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