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113 results on '"Gilloteau, I."'

1. Secukinumab demonstrates greater sustained improvements in daily activities and personal relationships than ustekinumab in patients with moderate‐to‐severe plaque psoriasis: 52‐week results from the CLEAR study

Author

Blauvelt, A, Reich, K, Mehlis, S, Vanaclocha, F, Sofen, H, Abramovits, W, Zhao, Y, Gilloteau, I, Davenport, E, Williams, N, Guana, A, and Tyring, S

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Clinical Research, Autoimmune Disease, HIV/AIDS, Psoriasis, Activities of Daily Living, Adult, Antibodies, Monoclonal, Antibodies, Monoclonal, Humanized, Dermatologic Agents, Double-Blind Method, Female, Humans, Interpersonal Relations, Male, Middle Aged, Severity of Illness Index, Ustekinumab, Dermatology & Venereal Diseases, Clinical sciences
Abstract

BackgroundPsoriasis can greatly impact patients' lives by influencing clothing worn as well as by impairing sexual functioning. Secukinumab, a human monoclonal antibody selectively neutralizing interleukin-17A, has demonstrated good efficacy and safety in the treatment of moderate-to-severe psoriasis and psoriatic arthritis with a rapid onset of action and sustained response.ObjectiveThis analysis using the CLEAR study, a phase 3b double-blind study comparing the efficacy and safety of secukinumab vs. ustekinumab in adults with moderate-to-severe plaque psoriasis, evaluated the treatment effects on patient's daily activities and personal relationships.MethodsImpact on daily activities (interference with home/shopping/garden, and influence on clothes worn) and impact on personal relationships (problems with partner/others, and sexual difficulties) as well as their corresponding subscales were selected from the Dermatology Life Quality Index scale and evaluated for patients treated with secukinumab vs. ustekinumab from the CLEAR study. Treatment differences in mean scores and proportions of responders (score = 0, indicating no impact) were evaluated through 52 weeks. Time to response was evaluated through Week 16.ResultsSignificant differences between secukinumab and ustekinumab were observed for daily activities and personal relationships at Week 16 and sustained through Week 52 (Week 52 response rates for daily activities: 82.9% vs. 73.5%, including interference with home/shopping/garden: 88.5% vs. 78.2%, and influence on clothes worn: 85.6% vs. 74.4%; personal relationships: 86.1% vs. 73.7%, including problems with partner/others: 86.6% vs. 74.8%, and sexual difficulties: 88.5% vs. 74.3%; all P < 0.01). The median time to response was 4 weeks for secukinumab vs. 8 weeks for ustekinumab for daily activities and personal relationships (both P < 0.05).ConclusionSecukinumab treatment helps patients with moderate-to-severe plaque psoriasis have a more normal life faster when compared to ustekinumab, by providing greater and sustained improvement in clothing choice and sexual functioning.

Published
2017

3. The effect of secukinumab on patient-reported outcomes in patients with active psoriatic arthritis in a randomised phase 3 trial

Author

Strand, V, Kaeley, GS, Bergman, MJ, Gladman, DD, Coates, LC, Sherif, B, Hur, P, Parikh, B, Gilloteau, I, and Mease, PJ

Subjects
Rheumatology, Immunology, Immunology and Allergy
Abstract

Background: The phase 3 FUTURE 5 trial (NCT02404350) showed the clinical and radiographical efficacy of secukinumab in patients with psoriatic arthritis. This analysis aimed to assess the effect of secukinumab on patient-reported outcomes (PROs). Methods: FUTURE 5 was a phase 3, multicentre, parallel-group randomised trial in which patients who were 18 years old or older, met the classification criteria for psoriatic arthritis at screening, and had symptoms of moderate-to-severe psoriatic arthritis for at least 6 months were randomly assigned to receive secukinumab 300 mg, 150 mg, 150 mg no loading dose (NL), or placebo weekly from baseline to week 4 and every 4 weeks thereafter. The prespecified PROs of the FUTURE 5 trial were assessed first in the overall population. We report mean changes from baseline and the proportion of patients reporting improvements equal to or more than the minimum clinically important differences (MCIDs) and scores equal to or more than the normative values for patient global assessments (PtGA) of disease activity; psoriasis and arthritis visual analogue scale (VAS) scores; pain VAS; Health Assessment Questionnaire Disability Index (HAQ-DI); 36-item Short Form Health Survey (SF-36); Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F); and quality of life questionnaires. Patients were then stratified and assessed according to their tumour necrosis factor (TNF) inhibitor status (TNF-naive and TNF-inadequate responder [TNF-IR] populations) as a post-hoc analysis. Findings: Patients in all secukinumab groups reported significant least-squares mean changes from placebo at week 16 in all PROs except SF-36 mental component summary (MCS), irrespective of TNF inhibitor use. These included PtGA (300 mg difference vs placebo −12·2 [95% CI −16·3 to −8·1], 150 mg −8·22 [−12·4 to −4·1], 150 mg NL −8·3 [−12·5 to −4·2]; all p Interpretation: Secukinumab resulted in early, statistically significant, clinically meaningful, sustained improvements in PROs across all doses compared with placebo in patients with active psoriatic arthritis. These improvements were seen irrespective of previous TNF inhibitor use, in a post-hoc analysis. These results indicate that secukinumab provides comprehensive improvement for patients with psoriatic arthritis, regardless of previous therapy.

