{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,17]],"date-time":"2026-02-17T18:05:32Z","timestamp":1771351532890,"version":"3.50.1"},"reference-count":27,"publisher":"Frontiers Media SA","license":[{"start":{"date-parts":[[2022,12,8]],"date-time":"2022-12-08T00:00:00Z","timestamp":1670457600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["frontiersin.org"],"crossmark-restriction":true},"short-container-title":["Front. Med."],"abstract":"<jats:sec><jats:title>Introduction<\/jats:title><jats:p>There is growing evidence that therapeutic drug monitoring of biologic therapy is beneficial in psoriatic patients. With respect to ustekinumab, the available evidence has not shown any relationship yet. The objective of this study is to identify correlations among ustekinumab trough concentrations, anti-ustekinumab antibodies and clinical response in moderate-to-severe plaque psoriasis patients, in a real-world setting.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Observational prospective follow-up study in psoriatic patients treated with ustekinumab. Patients were classified in optimal (PASI \u2264 3) and suboptimal responders (PASI &amp;gt; 3). Mann\u2013Whitney <jats:italic>U<\/jats:italic> test and Spearman\u2019s rank correlation coefficient were used. Receiver-operator characteristic curve analysis was performed to identify ustekinumab concentration cut-off to achieve optimal response. A <jats:italic>p<\/jats:italic>-value &amp;lt; 0.05 was considered statistically significant.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>A total of 59 patients were included. Forty-eight patients (81.4%) corresponded to optimal responders and 11 (18.6%) to suboptimal responders. There was significant difference to ustekinumab concentrations: 0.7 \u03bcg\/mL (range &amp;lt;0.1\u20131.8) vs. 0.4 \u03bcg\/mL (range &amp;lt;0.1\u20130.8) respectively (<jats:italic>p<\/jats:italic> = 0.007). Positive correlation between ustekinumab concentration and psoriasis area and severity index (PASI) value was detected (<jats:italic>p<\/jats:italic> = 0.009). A cut-off value of 0.6 \u03bcg\/mL ustekinumab concentration was found to achieve clinical response. Anti-ustekinumab antibodies were detected in 2 (3.4%) samples, both suboptimal responders.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>A positive correlation exits between ustekinumab concentration and clinical response (optimal response PASI values \u2264 3) in blood draws performed before drug administration. The measurement of anti-ustekinumab antibodies could be considered in treatment failure.<\/jats:p><\/jats:sec>","DOI":"10.3389\/fmed.2022.1017323","type":"journal-article","created":{"date-parts":[[2022,12,8]],"date-time":"2022-12-08T11:38:14Z","timestamp":1670499494000},"update-policy":"https:\/\/doi.org\/10.3389\/crossmark-policy","source":"Crossref","is-referenced-by-count":5,"title":["Real-world use of ustekinumab therapeutic drug monitoring in moderate to severe psoriasis"],"prefix":"10.3389","volume":"9","author":[{"given":"Laida","family":"Elberd\u00edn","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rosa M.","family":"Fern\u00e1ndez-Torres","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mar\u00eda","family":"Mateos","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mar\u00eda","family":"Outeda","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Eva","family":"Blanco","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mar\u00eda I.","family":"G\u00f3mez-Besteiro","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Isabel","family":"Mart\u00edn-Herranz","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Eduardo","family":"Fonseca","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"1965","published-online":{"date-parts":[[2022,12,8]]},"reference":[{"key":"B1","doi-asserted-by":"publisher","first-page":"1158","DOI":"10.1111\/bjd.18333","article-title":"Psoriasis treat to target: defining outcomes in psoriasis using data from a real-world, population-based cohort study (the British association of dermatologists biologics and immunomodulators register, BADBIR).","volume":"182","author":"Mahil","year":"2020","journal-title":"Br J Dermatol."},{"key":"B2","doi-asserted-by":"publisher","first-page":"1675","DOI":"10.1016\/S0140-6736(08)60726-6","article-title":"Efficacy and safety of ustekinumab, a human interleukin-12\/23 monoclonal antibody, in patients with psoriasis: 52-week results from a randomised, double-blind, placebo-controlled trial (PHOENIX 2).","volume":"371","author":"Papp","year":"2008","journal-title":"Lancet."