Anti inflammatory drugs! Yushi is approved for the treatment of non radiologic axial spondyloarthroarthritis (NR axspa) by cimzia and is available during pregnancy / lactation!

January 17, 2020 / BIOON / -- UCB, a Belgian pharmaceutical giant, recently announced that Health Canada has approved cimzia (Chinese trade name: ciminja ®, common name: certolizumab Pegol, peserizumab injection) a new indication for the treatment of adult patients with inflammatory objective evidence (C-reactive protein elevation and / or MRI evidence), insufficient or intolerant response to non steroidal anti-inflammatory drugs (NSAID), and severe active non radiologic axial spondyloarthroarthritis (NR axspa) This approval also marks cimzia's fifth indication in Canada In the United States, cimzia was approved by FDA in March 2019 as the first drug to treat NR axspa Cimzia is the only anti-tumor necrosis factor α (TNF - α) drug without Fc domain and modified by polyethylene glycol It has a very high affinity for human TNF - α and can selectively neutralize the pathophysiological role of TNF - α Because of its unique molecular structure without Fc domain, cimzia is the only anti-tumor necrosis factor (an-tnf) biological agent that has strong scientific evidence to prove that the drugs will not transfer to the fetus and infant when the women in childbearing age (from pregnancy to late pregnancy and lactation) receive treatment Up to now, cimzia has been approved by many countries and regions in the world for the treatment of a variety of inflammatory diseases, including rheumatoid arthritis, psoriatic arthritis, plaque psoriasis, ankylosing spondylitis, spinal arthritis, Crohn's disease, etc In China, cimzia was approved by the National Drug Administration (nmpa) in July 2019 for the treatment of patients with moderate to severe rheumatoid arthritis (RA) It is particularly worth mentioning that cimzia is the only biological preparation approved in China that can be used for the treatment of rheumatoid arthritis in the whole pregnancy if there is clinical need in the manual In December 2019, cimzia was officially launched in China, which is the first biotherapy approved by the ushibi product portfolio in China, and will also provide an important treatment option for Chinese women who need to manage RA without affecting pregnancy and breastfeeding programs NR axspa is a chronic inflammatory disease, which mainly affects the spine and sacroiliac joint The diagnosis and treatment of NR axspa are often inadequate Some patients may take as long as 10 years from symptoms to diagnosis NR axspa has no clear evidence of disease on X-ray films The disease usually occurs in the early adult stage, causing chronic and aging back pain, stiffness and fatigue, and usually has a profound impact on the life of patients This approval is based on the data of phase III clinical study c-axspan, which is a multicenter, randomized, double-blind, parallel group, 52 week study A total of 317 active axspa patients without X-ray evidence of ankylosing spondylitis (as) were enrolled in the study, and the efficacy of cimzia (subcutaneous injection: 400mg [2 200mg] at the 0, 2, and 4 weeks) relative to placebo was evaluated There is objective evidence of inflammatory disease in these patients, that is, MR imaging (MRI) shows sacroiliac arthritis and / or elevated C-reactive protein (CRP) levels, as well as inadequate response, contraindications or intolerance to at least two non steroidal anti-inflammatory drugs (NSAIDs) Inadequate response to NSAID was defined as a lack of response at least 14 days after continuous treatment with NSAID at the maximum tolerable dose The main purpose of this study was to evaluate the safety and efficacy of cimzia in the treatment of symptoms and signs of active axspa patients without as X-ray evidence The primary end point was the ankylosing spondylitis disease activity score - significant improvement (asdas-mi, defined as a reduction of asdas by ≥ 2.0 from baseline, or the lowest possible score [0.6] at week 52), and the secondary end point was the evaluation of efficacy, safety, tolerability, and the demonstration of cimzia for health outcomes, disease activity, MRI evaluation of sacroiliac joint inflammation, comorbidities, and background drugs Change The safety variables evaluated in the study included adverse events, vital signs, physical examination and laboratory parameter determination During the study, patients in both the cimzia and placebo groups continued to receive background treatment (including NSAID, corticosteroids, painkillers, and slow acting antirheumatics) and could be adjusted at any time The results showed that the study reached the primary end point: at week 52, a significantly higher proportion of patients in the cimzia treatment group reached asdas-mi (47.2% vs 7%) compared to the placebo group In addition, the study reached an important secondary end point: at week 12, a significantly higher proportion of patients in the cimzia treatment group achieved asas40 remission compared to the placebo group (improvement in the ankylosing spondylitis assessment score of 40%: 47% vs 11.4%) The safety in this study is consistent with previous clinical studies of cimzia The c-axspan study was designed as a special control trial for patients who were diagnosed with NR axspa and had active disease and objective inflammatory symptoms despite NSAID use What is unique about this study is that it is the first to use ASDAS-MI, a strict response threshold, as the main outcome indicator Source: cimzia (certolizumab PEG) now app roved in Canada for the treatment of non radiologic axial spindyloadhritis