*For medical professionals only, upatinib is the first targeted therapy approved in China for the treatment of psoriatic arthritis
On April 6, the China National Medical Products Administration has approved upatinib for active psoriatic arthritis (PsA) in patients with poor response or intolerance to one or more disease-modifying antirheumatic drugs (DMARDs).
For adult patients, it will be the first and currently only targeted therapy approved in China for the treatment of active PsA
It should be noted that PsA is the third indication for upatinib approved in China.
On March 22 this year, upatinib was approved for the treatment of rheumatoid arthritis (RA)
Treating RA, the effect is doubled! Upatinib is a selective JAK1 inhibitor, and studies have found that upatinib has a stronger inhibitory effect on JAK1 than JAK2, JAK3 and TYK2
In August 2019, the drug was approved by the U.
Food and Drug Administration (FDA) for the treatment of adult patients with moderately to severely active RA who have an inadequate response to or intolerance to methotrexate
Since then, the drug has been approved by the FDA for the treatment of refractory, moderate to severe atopic dermatitis and active PsA in adults and children and adolescents 12 years and older
Its approval in China this year is also based on the data of the Phase II/III SELECT-study.
The results of the study showed that compared with the control agent, upatinib significantly improved the symptoms and signs of adult patients with RA.
In the 12th week of treatment, rheumatoid The proportion of patients with a 50% improvement in arthritis assessment (ACR50) was doubled (52% vs 28%, p<0.
In addition, data from a post hoc analysis of the phase III SELECT-BEYOND clinical trial found  that 34% of RA patients treated with upatinib plus a background csDMARD achieved clinical disease at the first response by week 60 Activity index remission (CDAI ≤ 2.
8), and 79% of patients achieved CDAI low disease activity (LDA; CDAI ≤ 10)
In terms of maintenance response (defined as no loss of response at 2 consecutive study visits), CDAI remission and CDAI LDA were observed in 39% and 61% of patients, respectively, at 60 weeks
Of the patients who lost their CDAI remission on upatinib, 58% remained CDAI LDA and 22% regained their remission by the analysis cutoff
Similar patterns of sustained responses were observed for remission and LDA according to the simplified disease activity index (SDAI) criteria and DAS28 (CRP) <2.
At present, China's first and only targeted drug approved for the treatment of PsA has been approved for RA less than a month ago.
Yesterday, upatinib was pleased to mention the third indication - PsA! PsA is an inflammatory disease clinically characterized by arthritis, enthesitis, dactylitis, spondylitis, and psoriasis, often resulting in severe functional impairment, decreased quality of life, and premature death
Before the introduction of biologics and small molecule targeted drugs for the treatment of PsA, the choice of drugs was extremely limited, which seriously affected the physical function and quality of life of patients
With the in-depth exploration of the pathogenesis of PsA, new therapeutic targets continue to emerge, and multiple clinical trials of drugs for the treatment of PsA are underway.
The relevant research results will also update our treatment concept and management strategy
The therapeutic goal of PsA is to maximize patient outcomes by controlling inflammation and preventing irreversible joint damage and disability
At present, drugs for the treatment of PsA or with promising therapeutic prospects include csDMARDs, biological agents such as TNFi, IL-17 inhibitors, T cell regulators, and targeted synthetic DMARDs.
The approval of upatinib in China brings a new treatment option for more PsA patients! ■ The phase III clinical trial data to support the approval of the State Drug Administration is mainly based on the data support of the phase III clinical study SELECT-PsA1 .
SELECT-PsA1 is a multi-center, randomized, double-blind, parallel group, active A phase III and placebo-controlled clinical study to evaluate the safety and efficacy of upatinib compared with placebo and adalimumab in adult patients with active PsA who have an inadequate response to at least one nonbiologic DMARD
Patients were randomly assigned to upadatinib 15 mg, 30 mg, adalimumab 40 mg, or placebo at week 24 on uppatinib 15 mg or 30 mg
The primary endpoint was the percentage of patients who achieved an ACR 20 response relative to placebo after 12 weeks of treatment with upatinib 15 mg or 30 mg
RESULTS: At week 12, 71% and 79% of patients receiving 15 mg and 30 mg of upatinib achieved ACR 20, respectively, compared with 36% in the placebo group
The safety profile of upatinib was consistent with previously reported findings, and no new safety risks were identified
Conclusion Upatinib, as a targeted drug, has been approved successively in China this year, and will provide a new treatment option for more rheumatism patients in the future
References:  AbbVie to Present New Long-term Analysis Evaluating the Sustainability of Response to RINVOQ (Upadacitinib) Among Patients with Rheumatoid Arthritis Upadacitinib in patients with psoriatic arthritis and an inadequate response to non-biological therapy: 56- week data from the phase 3 SELECT-PsA 1 study.
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