Incidence and risk factors for adalimumab and infliximab anti-drug antibodies in rheumatoid arthritis: A European retrospective multicohort analysis

被引：49

作者：

Quistrebert, Jocelyn ^{[1
]}

Hassler, Signe ^{[1
]}

Bachelet, Delphine ^{[1
]}

Mbogning, Cyprien ^{[1
]}

Musters, Anne ^{[2
]}

Tak, Paul Peter ^{[2
,3
,4
,5
]}

Wijbrandts, Carla Ann ^{[2
,6
]}

Herenius, Marieke ^{[2
]}

Bergstra, Sytske Anne ^{[7
]}

Akdemir, Gulsah ^{[7
]}

Johannesson, Martina ^{[8
]}

Combe, Bernard ^{[9
]}

Fautrel, Bruno ^{[10
,11
]}

Chollet-Martin, Sylvie ^{[12
]}

Gleizes, Aude ^{[12
,13
]}

Donnellan, Naoimh ^{[14
]}

Deisenhammer, Florian ^{[15
]}

Davidson, Julie ^{[16
]}

Hincelin-Mery, Agnes ^{[17
]}

Donnes, Pierre ^{[18
]}

Fogdell-Hahn, Anna ^{[19
]}

De Vries, Niek ^{[2
]}

Huizinga, Tom ^{[7
]}

Abugessaisa, Imad ^{[20
]}

Saevarsdottir, Saedis ^{[8
]}

Hacein-Bey-Abina, Salima ^{[13
,21
]}

Pallardy, Marc ^{[12
]}

Broet, Philippe ^{[1
,22
,23
]}

Mariette, Xavier ^{[24
,25
]}

机构：

[1] Paris Saclay Univ, Paris Sud Univ, Fac Med, CESP,INSERM UMR 1018,UVSQ, Villejuif, France

[2] Univ Amsterdam, Acad Med Ctr, Amsterdam Rheumatol & Immunol Ctr, Amsterdam, Netherlands

[3] GlaxoSmithKline, Stevenage, Herts, England

[4] Univ Cambridge, Cambridge, England

[5] Univ Ghent, Ghent, Belgium

[6] Med Ctr Slotervaart, Amsterdam, Netherlands

[7] Leiden Univ, Med Ctr, Dept Rheumatol, Leiden, Netherlands

[8] Karolinska Inst, Karolinska Univ Hosp, Dept Med Solna, Rheumatol Unit, Stockholm, Sweden

[9] Univ Montpellier, Lapeyronie Hosp, Dept Rheumatol, Montpellier, France

[10] Hop La Pitie Salpetriere, AP HP, Dept Rheumatol, Paris, France

[11] UPMC, Pierre Louis Inst Epidemiol & Publ Hlth, GRC 08, Paris, France

[12] Paris Saclay Univ, Paris Sud Univ, Fac Pharm, INSERM UMR 996, Chatenay Malabry, France

[13] Le Kremlin Bicetre Hosp, Paris Sud Univ Hosp, AP HP, Clin Immunol Lab, Le Kremlin Bicetre, France

[14] IPSEN, Slough, Berks, England

[15] Innsbruck Med Univ, Dept Neurol, Innsbruck, Austria

[16] GlaxoSmithKline, Uxbridge, Middx, England

[17] Sanofi, Chilly Mazarin, France

[18] SciCross AB, Skovde, Sweden

[19] Karolinska Inst, Dept Clin Neurosci, Clin Neuroimmunol, Stockholm, Sweden

[20] Karolinska Inst, Dept Med Solna, Unit Computat Med, Stockholm, Sweden

[21] Paris Descartes Sorbonne Cite Univ, Fac Pharm, INSERM U1022, UTCBS,CNRS UMR 8258, Paris, France

