Efficacy and safety of subcutaneous tocilizumab versus intravenous tocilizumab in combination with traditional DMARDs in patients with RA at week 97 (SUMMACTA)
Identifieur interne : 002E64 ( Main/Exploration ); précédent : 002E63; suivant : 002E65Efficacy and safety of subcutaneous tocilizumab versus intravenous tocilizumab in combination with traditional DMARDs in patients with RA at week 97 (SUMMACTA)
Auteurs : Gerd R. Burmester [Allemagne] ; Andrea Rubbert-Roth [Allemagne] ; Alain Cantagrel [France] ; Stephen Hall [Australie] ; Piotr Leszczynski [Pologne] ; Daniel Feldman [Brésil] ; Madura J. Rangaraj [États-Unis] ; Georgia Roane [États-Unis] ; Charles Ludivico [États-Unis] ; Min Bao [États-Unis] ; Lucy Rowell [Royaume-Uni] ; Claire Davies [Royaume-Uni] ; Eduardo F. Mysler [Argentine]Source :
- Annals of the Rheumatic Diseases [ 0003-4967 ] ; 2015.
Descripteurs français
- KwdFr :
- Anticorps monoclonaux humanisés (administration et posologie), Anticorps monoclonaux humanisés (effets indésirables), Antirhumatismaux (administration et posologie), Antirhumatismaux (effets indésirables), Association de médicaments, Facteurs temps, Humains, Indice de gravité médicale, Injections sous-cutanées, Injections veineuses, Méthode en double aveugle, Polyarthrite rhumatoïde (traitement médicamenteux), Résultat thérapeutique, Voies d'administration de substances chimiques et des médicaments.
- MESH :
- administration et posologie : Anticorps monoclonaux humanisés, Antirhumatismaux.
- effets indésirables : Anticorps monoclonaux humanisés, Antirhumatismaux.
- traitement médicamenteux : Polyarthrite rhumatoïde.
- Association de médicaments, Facteurs temps, Humains, Indice de gravité médicale, Injections sous-cutanées, Injections veineuses, Méthode en double aveugle, Résultat thérapeutique, Voies d'administration de substances chimiques et des médicaments.
English descriptors
- KwdEn :
- Antibodies, Monoclonal, Humanized (administration & dosage), Antibodies, Monoclonal, Humanized (adverse effects), Antirheumatic Agents (administration & dosage), Antirheumatic Agents (adverse effects), Arthritis, Rheumatoid (drug therapy), Double-Blind Method, Drug Administration Routes, Drug Therapy, Combination, Humans, Injections, Intravenous, Injections, Subcutaneous, Severity of Illness Index, Time Factors, Treatment Outcome.
- MESH :
- chemical , administration & dosage : Antibodies, Monoclonal, Humanized, Antirheumatic Agents.
- chemical , adverse effects : Antibodies, Monoclonal, Humanized, Antirheumatic Agents.
- drug therapy : Arthritis, Rheumatoid.
- Double-Blind Method, Drug Administration Routes, Drug Therapy, Combination, Humans, Injections, Intravenous, Injections, Subcutaneous, Severity of Illness Index, Time Factors, Treatment Outcome.
Abstract
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).
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-SC–IV, n=48), and patients receiving TCZ-IV were re-randomised 2:1 to TCZ-IV (n=372) or TCZ-SC (TCZ-IV–SC; n=186). Maintenance of clinical responses and safety through week 97 were assessed.
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.
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.
NCT01194414.
