AnDaJing (vunakizumab) / Jiangsu Hengrui Pharma - LARVOL DELTA

Vunakizumab in patients with active psoriatic arthritis: a multicentre, randomized, double-blind, placebo-controlled, phase 2 study. (PubMed, Rheumatology (Oxford)) - P2 | "Vunakizumab demonstrated superior efficacy to placebo and was well tolerated with an acceptable safety profile in patients with active PsA. The findings support proceeding to a phase 3 study."

Clinical • Journal • P2 data • Immunology • Inflammatory Arthritis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies • IL17A

Impact of treatment interruption on the efficacy and safety of vunakizumab in patients with moderate-to-severe plaque psoriasis: a post-hoc analysis of a phase 3 trial. (PubMed, Front Immunol) - P3 | "The incidence of overall adverse events was similar between the two groups. Interrupted vunakizumab treatment reduced the clinical response and quality of life in patients with moderate-to-severe plaque psoriasis."

Clinical • Journal • P3 data • Retrospective data • Dermatology • Immunology • Psoriasis • IL17A

Efficacy of Vunakizumab in Erosive haNd osteoarthritiS (VENuS): a Multicenter, Double-Blind, Placebo-Controlled Randomized Clinical Trial (ChiCTR) - P=N/A | N=150 | Recruiting | Sponsor: Shanghai Sixth People's Hospital; Shanghai Sixth People's Hospital | Not yet recruiting ➔ Recruiting

Enrollment open • Immunology • Osteoarthritis • Pain • Rheumatology

Efficacy and Safety of an IL-1 Inhibitor in the Perioperative Period of Patients Undergoing Tophus Resection: A Single-Center, Prospective, Randomized, Positive-Controlled Study (ChiCTR) - P4 | N=54 | Not yet recruiting | Sponsor: The Fifth Hospital of Xi'an; The Fifth Hospital of Xi'an

New P4 trial • Immunology • Inflammatory Arthritis • Rheumatology

Vunakizumab Combined With Recaticimab in Subjects With Moderate to Severe Plaque Psoriasis and Dyslipidemia (clinicaltrials.gov) - P4 | N=40 | Not yet recruiting | Sponsor: Xiangya Hospital of Central South University

New P4 trial • Dermatology • Dyslipidemia • Immunology • Metabolic Disorders • Psoriasis

Safety profile of vunakizumab in elderly patients with moderate-to-severe plaque psoriasis: a post-hoc analysis. (PubMed, Front Med (Lausanne)) - P3 | "Patient-reported outcomes (PROs) at certain time points during 52 weeks were better in the vunakizumab group than in the placebo group. Vunakizumab is safe and effective in elderly patients with moderate-to-severe plaque psoriasis."

Journal • Retrospective data • Atopic Dermatitis • Dermatology • Dyslipidemia • Hypertriglyceridemia • Immunology • Infectious Disease • Psoriasis • Respiratory Diseases

Efficacy and safety of vunakizumab in moderate-to-severe plaque psoriasis patients with different body mass index: a post hoc analysis based on a phase III trial. (PubMed, Front Pharmacol) - P3 | "The incidences of any adverse events and most specific adverse events did not differ among the groups. A lower BMI is associated with a greater treatment response and quality of life in moderate-to-severe plaque psoriasis patients receiving vunakizumab."

Journal • P3 data • Retrospective data • Dermatology • Immunology • Psoriasis

Efficacy and safety of vunakizumab in patients with moderate-to-severe plaque psoriasis who have a history of systemic therapies: a post hoc analysis of a phase III trial. (PubMed, Int Immunopharmacol) - P3 | "Vunakizumab has better efficacy than placebo with satisfactory safety profiles in patients with moderate-to-severe plaque psoriasis who have a history of systemic therapies."

Journal • P3 data • Retrospective data • Dermatology • Immunology • Psoriasis

Efficacy and safety of vunakizumab between super responders and non-super responders of patients with moderate-to-severe plaque psoriasis: a post-hoc exploratory analysis of a phase III trial. (PubMed, Naunyn Schmiedebergs Arch Pharmacol) - P3 | "The incidence of any adverse events was not different between super responders and non-super responders (all P > 0.05). After vunakizumab treatment, super responder status is associated with better treatment response and PROs in patients with moderate-to-severe plaque psoriasis, while the safety is not affected by this status."

Journal • P3 data • Retrospective data • Dermatology • Immunology • Psoriasis

Early Response to Vunakizumab at Week 2 Predicts Favourable Long-Term Efficacy in Patients With Moderate-To-Severe Plaque Psoriasis: A Post Hoc Analysis of a Phase III, Randomised Controlled Trial. (PubMed, Immunology) - P3 | "Patients with moderate-to-severe plaque psoriasis receiving vunakizumab show a favourable clinical response, regardless of achieving early response or not. Particularly, patients with early response at Week 2 are significantly more likely to achieve better long-term treatment outcomes."

