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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.