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Randomized Controlled Trial
. 2017 May 8;17(1):6.
doi: 10.1186/s12895-017-0057-6.

Tight controlled dose reduction of biologics in psoriasis patients with low disease activity: a randomized pragmatic non-inferiority trial

Selma Atalay  1 , Juul M P A van den Reek  2 , Lieke J van Vugt  2 , Marisol E Otero  2 , Peter C M van de Kerkhof  2 , Alfons A den Broeder  3 , Wietske Kievit  4 , Elke M G J de Jong  2   5
Affiliations
Randomized Controlled Trial

Tight controlled dose reduction of biologics in psoriasis patients with low disease activity: a randomized pragmatic non-inferiority trial

Selma Atalay et al. BMC Dermatol. .

Abstract

Background: Psoriasis is an immune-mediated chronic inflammatory skin disorder for which several targeted biologic therapies became available in the last 10 years. Data from patients with rheumatoid arthritis revealed that dose tapering combined with tight control of disease activity is successful. For psoriasis patients the lowest effective dose of biologics needs to be determined. The objective was to assess whether dose tapering of biologics guided by Psoriasis Area and Severity Index (PASI) and Dermatology Quality of Life Index (DLQI) scores in psoriasis patients with controlled disease activity is non-inferior (NI) to usual care.

Methods/design: This is a multicenter, pragmatic, randomized, non-inferiority trial with cost- effectiveness analysis. One hundred and twenty patients with stable low disease activity (PASI ≤ 5 and DLQI ≤ 5) for at least 6 months with a stable use of adalimumab, etanercept or ustekinumab will be randomized 1:1 to the dose reduction group or usual care. In the dose reduction group, the treatment intervals will be prolonged stepwise, resulting in a 33% and 50% dose reduction, respectively. Disease activity is monitored every three months with PASI and DLQI. In case of flare the treatment is adjusted to the previous effective dose. The primary outcome (PASI) at 12 months will be analyzed with ANCOVA in which the baseline PASI will be included as covariate to gain efficiency. The secondary outcomes include number of and time to disease flares, health-related quality of life, serious adverse events, and costs.

Discussion: With this study we want to assess whether disease activity guided dose reduction of biologics can be achieved for psoriasis patients with low stable disease activity, without losing disease control. By using the lowest effective dose of biologics, we expect to minimize side effects and save costs.

Trial registration: This trial was registered at ClinicalTrials.gov ( NCT 02602925 ). Trial registration date October 9 2015.

Trial registration: ClinicalTrials.gov NCT02602925.

Keywords: Adalimumab; Biologics; Cost-effectiveness; Dose reduction; Etanercept; Non- inferiority; Psoriasis; Therapy; Ustekinumab.

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Figures

Fig. 1
Fig. 1
Patients using adalimumab, etanercept or ustekinumab will be randomized to dose tapering or usual care. Control visits will be planned every 3 months for the assessments of PASI, DLQI, cost-effectiveness questionnaires, drug levels and anti-drug antibodies (at trough moment). Ustekinumab blood samples for immunologic analyses are taken at deviating time points (trough moments) due to the low frequency of injections. CEQ = Cost-effectiveness questionnaires (SF-36, iMTA Medical Consumption Questionnaire and productivity cost questionnaire), PASI = Psoriasis Area and Severity Index, DLQI = Dermatology Quality of Life
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