Dermatologists on the medical need for therapeutic drug monitoring of biologics in psoriasis: results of a structured survey

References

• Kerdel F, Zaiac M. An evolution in switching therapy for psoriasis patients who fail to meet treatment goals. Dermatol Ther. 2015;28:390–403.
   PubMed Web of Science ®Google Scholar
• Alfonso-Cristancho R, Armstrong N, Arjunji R, et al. Comparative effectiveness of biologics for the management of rheumatoid arthritis: systematic review and network meta-analysis. Clin Rheumatol. 2017;36:25–34.
   PubMed Web of Science ®Google Scholar
• Lichtenstein GR, Loftus EV, Isaacs KL, et al. ACG Clinical Guideline: management of Crohn’s disease in adults. Am J Gastroenterol. 2018;113:481–517.
   PubMed Web of Science ®Google Scholar
• Kornbluth A, Sachar D, Practice Parameters Committee of the American College of Gastroenterology. Ulcerative colitis practice guidelines in adults: American College of Gastroenterology, Practice Parameters Committee. Am J Gastroenterol. 2010;105:501–523.
   PubMed Web of Science ®Google Scholar
• Kuek A, Hazleman BL, Östör AJK. Immune-mediated inflammatory diseases (IMIDs) and biologic therapy: a medical revolution . Postgrad Med J. 2007;83:251–260.
   PubMed Web of Science ®Google Scholar
• Cheng J, Feldman SR. The cost of biologics for psoriasis is increasing. Drugs Context. 2014;3:212266.
   PubMedGoogle Scholar
• Wu JJ, Feldman SR, Rastogi S, et al. Comparison of the cost-effectiveness of biologic drugs used for moderate-to-severe psoriasis treatment in the United States. J Dermatolog Treat. 2018;29:769–774.
   PubMed Web of Science ®Google Scholar
• Lin PT, Wang H, Chi CC. Drug survival of biologics in treating psoriasis: a meta-analysis of real-world evidence. Sci Rep. 2018;8:1–7.
   PubMed Web of Science ®Google Scholar
• Menter A, Papp KA, Gooderham M, et al. Drug survival of biologic therapy in a large, disease-based registry of patients with psoriasis: results from the Psoriasis Longitudinal Assessment and Registry (PSOLAR). J Eur Acad Dermatol Venereol. 2016;30:1148–1158.
   PubMed Web of Science ®Google Scholar
• Arnold T, Schaarschmidt ML, Herr R, et al. Drug survival rates and reasons for drug discontinuation in psoriasis. J Dtsch Dermatol Ges. 2016;14:1089–1099.
   PubMed Web of Science ®Google Scholar
• Gniadecki R, Bang B, Bryld LE, et al. Comparison of long-term drug survival and safety of biologic agents in patients with psoriasis vulgaris. Br J Dermatol. 2015;172:244–252.
   PubMed Web of Science ®Google Scholar
• Lirhus SS, Lie Høivik M, Moum B, et al. P221 Drug survival of biologics in ulcerative colitis treatment in Norway. J Crohns Colitis. 2019;13:S206–S206.
   Web of Science ®Google Scholar
• Gisbert JP, Arredondo M, Chaparro M, et al. P508 Drug survival and reasons for discontinuation of anti-TNF therapy in inflammatory bowel disease (IBD) in clinical practice. J Crohns Colitis. 2014;8:S279.
   Web of Science ®Google Scholar
• Emery P, Vlahos B, Szczypa P, et al. Long-term drug survival of tumor necrosis factor inhibitors in patients with rheumatoid arthritis. J Rheumatol. 2020;47:493–501.
   PubMed Web of Science ®Google Scholar
• Brodszky V, Bíró A, Szekanecz Z, et al. Determinants of biological drug survival in rheumatoid arthritis: evidence from a Hungarian rheumatology center over 8 years of retrospective data. CEOR. 2017;9:139–147.
   Google Scholar
• Kishimoto M, Komine M, Kamiya K, et al. Drug survival of biologic agents for psoriatic patients in a real-world setting in Japan. J Dermatol. 2020;47:33–40.
