INVESTIGATIVE REPORT
705 Advances in dermatology and venereology ActaDV Acta Dermato-Venereologica ActaDV
Routine Laboratory Parameter Dynamics and Laboratory Adverse Events in Psoriasis Patients on Long-term Treatment with Adalimumab, Etanercept, and Ustekinumab
Jochen H. O. HOFFMANN 1, Christian KNOOP 1, 2, Alexander H. ENK 1 and Eva N. HADASCHIK 1
1
Department of Dermatology, University of Heidelberg, Heidelberg, and 2 Current address: Artemed Fachklinik, Bad Oeynhausen, Germany
Only limited data on laboratory parameter dynamics and safety under prolonged biologic treatment in a“ real-world” scenario are available for recommendations on screening and monitoring. This study is a retrospective analysis of routine parameter dynamics and laboratory adverse events( LAE) in psoriasis patients on long-term treatment( n = 199) with tumour necrosis factor( TNF)-α-antagonists( adalimumab, etanercept), and the interleukin( IL) 12 / 23-antagonist ustekinumab. Overall, neutrophil( PMN) counts(– 11 %) and triglycerides(+ 9 %) changed considerably. TNFα-antagonists and ustekinumab differentially affected lymphocyte counts(+ 13 % and ± 0 %, respectively). Dynamics were pronounced during the first 180 days of treatment. In 340 treatment-years, 15 Common Terminology Criteria for Adverse Events( CTCAE) III – IV ° LAE were recorded( 11 involved liver enzymes). They prompted alteration of the biologic regime in only 2 cases. Age, sex, previous systemic treatments, and psoriatic arthritis did not significantly predict LAE. Liver enzyme and triglyceride screening may be warranted in some instances. Our data suggest that unguided monitoring of other routine laboratory parameters is unnecessary under long-term biologic treatment.
Key words: psoriasis; biological products; adalimumab; etanercept; ustekinumab; neutrophils; lymphocytes; transaminases; triglycerides; blood cell count; clinical chemistry tests.
Accepted Feb 20, 2017: Epub ahead of print Feb 22, 2017 Acta Derm Venereol 2017; 97: 705 – 710.
Corr: Jochen Hoffmann, Department of Dermatology, University of Heidelberg, INF 440, DE-69120 Heidelberg, Germany. E-mail: jochen. hoffmann @ med. uni-heidelberg. de
Recommendations of international dermatological societies on routine laboratory parameter monitoring under biologic treatment include complete blood count( CBC) and a comprehensive metabolic panel( 1 – 3). These recommendations are based on a limited number of studies. In particular“ real-world” data are sparse. A recent review( 4) identified only one study providing data on routine laboratory parameter dynamics under long-term treatment with adalimumab and etanercept( 5). Long-term treatment of psoriasis patients with the tumour necrosis factor α( TNF-α) antagonists adalimumab and etanercept, and the IL12 / 23 antagonist ustekinumab is, however, becoming increasingly common in everyday dermatological practice. A detailed description of routine parameter dynamics under long-term adalimumab and etanercept treatment and data on routine laboratory parameter dynamics under long-term ustekinumab treatment under“ real-world” conditions are therefore desirable to further optimize and harmonize recommendations on monitoring under biologic treatment.
We present here a retrospective data analysis that encompasses 199 treatments with adalimumab, etanercept, and ustekinumab. Parameter dynamics under treatment were assessed and compared among the individual biologics. Laboratory adverse events( LAEs) were identified and graded according to Common Terminology Criteria for Adverse Events( CTCAE) criteria. Finally, possible predictors of CTCAE III – IV ° adverse events were investigated.
MATERIALS AND METHODS Patients
Patients were eligible for study participation if:( i) they were treated with adalimumab, etanercept, or ustekinumab for psoriasis vulgaris( PV), psoriasis guttata( PG), psoriasis palmoplantaris pustulosa( PPP) with or without accompanying psoriasis arthritis( PA) at our institution;( ii) laboratory data under treatment was available for at least one biologic; and( iii) they gave informed consent to retrospective data analysis. A treatment cycle encompassed the interval from initiation to termination of a specific treatment. Patients consecutively treated with adalimumab, etanercept, and ustekinumab could contribute data to all biologics. Overall, 35 patients contributed data for 2 different biologics, and 10 patients contributed data for 3 different biologics. If treatment with a given biologic was, however, terminated for any reason and re-initiated later, only the first treatment cycle was eligible. This study was approved by the local ethics committee.
Standard treatment schemes and clinical status
Typically, 40 mg adalimumab( Humira; AbbVie, North Chicago, IL, USA) is administered subcutaneously( s. c.) every other week after an initial loading dose of 80 mg. Etanercept( Enbrel; Pfizer, New York City, USA) is administered s. c. with an initial dose of 25 – 50 mg biweekly or 25 mg weekly for 12 weeks followed by biweekly administration of 25 mg or weekly administration of 50 mg following national guidelines( 6). Ustekinumab( Stelara; Janssen-Cilag, Neuss, Germany) is administered s. c. at weeks 0, 4, and 12 – weekly thereafter, at weight-adapted doses of 45 or 90 mg. Routine visits are usually scheduled every 8 – 12 weeks. Psoriasis Area and Severity Index( PASI) scores were accepted as baseline score only if obtained less than 30 days prior to treatment initiation.
This is an open access article under the CC BY-NC license. www. medicaljournals. se / acta Journal Compilation © 2017 Acta Dermato-Venereologica. doi: 10.2340 / 00015555-2644 Acta Derm Venereol 2017; 97: 705 – 710