Trial of Tocilizumab in Giant-Cell Arteritis
Background Giant-cell arteritis commonly relapses when glucocorticoids are tapered, and the prolonged use of glucocorticoids is associated with side effects. The effect of the interleukin-6 receptor alpha inhibitor tocilizumab on the rates of relapse during glucocorticoid tapering was studied in pat...
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| Veröffentlicht in: | New England Journal of Medicine 2017, Vol.377 (4), p.317-328 |
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| creator | Stone, John H Tuckwell, Katie Dimonaco, Sophie Klearman, Micki Aringer, Martin Blockmans, Daniel Engelbert Brouwer, Elisabeth Cid, Maria C Dasgupta, Bhaskar Rech, Juergen Salvarani, Carlo Schett, Georg Schulze-Koops, Hendrik Spiera, Robert Unizony, Sebastian H Collinson, Neil |
| description | Background
Giant-cell arteritis commonly relapses when glucocorticoids are tapered, and the prolonged use of glucocorticoids is associated with side effects. The effect of the interleukin-6 receptor alpha inhibitor tocilizumab on the rates of relapse during glucocorticoid tapering was studied in patients with giant-cell arteritis.
Methods
In this 1-year trial, we randomly assigned 251 patients, in a 2:1:1:1 ratio, to receive subcutaneous tocilizumab (at a dose of 162 mg) weekly or every other week, combined with a 26-week prednisone taper, or placebo combined with a prednisone taper over a period of either 26 weeks or 52 weeks. The primary outcome was the rate of sustained glucocorticoid-free remission at week 52 in each tocilizumab group as compared with the rate in the placebo group that underwent the 26-week prednisone taper. The key secondary outcome was the rate of remission in each tocilizumab group as compared with the placebo group that underwent the 52-week prednisone taper. Dosing of prednisone and safety were also assessed.
Results
Sustained remission at week 52 occurred in 56% of the patients treated with tocilizumab weekly and in 53% of those treated with tocilizumab every other week, as compared with 14% of those in the placebo group that underwent the 26-week prednisone taper and 18% of those in the placebo group that underwent the 52-week prednisone taper (P |
| format | Article |
| fullrecord | <record><control><sourceid>kuleuven</sourceid><recordid>TN_cdi_kuleuven_dspace_123456789_592301</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>123456789_592301</sourcerecordid><originalsourceid>FETCH-kuleuven_dspace_123456789_5923013</originalsourceid><addsrcrecordid>eNpjYeA0MDCy0DUxtzTmYOAqLs4yAAJDE0tOBp2QoszEHIX8NIWQ_OTMnMyq0tzEJIXMPAX3zMS8El3n1JwcBceiktSizJLMYh4G1rTEnOJUXijNzaDu5hri7KGbXZqTWlqWmhefUlyQmJwab2hkbGJqZm5hGW9qaWRsYGhMikpt4lTGl1SUGAMAW7U_Cg</addsrcrecordid><sourcetype>Institutional Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype></control><display><type>article</type><title>Trial of Tocilizumab in Giant-Cell Arteritis</title><source>Lirias (KU Leuven Association)</source><source>Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals</source><source>ProQuest Central UK/Ireland</source><source>New England Journal of Medicine</source><creator>Stone, John H ; Tuckwell, Katie ; Dimonaco, Sophie ; Klearman, Micki ; Aringer, Martin ; Blockmans, Daniel Engelbert ; Brouwer, Elisabeth ; Cid, Maria C ; Dasgupta, Bhaskar ; Rech, Juergen ; Salvarani, Carlo ; Schett, Georg ; Schulze-Koops, Hendrik ; Spiera, Robert ; Unizony, Sebastian H ; Collinson, Neil</creator><creatorcontrib>Stone, John H ; Tuckwell, Katie ; Dimonaco, Sophie ; Klearman, Micki ; Aringer, Martin ; Blockmans, Daniel Engelbert ; Brouwer, Elisabeth ; Cid, Maria C ; Dasgupta, Bhaskar ; Rech, Juergen ; Salvarani, Carlo ; Schett, Georg ; Schulze-Koops, Hendrik ; Spiera, Robert ; Unizony, Sebastian H ; Collinson, Neil</creatorcontrib><description>Background
Giant-cell arteritis commonly relapses when glucocorticoids are tapered, and the prolonged use of glucocorticoids is associated with side effects. The effect of the interleukin-6 receptor alpha inhibitor tocilizumab on the rates of relapse during glucocorticoid tapering was studied in patients with giant-cell arteritis.
