Efficacy and safety of subcutaneous tocilizumab versus intravenous tocilizumab in combination with traditional DMARDs in patients with RA at week 97 (SUMMACTA)
| Autor(a) principal: | |
|---|---|
| Data de Publicação: | 2016 |
| Outros Autores: | , , , , , , , , , , , |
| Tipo de documento: | Artigo |
| Idioma: | eng |
| Título da fonte: | Repositório Institucional da UNIFESP |
| Texto Completo: | http://repositorio.unifesp.br/handle/11600/49698 http://dx.doi.org/10.1136/annrheumdis-2015-207281 |
Resumo: | Objectives To evaluate the long-term efficacy and safety of subcutaneous (SC) tocilizumab (TCZ) versus intravenous (IV) TCZ, including switching formulations, in patients with rheumatoid arthritis (RA) and inadequate response to disease-modifying antirheumatic drugs (DMARDs). Methods Patients (n=1262) were randomised 1: 1 to receive TCZ-SC 162 mg weekly (qw)+placebo-IV every four weeks (q4w) or TCZ-IV 8 mg/kg q4w+placebo-SC qw in combination with DMARD(s). After a 24-week double-blind period, patients receiving TCZ-SC were re-randomised 11: 1 to TCZ-SC (n=521) or TCZ-IV (TCZ-SCIV, n=48), and patients receiving TCZ-IV were re-randomised 2: 1 to TCZ-IV (n=372) or TCZ-SC (TCZ-IV-SC |
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Burmester, Gerd R.Rubbert-Roth, AndreaCantagrel, AlainHall, StephenLeszczynski, PiotrFeldman, Daniel [UNIFESP]Rangaraj, Madura J.Roane, GeorgiaLudivico, CharlesBao, MinRowell, LucyDavies, ClaireMysler, Eduardo F.2019-01-21T10:30:19Z2019-01-21T10:30:19Z2016Annals Of The Rheumatic Diseases. London, v. 75, n. 1, p. 68-74, 2016.0003-4967http://repositorio.unifesp.br/handle/11600/49698http://dx.doi.org/10.1136/annrheumdis-2015-20728110.1136/annrheumdis-2015-207281WOS:000366402400049Objectives To evaluate the long-term efficacy and safety of subcutaneous (SC) tocilizumab (TCZ) versus intravenous (IV) TCZ, including switching formulations, in patients with rheumatoid arthritis (RA) and inadequate response to disease-modifying antirheumatic drugs (DMARDs). Methods Patients (n=1262) were randomised 1: 1 to receive TCZ-SC 162 mg weekly (qw)+placebo-IV every four weeks (q4w) or TCZ-IV 8 mg/kg q4w+placebo-SC qw in combination with DMARD(s). After a 24-week double-blind period, patients receiving TCZ-SC were re-randomised 11: 1 to TCZ-SC (n=521) or TCZ-IV (TCZ-SCIV, n=48), and patients receiving TCZ-IV were re-randomised 2: 1 to TCZ-IV (n=372) or TCZ-SC (TCZ-IV-SCn=186). Maintenance of clinical responses and safety through week 97 were assessed. Results The proportions of patients who achieved American College of Rheumatology (ACR) 20/50/70 responses, Disease Activity Score in 28 joints remission and improvement from baseline in Health Assessment Questionnaire Disability Index >= 0.3 were sustained through week 97 and comparable across arms. TCZ-SC had a comparable safety profile to TCZ-IV through week 97, except that injection site reactions (ISRs) were more common with TCZ-SC. Safety profiles in patients who switched were similar to those in patients who received continuous TCZ-SC or TCZ-IV treatment. The proportion of patients who developed anti-TCZ antibodies remained low across treatment arms. No association between anti-TCZ antibody development and clinical response or adverse events was observed. Conclusions The long-term efficacy and safety of TCZ-SC was maintained and comparable to that of TCZ-IV, except for ISRs. Profiles in patients who switched formulations were comparable to those in patients who received TCZ-IV or TCZ-SC. TCZ-SC