analysis (AAD 2025) - "Tildrakizumab is associated with early and sustained long-term real-world effectiveness and quality of life improvement in US patients with moderate-to-severe plaque psoriasis, consistent with clinical trials and global real-world studies."

HEOR • Real-world • Real-world effectiveness • Real-world evidence • Retrospective data • Review • Dermatology • Immunology • Psoriasis

Effectiveness and drug survival of tildrakizumab by baseline disease severity in the CorEvitas Psoriasis Registry (AAD 2025) - "In real-world practice, tildrakizumab was effective based on clinician- and patient-reported outcomes, with a mean drug survival of almost 3 years, regardless of baseline BSA affected."

Dermatology • Fatigue • Immunology • Pain • Psoriasis

ILUMYA (tildrakizumab-asmn) Found Effective for Treatment of Moderate-to-Severe Plaque Psoriasis Affecting Nails in Study Presented at 2025 AAD Conference (PRNewswire) - P3 | N=99 | NCT03897075 | Sponsor: Sun Pharmaceutical Industries Limited | "Patients treated with ILUMYA demonstrated a significantly higher rate of 75% improvement from baseline in the Nail Psoriasis Severity Index (mNAPSI 75) at Week 28 (25.5% mNAPSI 75 response rate vs. 4.5% in the placebo group; P=0.003). 29.4% of patients treated with ILUMYA achieved normal nails or nails with minimal psoriasis (ViSENPsO score of 0 or 1), compared to 4.2% in the placebo group (P = 0.0008). ViSENPsO is a clinical tool used for detecting and assessing psoriasis including a visual medical scale to evaluate nail psoriasis severity and Patient Global Assessment (PGA) questionnaires. The safety profile was consistent with the known safety profile of ILUMYA, and no serious adverse events related to ILUMYA treatment occurred in this clinical trial."

P3 data • Psoriasis

Tildrakizumab improves overall well-being in patients with moderate-to-severe plaque psoriasis: results from the real-world TIGER and POSITIVE studies (AAD 2025) - "Patients with moderate-to-severe plaque psoriasis showed an impaired well-being score, below to other impacting diseases, such as breast cancer or diabetes, when sensitive areas are affected. Tildrakizumab consistently demonstrates significant improvements on the well-being of patients with moderate-to-severe psoriasis (including those with involvement of sensitive areas), achieving a well-being status similar to the general population after 16 weeks."

Clinical • Real-world • Real-world evidence • Breast Cancer • Dermatology • Diabetes • Immunology • Metabolic Disorders • Oncology • Psoriasis • Solid Tumor

Efficacy and safety of tildrakizumab for the treatment of obese patients with moderate-to-severe plaque psoriasis: Post hoc analysis of reSURFACE 1 and reSURFACE 2 (AAD 2025) - "Tildrakizumab demonstrated consistent efficacy and safety in obese and nonobese patients, with dose-related efficacy differences at W12 diminishing by W28."

Clinical • Retrospective data • Cardiovascular • Dermatology • Diabetes • Dyslipidemia • Genetic Disorders • Hypertension • Immunology • Metabolic Disorders • Obesity • Psoriasis

Is it time to change the concept of difficult-to-treat areas?: Reflections on the POSITIVE study (AAD 2025) - "In this non-interventional study, tildrakizumab demonstrated high efficacy in achieving skin clearance in "difficult-to-treat" areas such as the scalp, palms or soles, and nails in patients with moderate-to-severe plaque psoriasis after 28 weeks, with this improvement being sustained through week 52. Given these results, it may be time to reconsider the term "difficult-to-treat areas" and refer to them as "sensitive areas" instead."

Dermatology • Immunology • Psoriasis

Treatment Patterns in Patients with Moderate to Severe Psoriasis Treated with Biologics (AAD 2025) - "PDC≥80% was achieved by 69.8% (tildrakizumab), 58.6% (risankizumab), 47.0% (guselkumab), and 62.7% (ustekinumab) patients. These findings highlight the variability of treatment patterns among biologics, and the long persistence achieved on tildrakizumab."

Clinical • Dermatology • Immunology • Psoriasis

Effectiveness and drug survival of tildrakizumab in obese and nonobese patients in the CorEvitas Psoriasis Registry (AAD 2025) - "Based on clinician- and patient-reported outcomes and a mean drug survival of almost 3 years, tildrakizumab was effective among obese and nonobese real-world patients with psoriasis."

Clinical • Dermatology • Fatigue • Genetic Disorders • Immunology • Obesity • Pain • Psoriasis