Efficacy and safety of tocilizumab in treatment of Takayasu arteritis: A systematic review of randomized controlled trials.
Identifieur interne : 000407 ( 2020/Analysis ); précédent : 000406; suivant : 000408Efficacy and safety of tocilizumab in treatment of Takayasu arteritis: A systematic review of randomized controlled trials.
Auteurs : Ambrish Singh [Australie] ; Debashish Danda [Inde] ; Salman Hussain [Inde] ; Abul Kalam Najmi [Inde] ; Ashish Mathew [Inde] ; Ruchika Goel [Inde] ; Shaheen E. Lakhan [États-Unis] ; Belzik Tajudheen [Inde] ; Benny Antony [Australie]Source :
- Modern rheumatology [ 1439-7609 ] ; 2020.
Abstract
Background: Takayasu arteritis (TAK) is a chronic immune vasculitis in which Interleukin-6 (IL-6) receptors play a key role in pathogenesis. Tocilizumab (TCZ), an IL-6 receptor antagonist with a favorable safety and efficacy profile, has been tried as an option for patients with TAK. This systematic review analyzed the evidence from randomized control trials (RCT) assessing the safety and efficacy of TCZ in patients with TAK.Methods: MEDLINE, Embase, the Cochrane Library, and clinical trial registries were searched from inception to July 2018. We included RCT assessing the efficacy and safety of TCZ versus placebo/other comparators for the treatment of patients with TAK. The risk of bias (RoB) was assessed using Cochrane RoB tool.Results: 2799 identified articles were screened as per abstract and title; 42 selected full-texts articles were assessed for the potential inclusion. One trial, reported in two publications, comparing subcutaneous TCZ (162 mg/week) versus matching placebo in 36 patients with TAK was included. The relapse-free rate at 24 weeks was 50.6% and 22.9% in TCZ and placebo arm, respectively. The hazard ratio (HR) for time to first relapse was statistically significant in the per-protocol population (HR 0.34 [95.41% CI, 0.11-1.00]; p = .0345), while non-significant in the intention-to-treat population (HR 0.41 [95.41% CI, 0.15-1.10]; p = .0596). The serious adverse events were higher in the placebo arm.Conclusions: This systematic review finds the existing evidence from RCT on efficacy and safety profile of TCZ in TAK to be promising but limited. Additional evidence is required to draw a stronger conclusion.
DOI: 10.1080/14397595.2020.1724671
PubMed: 32000551
Affiliations:
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Tasmania</wicri:regionArea><wicri:noRegion>Tasmania</wicri:noRegion></affiliation></author><author><name sortKey="Danda, Debashish" sort="Danda, Debashish" uniqKey="Danda D" first="Debashish" last="Danda">Debashish Danda</name><affiliation wicri:level="1"><nlm:affiliation>Department of Clinical Immunology and Rheumatology, Christian Medical College, Vellore, India.</nlm:affiliation><country xml:lang="fr">Inde</country><wicri:regionArea>Department of Clinical Immunology and Rheumatology, Christian Medical College, Vellore</wicri:regionArea><wicri:noRegion>Vellore</wicri:noRegion></affiliation></author><author><name sortKey="Hussain, Salman" sort="Hussain, Salman" uniqKey="Hussain S" first="Salman" last="Hussain">Salman Hussain</name><affiliation wicri:level="1"><nlm:affiliation>Department of Pharmaceutical Medicine (Division of Pharmacology), School of Pharmaceutical Education and Research, Jamia Hamdard, New Delhi, India.</nlm:affiliation><country xml:lang="fr">Inde</country><wicri:regionArea>Department of Pharmaceutical Medicine (Division of Pharmacology), School of Pharmaceutical Education and Research, Jamia Hamdard, New Delhi</wicri:regionArea><wicri:noRegion>New Delhi</wicri:noRegion></affiliation></author><author><name sortKey="Najmi, Abul Kalam" sort="Najmi, Abul Kalam" uniqKey="Najmi A" first="Abul Kalam" last="Najmi">Abul Kalam Najmi</name><affiliation wicri:level="1"><nlm:affiliation>Department of Pharmacology, School of Pharmaceutical Education and Research, Jamia Hamdard, New Delhi, India.</nlm:affiliation><country xml:lang="fr">Inde</country><wicri:regionArea>Department of Pharmacology, School of Pharmaceutical Education and Research, Jamia Hamdard, New Delhi</wicri:regionArea><wicri:noRegion>New Delhi</wicri:noRegion></affiliation></author><author><name sortKey="Mathew, Ashish" sort="Mathew, Ashish" uniqKey="Mathew A" first="Ashish" last="Mathew">Ashish Mathew</name><affiliation wicri:level="1"><nlm:affiliation>Department of Clinical Immunology and Rheumatology, Christian Medical College, Vellore, India.</nlm:affiliation><country xml:lang="fr">Inde</country><wicri:regionArea>Department of Clinical Immunology and Rheumatology, Christian Medical College, Vellore</wicri:regionArea><wicri:noRegion>Vellore</wicri:noRegion></affiliation></author><author><name sortKey="Goel, Ruchika" sort="Goel, Ruchika" uniqKey="Goel R" first="Ruchika" last="Goel">Ruchika Goel</name><affiliation wicri:level="1"><nlm:affiliation>Department of Clinical Immunology and Rheumatology, Christian Medical College, Vellore, India.