   PubMed Web of Science ®Google Scholar
• Papamichael K, Vogelzang EH, Lambert J, et al. Therapeutic drug monitoring with biologic agents in immune mediated inflammatory diseases. Expert Rev Clin Immunol. 2019;15:837–848.
   PubMed Web of Science ®Google Scholar
• Menting SP, Coussens E, Pouw MF, et al. Developing a therapeutic range of adalimumab serum concentrations in management of psoriasis: a step toward personalized treatment. JAMA Dermatol. 2015;151:616–622.
   PubMed Web of Science ®Google Scholar
• Perry M. SAT0194 Significant overtreatment with biological drugs is common in routine care for patients where serum drug levels are monitored. Scientific Abstracts. Ann Rheum Dis. 2018;77:958.
   PubMed Web of Science ®Google Scholar
• Waljee AK, Chaisidhivej N, Saini SD, et al. De-escalation of IBD therapy: when, who, and how? Crohns Colitis 360. 2019;1:1–5.
   Google Scholar
• Takahashi H, Tsuji H, Ishida-Yamamoto A, et al. Plasma trough levels of adalimumab and infliximab in terms of clinical efficacy during the treatment of psoriasis. J Dermatol. 2013;40:39–42.
   PubMed Web of Science ®Google Scholar
• Gottlieb AB, Kalb RE, Blauvelt A, et al. The efficacy and safety of infliximab in patients with plaque psoriasis who had an inadequate response to etanercept: Results of a prospective, multicenter, open-label study. J Am Acad Dermatol. 2012;67:642–650.
   PubMed Web of Science ®Google Scholar
• Torii H, Nakagawa H. Infliximab monotherapy in Japanese patients with moderate-to-severe plaque psoriasis and psoriatic arthritis. A randomized, double-blind, placebo-controlled multicenter trial. J Dermatol Sci. 2010;59:40–49.
   PubMed Web of Science ®Google Scholar
• Wilkinson N, Tsakok T, Dand N, et al.; PSORT consortium. Defining the therapeutic range for adalimumab and predicting response in psoriasis: a multicenter prospective observational cohort study. J Invest Dermatol. 2019;139:115–123.
   PubMed Web of Science ®Google Scholar
• Mahil SK, Arkir Z, Richards G, et al. Predicting treatment response in psoriasis using serum levels of adalimumab and etanercept: a single-centre, cohort study. Br J Dermatol. 2013;169:306–313.
   PubMed Web of Science ®Google Scholar
• Carrascosa JM, Toro Montecinos M, Ballescá F, et al. Correlation between trough serum levels of adalimumab and absolute PASI score in a series of patients with psoriasis. J Dermatolog Treat. 2018;29:140–144.
   PubMed Web of Science ®Google Scholar
• Soenen R, Meulewaeter E, Grine L, et al. Defining a minimal effective serum trough concentration of secukinumab in psoriasis: a step toward personalized therapy. J Invest Dermatol. 2019;139:2232–2235.
   PubMed Web of Science ®Google Scholar
• Menting SP, van den Reek JMPA, Baerveldt EM, et al. The correlation of clinical efficacy, serum trough levels and antidrug antibodies in ustekinumab-treated patients with psoriasis in a clinical-practice setting. Br J Dermatol. 2015;173:855–857.
   PubMed Web of Science ®Google Scholar
• Toro-Montecinos M, Ballescá F, Ferrandiz C, et al. Usefulness and correlation with clinical response of serum ustekinumab levels measured at 6 weeks versus 12 weeks. J Dermatolog Treat. 2019;30:35–39.
   PubMed Web of Science ®Google Scholar
• Van den Berghe N, De Keyser E, Soenen R, et al. Clinical response correlates with 4-week postinjection ustekinumab concentrations in patients with moderate-to-severe psoriasis. Br J Dermatol. 2019;106:945–954.
