Adalimumab in the treatment of immune-mediated diseases.
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.
Rheumatology Unit, Interdisciplinary Department of Medicine, Medical School, University of Bari, Bari, Italy.
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Lapadula
G. Pini Orthopedic Institute, Milano, Italy.
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Marchesoni
IBD Unit, Complesso Integrato Columbus, Catholic University, Rome, Italy.
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Armuzzi
Division of Pharmacology, Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy.
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Blandizzi
Chair and Division of Rheumatology, IRCCS Policlinico San Matteo Foundation, Pavia, Italy.
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Caporali
Department of Dermatology, University of Rome Tor Vergata, Rome, Italy.
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Chimenti
Department of Paediatrics, Rheumatology Unit, Anna Meyer Childrens Hospital, University of Florence, Firenze, Italy.
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Cimaz
Ocular Immunology Unit, Ophthalmology, Unit, Arcispedale S Maria Nuova Reggio, Reggio, Emilia, Italy.
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Cimino
IBD Unit, Department of Medical and Surgical Sciences, S. Orsola-Malpighi Hospital, University of Bologna, Italy.
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Gionchetti
Department of Medicine, Section of Dermatology and Venereology, University of Verona, Verona, Italy.
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Girolomoni
Gastroenterology Unit, Anna Meyer Childrens Hospital, Department of Paediatrics, University of Firenze, Firenze, Italy.
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Lionetti
CEIS  Economic Evaluation and HTA (EEHTA), IGF Department, University of Tor Vergata, Rome, Italy.
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Marcellusi
CEIS  Economic Evaluation and HTA (EEHTA), IGF Department, University of Tor Vergata, Rome, Italy.
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Mennini
Rheumatology Unit, Department of Internal Medicine, Azienda Ospedaliera ASMN, Istituto di Ricovero e Cura a Carattere Scientifico, Reggio Emilia, Italy.
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Salvarani
D000068879:Adalimumab; D000818:Animals; D000893:Anti-Inflammatory Agents / Q000009:adverse effects / Q000191:economics / Q000493:pharmacokinetics / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized / Q000009:adverse effects / Q000191:economics / Q000493:pharmacokinetics / Q000627:therapeutic use*; D001327:Autoimmune Diseases / Q000188:drug therapy* / Q000276:immunology*; D002986:Clinical Trials as Topic; D003362:Cost-Benefit Analysis; D006801:Humans; D007249:Inflammation; D014409:Tumor Necrosis Factor-alpha / Q000037:antagonists & inhibitors*
D000893:Anti-Inflammatory Agents; D061067:Antibodies, Monoclonal, Humanized; D014409:Tumor Necrosis Factor-alpha; D000068879:Adalimumab