Url:
DOI: 10.1136/annrheumdis-2015-207281
PubMed: 26056119
PubMed Central: 4717437
Affiliations:
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Burmester</name><affiliation wicri:level="1"><nlm:aff id="af1"><institution>Free University and Humboldt University of Berlin</institution>,<addr-line>Berlin</addr-line>,<country>Germany</country></nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Rubbert Roth, Andrea" sort="Rubbert Roth, Andrea" uniqKey="Rubbert Roth A" first="Andrea" last="Rubbert-Roth">Andrea Rubbert-Roth</name><affiliation wicri:level="1"><nlm:aff id="af2"><institution>Klinikum der Universität zu Köln</institution>,<addr-line>Köln</addr-line>,<country>Germany</country></nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Cantagrel, Alain" sort="Cantagrel, Alain" uniqKey="Cantagrel A" first="Alain" last="Cantagrel">Alain Cantagrel</name><affiliation wicri:level="1"><nlm:aff id="af3"><institution>Centre Hospitalier Universitaire de Toulouse</institution>,<addr-line>Toulouse</addr-line>,<country>France</country></nlm:aff><country xml:lang="fr">France</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Hall, Stephen" sort="Hall, Stephen" uniqKey="Hall S" first="Stephen" last="Hall">Stephen Hall</name><affiliation wicri:level="1"><nlm:aff id="af4"><institution>Cabrini Medical Centre</institution>,<addr-line>Malvern</addr-line>,<country>Australia</country></nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Leszczynski, Piotr" sort="Leszczynski, Piotr" uniqKey="Leszczynski P" first="Piotr" last="Leszczynski">Piotr Leszczynski</name><affiliation wicri:level="1"><nlm:aff id="af5"><institution>Poznan Medical University</institution>,<addr-line>Poznan</addr-line>,<country>Poland</country></nlm:aff><country xml:lang="fr">Pologne</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Feldman, Daniel" sort="Feldman, Daniel" uniqKey="Feldman D" first="Daniel" last="Feldman">Daniel Feldman</name><affiliation wicri:level="1"><nlm:aff id="af6"><institution>Universidade Federal de São Paulo</institution>,<addr-line>São Paulo</addr-line>,<country>Brazil</country></nlm:aff><country xml:lang="fr">Brésil</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Rangaraj, Madura J" sort="Rangaraj, Madura J" uniqKey="Rangaraj M" first="Madura J" last="Rangaraj">Madura J. Rangaraj</name><affiliation wicri:level="1"><nlm:aff id="af7"><institution>Arthritis & Diabetes Clinic, Inc</institution>,<addr-line>Monroe, Louisiana</addr-line>,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Roane, Georgia" sort="Roane, Georgia" uniqKey="Roane G" first="Georgia" last="Roane">Georgia Roane</name><affiliation wicri:level="1"><nlm:aff id="af8"><institution>Rheumatology Associates of South Carolina</institution>,<addr-line>Charleston, South Carolina</addr-line>,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Ludivico, Charles" sort="Ludivico, Charles" uniqKey="Ludivico C" first="Charles" last="Ludivico">Charles Ludivico</name><affiliation wicri:level="1"><nlm:aff id="af9"><institution>East Penn Rheumatology Associates</institution>,<addr-line>Bethlehem, Pennsylvania</addr-line>,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Bao, Min" sort="Bao, Min" uniqKey="Bao M" first="Min" last="Bao">Min Bao</name><affiliation wicri:level="1"><nlm:aff id="af10"><institution>Genentech Inc</institution>,<addr-line>South San Francisco, California</addr-line>,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Rowell, Lucy" sort="Rowell, Lucy" uniqKey="Rowell L" first="Lucy" last="Rowell">Lucy Rowell</name><affiliation wicri:level="1"><nlm:aff id="af11"><institution>Roche Products Limited</institution>,<addr-line>Welwyn Garden City</addr-line>,<country>UK</country></nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Davies, Claire" sort="Davies, Claire" uniqKey="Davies C" first="Claire" last="Davies">Claire Davies</name><affiliation wicri:level="1"><nlm:aff id="af11"><institution>Roche Products Limited</institution>,<addr-line>Welwyn Garden City</addr-line>,<country>UK</country></nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Mysler, Eduardo F" sort="Mysler, Eduardo F" uniqKey="Mysler E" first="Eduardo F" last="Mysler">Eduardo F. Mysler</name><affiliation wicri:level="1"><nlm:aff id="af12"><institution>Organizacion Medica de Investigación</institution>,<addr-line>Buenos Aires</addr-line>,<country>Argentina</country></nlm:aff><country xml:lang="fr">Argentine</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author></analytic><series><title level="j">Annals of the Rheumatic