Objective: Adalimumab has proven effective in psoriasis; however, secondary failure may result from the drug's immunogenicity. Prevalence data on the immunogenicity of biologicals, and of adalimumab in particular, are highly variable. We investigated the prevalence of anti-adalimumab antibodies and the association with clinical indexes and tumour necrosis factor α (TNFα) serum levels in psoriatic patients. Design: Case-control, longitudinal. Setting: Single centre. Participants: Patient groups: I (n=20) receiving biological therapies after switching from adalimumab; II (n=30) ongoing adalimumab therapy; III (n=30) novel adalimumab therapy; IV (n=15) biological therapies other than adalimumab. Healthy subjects: (group V; n=15) never treated with immunosuppressants or biologicals. Interventions: All groups were tested at enrolment. Group II was also tested at 12 months, and group III at 1, 3, and 6 months. Primary and secondary outcome measures: Standard clinical evaluations (Psoriasis Area Severity Index (PASI)), blood samples and two-site ELISAbased measurement of serum adalimumab trough levels, anti-adalimumab antibodies and TNFα. Results: The false-positive rate was 23% for adalimumab detection and 22% for anti-adalimumab antibodies in patients naïve to adalimumab. Spurious positivity for anti-adalimumab antibodies (one-timepoint positivity in group III during follow-up) accounted for 33% of the total. The prevalence of antidrug antibodies was highest (87%) in group I patients. No correlations were found between the presence of anti-adalimumab antibodies or adalimumab levels and changes in PASI scores. Conclusions: High variability of results, high prevalence of false-positives and lack of association between anti-adalimumab antibodies and TNFα level/PASI score limit this assay's usefulness. Accurate clinical evaluation is key to early identification of treatment failures.
Anti-adalimumab antibodies in psoriasis : Lack of clinical utility and laboratory evidence / G. Lombardi, S. Perego, V. Sansoni, M. Diani, G. Banfi, G. Altomare. - In: BMJ OPEN. - ISSN 2044-6055. - 6:12(2016 Dec), pp. e011941.e011941-e011941.e011948.
|Titolo:||Anti-adalimumab antibodies in psoriasis : Lack of clinical utility and laboratory evidence|
ALTOMARE, GIANFRANCO (Ultimo)
|Parole Chiave:||ELISA; adalimumab; anti-drug antibodies; medicine (all)|
|Settore Scientifico Disciplinare:||Settore MED/35 - Malattie Cutanee e Veneree|
|Data di pubblicazione:||dic-2016|
|Data ahead of print / Data di stampa:||dic-2016|
|Digital Object Identifier (DOI):||http://dx.doi.org/10.1136/bmjopen-2016-011941|
|Appare nelle tipologie:||01 - Articolo su periodico|