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

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

Infection risk among psoriasis biologic-new users: a cohort study on the French National Health Data System. (PubMed, J Am Acad Dermatol) - "Biologics are associated with low overall infection risks. Among biologics, ustekinumab and IL-23 inhibitors show the lowest overall risk (time to the first inpatient/outpatient event)."

Journal • Dermatology • Immunology • Infectious Disease • Psoriasis • IL23A

Upadacitinib as a potential option for the management of paradoxical eczema induced by interleukin-23 inhibitors. (PubMed, Dermatol Reports) - "PE has been reported with anti-tumor necrosis factor (TNF)-α, anti-interleukin (IL)-17, and more recently with anti-IL-23 agents such as risankizumab, tildrakizumab, and guselkumab, with an estimated incidence of 1-3% among psoriatic patients treated with biologics, likely underestimated. Herein, we report the successful use of upadacitinib, an oral selective Janus kinase (JAK)-1 inhibitor approved for both psoriatic arthritis and atopic dermatitis, in the management of a PE induced by guselkumab. [...]."

Journal • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Inflammatory Arthritis • Oncology • Psoriasis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies • IL23A • TNFA

Relative Efficacy of Immunomodulatory Monotherapies for Psoriasis of the Scalp: A Network Meta-Analysis Study. (PubMed, J Cosmet Dermatol) - "We are the first to provide comparative evidence on the efficacy of newly investigated agents such as deucravacitinib, tildrakizumab, roflumilast and icotrokinra. In general, the IL-17 inhibitors (bimekizumab, ixekizumab, secukinumab, brodalumab) and IL-23 inhibitors (icotrokinra, guselkumab, tildrakizumab) were effective depending upon the outcome and time-point being considered. At 16 weeks, for PSSI-100, ixekizumab 150 mg at weeks 0, 2, 4, 8, and 12 ranked highest; at 16 weeks, for Sc-PGA 0/1 bimekizumab 320 mg every 4 weeks ranked highest; at 8 weeks, for PSSI-100 ixekizumab 80 mg every 2 weeks ranked highest; at 8 weeks, for Sc-PGA 0/1 secukinumab 300 mg at weeks 1, 2, 3 and then every 4 weeks ranked highest. Small-molecule therapies (apremilast, deucravacitinib, roflumilast) improved scalp psoriasis modestly. Our work would guide the design of future studies and clinical decision-making."

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

IL-23p19-inhibitor pharmacokinetics across immune-mediated inflammatory diseases: insights from a systematic review (ECCO-IBD 2026) - "Results A total of 21 studies were identified of which nine focused on risankizumab, three on tildrakizumab, six on guselkumab and three on mirikizumab. 2 ). These findings highlight the need for further research to better define PK parameters and influencing covariates, enabling personalized dosing strategies for IL-23p19 inhibitors in IBD."

PK/PD data • Review • Crohn's disease • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis

TIDRAKIZUMAB FOR THE PROPHYLAXIS OF GRAFT VERSUS HOST DISEASE AFTER ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION. (PubMed, Blood Adv) - P2 | "We conducted a phase 1-2 study in which patients undergoing allogeneic hematopoietic stem cell transplantation received tildrakizumab in addition to standard immune suppression with tacrolimus and methotrexate for graft versus host disease (GVHD) prophylaxis...All patients received myeloablative busulfan-based conditioning and were transplanted with HLA-matched related or unrelated peripheral blood stem cell grafts...Comparative examination of fecal microbial composition in tildrakizumab and a similarly transplanted cohort treated with tocilizumab prophylaxis demonstrated that both cytokine blockade strategies had a low frequency of enterococcal dominance. We conclude that tildrakizumab resulted in a low incidence of acute GVHD and attenuation of microbiome dominance with potentially pathogenic organisms but did not mitigate the emergence of chronic GVHD as administered on this dosing schedule. NCT04112810."

Journal • Acute Graft versus Host Disease • Bone Marrow Transplantation • Chronic Graft versus Host Disease • Graft versus Host Disease • Immunology • Transplantation

Tildrakizumab in Managing Psoriasis with Involvement of Difficult-to-Treat Areas: A Multicenter Real-Life Retrospective Study. (PubMed, J Clin Med) - " Over 104 weeks, tildrakizumab showed sustained long-term effectiveness in both global disease control and difficult-to-treat areas. The 200 mg dose, used in a more difficult-to-treat population, achieved comparable long-term outcomes, supporting dose optimization in clinical practice."

Journal • Retrospective data • Dermatology • Immunology • Psoriasis

Appearance of alopecia areata during treatment with tildrakizumab for severe palmoplantar psoriasis. (PubMed, Dermatol Reports) - "Tildrakizumab was discontinued, and the patient was treated with topical corticosteroids and low-dose oral methylprednisolone, achieving complete hair regrowth within 6 months. Psoriasis subsequently recurred, and treatment was successfully switched to bimekizumab, with sustained remission and no adverse events...The temporal correlation, lack of confounding risk factors, and resolution upon drug withdrawal suggest a causal relationship. This case expands the spectrum of paradoxical reactions (PRs) to biologic therapies and highlights the need for vigilance regarding autoimmune manifestations during interleukin (IL)-23 inhibition."

