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26-10-2019

Ixekizumab treatment and the impact on SF-36: results from three pivotal phase III randomised controlled trials in patients with moderate-to-severe plaque psoriasis

Auteurs: Richard G. B. Langley, Kristian Reich, Vibeke Strand, Steven R. Feldman, Carle Paul, Kenneth Gordon, Richard B. Warren, Darryl Toth, Enkeleida Nikaï, Baojin Zhu, Orin Goldblum, Emily Edson-Heredia, Hilde Carlier, Russel Burge, Chen-Yen Lin, Kristin Hollister, Matthias Augustin

Gepubliceerd in: Quality of Life Research | Uitgave 2/2020

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Abstract

Purpose

To assess improvements in health-related quality of life (HRQoL) with ixekizumab treatment in patients with moderate-to-severe psoriasis.

Methods

Adults with plaque psoriasis were enrolled in phase III, double-blind, randomised, controlled trials (UNCOVER-1, UNCOVER-2, or UNCOVER-3). All 3 protocols included a 12-week, placebo-controlled induction period; UNCOVER-2 and UNCOVER-3 also had an active-control group (50 mg etanercept) during induction. After induction, patients in UNCOVER-1 and UNCOVER-2 entered a 48-week withdrawal (maintenance) period (Weeks 12–60), during which Week-12 sPGA (0,1) responders were rerandomized to receive placebo, or 80 mg ixekizumab every 4 weeks (Q4W) or 12 weeks. As a secondary objective, HRQoL was measured by the generic Medical Outcomes Survey Short Form-36 (SF-36) at baseline and Weeks 12 and 60. