Toward the integration of biosimilars into pediatric rheumatology: adalimumab ABP 501 experience of PeRA research group

被引:8
作者
Demirkan, Fatma Gul [1 ]
Ulu, Kadir [2 ]
Ozturk, Kubra [3 ]
Karadas, Serife Gul [4 ]
Ozdel, Semanur [5 ]
Sonmez, Hafize Emine [6 ]
Cakmak, Figen [1 ]
Demir, Ferhat [2 ]
Sozeri, Betul [2 ]
Ayaz, Nuray Aktay [1 ]
机构
[1] Istanbul Univ, Istanbul Sch Med, Dept Pediat Rheumatol, Istanbul, Fatih, Turkey
[2] Univ Hlth Sci, Umraniye Res & Training Hosp, Dept Pediat Rheumatol, Istanbul, Turkey
[3] Istanbul Medeniyet Univ, Goztepe Res & Training Hosp, Sch Med, Dept Pediat Rheumatol, Istanbul, Turkey
[4] Univ Hlth Sci, Bakirkoy Dr SadiKonuk Training & Res Hosp, Dept Pediat Rheumatol, Istanbul, Turkey
[5] Univ Hlth Sci, Pediat Hlth & Dis Training & Res Hosp, Dept Pediat Rheumatol, Dr Sami Ulus Obstet & Gynecol, Ankara, Turkey
[6] Kocaeli Univ, Kocaeli Sch Med, Dept Pediat Rheumatol, Kocaeli, Turkey
关键词
Adalimumab; biosimilar; amgevita; juvenile idiopathic arthritis; ABP-501; JUVENILE IDIOPATHIC ARTHRITIS; DISEASE-ACTIVITY; PLAQUE PSORIASIS; DOUBLE-BLIND; VALIDATION; GUIDELINES; EFFICACY; SAFETY;
D O I
10.1080/14712598.2021.2002296
中图分类号
Q81 [生物工程学(生物技术)]; Q93 [微生物学];
学科分类号
071005 ; 0836 ; 090102 ; 100705 ;
摘要
Objectives To review the real-life data, to provide an input to the literature concerning treatment of juvenile idiopathic arthritis (JIA) with adalimumab (ADL) biosimilar. Method This multi-centric retrospective study was conducted among children with JIA, followed up for at least 24-weeks from the initiation of ADL biosimilar (ABP 501) treatment. Adverse events and alterations in disease activity scores were figured out. Results The median age of the group was 15.5 (5-18) years. JIA categories were oligoarticular (n =12), enthesitis-related (ERA) (n=24), psoriatic (PsA) (n=6), and polyarticular (n=4). Uveitis was detected at the initiation of the disease (n=3), during the disease course (n=5), or before the diagnosis (n=1). The first-line treatment preferences were ADL biosimilar (n=37) and etanercept (n=9). On the 6th month of ABP 501, 40 (86.9%) patients had achieved complete remission. Six patients (1 PsA, 1 polyarticular JIA, and 4 ERA) had ongoing active arthritis. Furthermore, all except one of the patients had remission of ophthalmologic findings. No life-threatening adverse events were observed. Conclusions ABP 501 has a gradual increase in prescription in pediatric rheumatology. Real-life data of the cohort announce that ADL biosimilar is a suitable and effective treatment option for patients with JIA in case of indication.
引用
收藏
页码:197 / 202
页数:6
相关论文
共 39 条
[1]   Drug Discontinuation in Studies Including a Switch From an Originator to a Biosimilar Monoclonal Antibody: A Systematic Literature Review [J].
Bakalos, Georgios ;
Zintzaras, Elias .
CLINICAL THERAPEUTICS, 2019, 41 (01) :155-173
[2]   Adalimumab Biosimilars in Europe: An Overview of the Clinical Evidence [J].
Bellinvia, Salvatore ;
Cummings, J. R. Fraser ;
Ardern-Jones, Michael R. ;
Edwards, Christopher J. .