Methods
In this 1-year trial, we randomly assigned 251 patients, in a 2:1:1:1 ratio, to receive subcutaneous tocilizumab (at a dose of 162 mg) weekly or every other week, combined with a 26-week prednisone taper, or placebo combined with a prednisone taper over a period of either 26 weeks or 52 weeks. The primary outcome was the rate of sustained glucocorticoid-free remission at week 52 in each tocilizumab group as compared with the rate in the placebo group that underwent the 26-week prednisone taper. The key secondary outcome was the rate of remission in each tocilizumab group as compared with the placebo group that underwent the 52-week prednisone taper. Dosing of prednisone and safety were also assessed.
Results
Sustained remission at week 52 occurred in 56% of the patients treated with tocilizumab weekly and in 53% of those treated with tocilizumab every other week, as compared with 14% of those in the placebo group that underwent the 26-week prednisone taper and 18% of those in the placebo group that underwent the 52-week prednisone taper (P<0.001 for the comparisons of either active treatment with placebo). The cumulative median prednisone dose over the 52-week period was 1862 mg in each tocilizumab group, as compared with 3296 mg in the placebo group that underwent the 26-week taper (P<0.001 for both comparisons) and 3818 mg in the placebo group that underwent the 52-week taper (P<0.001 for both comparisons). Serious adverse events occurred in 15% of the patients in the group that received tocilizumab weekly, 14% of those in the group that received tocilizumab every other week, 22% of those in the placebo group that underwent the 26-week taper, and 25% of those in the placebo group that underwent the 52-week taper. Anterior ischemic optic neuropathy developed in one patient in the group that received tocilizumab every other week.
Conclusions
Tocilizumab,received weekly or every other week, combined with a 26-week prednisone taper was superior to either 26-week or 52-week prednisone tapering plus placebo with regard to sustained glucocorticoid-free remission in patients with giant-cell arteritis. Longer follow-up is necessary to determine the durability of remission and safety of tocilizumab. (Funded by F. Hoffmann-La Roche; ClinicalTrials.gov number, NCT01791153.)</description><identifier>ISSN: 0028-4793</identifier><language>eng</language><publisher>MASSACHUSETTS MEDICAL SOC</publisher><ispartof>New England Journal of Medicine, 2017, Vol.377 (4), p.317-328</ispartof><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,315,780,784,4024,27860</link.rule.ids></links><search><creatorcontrib>Stone, John H</creatorcontrib><creatorcontrib>Tuckwell, Katie</creatorcontrib><creatorcontrib>Dimonaco, Sophie</creatorcontrib><creatorcontrib>Klearman, Micki</creatorcontrib><creatorcontrib>Aringer, Martin</creatorcontrib><creatorcontrib>Blockmans, Daniel Engelbert</creatorcontrib><creatorcontrib>Brouwer, Elisabeth</creatorcontrib><creatorcontrib>Cid, Maria C</creatorcontrib><creatorcontrib>Dasgupta, Bhaskar</creatorcontrib><creatorcontrib>Rech, Juergen</creatorcontrib><creatorcontrib>Salvarani, Carlo</creatorcontrib><creatorcontrib>Schett, Georg</creatorcontrib><creatorcontrib>Schulze-Koops, Hendrik</creatorcontrib><creatorcontrib>Spiera, Robert</creatorcontrib><creatorcontrib>Unizony, Sebastian H</creatorcontrib><creatorcontrib>Collinson, Neil</creatorcontrib><title>Trial of Tocilizumab in Giant-Cell Arteritis</title><title>New England Journal of Medicine</title><description>Background
Giant-cell arteritis commonly relapses when glucocorticoids are tapered, and the prolonged use of glucocorticoids is associated with side effects. The effect of the interleukin-6 receptor alpha inhibitor tocilizumab on the rates of relapse during glucocorticoid tapering was studied in patients with giant-cell arteritis.
