Adalimumab alone and in combination with disease-modifying antirheumatic drugs for the treatment of rheumatoid arthritis in clinical practice: the Research in Active Rheumatoid Arthritis (ReAct) trial
Identifieur interne : 000323 ( France/Analysis ); précédent : 000322; suivant : 000324Adalimumab alone and in combination with disease-modifying antirheumatic drugs for the treatment of rheumatoid arthritis in clinical practice: the Research in Active Rheumatoid Arthritis (ReAct) trial
Auteurs : Gerd R. Burmester [Allemagne] ; Xavier Mariette [France] ; Carlomaurizio Montecucco [Italie] ; Indalecio Monteagudo-Sáez [Espagne] ; Michel Malaise [Belgique] ; Athanasios G. Tzioufas [Grèce] ; Johannes W J. Bijlsma [Pays-Bas] ; Kristina Unnebrink [Allemagne] ; Sonja Kary [Allemagne] ; Hartmut Kupper [Allemagne]Source :
- Annals of the Rheumatic Diseases [ 0003-4967 ] ; 2007-06.
English descriptors
- KwdEn :
- ACR, American College of Rheumatology, AE, adverse event, AM, antimalarials, AZA, azathioprine, CsA, ciclosporin, DAS, Disease Activity Score, DMARD, disease-modifying antirheumatic drug, EULAR, European League Against Rheumatism, HAQ DI, Health Assessment Questionnaire Disability Index, LEF, leflunomide, MTX, methotrexate, PY, patient-year, RA, rheumatoid arthritis, SAE, serious adverse event, SEER, Surveillance, Epidemiology, and End Results, SIR, standardised incidence ratio, SSZ, sulfasalazine, TB, tuberculosis, TNF, tumour necrosis factor, adalimumab, antirheumatic agents, monoclonal antibody, rheumatoid arthritis, tumour necrosis factor.
- Teeft :
- Adalimumab, Adalimumab effectiveness, Adalimumab exposure, American college, Antimalarial, Antirheumatic, Antirheumatic drug, Antirheumatic drugs, Arthritis, Arthritis rheum, Baseline, Baseline characteristics, Baseline differences, Burmester, Clinical practice, Combination therapy, Concomitant, Concomitant dmard, Concomitant dmards, Disease activity score, Dmard, Dmard combinations, Dmards, Etanercept, Eular, Eular responses, European league, Health assessment questionnaire disability index, Infliximab, Leflunomide, Lymphoma, Malignancy, Methotrexate, National guidelines, Other dmard, Other dmards, Parenteral, Parenteral gold, Pulmonary disease, Rheum, Rheumatoid, Rheumatoid arthritis, Rheumatol, Rheumatology, Saes, Safety profile, Serious infection, Serious infections, Skin induration, Standardised, Standardised incidence ratio, Standardised mortality ratio, Study centres, Subgroup, Sulfasalazine.
Abstract
Objective: To evaluate the safety and effectiveness of adalimumab alone or in combination with standard disease-modifying antirheumatic drugs (DMARDs) for the treatment of rheumatoid arthritis (RA). Methods: Patients with active RA despite treatment with DMARDs or prior treatment with a tumour necrosis factor antagonist participated in a multicentre, open-label clinical study of adalimumab 40 mg every other week for 12 weeks with an optional extension phase. Patients were allowed to continue with pre-existing traditional DMARDs. Long-term safety results are reported for all patients (4210 patient-years (PYs) of adalimumab exposure). The observed effectiveness results at week 12 are reported using American College of Rheumatology (ACR) and European League Against Rheumatism (EULAR) response criteria. Results: Among the 6610 treated patients, adalimumab was generally well tolerated. Serious infections occurred in 3.1% of patients (5.5/100 PYs, including active tuberculosis, 0.5/100 PYs). Demyelinating disease (0.06%) and systemic lupus erythematosus (0.03%) were rare serious adverse events. The standardised incidence ratio of malignancy was 0.71 (95% CI 0.49 to 1.01). The standardised mortality ratio was 1.07 (95% CI 0.75 to 1.49). At week 12, 69% of patients achieved an ACR20 response, 83% a moderate, and 33% a good EULAR response. Adalimumab was effective in combination with a variety of DMARDs. The addition of adalimumab to antimalarials was comparably effective to the combination of adalimumab and methotrexate. Conclusions: Considering the limitations of an open-label study, adalimumab alone or in combination with standard DMARDs appeared to be well tolerated and effective in 6610 difficult-to-treat patients with active RA treated in clinical practice.