BIODRUGS, 2019, 33 (03) :241-253
[3]   Safety of biological agents in paediatric rheumatic diseases: A real-life multicenter retrospective study using the JIRcohorte database [J].
Cabrera, Natalia ;
Lega, Jean-Christophe ;
Kassai, Behrouz ;
Wouters, Carine ;
Kondi, Anuela ;
Cannizzaro, Elvira ;
Woerner, Andreas ;
Chausset, Aurelie ;
Roethlisberger, Samuel ;
Jeanneret, Cyril ;
Aeschlimann, Florence ;
Malik, Salma ;
Duquesne, Agnes ;
Kaiser, Daniela ;
Higel, Laetitia ;
Maes, Anne ;
Berthet, Gerald ;
Hentgen, Veronique ;
Kone-Paut, Isabelle ;
Belot, Alexandre ;
Hofer, Michael .
JOINT BONE SPINE, 2019, 86 (03) :343-350
[4]   The necessity, efficacy and safety of biologics in juvenile idiopathic arthritis [J].
Cakan, Mustafa ;
Ayaz, Nuray Aktay ;
Karadag, Serife Gul ;
Tanatar, Ayse .
NORTHERN CLINICS OF ISTANBUL, 2020, 7 (02) :118-123
[5]   Real-life efficacy and safety of biosimilar adalimumab (ZRC-3197) in patients with plaque psoriasis: A tertiary care center experience [J].
Chopra, Ajay ;
Mitra, Debdeep ;
Agarwal, Reetu ;
Saraswat, Neerja ;
Chemburkar, Pooja ;
Sharma, Loknandini .
INDIAN DERMATOLOGY ONLINE JOURNAL, 2020, 11 (02) :182-186
[6]   Overview of Humira® Biosimilars: Current European Landscape and Future Implications [J].
Coghlan, Jill ;
He, Hongliang ;
Schwendeman, Anna S. .
JOURNAL OF PHARMACEUTICAL SCIENCES, 2021, 110 (04) :1572-1582
[7]   Biosimilars for psoriasis: worldwide overview of regulatory guidelines, uptake and implications for dermatology clinical practice [J].
Cohen, A. D. ;
Wu, J. J. ;
Puig, L. ;
Chimenti, S. ;
Vender, R. ;
Rajagopalan, M. ;
Romiti, R. ;
de la Cruz, C. ;
Skov, L. ;
Zachariae, C. ;
Young, H. S. ;
Foley, P. ;
van der Walt, J. M. ;
Naldi, L. ;
Prens, E. P. ;
Blauvelt, A. .
BRITISH JOURNAL OF DERMATOLOGY, 2017, 177 (06) :1495-1502
[8]   Efficacy and safety of the biosimilar ABP 501 compared with adalimumab in patients with moderate to severe rheumatoid arthritis: a randomised, double-blind, phase III equivalence study [J].
Cohen, Stanley ;
Genovese, Mark C. ;
Choy, Ernest ;
Perez-Ruiz, Fernando ;
Matsumoto, Alan ;
Pavelka, Karel ;
Pablos, Jose L. ;
Rizzo, Warren ;
Hrycaj, Pawel ;
Zhang, Nan ;
Shergy, William ;
Kaur, Primal .
ANNALS OF THE RHEUMATIC DISEASES, 2017, 76 (10) :1679-1687
[9]   The Clinical Implications of Nocebo Effects for Biosimilar Therapy [J].
Colloca, Luana ;
Panaccione, Remo ;
Murphy, T. Kevin .
FRONTIERS IN PHARMACOLOGY, 2019, 10
[10]   Clinical outcome measures in juvenile idiopathic arthritis [J].
Consolaro, Alessandro ;
Giancane, Gabriella ;
Schiappapietra, Benedetta ;
Davi, Sergio ;
Calandra, Serena ;
Lanni, Stefano ;
Ravelli, Angelo .
PEDIATRIC RHEUMATOLOGY, 2016, 14