Journal • P3 data • Retrospective data • Dermatology • Immunology • Psoriasis

Efficacy and Safety of Biologics to Treat Adults With Active Radiographic Axial Spondyloarthritis: Systematic Review and Bayesian Network Meta-Analysis (ISPOR-EU 2025) - "OBJECTIVES: To compare efficacy and safety of IL-17 inhibitors in the treatment of adults with active radiographic axial spondyloarthritis (r-AxSpA) over a 16-week period using network meta-analysis (NMA). We conducted systematic literature search in PubMed and Embase in November 2024 to retrieve publications with results of randomized controlled trials (RCTs) evaluating efficacy and safety of IL-17 inhibitors (netakimab, secukinumab, ixekizumab, bimekizumab, brodalumab, xeligekimab, vunakizumab) in adults with active r-AxSpA... Netakimab showed the highest relative efficacy among available IL-17 inhibitors used to treat adults with active r-AxSpA over 16-week horizon and demonstrated a favorable safety profile."

Retrospective data • Review • Ankylosing Spondylitis • Immunology • Inflammatory Arthritis • Seronegative Spondyloarthropathies • Spondylarthritis • IL17A

Adebrelimab combined with vunakizumab for first-line maintenance treatment of extensive-stage small cell lung cancer: A prospective, single-center, single-arm clinical study (ChiCTR) - P4 | N=43 | Not yet recruiting | Sponsor: The First Affiliated Hospital of Nanjing Medical University; The First Affiliated Hospital of Nanjing Medical University

New P4 trial • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Efficacy and Safety of Vunakizumab in Patients with Active Ankylosing Spondylitis by Cigarette Smoking Status: A Post Hoc Analysis of a Randomized, Double-blind, Phase 2/3 Study (ACR Convergence 2025) - P2/3 | "Vunakizumab 120 mg showed significant efficacy and favorable safety in patients with active AS, regardless of cigarette smoking status."

Clinical • P2/3 data • Retrospective data • Ankylosing Spondylitis • Immunology • Inflammatory Arthritis • Rheumatology • Seronegative Spondyloarthropathies • Spondylarthritis • IL17A

Efficacy of Vunakizumab in Reducing Pain in Ankylosing Spondylitis: A Post-Hoc Analysis of a Phase 2/3 Clinical Trial (ACR Convergence 2025) - "Vunakizumab provided statistically significant and clinically meaningful reductions in pain outcomes in patients with active AS. Importantly, patients who switched from placebo to vunakizumab at week 16 experienced rapid pain improvement, supporting vunakizumab as an effective treatment strategy for managing pain in AS."

Clinical • P2/3 data • Retrospective data • Ankylosing Spondylitis • Back Pain • Immunology • Inflammation • Inflammatory Arthritis • Musculoskeletal Diseases • Musculoskeletal Pain • Orthopedics • Pain • Rheumatology • Seronegative Spondyloarthropathies • IL17A

Efficacy And Safety of Vunakizumab in Patients with Active Ankylosing Spondylitis Stratified by Disease Course: A Post-hoc Analysis of a Randomized, Double-Blind, Phase 2/3 Trial (ACR Convergence 2025) - P2/3 | "Vunakizumab 120 mg showed improved efficacy with a manageable safety profile in patients with active AS, irrespective of DC."

Clinical • P2/3 data • Retrospective data • Ankylosing Spondylitis • Immunology • Infectious Disease • Inflammatory Arthritis • Respiratory Diseases • Rheumatology • Seronegative Spondyloarthropathies • Spondylarthritis • IL17A

Vunakizumab for Treatment of Acrodermatitis Continua of Hallopeau: A Case Report and Literature Review. (PubMed, Psoriasis (Auckl)) - "Emerging evidence indicates that elevated IL-17 levels modulate keratinocyte proliferation and immune cell infiltration, contributing to ACH pathogenesis and representing a promising therapeutic target. Herein, we presented a case of ACH successfully treated with vunakizumab, China's first self-developed anti-IL-17A monoclonal antibody, and reviewed publications reporting IL-17 targeted therapies for ACH, highlighting the potential benefit of IL-17 targeted therapy in ACH management."

Journal • Dermatitis • Dermatology • Immunology • Psoriasis • Pustular Psoriasis • IL17A

Efficacy and safety of vunakizumab in patients with moderate-to-severe plaque psoriasis across different regions of China: a post-hoc exploratory analysis of a phase III, randomized controlled trial. (PubMed, J Dermatolog Treat) - P3 | "The incidence of adverse events was 80.5%, 90.1%, and 90.1% in the North, Central, and South China groups, respectively. The efficacy and safety of vunakizumab are not affected by different regions of China in patients with moderate-to-severe plaque psoriasis."

Clinical • Journal • P3 data • Retrospective data • Dermatology • Immunology • Psoriasis • IL17A

Efficacy and Safety of Vunakizumab in Psoriasis Patients with Prior IL-17 Inhibitor Failure: A Retrospective Study from China (EADV 2025) - "Vunakizumab has demonstrated favorable effectiveness and safety in patients with secukinumab or ixekizumab therapy failures."

