Article
Secukinumab relieves anxiety/depression up to 1 year in patients treated for psoriatic arthritis and moderate to severe psoriasis: an overview from phase 3 clinical trials
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Authors
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Frank Behrens
- Center for Innovative Diagnostics and Therapy in Rheumatology/Immunology (CIRI), Goethe University Frankfurt, Frankfurt/Main
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Philip Mease
- Department of Rheumatology, Swedish Medical Center, and University of Washington, Seattle, WA, USA
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Mark Lebwohl
- Icahn School of Medicine at Mount Sinai, New York, NY, USA
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Diamant Thaci
- Comprehensive Center for Inflammation Medicine (CCIM), University Hospital Schleswig-Holstein, Lübeck
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Isabelle Gilloteau
- Novartis Pharma AG, Basel, Schweiz
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Todd Fox
- Novartis Pharma AG, Basel, Schweiz
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Gabriele DiComite
- Novartis Pharma AG, Basel, Schweiz
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Adriana Guana
- Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA
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Steffen Jugl
- Novartis Pharma AG, Basel, Schweiz
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Daniel Peterlik
- Novartis Pharma GmbH, Nürnberg
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Stephanie Lefèvre
- Novartis Pharma GmbH, Nürnberg
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Alice B. Gottlieb
- Department of Dermatology, New York Medical College, Metropolitan Hospital, New York, NY, USA
| Published: | February 5, 2019 |
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Outline
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Background: Psoriatic arthritis (PsA) and psoriasis patients are at greater risk for psychological distress, including depression and suicidality. Secukinumab is a fully human monoclonal antibody that selectively neutralizes IL-17A, a key cytokine involved in the development of psoriasis and PsA. Secukinumab has shown a rapid onset of action, long lasting efficacy and safety in both diseases. Previous analysis from psoriasis studies reported high and sustained relief from anxiety/depression in patients treated with secukinumab up to week (wk) 52 (~80% of patients being “not anxious/depressed”). Here, we aim to confirm and extend these results in additionalsubanalyses fromsecukinumab trials for PsA and psoriasis patients.
Methods: Evaluation of the ‘anxiety/depression’ dimension of EuroQol 5-dimensional and 3-level questionnaire (EQ-5D-3L) derived from three phase 3 studies using approved secukinumab dose(s). FUTURE 1 and 2, two randomized, double-blind clinical trials comparing secukinumab 150 mg and 300 mg to placebo in active PsA, and CLEAR, a double-blind, parallel-group study comparing secukinumab 300 mg to ustekinumab in moderate to severe psoriasis. The proportions of patients reporting being “not anxious/depressed" up to wk 52 are described as “as observed” (FUTURE 1 and 2) and “last observation carried forward” (CLEAR).
Results: In FUTURE 1, 76/200 (38.0%) PsA patients treated with secukinumab 150 mg reported being “not anxious/depressed” at baseline, increasing to 99/192 (51.6%) at wk 4 and 109/184 (59.2%) at wk 52. In FUTURE 2, 32/100 (32.0%) and 41/99 (41.4%) PsA patients treated with secukinumab 150 mg/300 mg, respectively, reported being “not anxious/depressed” at baseline, increasing to 51/99 (51.5%) and 52/95 (54.7%) at wk 4 and 49/89 (55.1%) and 55/95 (57.9%) at wk 52. In the CLEAR study, 154/326 (47.2%) psoriasis patients treated with secukinumab 300mg reported being “not anxious/depressed” at baseline, 238/322 (73.9%) at wk 4, and 267/331, (80.7%) at wk 52, vs 156/330 (47.3%) psoriasis patients treated with ustekinumab reported being “not anxious/depressed” at baseline, 218/330 (66.1%) at wk 4, and 258/333 (77.5%) at wk 52.
Conclusion: Analysis of the EQ-5D-3L anxiety/depression measure from three phase 3 trials showed that psoriatic arthritis and moderate to severe psoriasis patients improved andsustained relief from anxiety/depression up to 1 year of secukinumab treatment.