</nlm:affiliation><country xml:lang="fr">Inde</country><wicri:regionArea>Department of Clinical Immunology and Rheumatology, Christian Medical College, Vellore</wicri:regionArea><wicri:noRegion>Vellore</wicri:noRegion></affiliation></author><author><name sortKey="Lakhan, Shaheen E" sort="Lakhan, Shaheen E" uniqKey="Lakhan S" first="Shaheen E" last="Lakhan">Shaheen E. Lakhan</name><affiliation wicri:level="2"><nlm:affiliation>Carilion Clinic and Virginia Tech, Virginia, VA, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Carilion Clinic and Virginia Tech, Virginia, VA</wicri:regionArea><placeName><region type="state">Virginie</region></placeName></affiliation></author><author><name sortKey="Tajudheen, Belzik" sort="Tajudheen, Belzik" uniqKey="Tajudheen B" first="Belzik" last="Tajudheen">Belzik Tajudheen</name><affiliation wicri:level="1"><nlm:affiliation>Jamia Salafia Pharmacy Collage, Pulikkal, India.</nlm:affiliation><country xml:lang="fr">Inde</country><wicri:regionArea>Jamia Salafia Pharmacy Collage, Pulikkal</wicri:regionArea><wicri:noRegion>Pulikkal</wicri:noRegion></affiliation></author><author><name sortKey="Antony, Benny" sort="Antony, Benny" uniqKey="Antony B" first="Benny" last="Antony">Benny Antony</name><affiliation wicri:level="1"><nlm:affiliation>Menzies Institute for Medical Research, University of Tasmania, Tasmania, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Menzies Institute for Medical Research, University of Tasmania, Tasmania</wicri:regionArea><wicri:noRegion>Tasmania</wicri:noRegion></affiliation></author></analytic><series><title level="j">Modern rheumatology</title><idno type="eISSN">1439-7609</idno><imprint><date when="2020" type="published">2020</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><b>Background:</b> Takayasu arteritis (TAK) is a chronic immune vasculitis in which Interleukin-6 (IL-6) receptors play a key role in pathogenesis. Tocilizumab (TCZ), an IL-6 receptor antagonist with a favorable safety and efficacy profile, has been tried as an option for patients with TAK. This systematic review analyzed the evidence from randomized control trials (RCT) assessing the safety and efficacy of TCZ in patients with TAK.<b>Methods:</b> MEDLINE, Embase, the Cochrane Library, and clinical trial registries were searched from inception to July 2018. We included RCT assessing the efficacy and safety of TCZ versus placebo/other comparators for the treatment of patients with TAK. The risk of bias (RoB) was assessed using Cochrane RoB tool.<b>Results:</b> 2799 identified articles were screened as per abstract and title; 42 selected full-texts articles were assessed for the potential inclusion. One trial, reported in two publications, comparing subcutaneous TCZ (162 mg/week) versus matching placebo in 36 patients with TAK was included. The relapse-free rate at 24 weeks was 50.6% and 22.9% in TCZ and placebo arm, respectively. The hazard ratio (HR) for time to first relapse was statistically significant in the per-protocol population (HR 0.34 [95.41% CI, 0.11-1.00]; <i>p</i> = .0345), while non-significant in the intention-to-treat population (HR 0.41 [95.41% CI, 0.15-1.10]; <i>p</i> = .0596). The serious adverse events were higher in the placebo arm.<b>Conclusions:</b> This systematic review finds the existing evidence from RCT on efficacy and safety profile of TCZ in TAK to be promising but limited. Additional evidence is required to draw a stronger conclusion.</div></front></TEI><affiliations><list><country><li>Australie</li><li>Inde</li><li>États-Unis</li></country><region><li>Virginie</li></region></list><tree><country name="Australie"><noRegion><name sortKey="Singh, Ambrish" sort="Singh, Ambrish" uniqKey="Singh A" first="Ambrish" last="Singh">Ambrish Singh</name></noRegion><name sortKey="Antony, Benny" sort="Antony, Benny" uniqKey="Antony B" first="Benny" last="Antony">Benny Antony</name></country><country name="Inde"><noRegion><name sortKey="Danda, Debashish" sort="Danda, Debashish" uniqKey="Danda D" first="Debashish" last="Danda">Debashish Danda</name></noRegion><name sortKey="Goel, Ruchika" sort="Goel, Ruchika" uniqKey="Goel R" first="Ruchika" last="Goel">Ruchika Goel</name><name sortKey="Hussain, Salman" sort="Hussain, Salman" uniqKey="Hussain S" first="Salman" last="Hussain">Salman Hussain</name><name sortKey="Mathew, Ashish" sort="Mathew, Ashish" uniqKey="Mathew A" first="Ashish" last="Mathew">Ashish Mathew</name><name sortKey="Najmi, Abul Kalam" sort="Najmi, Abul Kalam" uniqKey="Najmi A" first="Abul Kalam" last="Najmi">Abul Kalam Najmi</name><name sortKey="Tajudheen, Belzik" sort="Tajudheen, Belzik" uniqKey="Tajudheen B" first="Belzik" last="Tajudheen">Belzik Tajudheen</name></country><country name="États-Unis"><region name="Virginie"><name sortKey="Lakhan, Shaheen E" sort="Lakhan, Shaheen E" uniqKey="Lakhan S" first="Shaheen E" last="Lakhan">Shaheen E. Lakhan</name></region></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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