TY  - JOUR
A1  - Pinter, Andreas
A1  - Schwarz, Peter
A1  - Gerdes, Sascha
A1  - Simon, Jan C.
A1  - Saalbach, Anja
A1  - Rush, James
A1  - Melzer, Nima
A1  - Kramps, Thomas
A1  - Häberle, Benjamin
A1  - Reinhardt, Maximilian
T1  - Biologic treatment in combination with lifestyle intervention in moderate to severe plaque psoriasis and concomitant metabolic syndrome: rationale and methodology of the METABOLyx randomized controlled clinical trial
T2  - Nutrients
N2  - Inflammatory diseases including psoriasis are associated with metabolic and cardiovascular comorbidities, including obesity and metabolic syndrome. Obesity is associated with greater psoriasis disease severity and reduced response to treatment. Therefore, targeting metabolic comorbidities could improve patients’ health status and psoriasis-specific outcomes. METABOLyx is a randomized controlled trial evaluating the combination of a lifestyle intervention program with secukinumab treatment in psoriasis. Here, the rationale, methodology and baseline patient characteristics of METABOLyx are presented. A total of 768 patients with concomitant moderate to severe plaque psoriasis and metabolic syndrome were randomized to secukinumab 300 mg, or secukinumab 300 mg plus a tailored lifestyle intervention program, over 24 weeks. A substudy of immunologic and metabolic biomarkers is ongoing. The primary endpoint of METABOLyx is PASI90 response at week 24. Other endpoints include patient-reported outcomes and safety. METABOLyx represents the first large scale clinical trial of an immunomodulatory biologic in combination with a standardized lifestyle intervention.
KW  - psoriasis
KW  - obesity
KW  - metabolic syndrome
KW  - secukinumab
KW  - inflammation
Y1  - 2021
UR  - http://publikationen.ub.uni-frankfurt.de/frontdoor/index/index/docId/62181
UR  - https://nbn-resolving.org/urn:nbn:de:hebis:30:3-621818
SN  - 2072-6643
N1  - The METABOLyx study is sponsored by Novartis Pharma GmbH, Nuremberg, Germany.
VL  - 13
IS  - 9, art. 3015
SP  - 1
EP  - 14
PB  - MDPI
CY  - Basel
ER  -