   Google Scholar
• Tsakok T, Wilson N, Dand N, et al.; for the British Association of Dermatologists Biologic and Immunomodulators Register (BADBIR) Study Group and the Psoriasis Stratification to Optimise Relevant Therapy (PSORT) Consortium. Association of serum ustekinumab levels with clinical response in psoriasis. JAMA Dermatol. 2019;155:1235–1243.
   PubMed Web of Science ®Google Scholar
• Elberdín L, Outeda M, Salvador P, et al. Positive correlation between etanercept concentration and the decrease in Psoriasis Area and Severity Index scale value. Int J Clin Pharm. 2016;38:1142–1148.
   PubMed Web of Science ®Google Scholar
• Detrez I, Van Steen K, Segaert S, et al. The association between etanercept serum concentration and psoriasis severity is highly age-dependent. Clin Sci. 2017;131:1179–1189.
   PubMed Web of Science ®Google Scholar
• Chigutsa E, Velez de Mendizabal N, Chua L, et al. Exposure-response modeling to characterize the relationship between ixekizumab serum drug concentrations and efficacy responses at week 12 in patients with moderate to severe plaque psoriasis. J Clin Pharmacol. 2018;58:1489–1500.
   PubMed Web of Science ®Google Scholar
• Reich K, Jackson K, Ball S, et al. Ixekizumab pharmacokinetics, anti-drug antibodies, and efficacy through 60 weeks of treatment of moderate to severe plaque psoriasis. J Invest Dermatol. 2018;138:2168–2173.
   PubMed Web of Science ®Google Scholar
• Tham LS, Tang CC, Choi SL, et al. Population exposure-response model to support dosing evaluation of ixekizumab in patients with chronic plaque psoriasis. J Clin Pharmacol. 2014;54:1117–1124.
   PubMed Web of Science ®Google Scholar
• Hu C, Yao Z, Chen Y, et al. A comprehensive evaluation of exposure-response relationships in clinical trials: application to support guselkumab dose selection for patients with psoriasis. J Pharmacokinet Pharmacodyn. 2018;45:523–535.
   PubMed Web of Science ®Google Scholar
• Pang Y, Khatri A, Suleiman AA, et al. Clinical pharmacokinetics and pharmacodynamics of risankizumab in psoriasis patients. Clin Pharmacokinet. 2020;59:311–326.
   PubMed Web of Science ®Google Scholar
• Papp K, Thaçi D, Reich K, et al. Tildrakizumab (MK-3222), an anti-interleukin-23p19 monoclonal antibody, improves psoriasis in a phase IIb randomized placebo-controlled trial. Br J Dermatol. 2015;173:930–939.
   PubMed Web of Science ®Google Scholar
• Yanai H, Hanauer SB. Assessing response and loss of response to biological therapies in IBD. Am J Gastroenterol. 2011;106:685–698.
   PubMed Web of Science ®Google Scholar
• Restellini S, Chao CY, Lakatos PL, et al. Therapeutic drug monitoring guides the management of Crohn’s patients with secondary loss of response to adalimumab. Inflamm Bowel Dis. 2018;24:1531–1538.
   PubMed Web of Science ®Google Scholar
• Roblin X, Rinaudo M, Del Tedesco E, et al. Development of an algorithm incorporating pharmacokinetics of adalimumab in inflammatory bowel diseases. Am J Gastroenterol. 2014;109:1250–1256.
   PubMed Web of Science ®Google Scholar
• Guidi L, Pugliese D, Panici Tonucci T, et al. Therapeutic drug monitoring is more cost-effective than a clinically-based approach in the management of loss of response to infliximab in inflammatory bowel disease: an observational multi-centre study. J Crohns Colitis. 2018;12:1079–1088.
   PubMed Web of Science ®Google Scholar
• Papamichael K, Vajravelu RK, Vaughn BP, et al. Proactive infliximab monitoring following reactive testing is associated with better clinical outcomes than reactive testing alone in patients with inflammatory bowel disease. J Crohns Colitis. 2018;12:804–810.