},{"key":"B3","doi-asserted-by":"publisher","first-page":"1148","DOI":"10.1111\/jdv.13611","article-title":"Drug survival of biologic therapy in a large, disease-based registry of patients with psoriasis: results from the psoriasis longitudinal assessment and registry (PSOLAR).","volume":"30","author":"Menter","year":"2016","journal-title":"J Eur Acad Dermatol Venereol."},{"key":"B4","doi-asserted-by":"publisher","first-page":"1665","DOI":"10.1016\/S0140-6736(08)60725-4","article-title":"Efficacy and safety of ustekinumab, a human interleukin-12\/23 monoclonal antibody, in patients with psoriasis: 76-week results from a randomised, double-blind, placebo-controlled trial (PHOENIX 1).","volume":"371","author":"Leonardi","year":"2008","journal-title":"Lancet."},{"key":"B5","doi-asserted-by":"publisher","first-page":"698","DOI":"10.1080\/09546634.2019.1605140","article-title":"Ustekinumab treatment for moderate to severe psoriasis. Eight-year real-world follow-up of 61 cases in a tertiary level hospital.","volume":"31","author":"Elberd\u00edn","year":"2020","journal-title":"J Dermatol Treat."},{"key":"B6","doi-asserted-by":"publisher","first-page":"127","DOI":"10.2147\/BTT.S188286","article-title":"Therapeutic drug monitoring of biologics in psoriasis.","volume":"13","author":"Liau","year":"2019","journal-title":"Biol Targets Ther."},{"key":"B7","doi-asserted-by":"publisher","first-page":"356","DOI":"10.1097\/FTD.0000000000000401","article-title":"Current practice for therapeutic drug monitoring of biopharmaceuticals in psoriasis patients.","volume":"39","author":"Hermans","year":"2017","journal-title":"Ther Drug Monit."},{"key":"B8","doi-asserted-by":"publisher","first-page":"1142","DOI":"10.1007\/s11096-016-0343-0","article-title":"Positive correlation between etanercept concentration and the decrease in psoriasis area and severity index scale value.","volume":"38","author":"Elberd\u00edn","year":"2016","journal-title":"Int J Clin Pharm."},{"key":"B9","doi-asserted-by":"publisher","first-page":"54","DOI":"10.3109\/09546634.2012.755254","article-title":"Long-term response to etanercept monotherapy in moderate to severe psoriasis: assessment in daily practice by the maintenance of low values of PASI and BSA.","volume":"25","author":"Fern\u00e1ndez-Torres","year":"2014","journal-title":"J Dermatol Treat."},{"key":"B10","doi-asserted-by":"publisher","first-page":"261","DOI":"10.1016\/j.ad.2021.10.003","article-title":"Practical update of the recommendations published by the psoriasis group of the Spanish academy of dermatology and venereology (GPs) on the treatment of psoriasis with biologic therapy.","volume":"113","author":"Carrascosa","year":"2022","journal-title":"Actas Dermosifiliogr."},{"key":"B11","doi-asserted-by":"publisher","first-page":"761","DOI":"10.1007\/s13555-022-00693-2","article-title":"Biologic therapy for moderate to severe psoriasis. Real-world follow-up of patients who initiated biologic therapy at least 10 years ago.","volume":"12","author":"Elberd\u00edn","year":"2022","journal-title":"Dermatol Ther (Heidelb)."},{"key":"B12","doi-asserted-by":"publisher","first-page":"217","DOI":"10.3109\/09546634.2014.933166","article-title":"Efficacy and safety of adalimumab in psoriatic patients previously treated with etanercept in a real-world setting.","volume":"26","author":"Fonseca","year":"2015","journal-title":"J Dermatol Treat."},{"key":"B13","doi-asserted-by":"publisher","first-page":"294","DOI":"10.1111\/bjd.18981","article-title":"Drug survival of adalimumab, ustekinumab and secukinumab in patients with psoriasis: a prospective cohort study from the British association of dermatologists biologics and immunomodulators register (BADBIR).","volume":"183","author":"Yiu","year":"2020","journal-title":"Br J Dermatol."},{"key":"B14","doi-asserted-by":"publisher","first-page":"1131","DOI":"10.1001\/jamadermatol.2022.2909","article-title":"drug survival associated with effectiveness and safety of treatment with guselkumab, ixekizumab, secukinumab, ustekinumab, and adalimumab in patients with psoriasis.","volume":"158","author":"Yiu","year":"2022","journal-title":"JAMA Dermatol."},{"key":"B15","doi-asserted-by":"publisher","first-page":"35","DOI":"10.1080\/09546634.2018.1468065","article-title":"Usefulness and correlation with clinical response of serum ustekinumab levels measured at 6 weeks versus 12 weeks.","volume":"30","author":"Toro-Montecinos","year":"2019","journal-title":"J Dermatol Treat."