New psyllite arthritis (PsA) drug! Johnson and Johnson IL-23 inhibitor Tremfya (Tenoya ®) was approved by the U.S. FDA and is listed in China!

July 14, 2020 // Johnson and Johnson (JNJ) Janssen Pharmaceuticals (JNJ) recently announced that the U.SFood and Drug Administration (FDA) has approved Tremfya (Tenoya®, generic name: guselkumab, gusekkuma) for the treatment of active psoriasis arthritis (PSA) adult patients, a chronic inflammatory disease characterized by joint pain and skin inflammationclinical studies showed that Tremfya significantly improved the joints, skin, soft tissue symptoms and signs of active PsA patients compared to placeboTremfya is a monoclonal antibody that selectively binds to the p19 subkey of leukocyte interleukin-23 (IL-23) and inhibits its interaction with il-23 receptorsIL-23 is a naturally occurring cytokine and an important driver of the pathogenesis of inflammatory diseases such as psoriasis and PsAin the United States, Tremfya was first approved in July 2017 for the treatment of adult patients with moderate to severe plaque psoriasisnote, Tremfya is the first IL-23 selective inhibitor approved for the treatment of active PsA, and the only biologic approved for the treatment of active PsA, and product label prescription information shows that facIT-F evaluation can improve patient fatigue symptomsmedication, Tremfya was administered by subcutaneous injection, and the treatment plan was: once at the 0th and 4th weeks, and then once every 8 weeks, at a dose of 100 mgTremfya can be used alone or in combination with traditional disease-modified anti-rheumatic drugs (DMARD, such as methotrexate)psoriasis arthritis (photo: onhealth.com) this new indication is approved, based on data from two Phase III clinical studies (DISCOVER-1 and DISCOVER-2)two studies evaluated the efficacy and safety of Tremfya relative to placebo, the DISCOVER-1 study included patients who had not previously received biotherapy (primary treatment of biotherapy) or who had received anti-tumor necrosis factor alpha (TNf alpha) biological agentsTHE DISCOVER-2 STUDY, which also assessed radiology progress toward joint injury, included only patients with biotherapeutic primary treatmentin 2 studies, patients were randomly assigned to Tremfya 100mg every 4 weeks (Q4W) or every 8 weeks (Q8W) for 52 weeks, and patients receiving a placebo switched to Tremfya Q4W at the 24th week of treatment until week 52The results of24-week study were published in April this year in The Lancet, the world's top medical journalresults showed that both studies reached the primary endpoint: 24 weeks of treatment, and a significantly higher proportion of patients in the Tremfya treatment group improved their symptoms and symptoms by at least 20% (ACR20 remission) compared to the placebo group specific data, in the two studies, the proportion of patients with ACR20 remission in The Tremfya group was 52%, 64%, and the placebo group was 22% and 33%, respectively in addition, in two studies, the Tremfya treatment group showed significant improvement 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 The Chronic Disease Treatment Function Assessment-Fatigue Scale (FACIT-F) also improves fatigue symptoms in patients the overall safety observed in in PsA patients was generally consistent with that of plaque-type psoriasis patients, accompanied by a decrease in bronchitis and neutrophil count Tremfya is an anti-white interlein 23 (IL-23) p19,000 monotonica, 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 (IIb/III), ulcerative colitis (IIb/III), and pus sweat adenine (Phase II) 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 (Tenoya) 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 of China (NMPA) in December 2019 for the treatment of adult patients with moderate and severe plaque dorseformd psoriasis suitable for systematic treatment it worth mentioning, Tremfya was included in the NMPA Drug Review Center (CDE) issued the "first batch of clinically urgentoverseas new drugs list", the treatment of adaptation is: red skin psoriasis, plaque-type psoriasis, pustulitous psoriasis, psoriasis arthritis, common psoriasis NMPA to expedite the approval of Tremfya in accordance with the priority review approval process original source of () TREMFYA ® (guselkum) approved by U.S Food and Drug Drug as the first First Selective Interleukin (IL)-23 Putaford for Active Active Associates Arthritis.