[22] Hop Paul Brousse, Paris Sud Univ Hosp, AP HP, Villejuif, France

[23] CHU St Justine, Quebec City, PQ, Canada

[24] Paris Saclay Univ, Paris Sud Univ, Ctr Immunol Viral Infect & Autoimmune Dis, INSERM U1184, 63 Rue Gabriel Peri, F-94276 Le Kremlin Bicetre, France

[25] Le Kremlin Bicetre Hosp, Paris Sud Univ Hosp, AP HP, Dept Rheumatol, Le Kremlin Bicetre, France

来源：

SEMINARS IN ARTHRITIS AND RHEUMATISM | 2019年 / 48卷 / 06期

关键词：

Rheumatoid arthritis; Anti-drug antibodies; Anti-TNF treatment; Incidence; Risk factors; LONG-TERM TREATMENT; CLINICAL-RESPONSE; NEUTRALIZING ANTIBODIES; DISEASE-ACTIVITY; IMMUNOGENICITY; RECOMMENDATIONS; METHOTREXATE; ETANERCEPT; VALIDATION; INHIBITORS;

D O I：

10.1016/j.semarthrit.2018.10.006

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

Objectives: To evaluate the incidence of anti-drug antibody (ADA) occurrences and ADA-related risk factors under adalimumab and infliximab treatment in rheumatoid arthritis (RA) patients. Methods: The study combined retrospective cohorts from the ABIRISK project totaling 366 RA patients treated with adalimumab (n = 240) or infliximab (n =126), 92.4% of them anti-TNF naive (n = 328/355) and 96.6% of them co-treated with methotrexate (n=341/353) with up to 18 months follow-up. ADA positivity was measured by enzyme-linked immunosorbent assay. The cumulative incidence of ADA was estimated, and potential bio-clinical factors were investigated using a Cox regression model on interval-censored data. Results: ADAs were detected within 18 months in 19.2% (n = 46) of the adalimumab-treated patients and 29.4% (n = 37) of the infliximab-treated patients. The cumulative incidence of ADA increased over time. In the adalimumab and infliximab groups, respectively, the incidence was 15.4% (5.2-20.2) and 0% (0-5.9) at 3 months, 17.6% (11.4-26.4) and 0% (0-25.9) at 6 months, 17.7% (12.6-37.5) and 34.1% (11.4-46.3) at 12 months, 50.0% (25.9-87.5) and 37.5% (25.9-77.4) at 15 months and 50.0% (25.9-87.5) and 66.7% (37.7-100) at 18 months. Factors associated with a higher risk of ADA development were: longer disease duration (1-3 vs. < 1 year; adalimumab: HR 3.0, 95% CI 1.0-8.7; infliximab: HR 2.7, 95% CI 1.1-6.8), moderate disease activity (DAS28 3.2-5.1 vs. < 3.2; adalimumab: HR 6.6, 95% CI 1.3-33.7) and lifetime smoking (infliximab: HR 2.7, 95% CI 1.2-6.3). Conclusions: The current study focusing on patients co-treated with methotrexate for more than 95% of them found a late occurrence of ADAs not previously observed, whereby the risk continued to increase over 18 months. Disease duration, DAS28 and lifetime smoking are clinical predictors of ADA development. (C) 2018 Elsevier Inc. All rights reserved.

引用

页码：967 / 975

页数：9

共 58 条

[1] Accelerating Translational Research by Clinically Driven Development of an Informatics Platform-A Case Study [J].

Abugessaisa, Imad ;

Saevarsdottir, Saedis ;

Tsipras, Giorgos ;

Lindblad, Staffan ;

Sandin, Charlotta ;

Nikamo, Pernilla ;

Stahle, Mona ;

Malmstrom, Vivianne ;

Klareskog, Lars ;

Tegner, Jesper .

PLOS ONE, 2014, 9 (09)

[2] Implementation of the CDC translational informatics platform - from genetic variants to the national Swedish Rheumatology Quality Register [J].

Abugessaisa, Imad ;

Gomez-Cabrero, David ;

Snir, Omri ;

Lindblad, Staffan ;

Klareskog, Lars ;

Malmstrom, Vivianne ;

Tegner, Jesper .

