Objective To analyze the withdrawal reason of natalizumab in depth based on the serious adverse reaction reports and approval channel, and to provide decision references for more safe and effective report method of other biologicals. Methods We searched MEDLINE, EMbase, and the official websites of Food and Drug Administration (FDA) for case reports, approval channel, and the relevant information of drug marketing or withdrawal. Results Four case reports and fourteen official reports were included. Three cases of progressive multifocal leukoencephalopathy (PML) were reported in the clinical trials after natalizumab’s initially approval with two dead and one disabled, which could be retrieved by hemodialysis (2 cases hitherto). Consequently, multiple sclerosis (MS) patients were willing to bear the risk. Two cases of natalizumab-related PML (0.06‰) were confirmed in 32 000 patients without death report after two years of its remarketing, in July 2008. Another PML patient was reported in October 2008. Because of its non-substitutability for treating MS and Crohn disease (CD), FDA announced that patients could still use natalizumab under the close monitoring. Conclusion (1) The most serious adverse reaction of treating MS and CD with natalizumab is PML, but it can be preventable and curable now. The monitoring findings of efficacy and adverse reaction during the postmarketing indicate that the review system is perfect and practicable relatively, and can give references for other high-risk drugs on the fast or standard approval channel, for example, Chinese medicine injection can draw lessons from it. (2) The remarketing of natalizumab not only provide significant risk management precedent for other drug-development firms, but also brings hope to the remarketing or relaunching clinical trials for the suspected sideeffect drugs. (3) Because of the fast-track reviewing of natalizumab and the overlap between the research of Good Clinical Practice (GCP) and the post-marketing evaluation, we should continue to track the information and provide new evidence.
Behçet uveitis (BU), one of the common manifestations of Behçet syndrome, has a poor prognosis, high blinding rate, and severely impairs the quality of patients’ life. The current treatment principle mainly induce and maintain inflammation remission by suppressing the immune response. The glucocorticoid combined with immunosuppressive therapy for the treatment of BU has disadvantages such as long medication time, severe adverse effects, and poor long-term prognosis, whereas biologics have gradually attracted attention about the treatment of BU because of their high efficacy, low toxicity, and good long-term prognosis. The biologics used to treat BU include tumor necrosis factor-α inhibitors, interferon-α, interleukin blockers, and lymphocyte targeting preparations. It is believed that with the progress of various studies and clinical trials, the stepwise application of biologics is promising, and it is hopeful to provide more accurate and effective treatment for patients with BU in the future.
ObjectiveTo systematically review the long-term efficacy of biologics for moderate to severe plaque psoriasis. MethodsPubMed, EMbase, Web of Science and The Cochrane Library were electronically searched to collect randomized controlled trials (RCTs) on the long-term efficacy of approved biologics for moderate to severe plaque psoriasis from inception to May 2021. Two reviewers independently screened the literature, extracted data and assessed the risk of bias of the included studies; then, the network meta-analysis was performed by using Stata 16.0 software. ResultsA total of 26 RCTs were included. The results of network meta-analysis showed that among 11 biologics, the most effective biologics were risankizumab, followed by bimekizumab, brodalumab, guselkumab, and ixekizumab, and followed by secukinumab, adalimumab, ustekinumab, and etanercept was the last. ConclusionCurrent evidence shows that risankizumab is likely to be the best option for long-term treatment of moderate-to-severe plaque psoriasis. Due to the limited quality and quantity of the included studies, more high-quality studies are needed to verify the above conclusion.
Anti-tumor necrosis factor-α monoclonal antibody agents have been widely applied in the management of autoimmune diseases. Among them, Adalimumab and Infliximab have been used for years in clinical practice in treating non-infectious uveitis and achieved satisfactory effects and safety. However, no guideline or expert consensus for their usage is available in China currently. It hopefully promotes standardized clinical application of anti-tumor necrosis factor -α monoclonal antibody in treating non-infectious uveitis, together with other senior experts in uveitis, the Ocular Immunology Group of Immunology and Rheumatology Academy in Cross-Straits Medicine Exchange Association form this evidence-based recommendations for clinicians’ reference.