New psoriasis arthritis (PsA) drug! Johnson and Johnson IL-23 inhibitor Tremfya (Tenoya ®) 52-week data: significant improvement in joint/skin symptoms!

June 04, 2020 /
BiovalleyBIOON/ -- Jansen Pharmaceuticals of Johnson and Johnson (JNJ) recently released new data for 2 Phase III Clinical Studies (DISCOVER-1 and DISCOVER-2) at the 2020 European Rheumatology Alliance (EULAR) ElectronicConference
These two studies assessed the efficacy and safety of Tremfya (Tenorya ®, common name: guselkumab, Gusekuda) for the treatment of adult patients with active psoriasis arthritis (PsA)New data show that in the 52nd week of treatment, Tremfya showed improvements in several clinical outcomes, including joint symptoms, skin symptoms, soft tissue inflammation, physical function, and reduced imaging progressionTremfya is a monoclonal antibody that selectively binds to the p19 subunit of leukocyte interleukin-23 (IL-23) and inhibits its interaction with IL-23 receptorsIL-23 is an important driver of the pathogenesis of inflammatory diseases such as psoriasis and psoriasis arthritis (PsA)it is worth noting that the new data released are the first one-year Phase III results of p19 subrangespecific IL-23 inhibitors evaluated in active PsACurrently, Tremfya has not been approved for the treatment of PsABased on the main endpoints of these two studies, Jansen filed an application for supplementary biologics (sBLA) with the U.SFood and Drug Administration (
FDA) in September 2019 for tremfya to treat active Psa adult patients"Patients with active PsA face debilitating symptoms and inflammation that can eventually lead to irreversible joint damage," said lead researcher drChristopher Ritchlini, lead researcher in the DISCOVER-1 study and director of the Center for Clinical Immunology At robeing sand at the University of Rochester Medical Center and chief of the Allergy and Immunology and Rheumatology Section The findings from the DISCOVER-1 and DISCOVER-2 studies are very encouraging for patients and doctors who may be seeking new treatments that differ from TNF alpha biologic sore mechanisms to combat PsA syndrome "
DISCOVER-1 and DISCOVER-2 studies assessed the efficacy and safety of Tremfya relative to placebo The DISCOVER-1 study included patients who had not previously received biological therapy (biotherapy) or had been treated with anti
tumor necrosis factor alpha (TNf alpha) biologics The DISCOVER-2 study, which included only patients with first-stage treatment of biotherapy, also assessed radiology progress in joint damage In two studies, patients were randomly assigned to Tremfya 100mg once every 4 weeks (Q4W) or once every 8 weeks (Q8W) for 52 weeks, and patients receiving a placebo switched to Tremfya Q4W at the 24th week of treatment until week 52 The 24-week results of 2 studies were published in April in The Lancet, the world's top medical journal The results showed that both studies reached the main endpoint: 24 weeks of treatment, and a significantly higher percentage of patients in the Tremfya treatment group improved at least 20 percent (ACR20 relief) in terms of signs and symptoms of the disease compared to the placebo group In addition, the Tremfya treatment group showed significant improvements in multiple secondary endpoints (joint symptoms, skin symptoms, soft tissue inflammation and disease activity, physical function and health-related quality of life) compared to the placebo group Psoriasis arthritis (photo: onhealth.com) In both studies, the 52nd week of the American Society of Rheumatology (ACR) remission included non-responder interpolation (NRI) data, which would classify patients who sat down from week 24 to week 52 as non-responders -DISCOVER-1 study for week 52 data showed that 73% of patients in the (1) Tremfya Q4W group and Q8W group reached ACR20, 54% and 39% of patients reached ACR50 (NRI) respectively (2) In patients with clinically related psoriasis at baseline, 83%, 69%, and 82% of patients in the Tremfya Q4W group, Q8W group, and from placebo to Q4W, respectively, achieved an IGA score of 0 (complete removal of skin damage) or 1 (almost complete removal of skin damage) and a score of at least 2 levels (observation data) relative to the baseline Data for week 52 of the -DISCOVER-2 study showed that 71% of patients in the (1) Tremfya Q4W group and 75% of patients in the Q8W group achieved ACR20 remission, 46% and 48% of patients with ACR50 (NRI), respectively (2) In patients with clinically related psoriasis at baseline, 84%, 77%, and 84% of patients in the Tremfya Q4W group, Q8W group, and from placebo to Q4W, respectively, achieved an IGA score of 0 (complete removal of skin damage) or 1 (almost complete removal of skin damage) and a score of at least 2 levels (observation data) relative to the baseline (3) During the 52-week period of treatment, Tremfya Q4W and Q8W showed sustained improvement in the progress of imaging in inhibition of joint structural damage (observation data) - Other findings of 2 studies: week 52 showed improvement at several secondary endpoints compared to week 24, including: ACR70 relief, complete elimination of soft tissue inflammation (end and toe (referring to) inflammation), disease activity score (DAS-28), C-reactive protein (CRP), Minimum Disease Activity (MDA), Very Low Sickness Activity (VLDA), Physical Improvement (Health Assessment Questionnaire Disability Index (HAQ-DI), General Health Outcomes (SF-36 Physiological Total Score (PCS) and Total Psychological Score (MCS) 2 studies, Tremfya was well tolerated, and the adverse events (AE) observed were generally consistent with previous studies of Tremfya and current prescription information Dr Alyssa Johnsen, vice president of research and development at Janssen and head of rheumatology, said: "The efficacy of Tremfya's treatment of PsA was shown to be superior to placebo before the 24th week The new data show that the efficacy lasts up to 52 weeks, and the safety data are consistent with the existing safety of Tremfya in psoriasis patients "
Tremfya is an anti-media interleukin 23 (IL-23) p19 sub-type, the drug is the first approved selective IL-23 inhibitor IL-23 is a cytokine that plays a key role in a variety of autoimmune diseases Currently, Tremfya is also developing treatments for other autoimmune diseases, including Crohn's disease (phase IIb/III), ulcerative colitis (phase IIb/III), and septic sweat adenitis (phase II) Tremfya is administered by subcutaneous injection, the treatment of plaque-type psoriasis is: in the 0th and 4th weeks, the drug is administered once every 8 weeks, the dose is 100 mg To date, Tremfya has been approved in many countries and regions around the world for the treatment of adult patients with moderate to severe plaque psoriasis In China, Tremfya was approved for listing in Hong Kong in November 2018, declared on the mainland in late June 2019 and approved by the State Drug Administration (NMPA) in December 2019 for the treatment of adult patients with moderately severe plaque psoriasis suitable for systemic treatment it is worth mentioning that Tremfya was included in the NMPA Drug Review Center (CDE) issued the "first clinically urgent overseas new drug list", the treatment of indications are: red skin psoriasis, plaque psoriasis, pustules psoriasis, psoriasis arthritis, common psoriasis The NMPA accelerated the approval of the Tremfya listing in accordance with the priority review approval process (BioValleyBioon.com) original source: New First-in-Class Phase 3 TREMFYA ® (guselkumab) Data Demonstrate Sion In Psoria Arthritis Joint and Skin Symptoms at Week 52