   PubMed Web of Science ®Google Scholar
• Papamichael K, Juncadella A, Wong D, et al. Proactive therapeutic drug monitoring of adalimumab is associated with better long-term outcomes compared with standard of care in patients with inflammatory bowel disease. J Crohns Colitis. 2019;13:976–981.
   PubMed Web of Science ®Google Scholar
• Papamichael K, Chachu KA, Vajravelu RK, et al. Improved long-term outcomes of patients with inflammatory bowel disease receiving proactive compared with reactive monitoring of serum concentrations of infliximab. Clin Gastroenterol Hepatol. 2017;15:1580–1588.
   PubMed Web of Science ®Google Scholar
• Papamichael K, Vande Casteele N, Gils A, et al. Long-term outcome of patients with Crohn’s disease who discontinued infliximab therapy upon clinical remission. Clin Gastroenterol Hepatol. 2015;13:1103–1110.
   PubMed Web of Science ®Google Scholar
• Lucidarme C, Petitcollin A, Brochard C, et al. Predictors of relapse following infliximab de-escalation in patients with inflammatory bowel disease: the value of a strategy based on therapeutic drug monitoring. Aliment Pharmacol Ther. 2019;49:147–154.
   PubMed Web of Science ®Google Scholar
• Papamichael K, Cheifetz AS. Therapeutic drug monitoring in patients on biologics: lessons from gastroenterology. Curr Opin Rheumatol. 2020;32:371–379.
   PubMed Web of Science ®Google Scholar
• Detrez I, Van Stappen T, Martín Arranz MD, et al. Current practice for therapeutic drug monitoring of biopharmaceuticals in inflammatory bowel disease. Ther Drug Monit. 2017;39:344–349.
   PubMed Web of Science ®Google Scholar
• van de Kerkhof PCM, Reich K, Kavanaugh A, et al. Physician perspectives in the management of psoriasis and psoriatic arthritis: results from the population-based Multinational Assessment of Psoriasis and Psoriatic Arthritis survey. J Eur Acad Dermatol Venereol. 2015;29:2002–2010.
   PubMed Web of Science ®Google Scholar
• Phung M, Georgakopoulos JR, Ighani A, et al. Secukinumab dose optimization in adult psoriasis patients: a retrospective, multicenter case series. JAAD Case Rep. 2018;4:310–313.
   PubMedGoogle Scholar
• Phung M, Ighani A, Georgakopoulos JR, et al. Off-label high-dose secukinumab for the treatment of moderate-to-severe psoriasis. J Cutan Med Surg. 2019;23:391–393.
   PubMed Web of Science ®Google Scholar
• Hermans C, Herranz P, Segaert S, et al. Current practice of therapeutic drug monitoring of biopharmaceuticals in psoriasis patients. Ther Drug Monit. 2017;39:356–359.
   PubMed Web of Science ®Google Scholar
• Edwards CJ, Fautrel B, Schulze-Koops H, et al. Dosing down with biologic therapies: a systematic review and clinicians’ perspective. Rheumatology (Oxford). 2017;56:1847–1856.
   PubMed Web of Science ®Google Scholar
• Bouman CA, van Herwaarden N, van den Hoogen FH, et al. Long-term outcomes after disease activity-guided dose reduction of TNF inhibition in rheumatoid arthritis: 3-year data of the DRESS study - a randomised controlled pragmatic non-inferiority strategy trial. Ann Rheum Dis. 2017;76:1716–1722.
   PubMed Web of Science ®Google Scholar
• Grossberg LB, Papamichael K, Feuerstein JD, et al. A survey study of Gastroenterologists’ attitudes and barriers toward therapeutic drug monitoring of anti-TNF therapy in inflammatory bowel disease. Inflamm Bowel Dis. 2017;24:191–197.
   PubMed Web of Science ®Google Scholar
• Vermeire S, Dreesen E, Papamichael K, et al. How, when, and for whom should we perform therapeutic drug monitoring? Clin Gastroenterol Hepatol. 2020;18:1291–1299.
   PubMed Web of Science ®Google Scholar