JOURNAL OF TRANSLATIONAL MEDICINE, 2013, 11

[3]

Anderson JJ, 2000, ARTHRITIS RHEUM, V43, P22, DOI 10.1002/1529-0131(200001)43:1<22::AID-ANR4>3.0.CO

[4]

2-9

[5] Effects of tobacco smoke on immunity, inflammation and autoimmunity [J].

Arnson, Yoav ;

Shoenfeld, Yehuda ;

Amital, Howard .

JOURNAL OF AUTOIMMUNITY, 2010, 34 (03) :J258-J265

[6] Serum Cotinine Does Not Predict Neutralizing Antibodies Against Interferon Beta in an Austrian MS Cohort [J].

Auer, Michael ;

Hegen, Harald ;

Luft, Thomas ;

Bsteh, Gabriel ;

Fogdell-Hahn, Anna ;

Loercher, Amy ;

Deisenhammer, Florian .

JOURNAL OF INTERFERON AND CYTOKINE RESEARCH, 2016, 36 (12) :667-670

[7] Occurrence of Anti-Drug Antibodies against Interferon-Beta and Natalizumab in Multiple Sclerosis: A Collaborative Cohort Analysis [J].

Bachelet, Delphine ;

Hassler, Signe ;

Mbogning, Cyprien ;

Link, Jenny ;

Ryner, Malin ;

Ramanujam, Ryan ;

Auer, Michael ;

Jensen, Poul Erik Hyldgaard ;

Koch-Henriksen, Nils ;

Warnke, Clemens ;

Ingenhoven, Kathleen ;

Buck, Dorothea ;

Grummel, Verena ;

Lawton, Andy ;

Donnellan, Naoimh ;

Hincelin-Mery, Agnes ;

Sikkema, Dan ;

Pallardy, Marc ;

Kieseier, Bernd ;

Hemmer, Bernard ;

Hartung, Hans Peter ;

Sorensen, Per Soelberg ;

Deisenhammer, Florian ;

Donnes, Pierre ;

Davidson, Julie ;

Fogdell-Hahn, Anna ;

Broet, Philippe .

PLOS ONE, 2016, 11 (11)

[8] Anti-infliximab and anti-adalimumab antibodies in relation to response to adalimumab in infliximab switchers and anti-tumour necrosis factor naive patients: a cohort study [J].

Bartelds, G. M. ;

Wijbrandts, C. A. ;

Nurmohamed, M. T. ;

Stapel, S. ;

Lems, W. F. ;

Aarden, L. ;

Dijkmans, B. A. C. ;

Tak, P. P. ;

Wolbink, G. J. .

ANNALS OF THE RHEUMATIC DISEASES, 2010, 69 (05) :817-821

[9] Clinical response to adalimumab: relationship to anti-adalimumab antibodies and serum adalimumab concentrations in rheumatoid arthritis [J].

Bartelds, Geertje M. ;

Wijbrandts, Carla A. ;

Nurmohamed, Michael T. ;

Stapel, Steven ;

Lems, Willem F. ;

Aarden, Lucien ;

Dijkmans, Ben A. C. ;

Tak, Paul Peter ;

Wolbink, Gerrit Jan .

ANNALS OF THE RHEUMATIC DISEASES, 2007, 66 (07) :921-926

[10] Development of Antidrug Antibodies Against Adalimumab and Association With Disease Activity and Treatment Failure During Long-term Follow-up [J].

Bartelds, Geertje M. ;

Krieckaert, Charlotte L. M. ;

Nurmohamed, Michael T. ;

van Schouwenburg, Pauline A. ;

Lems, Willem F. ;

Twisk, Jos W. R. ;

Dijkmans, A. C. ;

Aarden, Lucien ;

Wolbink, Gerrit Jan .

JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 2011, 305 (14) :1460-1468

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