Adalimumab in the Treatment of Immune-Mediated Diseases

Author:

Lapadula G.1,Marchesoni A.2,Armuzzi A.3,Blandizzi C.4,Caporali R.5,Chimenti S.6,Cimaz R.7,Cimino L.8,Gionchetti P.,Girolomoni G.9,Lionetti P.10,Marcellusi A.11,Mennini F.S.11,Salvarani C.12

Affiliation:

1. Rheumatology Unit, Interdisciplinary Department of Medicine, Medical School, University of Bari, Bari, Italy

2. G. Pini Orthopedic Institute, Piazza A. Ferrari 1, 20122 Milano, Italy

3. IBD Unit, Complesso Integrato Columbus, Catholic University, Via G. Moscati 31-33 00168 Rome, Italy

4. Division of Pharmacology, Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy

5. Chair and Division of Rheumatology, IRCCS Policlinico San Matteo Foundation, Pavia, Italy

6. Department of Dermatology, University of Rome “Tor Vergata”, Rome, Italy

7. Department of Paediatrics, Rheumatology Unit, Anna Meyer Children's Hospital, University of Florence, Viale Pieraccini 24, Florence, 50139, Italy

8. Ocular Immunology Unit, Ophthalmology Unit, Arcispedale S Maria Nuova Reggio, Viale Risorgimento 80, Reggio Emilia, 42123, Italy 9IBD Unit, Department of Medical and Surgical Sciences, S. Orsola-Malpighi Hospital, University of Bologna, Italy

9. Department of Medicine, Section of Dermatology and Venereology, University of Verona, Verona, Italy

10. Gastroenterology Unit, Anna Meyer Children's Hospital, Department of Paediatrics, University of Firenze, Viale Peraccini 24, 50139, Florence, Italy

11. CEIS - Economic Evaluation and HTA (EEHTA), IGF Department, University of Tor Vergata, Rome, Italy

12. Rheumatology Unit, Department of Internal Medicine, Azienda Ospedaliera ASMN, Istituto di Ricovero e Cura a Carattere Scientifico, Viale Risorgimento 80, Reggio Emilia, 42123, Italy

Abstract

Tumour necrosis factor (TNF) plays an important role in the pathogenesis of immune-mediated inflammatory diseases (IMIDs). TNF inhibition results in down-regulation of abnormal and progressive inflammatory processes, resulting in rapid and sustained clinical remission, improved quality of life and prevention of target organ damage. Adalimumab is the first fully human monoclonal antibody directed against TNF. In this article, we review the role and cost effectiveness of adalimumab in the treatment of IMIDs in adults and children. The efficacy and tolerability of adalimumab has been demonstrated in patients with a wide range of inflammatory conditions, leading to regulatory approval in rheumatoid arthritis (RA), psoriatic arthritis (PsA), plaque psoriasis, inflammatory bowel diseases (Crohn's disease, ulcerative colitis, paediatric Crohn's disease, and intestinal Behçet's disease), ankylosing spondylitis (AS), axial spondyloarthritis (SpA) and juvenile idiopathic arthritis. The major tolerability issues with adalimumab are class effects, such as injection site reactions and increased risk of infection and lymphoma. As with all anti-TNF agents, adalimumab is immunogenic, although less than infliximab, and some patients receiving long-term adalimumab will develop anti-drug antibodies, causing a loss of response. Comparisons of its clinical utility and cost effectiveness have shown it to be a valid treatment choice in a wide range of patients. Recent data from Italian economic studies show the cost effectiveness of adalimumab to be below the threshold value for health care interventions for most indications. In addition, analysis of indirect costs shows that adalimumab significantly reduces social costs associated with RA, PsA, AS, Crohn's disease and psoriasis. The fact that adalimumab has the widest range of approved indications, many often presenting together in the same patient due to the common pathogenesis, may further improve the utility of adalimumab. Current clinical evidence shows adalimumab to be a valuable resource in the management of IMIDs. Further research, designed to identify patients who may benefit most from this drug, will better highlight the role and cost-effectiveness of this versatile TNF inhibitor.

Publisher

SAGE Publications

Subject

Pharmacology,Immunology,Immunology and Allergy

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