Инхибитор Ксељанз (тофацитиниб) је одобрила америчка ФДА за своју пету индикацију!

Pfizer recently announced that the US Food and Drug Administration (FDA) has approved a new indication for the anti-inflammatory drug Xeljanz (): за лечење одговора на један или више блокатора фактора туморске некрозе (ТНФ) Одрасли пацијенти са недовољним или нетолерантним активним анкилозирајућим спондилитисом (АС). У Европској унији, Ксељанз је одобрен у новембру 2021. за лечење одраслих пацијената са активним АС који не реагују на конвенционалне третмане.

Анкилозантни спондилитис (АС) је врста артритиса која може изазвати упалу у одређеним деловима кичме, погађајући више од 350.000 људи у Сједињеним Државама. Ова болест се обично јавља у раном одраслом добу и може изазвати бол, оток и може ограничити кретање. Ово одобрење даје клиничарима и пацијентима додатну опцију оралног лечења.

This regulatory approval also confirms the clinical value and versatility of Xeljanz. Xeljanz is the first and only oral JAK inhibitor approved for 5 indications in the United States and the European Union. It is the largest of all JAK inhibitors. The 4 indications previously approved include: (1) Moderate to severe Adult patients with active rheumatoid arthritis (RA); (2) adults with active psoriatic arthritis (PsA); (3) adults with moderate to severe active ulcerative colitis (UC); (4) ) Patients with active polyarticular juvenile idiopathic arthritis (pcJIA) and juvenile PsA aged 2 years and older.

Одобрење за АС индикацију је засновано на позитивним резултатима клиничке студије фазе 3 (А3921120). Подаци су показали да је према стандардима за процену Међународног удружења спондилног артритиса (АСАС), у 16. недељи лечења, Ксељанз постигао примарну крајњу тачку (АСАС20 одговор) и кључну секундарну крајњу тачку (АСАС40 одговор) у поређењу са плацебом.

A3921120 is a multi-center, double-blind, placebo-controlled phase 3 study conducted in 270 adult patients with active AS. These patients meet the modified AS New York criteria (MNY) and are tested for 2 or more non-steroids Insufficient response or intolerance to anti-inflammatory drugs (NSAID) treatment. In the study, patients were randomly assigned to take 5mg doses of Xeljanz or placebo twice a day for 16 weeks, and a total of 269 patients received treatment. Eligible patients who completed the 16-week double-blind treatment period were assigned to receive open-label Xeljanz treatment at a dose of 5 mg twice a day for an additional 32 weeks, and then entered a 4-week follow-up period.

The results showed that the study reached the primary endpoint: at the 16th week of treatment, compared with the placebo group, the proportion of patients in the Xeljanz treatment group who achieved an ASAS20 response significantly increased (56.4% vs 29.4%; p<0.0001). in="" addition,="" compared="" with="" the="" placebo="" group,="" the="" proportion="" of="" patients="" in="" the="" xeljanz="" treatment="" group="" who="" achieved="" an="" asas40="" response="" significantly="" increased="" (40.6%="" vs="" 12.5%;=""><0.0001), which="" is="" a="" key="" secondary="" endpoint="" of="" the="" study.="" asas20/40="" is="" used="" to="" determine="" improvement="" or="" treatment="" response.="" in="" this="" study,="" the="" safety="" profile="" observed="" in="" as="" patients="" treated="" with="" xeljanz="" was="" consistent="" with="" the="" safety="" profile="" observed="" in="" patients="" with="" rheumatoid="" arthritis="" (ra)="" and="" psoriatic="" arthritis="" (psa),="" occurring="" in="" any="" treatment="" group="" the="" most="" common="" adverse="" events="" in="">5% of patients include: upper respiratory tract infection, nasopharyngitis, diarrhea, elevated alanine aminotransferase (ALT), arthralgia, and headache.

Ankylosing spondylitis (AS) is a chronic inflammatory disease that affects men and women in early adulthood. The first symptoms usually occur before the age of 30 and rarely appear after the age of 45. Symptoms of AS include back and buttocks pain and stiffness. Over time, some patients may experience spinal fusion. AS can cause severe chronic pain to patients and negatively affect health-related quality of life.

Активни фармацеутски састојак Ксељанза јетофацитиниб

In the Chinese market, Xeljanz was approved for marketing in March 2017 for the treatment of moderate to severely active RA adult patients with insufficient or intolerable MTX treatment. Xeljanz can be used in combination with MTX or other non-biological DMARDs. The approved recommended dose of this drug is 5 mg, taken orally twice a day, with or without food. This approval makes Xeljanz the first JAK inhibitor to treat rheumatoid arthritis (RA) in the Chinese market.