Journal • Alopecia • Dermatology • Immunology • Psoriasis

PRO/PsO: Impact of Tildrakizumab on Patient Reported Outcomes in Patients With Moderate-to-severe Psoriasis in Canada (clinicaltrials.gov) - P=N/A | N=80 | Recruiting | Sponsor: Chronicle Academy

New trial • Real-world evidence • Dermatology • Immunology • Psoriasis

Tildrakizumab Drug Survival: Can We Really Attribute the Benefit to Male Sex? (PubMed, Clin Exp Dermatol) - No abstract available

Journal

Real-World Effectiveness and Safety of Tildrakizumab for Plaque Psoriasis: A 3-Year International Multicenter Retrospective Study. (PubMed, Dermatol Ther (Heidelb)) - No abstract available

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

Safety Study for Prospective Assessment of Pregnancy Outcomes in Patients Treated With Tildrakizumab (clinicaltrials.gov) - P=N/A | N=200 | Recruiting | Sponsor: Sun Pharmaceutical Industries Limited | Trial completion date: Dec 2025 ➔ Jul 2028 | Trial primary completion date: Dec 2025 ➔ Jul 2028

Trial completion date • Trial primary completion date

Real-World Benefit of Tildrakizumab for Moderate-to-Severe Plaque Psoriasis: Findings from a Systematic Literature Review and Meta-Analysis. (PubMed, Dermatol Ther (Heidelb)) - "Tildrakizumab demonstrated effectiveness, with reduction from moderate-to-severe to mild disease and improved DLQI scores, without notable safety concerns, for up to 1 year in this real-world meta-analysis. Although real-world data must be interpreted cautiously because of heterogeneity and potential bias, these findings align with randomized trial results, further supporting the use of tildrakizumab in clinical practice."

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

Tildrakizumab for Psoriasis in Patients With Current or Prior Malignancy: Methodological Considerations and Clinical Implications. (PubMed, Int J Dermatol) - No abstract available

Journal • Dermatology • Immunology • Oncology • Psoriasis

Efficacy and Safety of Tildrakizumab Compared to Placebo in Subjects With Active Psoriatic Arthritis I (INSPIRE 1) (clinicaltrials.gov) - P3 | N=508 | Completed | Sponsor: Sun Pharmaceutical Industries Limited | Active, not recruiting ➔ Completed | Trial completion date: May 2026 ➔ Dec 2025

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

Almirall’s sustained trajectory of growth and profitability enables the company to reach more patients and supports a growth outlook of double-digit net sales through 2030, combined biologics peak sales of approximately €800 MM (Ebglyss and Ilumetri), and a 25% EBITDA margin by 2028. (Businesswire)

Sales projection • Atopic Dermatitis • Psoriasis

ILUMYA (tildrakizumab) Pen (Auto-Injector) Now Available for Canadians Living with Moderate-to-Severe Plaque Psoriasis (Canada Newswire)

Launch Canada • Psoriasis

Tildrakizumab has positive impact on psychological wellbeing in psoriasis, study finds (Hospital Pharmacy Europe) - "After 16 weeks of treatment, participant median scores improved to 63.2. At 24 months, wellbeing scores had further improved to 70.43, surpassing the general population mean average. Participants also experienced skin clearance improvements based on Psoriasis Area and Severity Index (PASI) scores. At baseline, median PASI scores were 12.9. At week 16 this had decreased to 2.4 and by year two the average PASI score reached 1.3. Added to this, 79% of patients maintained a PASI lower than 2 after two years."

Observational data • 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 primary completion date: Jun 2025 ➔ Sep 2025

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

Efficacy and Safety of Tildrakizumab Compared to Placebo in Subjects With Active Psoriatic Arthritis I (INSPIRE 1) (clinicaltrials.gov) - P3 | N=508 | Active, not recruiting | Sponsor: Sun Pharmaceutical Industries Limited | Trial primary completion date: Sep 2025 ➔ Mar 2025

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

Pyoderma Gangrenosum with Biological Agents Therapy: A Systematic Review. (PubMed, Clin Cosmet Investig Dermatol) - "The number of included cases and the efficacy are Infliximab (n=52, 88.4%), Adalimumab (n=23, 91.3%), Etanercept (n=13, 84.6%), Certolizumab (n=3, 66.6%), Golimumab (n=1, 100.0%), Anakinra (n=11, 100.0%), Canakinumab (n=7, 100.0%), Secukinumab (n=5, 40.0%), Brodalumab (n=3, 100.0%), Ixekizumab (n=1, 100.0%), Ustekinumab (n=12, 100.0%), Spesolimab (n=3, 100.0%), Guselkumab (n=2, 100.0%), Tildrakizumab (n=2, 100.0%), Risankizuma (n=1, 100.0%). However, IL inhibitors demonstrate an advantage with shorter treatment cycles. Additionally, Infliximab has a wider range of side effects and should be used with caution.PROSPERO number: CRD42024608039."

Journal • Review • Oncology • Pain • Pyoderma Gangrenosum • Rare Diseases

Tildrakizumab in real-world Chinese psoriasis: efficacy-safety profiles from a 28-week retrospective cohort with geriatric, late-onset and metabolic syndrome stratification. (PubMed, J Dermatolog Treat) - "Safety monitoring identified 4 (5.0%) treatment-emergent adverse events, with no treatment discontinuation for psoriasis exacerbation. Tildrakizumab demonstrated sustained efficacy in real-world management of moderate-to-severe psoriasis and supported broad applicability across diverse psoriasis subtypes."

Journal • Real-world evidence • Retrospective data • Dermatology • Geriatric Disorders • Immunology • Metabolic Disorders • Psoriasis

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