{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,18]],"date-time":"2026-06-18T04:21:32Z","timestamp":1781756492960,"version":"3.54.5"},"reference-count":35,"publisher":"BMJ","issue":"12","funder":[{"DOI":"10.13039\/501100003196","name":"Ministero della Salute","doi-asserted-by":"publisher","award":["n.a."],"award-info":[{"award-number":["n.a."]}],"id":[{"id":"10.13039\/501100003196","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2016,11,10]]},"published-print":{"date-parts":[[2016,12]]},"abstract":"<jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>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 \u03b1 (TNF\u03b1) serum levels in psoriatic patients.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Design<\/jats:title>\n                    <jats:p>Case\u2013control, longitudinal.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Setting<\/jats:title>\n                    <jats:p>Single centre.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Participants<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                    <jats:p>\n                      <jats:italic>Healthy subjects<\/jats:italic>\n                      : (group V; n=15) never treated with immunosuppressants or biologicals.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Interventions<\/jats:title>\n                    <jats:p>All groups were tested at enrolment. Group II was also tested at 12\u2005months, and group III at 1, 3, and 6\u2005months.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Primary and secondary outcome measures<\/jats:title>\n                    <jats:p>Standard clinical evaluations (Psoriasis Area Severity Index (PASI)), blood samples and two-site ELISA-based measurement of serum adalimumab trough levels, anti-adalimumab antibodies and TNF\u03b1.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>The false-positive rate was 23% for adalimumab detection and 22% for anti-adalimumab antibodies in patients na\u00efve to adalimumab. Spurious positivity for anti-adalimumab antibodies (one-time-point positivity in group III during follow-up) accounted for 33% of the total. The prevalence of anti-drug 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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>High variability of results, high prevalence of false-positives and lack of association between anti-adalimumab antibodies and TNF\u03b1 level\/PASI score limit this assay's usefulness. Accurate clinical evaluation is key to early identification of treatment failures.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2016-011941","type":"journal-article","created":{"date-parts":[[2016,12,10]],"date-time":"2016-12-10T03:08:01Z","timestamp":1481339281000},"page":"e011941","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":12,"title":["Anti-adalimumab antibodies in psoriasis: lack of clinical utility and laboratory evidence"],"prefix":"10.1136","volume":"6","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-8365-985X","authenticated-orcid":false,"given":"G","family":"Lombardi","sequence":"first","affiliation":[{"name":"Laboratory of Experimental Biochemistry and Molecular Biology, I.R.C.C.S. 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