New drug for psoriasis arthritis (PsA)! The Johnson and Johnson IL-23 inhibitor Tremfya (Tenoya ®) has been approved by the European Union and is listed in China!

November 28, 2020 // -- Johnson and Johnson (JNJ)'s Janssen Pharmaceuticals recently announced that the European Commission (EC) has approved Tremfya (Chinese product name: Tenoya ®, GM name : guselkumab, gusekumab), used to treat adult patients with active psoriasis arthritis (PsA) that is suitable for system therapy and who have received modified rheumatoid drugs (DMARD) for previously accepted diseases.
First Approved in November 2017 for the treatment of adult patients with moderate to severe plaque psoriasis suitable for systemic therapy.
noted that Tremfya is the first EU-approved selected IL-23 p19 sub-base inhibitor for both PSA and plaque psoriasis.
Tremfya is a monoclonal antibody that selectively binds to the p19 sub-base of leukocyte mesokine-23 (IL-23) and inhibits its interaction with IL-23 receptors.
IL-23 is a naturally occurring cytokine and an important driver of the pathogenesis of inflammatory diseases such as psoriasis and PSA.
PSA is a chronic ongoing disease characterized by joint pain and skin inflammation, and there is currently no cure.
atlas, there are 14 million psoriasis patients in Europe, up to a third of whom develop PSA.
clinical studies have shown that Tremfya significantly improves the joints, skin, soft tissue symptoms and signs of active PSA patients compared to placebos.
the United States, Tremfya was first approved in July 2017 for the treatment of adult patients with moderate to severe plaque-type psoriasis.
2020, Tremfya was approved to treat adult patients with active PSA.
It is worth noting that Tremfya is the first IL-23 selective inhibitor approved for the treatment of active PSA and the first biologic agent to be approved for the treatment of active PSA, and product label prescription information indicates that FACIT-F evaluation can improve patient fatigue symptoms.
the use of drugs, Tremfya is injected under the skin at a dose of 100 mg, once in weeks 0 and 4, and every 8 weeks therein.
tremfya can be used alone or in combination with traditional disease-modified anti-rheumate drugs such as methotrexate.
psoriasis arthritis (Photo: onhealth.com) is approved by the European Union, based on data from two Phase III clinical studies (DISCOVER-1 and DISCOVER-2).
two studies evaluated Tremfya's efficacy and safety relative to placebos.
, the DISCOVER-1 study included patients who had not previously received biotherapy (the initial treatment of biotherapy) or had been treated with anti-tumor necrosis factor α (TNF alpha) biologics.
the DISCOVER-2 study, which included only first-time patients with biotherapy, also assessed radiological advances in joint injuries.
In 2 studies, patients were randomly assigned to Tremfya 100mg every 4 weeks (Q4W) or every 8 weeks (Q8W) for 52 weeks, and patients receiving placebo were treated with Tremfya Q4W at the 24th week of treatment until week 52.
24-week results from two studies were published in April in The Lancet, the world's top medical journal.
results showed that both studies reached the primary endpoint: at 24 weeks of treatment, a significantly higher percentage of patients in the Tremfya treatment group improved their symptoms and symptoms by at least 20 percent (ACR20 remission) compared to the placebo group.
, the Tremfya group had 52 percent, 64 percent and placebo groups 22 percent and 33 percent, respectively, in two studies.
In addition, in two studies, 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.
also improved the patient's fatigue symptoms through the Chronic Disease Treatment Function Assessment-Fatigue Scale (FACIT-F).
overall safety observed in PSA patients was generally consistent with that of plaque-type psoriasis patients, accompanied by a decrease in bronchitis and neutral granulocyte counts.
Tremfya is a human monoantigen 23 (IL-23) p19 subi, 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 (IIb/III), ulcerative colitis (IIb/III), and purulent sweat adenitis (Phase II).
, Tremfya has been approved in many countries and regions around the world for the treatment of adult patients with moderate to severe plaque-type psoriasis.
in China, Tremfya was approved for listing in Hong Kong in November 2018, declared public on the mainland in late June 2019 and approved by china's State Drug Administration (NMPA) in December 2019 for the treatment of adult patients with moderate to 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 batch of clinically urgent need for new drugs abroad list", treatment of adaptation: red leather psoriasis, plaque psoriasis, pustules psoriasis, psoriasis arthritis, common psoriasis.
NMPA has accelerated its approval of Tremfya's listing in accordance with the priority review approval process.
() Origin: European Commission approves Janssen's TREMFYA (guselkumab), a First-in-Class Treatment for Active Psatic Arthritis (PsA)