},{"key":"B16","doi-asserted-by":"publisher","first-page":"1235","DOI":"10.1001\/jamadermatol.2019.1783","article-title":"Association of serum ustekinumab levels with clinical response in psoriasis.","volume":"155","author":"Tsakok","year":"2019","journal-title":"JAMA Dermatol."},{"key":"B17","doi-asserted-by":"publisher","first-page":"1782","DOI":"10.1016\/j.jaad.2018.12.021","article-title":"Optimal concentration range of ustekinumab in patients with plaque-type psoriasis.","volume":"80","author":"Mart\u00edn-Gonz\u00e1lez","year":"2019","journal-title":"J Am Acad Dermatol."},{"key":"B18","doi-asserted-by":"publisher","first-page":"855","DOI":"10.1111\/bjd.13834","article-title":"The correlation of clinical efficacy, serum trough levels and antidrug antibodies in ustekinumab-treated patients with psoriasis in a clinical-practice setting.","volume":"173","author":"Menting","year":"2015","journal-title":"Br J Dermatol."},{"key":"B19","doi-asserted-by":"publisher","first-page":"634","DOI":"10.1097\/FTD.0000000000000646","article-title":"Clinical consequences of antibody formation, serum concentrations, and HLA-Cw6 status in psoriasis patients on ustekinumab.","volume":"41","author":"De Keyser","year":"2019","journal-title":"Ther Drug Monit."},{"key":"B20","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0142930","article-title":"The association between clinical response to ustekinumab and immunogenicity to ustekinumab and prior adalimumab.","volume":"10","author":"Chiu","year":"2015","journal-title":"PLoS One."},{"key":"B21","doi-asserted-by":"publisher","first-page":"489","DOI":"10.1111\/bjd.15387","article-title":"Role of the HLA-C*06 allele in clinical response to ustekinumab: evidence from real life in a large cohort of European patients.","volume":"177","author":"Talamonti","year":"2017","journal-title":"Br J Dermatol."},{"key":"B22","doi-asserted-by":"publisher","first-page":"2120","DOI":"10.1016\/j.jaci.2018.11.038","article-title":"HLA-C*06:02 genotype is a predictive biomarker of biologic treatment response in psoriasis.","volume":"143","author":"Dand","year":"2019","journal-title":"J Allergy Clin Immunol."},{"key":"B23","doi-asserted-by":"publisher","first-page":"2364","DOI":"10.1016\/j.jid.2016.06.631","article-title":"HLA-C*06:02 Allele and response to IL-12\/23 inhibition: results from the ustekinumab phase 3 psoriasis program.","volume":"136","author":"Li","year":"2016","journal-title":"J Invest Dermatol."},{"key":"B24","doi-asserted-by":"publisher","first-page":"708","DOI":"10.1001\/jamadermatol.2019.0098","article-title":"Association of HLA-C*06:02 status with differential response to ustekinumab in patients with psoriasis: a systematic review and meta-analysis.","volume":"155","author":"Van Vugt","year":"2019","journal-title":"JAMA Dermatol."},{"key":"B25","doi-asserted-by":"publisher","first-page":"244","DOI":"10.5114\/ada.2019.91504","article-title":"Ustekinumab therapy changes the transcriptional activity pattern of TGF-\u03b21-3 genes.","volume":"38","author":"Grabarek","year":"2021","journal-title":"Postepy Dermatol Alergol."},{"key":"B26","doi-asserted-by":"publisher","first-page":"235","DOI":"10.17219\/acem\/112607","article-title":"Analysis of the clinical response and changes in the expression of TNF-\u03b1 and its TNFR1 and TNFR2 receptors in patients with psoriasis vulgaris treated with ustekinumab.","volume":"29","author":"Wcis\u0142o-Dziadecka","year":"2020","journal-title":"Adv Clin Exp Med."},{"key":"B27","doi-asserted-by":"publisher","first-page":"173","DOI":"10.5114\/ada.2021.104295","article-title":"The comparison of effectiveness of therapy with ustekinumab and etanercept in psoriatic patients during 48 weeks\u2019 observation.","volume":"38","author":"Wcis\u0142o-Dziadecka","year":"2021","journal-title":"Postepy Dermatol Alergol."}],"container-title":["Frontiers in Medicine"],"original-title":[],"link":[{"URL":"https:\/\/www.frontiersin.org\/articles\/10.3389\/fmed.2022.1017323\/full","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2022,12,8]],"date-time":"2022-12-08T11:38:17Z","timestamp":1670499497000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.frontiersin.org\/articles\/10.3389\/fmed.2022.1017323\/full"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,12,8]]},"references-count":27,"alternative-id":["10.3389\/fmed.2022.1017323"],"URL":"https:\/\/doi.org\/10.3389\/fmed.2022.1017323","relation":{},"ISSN":["2296-858X"],"issn-type":[{"value":"2296-858X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2022,12,8]]},"article-number":"1017323"}}