Retrospective data • Dermatology • Immunology • Psoriasis • IL17A • IL23A • TNFA

Early response to vunakizumab and its baseline predictors in patients with moderate-to-severe plaque psoriasis: a post hoc analysis of a phase-III trial. (PubMed, J Dermatolog Treat) - P3 | "The nomogram demonstrated good calibration performance (mean absolute error: 0.021) with a limited discriminative ability (C-index: 0.580). Early response rate to vunakizumab was 54.0% in patients with moderate-to-severe plaque psoriasis, where female gender and naïve status to local therapy predicted early response."

Clinical • Journal • P3 data • Retrospective data • Dermatology • Immunology • Psoriasis

Efficacy and Safety of Vunakizumab in Scalp Psoriasis :A Case Report of Three Patients (EADV 2025) - P3 | "PSSI score of patient 3 who once treated with Secukinumab also achieved significant improvement .No adverse events were reported during the observation period. Vunakizumab, an IL-17A inhibitor, demonstrated rapid and profound efficacy in three patients with severe scalp psoriasis, nearly achieving complete lesion clearance by 8 weeks. These findings align with phase III trial data, supporting its role as a potent therapeutic option for recalcitrant scalp involvement. Larger studies are warranted to confirm long-term safety and durability."

Case report • Clinical • Dermatology • Immunology • Psoriasis • IL17A

Efficacy and safety of switching biological agents to Vunakizumab in patients with plaque psoriasis: a multicenter prospective observational study (EADV 2025) - "Baseline Characteristics and Clinical Outcomes PARAMETER BASELINE WEEK 8 CHANGE MEDIAN PASI (RANGE) 9.4 (3.3–25.2) 1.6 (0.6–3.2) -83% IGA ≥3, N (%) 13 (86.7%) 0 (0%) — IGA 0/1, N (%) 0 (0%) 15 (100%) — MEDIAN BSA % (RANGE) 20 (5-62) 10 (2-17) -50% MEDIAN DLQI (RANGE) 15 (9–25) 5 (0–9) -66.7% DEMOGRAPHICS MEAN AGE (YEARS) 35.5 ± 8.2 — — MALE, N (%) 13 (86.7%) — — PRIOR THERAPIES IL-17A INHIBITORS, N (%) 10 (66.7%) — — TNF-Α INHIBITORS, N (%) 3 (20%) — — OTHER BIOLOGICS*, N (%) 2 (13.3%) — — *Including guselkumab. Vunakizumab demonstrated rapid and profound efficacy in patients resistant to multiple biologics, achieving 100% IGA 0/1 response with no significant safety concerns. Its high binding affinity for IL-17A may explain its salvage potential. Larger, long-term studies are needed to validate these findings."

Clinical • Observational data • Dermatology • Immunology • Infectious Disease • Psoriasis • IL17A

Refractory Palmoplantar Pustulosis Achieving Remission with Anti-IL-17A Agent Vunakizumab (EADV 2025) - "We report a case of refractory PPP that exhibited significant clinical improvement following 6 weeks of vunakizumab treatment. The patient remains on this therapeutic regimen, with ongoing follow-up to evaluate the treatment's long-term efficacy and safety. The treatment rationale for this case was informed by a randomized controlled trial which demonstrated the efficacy of an IL-17RA inhibitor, brodalumab, in PPP management."

Clinical • Dermatology • Immunology • Inflammation • Pruritus • Psoriasis • IL13 • IL17A • IL17RA • IL4

Successful treatment of a 15-year-old male with severe plaque psoriasis using Vunakizumab (anti-IL-17) - a case report (EADV 2025) - "We present the case of a 15-year-old adolescent patient with severe plaque psoriasis who was successfully treated with Vunakizumab. Clinical studies have demonstrated quick and meaningful responses to Vunakizumab in moderate-to-severe plaque psoriasis within 12 weeks. Likewise, our patient exhibited considerable improvement of both skin lesions and quality of life after just 4 weeks of treatment, with sustained response at 28 weeks."

Case report • Clinical • Dermatology • Immunology • Psoriasis • IL17A

Safety, pharmacokinetics, and bioequivalence of vunakizumab injection, a specific dermatitis drug, in healthy Chinese volunteers: an open-label, randomized, two-stage, two-sequence cross-over study. (PubMed, Expert Opin Drug Metab Toxicol) - P1 | "Both injection devices were well-tolerated in terms of safety. Participants preferred a single 2 mL subcutaneous injection over two 1 mL subcutaneous injections.Clinical Trial Registration www.clinicaltrials.gov, identifier: NCT06182384."

Journal • PK/PD data • Dermatitis • Dermatology • Immunology • Pain • Psoriasis • IL17A

Comparison of patient-reported outcomes in patients achieving complete versus near-complete skin clearance following Vunakizumab treatment: a post-hoc analysis of a phase III trial. (PubMed, Naunyn Schmiedebergs Arch Pharmacol) - P3 | "Patients with complete skin clearance following Vunakizumab treatment showed improved quality of life, reduced pruritus, and enhanced mental health compared to those with near-complete skin clearance."

Journal • P3 data • Retrospective data • Dermatology • Immunology • Pruritus • Psoriasis