FDA approves Janssen Pharmaceuticals Tremfya ® One Pres for treatment in adult patients with moderate to severe plaque psoriasis

recently, the U.SPharmaceutical(http://http://
giant
,,janssenPharmaceutical(http://announced that the U.SFDA http://
has approved Tremfya ® One Press, a single-dose, patient-controlled syringe for the treatment of adult patients with moderate to severe plaque psoriasisnearly 99 percent of patients with the syringe were successfully injected for the first time, and the drug was effective, with nearly half of patients completely clean after three injectionsAbout Tremfya®
Tremfya ® (guselkumab) was approved by the FDA in July 2017 for the treatment of severe plaque psoriasis in adults Tremfya ® is the world's first listed anti-IL-23 mono-anti-
drug (http:// , and IL-23 plays a key role in plaque-type psoriasis The use of Tremfya ® is 0th, given a starting dose at 4 weeks, followed by 100 mg of subcutaneous injection every 8 weeks 　　Tremfya ® is the first FDA-approved product (http:// to offer One-Press patient control syringes One-Press is specifically designed for patients: the product can be held in the hands for controlled injections, a process that is simple and easy to operate, and the needle is hidden throughout the process Tremfya ® to be used under the guidance and supervision of a physician, and with the approval and appropriate training of the doctor, patients can use Tremfya ® One-Press to inject themselves Tremfya ® One-Press is now available in the United States related studies
ORION is a Phase III clinical study that evaluates pharmacokinetics, efficacy, and safety after tremfya ® (gukumselab) use of One-Press syringes A total of 78 patients were randomly assigned to tremfya (n-62) and placebo (n-16) common primary endpoints are the proportion of patients with an IGA score of 0 (complete skin cleansing) /1 (minimal skin cleansing or minimal impact of disease) and the proportion of patients who responded with PASI 90 (90% improvement in psoriasis area and severity index compared to baseline) at week 16, and the secondary endpoint includes the proportion of patients who achieved an IGA score of 0 in week 16 and a pasi-type 100 (psoriasis area and 100 00% baseline improvement) response in week 16 Most injection sites using One-Press respond to symptoms that are mild and transient 　　In the ORION study, a self-injection assessment questionnaire was used to assess the patient experience using One-Press syringes, and in weeks 0, 4, and 12, the patient was assessed for six aspects of injection sensation, self-image, self-confidence, pain and skin response during or after injection, ease of use of self-injection device, and satisfaction with self-injection results showed an average score of 9.18 (10 for "very satisfied" in "self-injection satisfaction" and 9.24 for "easy use" (of which 10 was "very easy")