Niveles de Ustekinumab, utiles?

Published in Dermatology

Journal Scan / Research · October 12, 2019

Association of Serum Ustekinumab Levels With Clinical Response in Psoriasis

JAMA Dermatology

TAKE-HOME MESSAGE

• This prospective observational cohort study evaluated the clinical utility of therapeutic drug monitoring for ustekinumab by including 491 adults in whom ustekinumab levels were measured by enzyme-linked immunosorbent assay (ELISA). Multivariable models for a 75% reduction in PASI score that adjusted for drug dose, baseline PASI score, and age demonstrated that treatment response increased along with increasing drug levels. Antidrug antibodies were detected in only 3.5% of patients within the first year of treatment.

• This study provides evidence that early ustekinumab levels (at less than 12 weeks) were significantly associated with a 6-month response in 75% reduction in PASI, but not with a 90% reduction in PASI or a PASI score of ≤1.5.

– Caroline Crabtree,MD

Abstract 

High-cost biologic therapies have transformed the management of immune-mediated inflammatory diseases. To optimize outcomes and reduce costs, dose adjustment informed by measurement of circulating drug levels has been shown to be effective in various settings. However, limited evidence exists for this approach with the interleukin 12 and interleukin 23 inhibitor ustekinumab.

OBJECTIVE

To evaluate clinical utility of therapeutic drug monitoring for ustekinumab in patients with psoriasis.

DESIGN, SETTING, AND PARTICIPANTS

A prospective observational cohort of 491 adults with psoriasis was recruited to the multicenter Biomarkers of Systemic Treatment Outcomes in Psoriasis study within the British Association of Dermatologists Biologic and Immunomodulators Register from June 2009 to December 2017; samples from some patients were taken between 2009 and 2011 as part of a pilot study with the same inclusion criteria.

EXPOSURE

Serum ustekinumab level measured at any point during the dosing cycle using an enzyme-linked immunosorbent assay.

MAIN OUTCOMES AND MEASURES

Disease activity measured using the Psoriasis Area and Severity Index (PASI) score. Treatment response outcomes were PASI75 (75% reduction in PASI score from baseline [primary outcome]), PASI90 (90% reduction of PASI score from baseline), and absolute PASI score of 1.5 or less.

RESULTS

A total of 491 patients (171 women and 320 men; mean [SD] age, 45.7 [12.8] years) had 1 or more serum samples (total, 853 samples obtained 0-56 weeks from start of treatment) and 1 or more PASI scores within the first year of treatment. Antidrug antibodies were detected in only 17 of 490 patients (3.5%). Early measured drug levels (1-12 weeks after starting treatment) were associated with PASI75 response 6 months after starting treatment (odds ratio, 1.38; 95% CI, 1.11-1.71) when adjusted for baseline PASI score, age, and ustekinumab dose. However, this finding was not consistent across the other PASI outcomes (PASI90 and PASI score of ≤1.5).

CONCLUSIONS AND RELEVANCE

This real-world study provides evidence that measurement of early serum ustekinumab levels could be useful to direct the treatment strategy for psoriasis. Adequate drug exposure early in the treatment cycle may be particularly important in determining clinical outcome

JAMA Dermatology

Association of Serum Ustekinumab Levels With Clinical Response in Psoriasis

JAMA Dermatol 2019 Sep 18;[EPub Ahead of Print], T Tsakok, N Wilson, N Dand, FC Loeff, K Bloem, D Baudry, M Duckworth, S Pan, A Pushpa-Rajah, JF Standing, A de Vries, A Alsharqi, G Becher, R Murphy, S Wahie, A Wright, CEM Griffiths, NJ Reynolds, J Barker, RB Warren, AD Burden, T Rispens, D Stocken, C Smith 

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Benjamin Hidalgo-Matlock
Skin Care Physicians of Costa Rica

Clinica Victoria en San Pedro: 4000-1054
Momentum Escazu: 2101-9574

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