provides additional treatment options for patients with RA.RocheF. Hoffmann-La Roche, Ltd.Free Univ Berlin, Berlin, GermanyHumboldt Univ, D-10099 Berlin, GermanyKlinikum Univ Koln, Cologne, GermanyCtr Hosp Univ Toulouse, Toulouse, FranceCabrini Med Ctr, Malvern, Vic, AustraliaPoznan Med Univ, Poznan, PolandUniv Fed Sao Paulo, Sao Paulo, BrazilArthrit & Diabet Clin Inc, Monroe, LA USARheumatol Associates South Carolina, Charleston, SC USAEast Penn Rheumatol Associates, Bethlehem, PA USAGenentech Inc, San Francisco, CA 94080 USARoche Prod Ltd, Welwyn Garden City AL7 3AY, Herts, EnglandOrg Med Invest, Buenos Aires, DF, ArgentinaUniversidade Federal de São Paulo, São Paulo, BrazilWeb of Science68-74engBmj Publishing GroupAnnals Of The Rheumatic DiseasesModifying Antirheumatic DrugsInterleukin-6 Receptor InhibitionRheumatoid-ArthritisDouble-BlindBiologic AgentsPlaceboTrialProfessionalsMonotherapyPreferencesEfficacy and safety of subcutaneous tocilizumab versus intravenous tocilizumab in combination with traditional DMARDs in patients with RA at week 97 (SUMMACTA)info:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleinfo:eu-repo/semantics/openAccessreponame:Repositório Institucional da UNIFESPinstname:Universidade Federal de São Paulo (UNIFESP)instacron:UNIFESP11600/496982021-10-05 22:12:43.998metadata only accessoai:repositorio.unifesp.br:11600/49698Repositório InstitucionalPUBhttp://www.repositorio.unifesp.br/oai/requestopendoar:34652021-10-06T01:12:43Repositório Institucional da UNIFESP - Universidade Federal de São Paulo (UNIFESP)false |
| dc.title.en.fl_str_mv |
Efficacy and safety of subcutaneous tocilizumab versus intravenous tocilizumab in combination with traditional DMARDs in patients with RA at week 97 (SUMMACTA) |
| title |
Efficacy and safety of subcutaneous tocilizumab versus intravenous tocilizumab in combination with traditional DMARDs in patients with RA at week 97 (SUMMACTA) |
| spellingShingle |
Efficacy and safety of subcutaneous tocilizumab versus intravenous tocilizumab in combination with traditional DMARDs in patients with RA at week 97 (SUMMACTA) Burmester, Gerd R. Modifying Antirheumatic Drugs Interleukin-6 Receptor Inhibition Rheumatoid-Arthritis Double-Blind Biologic Agents Placebo Trial Professionals Monotherapy Preferences |
| title_short |
Efficacy and safety of subcutaneous tocilizumab versus intravenous tocilizumab in combination with traditional DMARDs in patients with RA at week 97 (SUMMACTA) |
| title_full |
Efficacy and safety of subcutaneous tocilizumab versus intravenous tocilizumab in combination with traditional DMARDs in patients with RA at week 97 (SUMMACTA) |
| title_fullStr |
Efficacy and safety of subcutaneous tocilizumab versus intravenous tocilizumab in combination with traditional DMARDs in patients with RA at week 97 (SUMMACTA) |
| title_full_unstemmed |
Efficacy and safety of subcutaneous tocilizumab versus intravenous tocilizumab in combination with traditional DMARDs in patients with RA at week 97 (SUMMACTA) |
| title_sort |
Efficacy and safety of subcutaneous tocilizumab versus intravenous tocilizumab in combination with traditional DMARDs in patients with RA at week 97 (SUMMACTA) |
| author |
Burmester, Gerd R. |
| author_facet |
Burmester, Gerd R. Rubbert-Roth, Andrea Cantagrel, Alain Hall, Stephen Leszczynski, Piotr Feldman, Daniel [UNIFESP] Rangaraj, Madura J. Roane, Georgia Ludivico, Charles Bao, Min Rowell, Lucy Davies, Claire Mysler, Eduardo F. |
| author_role |
author |
| author2 |