Diseases</title><idno type="ISSN">0003-4967</idno><idno type="eISSN">1468-2060</idno><imprint><date when="2015">2015</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Antibodies, Monoclonal, Humanized (administration & dosage)</term><term>Antibodies, Monoclonal, Humanized (adverse effects)</term><term>Antirheumatic Agents (administration & dosage)</term><term>Antirheumatic Agents (adverse effects)</term><term>Arthritis, Rheumatoid (drug therapy)</term><term>Double-Blind Method</term><term>Drug Administration Routes</term><term>Drug Therapy, Combination</term><term>Humans</term><term>Injections, Intravenous</term><term>Injections, Subcutaneous</term><term>Severity of Illness Index</term><term>Time Factors</term><term>Treatment Outcome</term></keywords><keywords scheme="KwdFr" xml:lang="fr"><term>Anticorps monoclonaux humanisés (administration et posologie)</term><term>Anticorps monoclonaux humanisés (effets indésirables)</term><term>Antirhumatismaux (administration et posologie)</term><term>Antirhumatismaux (effets indésirables)</term><term>Association de médicaments</term><term>Facteurs temps</term><term>Humains</term><term>Indice de gravité médicale</term><term>Injections sous-cutanées</term><term>Injections veineuses</term><term>Méthode en double aveugle</term><term>Polyarthrite rhumatoïde (traitement médicamenteux)</term><term>Résultat thérapeutique</term><term>Voies d'administration de substances chimiques et des médicaments</term></keywords><keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en"><term>Antibodies, Monoclonal, Humanized</term><term>Antirheumatic Agents</term></keywords><keywords scheme="MESH" type="chemical" qualifier="adverse effects" xml:lang="en"><term>Antibodies, Monoclonal, Humanized</term><term>Antirheumatic Agents</term></keywords><keywords scheme="MESH" qualifier="administration et posologie" xml:lang="fr"><term>Anticorps monoclonaux humanisés</term><term>Antirhumatismaux</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Arthritis, Rheumatoid</term></keywords><keywords scheme="MESH" qualifier="effets indésirables" xml:lang="fr"><term>Anticorps monoclonaux humanisés</term><term>Antirhumatismaux</term></keywords><keywords scheme="MESH" qualifier="traitement médicamenteux" xml:lang="fr"><term>Polyarthrite rhumatoïde</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Double-Blind Method</term><term>Drug Administration Routes</term><term>Drug Therapy, Combination</term><term>Humans</term><term>Injections, Intravenous</term><term>Injections, Subcutaneous</term><term>Severity of Illness Index</term><term>Time Factors</term><term>Treatment Outcome</term></keywords><keywords scheme="MESH" xml:lang="fr"><term>Association de médicaments</term><term>Facteurs temps</term><term>Humains</term><term>Indice de gravité médicale</term><term>Injections sous-cutanées</term><term>Injections veineuses</term><term>Méthode en double aveugle</term><term>Résultat thérapeutique</term><term>Voies d'administration de substances chimiques et des médicaments</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><sec><title>Objectives</title><p>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).</p></sec><sec><title>Methods</title><p>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-SC–IV, n=48), and patients receiving TCZ-IV were re-randomised 2:1 to TCZ-IV (n=372) or TCZ-SC (TCZ-IV–SC; n=186). Maintenance of clinical responses and safety through week 97 were assessed.</p></sec><sec><title>Results</title><p>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.</p></sec><sec><title>Conclusions</title><p>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.</p></sec><sec><title>Trial registration number</title><p>NCT01194414.</p></sec></div></front><back><div1 type="bibliography"><listBibl><biblStruct><analytic><author><name sortKey="Agarwal, Sk" uniqKey="Agarwal S">SK Agarwal</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Huynh, Tk" uniqKey="Huynh T">TK Huynh</name></author><author><name sortKey="Ostergaard, A" uniqKey="Ostergaard A">A Ostergaard</name></author><author><name sortKey="Egsmose, C" uniqKey="Egsmose C">C Egsmose</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Barton, Jl" uniqKey="Barton J">JL Barton</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Smolen, Js" uniqKey="Smolen J">JS Smolen</name></author><author><name sortKey="Beaulieu, A" uniqKey="Beaulieu A">A Beaulieu</name></author><author><name sortKey="Rubbert Roth, A" uniqKey="Rubbert Roth A">A Rubbert-Roth</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Genovese, Mc" uniqKey="Genovese