Published
2022
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4. Secukinumab Provides Sustained Reduction in Fatigue in Patients with Ankylosing Spondylitis: Long‐term Results of Two Phase III Randomized Controlled Trials

Author

Kvien, TK, Conaghan, PG, Gossec, L, Strand, V, Østergaard, M, Poddubnyy, D, Williams, N, Porter, B, Shete, A, Gilloteau, I, and Deodhar, A

Abstract

Objective To investigate the longer‐term effects of secukinumab 150 mg on fatigue in patients with ankylosing spondylitis (AS) in MEASURE 1 (up to 3 years) and MEASURE 2 (up to 2 years). Methods Patients with active AS were randomized to secukinumab or placebo in MEASURE 1 (10 mg/kg intravenous [IV] followed by 150 mg subcutaneous [SC]) and MEASURE 2 (150 mg SC). Patients were naive to or had an inadequate response/intolerance to tumor necrosis factor inhibitors (anti‐TNF‐naive/ anti‐TNF‐IR). Fatigue was measured using the Functional Assessment of Chronic Illness Therapy‐Fatigue (FACIT‐F) scale. Relationships between fatigue response and baseline characteristics and clinical/laboratory variables were explored. Results Significant improvements in FACIT‐F scores from baseline were observed with secukinumab across both studies versus placebo at week 16 (P < 0.05). Improvements were sustained through week 156 (MEASURE 1)/week 104 (MEASURE 2). Significantly more patients reported fatigue responses (FACIT‐F increase ≥4; observed data) with secukinumab 150 mg than placebo at week 16 in both MEASURE 1 (P < 0.05) and MEASURE 2 (P < 0.01). Fatigue responses were achieved by 75.6% of patients receiving secukinumab at week 156 (MEASURE 1) and 81.4% at week 104 (MEASURE 2); these results were consistent in both anti‐TNF‐naive (74.3% and 84.6%) and anti‐TNF‐IR (81.3% and 75.0%) patients. Baseline characteristics did not predict improvement in fatigue consistently. Fatigue responses were moderately to strongly correlated with responses in several clinical measures, including Assessment of SpondyloArthritis international Society (ASAS)20/40, ASAS5/6 responses, Ankylosing Spondylitis Disease Activity Score‐C reactive protein (ASDAS‐CRP), Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), and Short‐form (SF)‐36 scores. Conclusion Secukinumab provided rapid and sustained improvements in fatigue for up to 3 years, regardless of prior anti‐TNF exposure.

Published
2022

5. 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

Author

Behrens, F, Mease, P, Lebwohl, M, Thaci, D, Gilloteau, I, Fox, T, DiComite, G, Guana, A, Jugl, S, Peterlik, D, Lefèvre, S, and Gottlieb, AB

Subjects
ddc: 610, 610 Medical sciences, Medicine, urologic and male genital diseases
Abstract

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[for full text, please go to the a.m. URL], 46. Kongress der Deutschen Gesellschaft für Rheumatologie (DGRh), 32. Jahrestagung der Deutschen Gesellschaft für Orthopädische Rheumatologie (DGORh), Wissenschaftliche Herbsttagung der Gesellschaft für Kinder- und Jugendrheumatologie (GKJR)

Published
2019
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6. Secukinumab demonstrates sustained efficacy in clearing skin and improving patient-reported outcomes in patients with moderate-to-severe psoriasis through 2 years of treatment : Results from the CLEAR study

Author

Thaçi, Diamant, Puig Sanz, Lluís., Reich, K., Tsai, T.F., Tyring, S., Kingo, K., Ziv, M., Pinter, A., Vender, R., Lacombe, A., Xia, S., Bhosekar, V., Gilloteau, I., Guana, A., Blauvelt, A., and Universitat Autònoma de Barcelona

Subjects
medicine.medical_specialty, business.industry, Moderate to severe psoriasis, MEDLINE, Dermatology, Treatment results, law.invention, Randomized controlled trial, law, Internal medicine, Severity of illness, Monoclonal, Medicine, In patient, Secukinumab, business
Abstract

Altres ajuts: The authors thank Dhaval Gupta, MPH (Novartis Healthcare Pvt Ltd, India), and Jackie L. Johnson, PhD (Novartis Ireland Ltd), for providing medical writing support, which was funded by Novartis Pharma AG, Basel, Switzerland, in accordance with Good Publication Practice guidelines (http://www.ismpp.org/gpp3).

Published
2019

15. Cost Per-Responder Analysis of Secukinumab Compared to Other Biologics for Treatment of Moderate to Severe Psoriasis Patients in Saudi Arabia

Author

Al Howimel, M, primary, Al Jufan, K, additional, AlAlwan, A, additional, Alshehri, N, additional, Al Amri, A, additional, Al Hamdan, H, additional, Al Mudaiheem, H, additional, Zakaria, N, additional, Al Kateb, L, additional, Gilloteau, I, additional, Graham, CN, additional, and Sekharan, M, additional

Published
2018
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16. A Cost-Per-Responder Analysis of Secukinumab Compared with Ustekinumab in Saudi Arabia: Results from the Clear Study of Patients With Moderate to Severe Psoriasis

Author

Al Howimel, M, primary, Al Jufan, K, additional, AlAlwan, A, additional, Alshehri, N, additional, Al Mudaiheem, H, additional, Al Amri, A, additional, Al Hamdan, H, additional, Zakaria, N, additional, Al Kateb, L, additional, Gilloteau, I, additional, Graham, CN, additional, and Sekharan, M, additional

Published
2018
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33. Effect of nivolumab (NIVO) on quality of life (QoL) in patients (pts) with treatment-naïve advanced melanoma (MEL): results of a phase III study (CheckMate 066)

Author

Long, G.V., primary, Atkinson, V., additional, Ascierto, P.A., additional, Robert, C., additional, Hassel, J.C., additional, Rutkowski, P., additional, Savage, K.J., additional, Taylor, F., additional, Coon, C., additional, Gilloteau, I., additional, Dastani, H.B., additional, Waxman, I., additional, and Abernethy, A.P., additional

Published
2015
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