New drug for psoriasis! The Johnson il-23 inhibitor Tremfya (Tenoya ®) has been used continuously for 5 consecutive years and has shown high efficacy, and China has been listed!

October 16, 2020 // -- Johnson and Johnson (JNJ)'s Jansen Pharmaceuticals recently announced the anti-inflammatory drug Tremfya (Tenoya ®, common name: guselkumab, Gusekumab) treatment of moderate to severe adult patients phase 3 VOYAGE 1 study of new open label expansion data, showing that Tremfya treatment showed a high rate of skin loss removal, treatment in the last 5 years found no new safety signals.
noted that this is the first clinical study to evaluate an IL-23 inhibitor to demonstrate efficacy and safety during nearly 5 years of use.
at week 252, 84% of patients in the combined Tremfya treatment group (patients initially randomly assigned to Tremfya treatment, and those initially assigned to a placebo and switched to Tremfya in week 16) achieved PASI90 Remission (psoriasis area severity index PASI score improved by at least 90% relative to baseline), 82.4% of patients achieved a researcher's overall assessment (IGA) score of 0 or 1 (IGA 0/1: skin loss removal or almost complete removal).
results observed during the 264-week study, with no new safety signals.
Tremfya is the first approved all-human monoantitor to be approved for the use of leukolytin 23 (IL-23) p19 subi, which inhibits its interaction with IL-23 receptors, disrupts the cascading reaction of IL-23-mediated signal conduction, activation, and cytokines, and inhibits IL-23 biological activity.
IL-23 is a cytokine that plays a key role in plaque-type psoriasis.
, Tremfya has been approved in several countries to treat moderate to severe plaque psoriasis.
, Tremfya was approved by the State Drug Administration in December 2019 for use in adult patients with moderate to severe plaque psoriasis for systematic treatment.
Griffiths, M.D., Dermatology Centre, University of Manchester, UK, said: "People with psoriasis face a lifelong struggle as a result of this complex and disabling chronic disease.
The Tremfya data from the VOYAGE 1 study is the first to show that IL-23 p19 inhibitors achieve skin loss removal in most patients over the course of nearly five years of treatment, which is very encouraging for both patients and doctors seeking long-term treatment options.
" VOYAGE 1 was a randomized, double-blind, placebo, and positive drug-controlled Phase 3 trial that included 837 adult patients with moderate to severe plaque-type psoriasis.
study, a total of 494 patients were randomly divided into Tremfya (n-329) in week 0, or randomly divided into placebo groups and switched to Tremfya therapy (n-165) in week 16;
, the PASI90 response rate was stable and consistent, based on the main pre-defined treatment failure rules (TFR), through nearly five years of continuous use of Tremfya.
week 52, PASI90 response rates were 79.7 per cent, 75.5 per cent, 80.6 per cent, respectively, according to TFR, non-responder interpolation (NRI) and observation (As Observed, OBS), while in week 252, the corresponding PASI90 response rates were 84.1 per cent, 66.6 per cent and 86.6 per cent, respectively.
, PASI100, IGA0/1, and IGA0 response rates were consistent from week 52 to week 252.
patients who were randomly treated with Tremfya in week 0 (n-329) also had consistent response rates over 252 weeks.
note that each patient may not have received an answer at each observation point in time.
year, patients and researchers knew that all study participants were using Tremfya, which could affect the outcome.
findings are usually consistent with previously observed results and summaries of current product characteristics.
At the end of the safety assessment (264 weeks), all patients (n=774), the combined Tremfya group (n=494), and a group of patients who initially received adamo monoantigen therapy (n=280) reported at least one adverse event (AE), severe adverse event (SAE), and 87.7%, 16.4%, and 6.1% of patients who were suspended due to AE, respectively.
During the control period of clinical studies, Tremfya was very common (≥10%) and common (≥1%) adverse events were upper respiratory tract infections, gastroenteritis, herpes simplex infections, femoral infections, headaches, diarrhea, urticaria, joint pain and injection site reactions.
adverse events (0.1%) ≥ (0.1%) were hypersensitive, allergic and rash.
Dr Lloyd Miller, vice president of research and development at jansen and head of immunology, said: "We are pleased to share this data to demonstrate Tremfya's ability to help adult patients with moderate to severe plaque psoriasis, providing the majority of patients with continuous clearance rates for nearly five years.
the ultimate goal of mitigation, we are committed to continuing to apply the best scientific and disease insights to the treatments that improve patients' lives.
Origin: New First-in-Class Phase 3 Data Station TREMFYA (guselkumab) Maintained Skin Rates Clearance Through Nearly 5 Years of Continuous Use in Adult Patients with Moderate to Severe Plaque Poriasis