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CLINICAL REPORT Advances in dermatology and venereology ActaDV Acta Dermato-Venereologica ActaDV
Adalimumab Dose Tapering in Psoriasis : Predictive Factors for Maintenance of Complete Clearance
Katharina HANSEL 1 , Leonardo BIANCHI 1 , Francesco LANZA 1 , Vittorio BINI 2 and Luca STINGENI 1
1
Clinical , Allergological and Venereological Dermatology Section , and 2 Internal Medicine , Endocrine and Metabolic Sciences Section , Department of Medicine , University of Perugia , Perugia , Italy
Psoriasis can be managed successfully with long-term biologics . Real-life clinical practice may require dose tapering as a therapeutic option to reduce the risk of drug-exposure and to increase cost-effectiveness . The responsiveness to extended intervals between adalimumab doses and the possible predictive factors of maintenance of complete clearance were studied in a retrospective 7-year single-centre analysis . Thirty patients who achieved complete clearance with adalimumab underwent dose tapering , progressively extending between-dose intervals ( to 21 – 28 days ). Sixty percent of subjects ( group A ) maintained complete clearance , whereas 40.0 % ( group B ) relapsed and were switched back to the standard dosage to re-achieve complete clearance . Body mass index ( BMI ) and time to achieve Psoriasis Area Severity Index ( PASI-100 ) with adalimumab standard treatment before dose tapering were significantly lower in group A than in group B ( multivariate Cox regression : p < 0.05 , Kaplan – Meier analysis : p < 0.001 , respectively ). This study suggests that patients with lower BMI and shorter time to achieve PASI-100 with adalimumab standard dose were significantly more likely to be candidates for dose tapering .
Key words : adalimumab ; psoriasis ; dose tapering ; long-term safety ; cost-saving ; patient compliance .
Accepted Nov 8 , 2016 ; Epub ahead of print Nov 10 , 2016 Acta Derm Venereol 2017 ; 97 : 346 – 350 .
Corr : Luca Stingeni , Clinical , Allergological and Venereological Dermatology Section , Department of Medicine , Azienda ospedaliero-universitaria of Perugia , Santa Maria della Misericordia Hospital , Sant ’ Andrea delle Fratte , IT-06129 Perugia , Italy . E-mail : luca . stingeni @ unipg . it
Psoriasis ( PsO ) is a chronic immune-mediated inflammatory skin disease affecting approximately 2 – 3 % of the general population worldwide ( 1 ) and impairing patient ’ s quality of life ( 2 ). The advent of tumour necrosis factor ( TNF ) -α inhibitors allows a more targeted and effective approach to the treatment of moderate-to-severe PsO and represents a major breakthrough for patients ( 3 ). Among TNF-α inhibitors , adalimumab is a recombinant , fully human , monoclonal antibody approved for the treatment of some chronic immune-mediated inflammatory diseases , including moderate-to-severe plaque PsO in adult and paediatric patients , and psoriatic arthritis ( PsA ) ( 4 ).
The safety and long-term effectiveness of adalimumab in the treatment of PsO were confirmed recently by observational post-marketing studies ( 5 , 6 ) and reallife experiences ( 7 , 8 ). Currently , continuous long-term treatment with adalimumab after the achievement of 75 / 90 / 100 % reduction in the Psoriasis Area and Severity Index ( PASI-75 / 90 / 100 ) is recommended ( 9 ). However , considering the possible dose-dependent higher risk of malignancies ( 10 ), the cost-effectiveness of this treatment ( 11 ), and the individual needs ( 2 ) of patients treated with biologic drugs , the question is whether patients in stable complete clearance ( PASI-100 ) should be treated at full dosage , a tapered dosage , or whether treatment should be discontinued .
Adalimumab dose tapering , obtained either by increasing the interval between doses or by reducing dosage , was previously and successfully reported in a consistent proportion of patients with rheumatoid arthritis ( 12 , 13 ), ankylosing spondylitis ( 14 , 15 ), and with PsA ( 16 ). Dose tapering of adalimumab is rarely reported in PsO ( 17 – 21 ), and there is no evidence regarding predictive factors to define the profile of patients suited to this drug-specific therapeutic strategy . Carrascosa et al . ( 19 ) reported greater PASI improvement with biologics ( adalimumab , etanercept , infliximab , and ustekinumab ) in dose-tapered patients .
The primary objective of this retrospective study was to investigate responsiveness to dose tapering obtained with progressive extension of between-dose intervals in patients treated with adalimumab and having sustained complete clearance . The secondary objective was to identify in these patients the predictive factors of maintenance of complete clearance .
METHODS Study population
An up-to 7-year follow-up observational retrospective study was performed of patients referred to the PsO outpatient clinic within the Dermatology Section of Perugia University , Perugia , Italy , who had been optimally treated with adalimumab between 2008 and 2015 . All patients received treatment with adalimumab at an initial dose of subcutaneous 80 mg , followed by a standard dose ( 40 mg ) administered every other week ( EOW ), starting one week after the initial booster dose . Inclusion criteria were : ( i ) longstanding moderate-to-severe PsO treated with adalimumab administered EOW at standard dose ; ( ii ) achieved and sustained PASI-100 for one year . Exclusion criteria were : ( i ) not achieved PASI-100 ; ( ii ) doi : 10.2340 / 00015555-2571 Acta Derm Venereol 2017 ; 97 : 346 – 350
This is an open access article under the CC BY-NC license . www . medicaljournals . se / acta Journal Compilation © 2017 Acta Dermato-Venereologica .