Methods
In this 1-year trial, we randomly assigned 251 patients, in a 2:1:1:1 ratio, to receive subcutaneous tocilizumab (at a dose of 162 mg) weekly or every other week, combined with a 26-week prednisone taper, or placebo combined with a prednisone taper over a period of either 26 weeks or 52 weeks. The primary outcome was the rate of sustained glucocorticoid-free remission at week 52 in each tocilizumab group as compared with the rate in the placebo group that underwent the 26-week prednisone taper. The key secondary outcome was the rate of remission in each tocilizumab group as compared with the placebo group that underwent the 52-week prednisone taper. Dosing of prednisone and safety were also assessed.
Results
Sustained remission at week 52 occurred in 56% of the patients treated with tocilizumab weekly and in 53% of those treated with tocilizumab every other week, as compared with 14% of those in the placebo group that underwent the 26-week prednisone taper and 18% of those in the placebo group that underwent the 52-week prednisone taper (P<0.001 for the comparisons of either active treatment with placebo). The cumulative median prednisone dose over the 52-week period was 1862 mg in each tocilizumab group, as compared with 3296 mg in the placebo group that underwent the 26-week taper (P<0.001 for both comparisons) and 3818 mg in the placebo group that underwent the 52-week taper (P<0.001 for both comparisons). Serious adverse events occurred in 15% of the patients in the group that received tocilizumab weekly, 14% of those in the group that received tocilizumab every other week, 22% of those in the placebo group that underwent the 26-week taper, and 25% of those in the placebo group that underwent the 52-week taper. Anterior ischemic optic neuropathy developed in one patient in the group that received tocilizumab every other week.
Conclusions
Tocilizumab,received weekly or every other week, combined with a 26-week prednisone taper was superior to either 26-week or 52-week prednisone tapering plus placebo with regard to sustained glucocorticoid-free remission in patients with giant-cell arteritis. Longer follow-up is necessary to determine the durability of remission and safety of tocilizumab. (Funded by F. Hoffmann-La Roche; ClinicalTrials.gov number, NCT01791153.)</description><issn>0028-4793</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2017</creationdate><recordtype>article</recordtype><sourceid>FZOIL</sourceid><recordid>eNpjYeA0MDCy0DUxtzTmYOAqLs4yAAJDE0tOBp2QoszEHIX8NIWQ_OTMnMyq0tzEJIXMPAX3zMS8El3n1JwcBceiktSizJLMYh4G1rTEnOJUXijNzaDu5hri7KGbXZqTWlqWmhefUlyQmJwab2hkbGJqZm5hGW9qaWRsYGhMikpt4lTGl1SUGAMAW7U_Cg</recordid><startdate>2017</startdate><enddate>2017</enddate><creator>Stone, John H</creator><creator>Tuckwell, Katie</creator><creator>Dimonaco, Sophie</creator><creator>Klearman, Micki</creator><creator>Aringer, Martin</creator><creator>Blockmans, Daniel Engelbert</creator><creator>Brouwer, Elisabeth</creator><creator>Cid, Maria C</creator><creator>Dasgupta, Bhaskar</creator><creator>Rech, Juergen</creator><creator>Salvarani, Carlo</creator><creator>Schett, Georg</creator><creator>Schulze-Koops, Hendrik</creator><creator>Spiera, Robert</creator><creator>Unizony, Sebastian H</creator><creator>Collinson, Neil</creator><general>MASSACHUSETTS MEDICAL SOC</general><scope>FZOIL</scope></search><sort><creationdate>2017</creationdate><title>Trial of Tocilizumab in Giant-Cell Arteritis</title><author>Stone, John H ; Tuckwell, Katie ; Dimonaco, Sophie ; Klearman, Micki ; Aringer, Martin ; Blockmans, Daniel Engelbert ; Brouwer, Elisabeth ; Cid, Maria C ; Dasgupta, Bhaskar ; Rech, Juergen ; Salvarani, Carlo ; Schett, Georg ; Schulze-Koops, Hendrik ; Spiera, Robert ; Unizony, Sebastian H ; Collinson, Neil</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-kuleuven_dspace_123456789_5923013</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2017</creationdate><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Stone, John H</creatorcontrib><creatorcontrib>Tuckwell, Katie</creatorcontrib><creatorcontrib>Dimonaco, Sophie</creatorcontrib><creatorcontrib>Klearman, Micki</creatorcontrib><creatorcontrib>Aringer, Martin</creatorcontrib><creatorcontrib>Blockmans, Daniel Engelbert</creatorcontrib><creatorcontrib>Brouwer, Elisabeth</creatorcontrib><creatorcontrib>Cid, Maria