Url:
DOI: 10.1136/ard.2006.066761
Affiliations:
- Allemagne, Belgique, Espagne, France, Grèce, Italie, Pays-Bas
- Attique (région), Berlin, Communauté de Madrid, Utrecht (province)
- Athènes, Berlin, Madrid, Utrecht
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Burmester</name><affiliation wicri:level="3"><country xml:lang="fr">Allemagne</country><wicri:regionArea>Charité – University Medicine Berlin, Berlin</wicri:regionArea><placeName><region type="land" nuts="3">Berlin</region><settlement type="city">Berlin</settlement></placeName></affiliation></author><author><name sortKey="Mariette, Xavier" sort="Mariette, Xavier" uniqKey="Mariette X" first="Xavier" last="Mariette">Xavier Mariette</name><affiliation wicri:level="1"><country xml:lang="fr">France</country><wicri:regionArea>Hôpital Bicêtre, Assistance Publique-Hôpitaux de Paris, Université Paris-Sud 11, Le Kremlin Bicêtre</wicri:regionArea><wicri:noRegion>Le Kremlin Bicêtre</wicri:noRegion><wicri:noRegion>Le Kremlin Bicêtre</wicri:noRegion></affiliation></author><author><name sortKey="Montecucco, Carlomaurizio" sort="Montecucco, Carlomaurizio" uniqKey="Montecucco C" first="Carlomaurizio" last="Montecucco">Carlomaurizio Montecucco</name><affiliation wicri:level="1"><country xml:lang="fr">Italie</country><wicri:regionArea>University of Pavia, IRCCS Policlinico San Matteo, Pavia</wicri:regionArea><wicri:noRegion>Pavia</wicri:noRegion></affiliation></author><author><name sortKey="Monteagudo Saez, Indalecio" sort="Monteagudo Saez, Indalecio" uniqKey="Monteagudo Saez I" first="Indalecio" last="Monteagudo-Sáez">Indalecio Monteagudo-Sáez</name><affiliation wicri:level="3"><country xml:lang="fr">Espagne</country><wicri:regionArea>HGU Gregorio Marañón, Madrid</wicri:regionArea><placeName><settlement type="city">Madrid</settlement><region nuts="2" type="region">Communauté de Madrid</region></placeName></affiliation></author><author><name sortKey="Malaise, Michel" sort="Malaise, Michel" uniqKey="Malaise M" first="Michel" last="Malaise">Michel Malaise</name><affiliation wicri:level="1"><country xml:lang="fr">Belgique</country><wicri:regionArea>CHU Liège, Liège</wicri:regionArea><wicri:noRegion>Liège</wicri:noRegion></affiliation></author><author><name sortKey="Tzioufas, Athanasios G" sort="Tzioufas, Athanasios G" uniqKey="Tzioufas A" first="Athanasios G" last="Tzioufas">Athanasios G. Tzioufas</name><affiliation wicri:level="3"><country xml:lang="fr">Grèce</country><wicri:regionArea>Department of Pathophysiology, School of Medicine, University of Athens, Athens</wicri:regionArea><placeName><settlement type="city">Athènes</settlement><region nuts="2" type="region">Attique (région)</region></placeName></affiliation></author><author><name sortKey="Bijlsma, Johannes W J" sort="Bijlsma, Johannes W J" uniqKey="Bijlsma J" first="Johannes W J" last="Bijlsma">Johannes W J. Bijlsma</name><affiliation wicri:level="3"><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>University Medical Center Utrecht, Utrecht</wicri:regionArea><placeName><settlement type="city">Utrecht</settlement><region nuts="2" type="province">Utrecht (province)</region></placeName></affiliation></author><author><name sortKey="Unnebrink, Kristina" sort="Unnebrink, Kristina" uniqKey="Unnebrink K" first="Kristina" last="Unnebrink">Kristina Unnebrink</name><affiliation wicri:level="1"><country xml:lang="fr">Allemagne</country><wicri:regionArea>Abbott GmbH & Co KG, Ludwigshafen</wicri:regionArea><wicri:noRegion>Ludwigshafen</wicri:noRegion><wicri:noRegion>Ludwigshafen</wicri:noRegion></affiliation></author><author><name sortKey="Kary, Sonja" sort="Kary, Sonja" uniqKey="Kary S" first="Sonja" last="Kary">Sonja Kary</name><affiliation wicri:level="1"><country xml:lang="fr">Allemagne</country><wicri:regionArea>Abbott GmbH & Co KG, Ludwigshafen</wicri:regionArea><wicri:noRegion>Ludwigshafen</wicri:noRegion><wicri:noRegion>Ludwigshafen</wicri:noRegion></affiliation></author><author><name