M">MC Genovese</name></author><author><name sortKey="Mckay, Jd" uniqKey="Mckay J">JD McKay</name></author><author><name sortKey="Nasonov, El" uniqKey="Nasonov E">EL Nasonov</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Emery, P" uniqKey="Emery P">P Emery</name></author><author><name sortKey="Keystone, E" uniqKey="Keystone E">E Keystone</name></author><author><name sortKey="Tony, Hp" uniqKey="Tony H">HP Tony</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Jones, G" uniqKey="Jones G">G Jones</name></author><author><name sortKey="Sebba, A" uniqKey="Sebba A">A Sebba</name></author><author><name sortKey="Gu, J" uniqKey="Gu J">J Gu</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Kremer, Jm" uniqKey="Kremer J">JM Kremer</name></author><author><name sortKey="Blanco, R" uniqKey="Blanco R">R Blanco</name></author><author><name sortKey="Brzosko, M" uniqKey="Brzosko M">M Brzosko</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Gabay, C" uniqKey="Gabay C">C Gabay</name></author><author><name sortKey="Emery, P" uniqKey="Emery P">P Emery</name></author><author><name sortKey="Van Vollenhoven, R" uniqKey="Van Vollenhoven R">R van Vollenhoven</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Burmester, Gr" uniqKey="Burmester G">GR Burmester</name></author><author><name sortKey="Rubbert Roth, A" uniqKey="Rubbert Roth A">A Rubbert-Roth</name></author><author><name sortKey="Cantagrel, A" uniqKey="Cantagrel A">A Cantagrel</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Kivitz, A" uniqKey="Kivitz A">A Kivitz</name></author><author><name sortKey="Olech, E" uniqKey="Olech E">E Olech</name></author><author><name sortKey="Borofsky, M" uniqKey="Borofsky M">M Borofsky</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Ogata, A" uniqKey="Ogata A">A Ogata</name></author><author><name sortKey="Tanimura, K" uniqKey="Tanimura K">K Tanimura</name></author><author><name sortKey="Sugimoto, T" uniqKey="Sugimoto T">T Sugimoto</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Besada, E" uniqKey="Besada E">E Besada</name></author></analytic></biblStruct></listBibl></div1></back></TEI><affiliations><list><country><li>Allemagne</li><li>Argentine</li><li>Australie</li><li>Brésil</li><li>France</li><li>Pologne</li><li>Royaume-Uni</li><li>États-Unis</li></country></list><tree><country name="Allemagne"><noRegion><name sortKey="Burmester, Gerd R" sort="Burmester, Gerd R" uniqKey="Burmester G" first="Gerd R" last="Burmester">Gerd R. Burmester</name></noRegion><name sortKey="Rubbert Roth, Andrea" sort="Rubbert Roth, Andrea" uniqKey="Rubbert Roth A" first="Andrea" last="Rubbert-Roth">Andrea Rubbert-Roth</name></country><country name="France"><noRegion><name sortKey="Cantagrel, Alain" sort="Cantagrel, Alain" uniqKey="Cantagrel A" first="Alain" last="Cantagrel">Alain Cantagrel</name></noRegion></country><country name="Australie"><noRegion><name sortKey="Hall, Stephen" sort="Hall, Stephen" uniqKey="Hall S" first="Stephen" last="Hall">Stephen Hall</name></noRegion></country><country name="Pologne"><noRegion><name sortKey="Leszczynski, Piotr" sort="Leszczynski, Piotr" uniqKey="Leszczynski P" first="Piotr" last="Leszczynski">Piotr Leszczynski</name></noRegion></country><country name="Brésil"><noRegion><name sortKey="Feldman, Daniel" sort="Feldman, Daniel" uniqKey="Feldman D" first="Daniel" last="Feldman">Daniel Feldman</name></noRegion></country><country name="États-Unis"><noRegion><name sortKey="Rangaraj, Madura J" sort="Rangaraj, Madura J" uniqKey="Rangaraj M" first="Madura J" last="Rangaraj">Madura J. Rangaraj</name></noRegion><name sortKey="Bao, Min" sort="Bao, Min" uniqKey="Bao M" first="Min" last="Bao">Min Bao</name><name sortKey="Ludivico, Charles" sort="Ludivico, Charles" uniqKey="Ludivico C" first="Charles" last="Ludivico">Charles Ludivico</name><name sortKey="Roane, Georgia" sort="Roane, Georgia" uniqKey="Roane G" first="Georgia" last="Roane">Georgia Roane</name></country><country name="Royaume-Uni"><noRegion><name sortKey="Rowell, Lucy" sort="Rowell, Lucy" uniqKey="Rowell L" first="Lucy" last="Rowell">Lucy Rowell</name></noRegion><name sortKey="Davies, Claire" sort="Davies, Claire" uniqKey="Davies C" first="Claire" last="Davies">Claire Davies</name></country><country name="Argentine"><noRegion><name sortKey="Mysler, Eduardo F" sort="Mysler, Eduardo F" uniqKey="Mysler E" first="Eduardo F" last="Mysler">Eduardo F. Mysler</name></noRegion></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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