Anti inflammatory drugs! The large-scale phase III study on the treatment of psoriatic arthritis (PSA) with rinvoq, an oral inhibitor of Jak1, was successful!

February 6, 2020 / BIOON / -- abbvie recently announced the positive top line results of phase III select PSA study (nct03104400) of anti-inflammatory drug rinvoq (upadacitinib) in the treatment of psoriatic arthritis (PSA) The study was carried out in adult patients with active PSA who did not respond adequately or tolerated one or more non biological disease modified anti rheumatic drugs (DMARD) The results showed that the two doses of rinvoq (15mg and 30mg, once a day) reached the main end point of ACR20 response compared with placebo In addition, the study reached multiple secondary endpoints Rinvoq, a selective and reversible JAK inhibitor, is currently being developed as a daily oral therapy for PSA and a variety of immune-mediated inflammatory diseases Select PSA is a multicenter, randomized, double-blind, parallel group, positive drug and placebo-controlled phase III study conducted in 1705 adult patients with inadequate response to at least one non biological DMARD The efficacy and safety of two doses of rinvoq (15mg and 30mg once a day) compared with placebo and adalimumab were evaluated In the study, patients were randomly assigned to receive rinvoq 15mg, rinvoq 30mg, adalimumab (40mg, once a week [EOW]), placebo The primary end point was the proportion of patients who achieved ACR20 response at week 12 in the two doses of rinvoq compared with the placebo group Secondary endpoints included changes in the Health Assessment Questionnaire Disability Index (HAQ-DI) score relative to baseline at week 12, the proportion of patients who reached PASI75 (75% improvement in psoriasis area severity index) at week 16, and the proportion of patients who reached the minimum disease activity (MDA) at week 24 The data showed that the study reached the main end point: in the 12th week, 71% of patients in the 15 mg group and 79% in the 30 mg group achieved ACR20 response, while 36% in the placebo group (P < 0.0001) When compared with adalimumab, the two doses of rinvoq achieved non inferiority in the response rate of ACR20 at the 12th week of treatment, and only 30mg showed superiority The response rate of acr50 at the 12th week was 38%, 52% and 13% in the 15mg group, 30mg group and placebo group respectively (nominal P < 0.0001) The response rate of acr75 at the 12th week was 16%, 25% and 2% in the 15mg group, 30mg group and placebo group respectively (nominal P < 0.0001) According to the measurement of HAQ-DI score, the physical function of the patients receiving rinvoq treatment also improved significantly at the 12th week: the HAQ-DI score of the patients in the 15 mg and 30 mg rinvoq treatment groups changed by - 0.42 and - 0.47 compared with the baseline respectively, and the change in the placebo group was - 0.14 (P < 0.0001) At the 16th week, rinvoq also showed improvement in skin symptoms 63% and 62% of the patients receiving 15 mg and 30 mg rinvoq reached PASI75 respectively, compared with 21% in the placebo group (P < 0.0001) The proportion of patients reaching MDA at the 24th week was 37% and 45% in rinvoq group and 12% in placebo group (P < 0.0001) After 24 weeks of treatment, rinvoq 15mg and 30mg significantly inhibited the progress of Radiology compared with placebo (P < 0.01, evaluated with the change of PSA sharp / van der Heijde score relative to the baseline) Inhibition of joint injury is important in patients with psoriatic arthritis because it affects physical function and disability In the study, rinvoq's security is consistent with that previously reported, and no new security risk is found "People with psoriatic arthritis often suffer from joint pain, stiffness and fatigue, which affects their ability to work and physical activity," said Michael Severino, M.D., vice president and President of Aberdeen The results of this large-scale phase III study further support rinvoq's potential to help these patients We look forward to sharing this data with regulators around the world to support our application for rinvoq's extended label to include the treatment of adult patients with active psoriatic arthritis " Rinvoq's active drug ingredient is upadacitinib, which is an oral selective Jak1 inhibitor discovered and developed by Aberdeen It is being developed to treat moderate to severe rheumatoid arthritis (RA) and many other immune-mediated inflammatory diseases Jak1 is a kinase that plays a key role in the pathophysiological process of various inflammatory diseases In August 2019, rinvoq won the first batch in the world in the United States At present, the drug has been listed in the United States One tablet (15mg) is taken orally once a day The drug is not suitable for patients who have not received MTX treatment It is worth mentioning that Albright accelerated rinvoq's review in the US FDA by using a priority review voucher (PRV) In December 2019, rinvoq was approved by the European Union for the treatment of adult patients with moderate to severe RA who have insufficient or intolerable response to one or more dmars At present, the phase III clinical study of rinvoq in the treatment of psoriatic arthritis (PSA), Crohn's disease (CD), atopic dermatitis (AD), ulcerative colitis (UC), giant cell arteritis is in progress In addition, rinvoq is being evaluated for the treatment of ankylosing spondylitis The industry is very optimistic about rinvoq's business prospects According to a previous report released by evaluatepharma, a pharmaceutical market research organization, rinvoq's global sales will reach US $2.57 billion in 2024, making it the fifth largest selling anti rheumatic drug in the world Source: rinvoq (upadacitinib) meets primary and key secondary endpoints in phase 3 study in psychological Arts