sortKey="Kupper, Hartmut" sort="Kupper, Hartmut" uniqKey="Kupper H" first="Hartmut" last="Kupper">Hartmut Kupper</name><affiliation wicri:level="1"><country xml:lang="fr">Allemagne</country><wicri:regionArea>Abbott GmbH & Co KG, Ludwigshafen</wicri:regionArea><wicri:noRegion>Ludwigshafen</wicri:noRegion><wicri:noRegion>Ludwigshafen</wicri:noRegion></affiliation></author></analytic><monogr></monogr><series><title level="j">Annals of the Rheumatic Diseases</title><title level="j" type="abbrev">Ann Rheum Dis</title><idno type="ISSN">0003-4967</idno><idno type="eISSN">1468-2060</idno><imprint><publisher>BMJ Publishing Group Ltd and European League Against Rheumatism</publisher><date type="published" when="2007-06">2007-06</date><biblScope unit="volume">66</biblScope><biblScope unit="issue">6</biblScope><biblScope unit="page" from="732">732</biblScope></imprint><idno type="ISSN">0003-4967</idno></series></biblStruct></sourceDesc><seriesStmt><idno type="ISSN">0003-4967</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>ACR, American College of Rheumatology</term><term>AE, adverse event</term><term>AM, antimalarials</term><term>AZA, azathioprine</term><term>CsA, ciclosporin</term><term>DAS, Disease Activity Score</term><term>DMARD, disease-modifying antirheumatic drug</term><term>EULAR, European League Against Rheumatism</term><term>HAQ DI, Health Assessment Questionnaire Disability Index</term><term>LEF, leflunomide</term><term>MTX, methotrexate</term><term>PY, patient-year</term><term>RA, rheumatoid arthritis</term><term>SAE, serious adverse event</term><term>SEER, Surveillance, Epidemiology, and End Results</term><term>SIR, standardised incidence ratio</term><term>SSZ, sulfasalazine</term><term>TB, tuberculosis</term><term>TNF, tumour necrosis factor</term><term>adalimumab</term><term>antirheumatic agents</term><term>monoclonal antibody</term><term>rheumatoid arthritis</term><term>tumour necrosis factor</term></keywords><keywords scheme="Teeft" xml:lang="en"><term>Adalimumab</term><term>Adalimumab effectiveness</term><term>Adalimumab exposure</term><term>American college</term><term>Antimalarial</term><term>Antirheumatic</term><term>Antirheumatic drug</term><term>Antirheumatic drugs</term><term>Arthritis</term><term>Arthritis rheum</term><term>Baseline</term><term>Baseline characteristics</term><term>Baseline differences</term><term>Burmester</term><term>Clinical practice</term><term>Combination therapy</term><term>Concomitant</term><term>Concomitant dmard</term><term>Concomitant dmards</term><term>Disease activity score</term><term>Dmard</term><term>Dmard combinations</term><term>Dmards</term><term>Etanercept</term><term>Eular</term><term>Eular responses</term><term>European league</term><term>Health assessment questionnaire disability index</term><term>Infliximab</term><term>Leflunomide</term><term>Lymphoma</term><term>Malignancy</term><term>Methotrexate</term><term>National guidelines</term><term>Other dmard</term><term>Other dmards</term><term>Parenteral</term><term>Parenteral gold</term><term>Pulmonary disease</term><term>Rheum</term><term>Rheumatoid</term><term>Rheumatoid arthritis</term><term>Rheumatol</term><term>Rheumatology</term><term>Saes</term><term>Safety profile</term><term>Serious infection</term><term>Serious infections</term><term>Skin induration</term><term>Standardised</term><term>Standardised incidence ratio</term><term>Standardised mortality ratio</term><term>Study centres</term><term>Subgroup</term><term>Sulfasalazine</term></keywords></textClass><langUsage><language ident="en">en</language></langUsage></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Objective: To evaluate the safety and effectiveness of adalimumab alone or in combination with standard disease-modifying antirheumatic drugs (DMARDs) for the treatment of rheumatoid arthritis (RA). Methods: Patients with active RA