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
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 impr...
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| Format: | Article |
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MDPI AG
2021-08-01
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| Series: | Nutrients |
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| Online Access: | https://www.mdpi.com/2072-6643/13/9/3015 |
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| author | Andreas Pinter Peter Schwarz Sascha Gerdes Jan C. Simon Anja Saalbach James Rush Nima Melzer Thomas Kramps Benjamin Häberle Maximilian Reinhardt |
| author_facet | Andreas Pinter Peter Schwarz Sascha Gerdes Jan C. Simon Anja Saalbach James Rush Nima Melzer Thomas Kramps Benjamin Häberle Maximilian Reinhardt |
| author_sort | Andreas Pinter |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-03-10T07:21:42Z |
| format | Article |
| id | doaj.art-da6db7c9ac154fdda4bc49ef936dc6a2 |
| institution | Directory Open Access Journal |
| issn | 2072-6643 |
| language | English |
| last_indexed | 2024-03-10T07:21:42Z |
| publishDate | 2021-08-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Nutrients |
| spelling | doaj.art-da6db7c9ac154fdda4bc49ef936dc6a22023-11-22T14:35:59ZengMDPI AGNutrients2072-66432021-08-01139301510.3390/nu13093015Biologic 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 TrialAndreas Pinter0Peter Schwarz1Sascha Gerdes2Jan C. Simon3Anja Saalbach4James Rush5Nima Melzer6Thomas Kramps7Benjamin Häberle8Maximilian Reinhardt9Department of Dermatology, Venereology and Allergology, Clinical Research Division University Hospital Frankfurt am Main, Theodor-Stern-Kai 7, 60590 Frankfurt am Main, GermanyDepartment for Prevention and Care of Diabetes, Medical Faculty Carl Gustav Carus, Technical University of Dresden, 01062 Dresden, GermanyPsoriasis-Center, Department of Dermatology, Campus Kiel, University Medical Center Schleswig-Holstein, 24105 Kiel, GermanyDepartment of Dermatology, Venerology and Allergology, Leipzig University Medical Center, 04103 Leipzig, GermanyDepartment of Dermatology, Venerology and Allergology, Leipzig University Medical Center, 04103 Leipzig, GermanyNovartis Pharma AG, 4056 Basel, SwitzerlandNovartis Pharma GmbH, 90429 Nuremberg, GermanyNovartis Pharma GmbH, 90429 Nuremberg, GermanyNovartis Pharma GmbH, 90429 Nuremberg, GermanyNovartis Pharma AG, 4056 Basel, SwitzerlandInflammatory 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.https://www.mdpi.com/2072-6643/13/9/3015psoriasisobesitymetabolic syndromesecukinumabinflammation |
| spellingShingle | Andreas Pinter Peter Schwarz Sascha Gerdes Jan C. Simon Anja Saalbach James Rush Nima Melzer Thomas Kramps Benjamin Häberle Maximilian Reinhardt 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 Nutrients psoriasis obesity metabolic syndrome secukinumab inflammation |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | psoriasis obesity metabolic syndrome secukinumab inflammation |
| url | https://www.mdpi.com/2072-6643/13/9/3015 |
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