C</creatorcontrib><creatorcontrib>Dasgupta, Bhaskar</creatorcontrib><creatorcontrib>Rech, Juergen</creatorcontrib><creatorcontrib>Salvarani, Carlo</creatorcontrib><creatorcontrib>Schett, Georg</creatorcontrib><creatorcontrib>Schulze-Koops, Hendrik</creatorcontrib><creatorcontrib>Spiera, Robert</creatorcontrib><creatorcontrib>Unizony, Sebastian H</creatorcontrib><creatorcontrib>Collinson, Neil</creatorcontrib><collection>Lirias (KU Leuven Association)</collection><jtitle>New England Journal of Medicine</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Stone, John H</au><au>Tuckwell, Katie</au><au>Dimonaco, Sophie</au><au>Klearman, Micki</au><au>Aringer, Martin</au><au>Blockmans, Daniel Engelbert</au><au>Brouwer, Elisabeth</au><au>Cid, Maria C</au><au>Dasgupta, Bhaskar</au><au>Rech, Juergen</au><au>Salvarani, Carlo</au><au>Schett, Georg</au><au>Schulze-Koops, Hendrik</au><au>Spiera, Robert</au><au>Unizony, Sebastian H</au><au>Collinson, Neil</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Trial of Tocilizumab in Giant-Cell Arteritis</atitle><jtitle>New England Journal of Medicine</jtitle><date>2017</date><risdate>2017</risdate><volume>377</volume><issue>4</issue><spage>317</spage><epage>328</epage><pages>317-328</pages><issn>0028-4793</issn><abstract>Background
Giant-cell arteritis commonly relapses when glucocorticoids are tapered, and the prolonged use of glucocorticoids is associated with side effects. The effect of the interleukin-6 receptor alpha inhibitor tocilizumab on the rates of relapse during glucocorticoid tapering was studied in patients with giant-cell arteritis.
Methods
In this 1-year trial, we randomly assigned 251 patients, in a 2:1:1:1 ratio, to receive subcutaneous tocilizumab (at a dose of 162 mg) weekly or every other week, combined with a 26-week prednisone taper, or placebo combined with a prednisone taper over a period of either 26 weeks or 52 weeks. The primary outcome was the rate of sustained glucocorticoid-free remission at week 52 in each tocilizumab group as compared with the rate in the placebo group that underwent the 26-week prednisone taper. The key secondary outcome was the rate of remission in each tocilizumab group as compared with the placebo group that underwent the 52-week prednisone taper. Dosing of prednisone and safety were also assessed.
Results
Sustained remission at week 52 occurred in 56% of the patients treated with tocilizumab weekly and in 53% of those treated with tocilizumab every other week, as compared with 14% of those in the placebo group that underwent the 26-week prednisone taper and 18% of those in the placebo group that underwent the 52-week prednisone taper (P<0.001 for the comparisons of either active treatment with placebo). The cumulative median prednisone dose over the 52-week period was 1862 mg in each tocilizumab group, as compared with 3296 mg in the placebo group that underwent the 26-week taper (P<0.001 for both comparisons) and 3818 mg in the placebo group that underwent the 52-week taper (P<0.001 for both comparisons). Serious adverse events occurred in 15% of the patients in the group that received tocilizumab weekly, 14% of those in the group that received tocilizumab every other week, 22% of those in the placebo group that underwent the 26-week taper, and 25% of those in the placebo group that underwent the 52-week taper. Anterior ischemic optic neuropathy developed in one patient in the group that received tocilizumab every other week.
Conclusions
Tocilizumab,received weekly or every other week, combined with a 26-week prednisone taper was superior to either 26-week or 52-week prednisone tapering plus placebo with regard to sustained glucocorticoid-free remission in patients with giant-cell arteritis. Longer follow-up is necessary to determine the durability of remission and safety of tocilizumab. (Funded by F. Hoffmann-La Roche; ClinicalTrials.gov number, NCT01791153.)</abstract><pub>MASSACHUSETTS MEDICAL SOC</pub></addata></record> |
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| source | Lirias (KU Leuven Association); Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; ProQuest Central UK/Ireland; New England Journal of Medicine |
| title | Trial of Tocilizumab in Giant-Cell Arteritis |
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