Rubbert-Roth, Andrea Cantagrel, Alain Hall, Stephen Leszczynski, Piotr Feldman, Daniel [UNIFESP] Rangaraj, Madura J. Roane, Georgia Ludivico, Charles Bao, Min Rowell, Lucy Davies, Claire Mysler, Eduardo F. |
| author2_role |
author author author author author author author author author author author author |
| dc.contributor.author.fl_str_mv |
Burmester, Gerd R. Rubbert-Roth, Andrea Cantagrel, Alain Hall, Stephen Leszczynski, Piotr Feldman, Daniel [UNIFESP] Rangaraj, Madura J. Roane, Georgia Ludivico, Charles Bao, Min Rowell, Lucy Davies, Claire Mysler, Eduardo F. |
| dc.subject.eng.fl_str_mv |
Modifying Antirheumatic Drugs Interleukin-6 Receptor Inhibition Rheumatoid-Arthritis Double-Blind Biologic Agents Placebo Trial Professionals Monotherapy Preferences |
| topic |
Modifying Antirheumatic Drugs Interleukin-6 Receptor Inhibition Rheumatoid-Arthritis Double-Blind Biologic Agents Placebo Trial Professionals Monotherapy Preferences |
| description |
Objectives To evaluate the long-term efficacy and safety of subcutaneous (SC) tocilizumab (TCZ) versus intravenous (IV) TCZ, including switching formulations, in patients with rheumatoid arthritis (RA) and inadequate response to disease-modifying antirheumatic drugs (DMARDs). Methods Patients (n=1262) were randomised 1: 1 to receive TCZ-SC 162 mg weekly (qw)+placebo-IV every four weeks (q4w) or TCZ-IV 8 mg/kg q4w+placebo-SC qw in combination with DMARD(s). After a 24-week double-blind period, patients receiving TCZ-SC were re-randomised 11: 1 to TCZ-SC (n=521) or TCZ-IV (TCZ-SCIV, n=48), and patients receiving TCZ-IV were re-randomised 2: 1 to TCZ-IV (n=372) or TCZ-SC (TCZ-IV-SC |
| publishDate |
2016 |
| dc.date.issued.fl_str_mv |
2016 |
| dc.date.accessioned.fl_str_mv |
2019-01-21T10:30:19Z |
| dc.date.available.fl_str_mv |
2019-01-21T10:30:19Z |
| dc.type.status.fl_str_mv |
info:eu-repo/semantics/publishedVersion |
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info:eu-repo/semantics/article |
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article |
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publishedVersion |
| dc.identifier.citation.fl_str_mv |
Annals Of The Rheumatic Diseases. London, v. 75, n. 1, p. 68-74, 2016. |
| dc.identifier.uri.fl_str_mv |
http://repositorio.unifesp.br/handle/11600/49698 http://dx.doi.org/10.1136/annrheumdis-2015-207281 |
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0003-4967 |
| dc.identifier.doi.none.fl_str_mv |
10.1136/annrheumdis-2015-207281 |
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WOS:000366402400049 |
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Annals Of The Rheumatic Diseases. London, v. 75, n. 1, p. 68-74, 2016. 0003-4967 10.1136/annrheumdis-2015-207281 WOS:000366402400049 |
| url |
http://repositorio.unifesp.br/handle/11600/49698 http://dx.doi.org/10.1136/annrheumdis-2015-207281 |
| dc.language.iso.fl_str_mv |
eng |
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eng |
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Annals Of The Rheumatic Diseases |
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openAccess |
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68-74 |
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Bmj Publishing Group |
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Bmj Publishing Group |
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reponame:Repositório Institucional da UNIFESP instname:Universidade Federal de São Paulo (UNIFESP) instacron:UNIFESP |
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