despite treatment with DMARDs or prior treatment with a tumour necrosis factor antagonist participated in a multicentre, open-label clinical study of adalimumab 40 mg every other week for 12 weeks with an optional extension phase. Patients were allowed to continue with pre-existing traditional DMARDs. Long-term safety results are reported for all patients (4210 patient-years (PYs) of adalimumab exposure). The observed effectiveness results at week 12 are reported using American College of Rheumatology (ACR) and European League Against Rheumatism (EULAR) response criteria. Results: Among the 6610 treated patients, adalimumab was generally well tolerated. Serious infections occurred in 3.1% of patients (5.5/100 PYs, including active tuberculosis, 0.5/100 PYs). Demyelinating disease (0.06%) and systemic lupus erythematosus (0.03%) were rare serious adverse events. The standardised incidence ratio of malignancy was 0.71 (95% CI 0.49 to 1.01). The standardised mortality ratio was 1.07 (95% CI 0.75 to 1.49). At week 12, 69% of patients achieved an ACR20 response, 83% a moderate, and 33% a good EULAR response. Adalimumab was effective in combination with a variety of DMARDs. The addition of adalimumab to antimalarials was comparably effective to the combination of adalimumab and methotrexate. Conclusions: Considering the limitations of an open-label study, adalimumab alone or in combination with standard DMARDs appeared to be well tolerated and effective in 6610 difficult-to-treat patients with active RA treated in clinical practice.</div></front></TEI><affiliations><list><country><li>Allemagne</li><li>Belgique</li><li>Espagne</li><li>France</li><li>Grèce</li><li>Italie</li><li>Pays-Bas</li></country><region><li>Attique (région)</li><li>Berlin</li><li>Communauté de Madrid</li><li>Utrecht (province)</li></region><settlement><li>Athènes</li><li>Berlin</li><li>Madrid</li><li>Utrecht</li></settlement></list><tree><country name="Allemagne"><region name="Berlin"><name sortKey="Burmester, Gerd R" sort="Burmester, Gerd R" uniqKey="Burmester G" first="Gerd R" last="Burmester">Gerd R. Burmester</name></region><name sortKey="Kary, Sonja" sort="Kary, Sonja" uniqKey="Kary S" first="Sonja" last="Kary">Sonja Kary</name><name sortKey="Kupper, Hartmut" sort="Kupper, Hartmut" uniqKey="Kupper H" first="Hartmut" last="Kupper">Hartmut Kupper</name><name sortKey="Unnebrink, Kristina" sort="Unnebrink, Kristina" uniqKey="Unnebrink K" first="Kristina" last="Unnebrink">Kristina Unnebrink</name></country><country name="France"><noRegion><name sortKey="Mariette, Xavier" sort="Mariette, Xavier" uniqKey="Mariette X" first="Xavier" last="Mariette">Xavier Mariette</name></noRegion></country><country name="Italie"><noRegion><name sortKey="Montecucco, Carlomaurizio" sort="Montecucco, Carlomaurizio" uniqKey="Montecucco C" first="Carlomaurizio" last="Montecucco">Carlomaurizio Montecucco</name></noRegion></country><country name="Espagne"><region name="Communauté de Madrid"><name sortKey="Monteagudo Saez, Indalecio" sort="Monteagudo Saez, Indalecio" uniqKey="Monteagudo Saez I" first="Indalecio" last="Monteagudo-Sáez">Indalecio Monteagudo-Sáez</name></region></country><country name="Belgique"><noRegion><name sortKey="Malaise, Michel" sort="Malaise, Michel" uniqKey="Malaise M" first="Michel" last="Malaise">Michel Malaise</name></noRegion></country><country name="Grèce"><region name="Attique (région)"><name sortKey="Tzioufas, Athanasios G" sort="Tzioufas, Athanasios G" uniqKey="Tzioufas A" first="Athanasios G" last="Tzioufas">Athanasios G. Tzioufas</name></region></country><country name="Pays-Bas"><region name="Utrecht (province)"><name sortKey="Bijlsma, Johannes W J" sort="Bijlsma, Johannes W J" uniqKey="Bijlsma J" first="Johannes W J" last="Bijlsma">Johannes W J. Bijlsma</name></region></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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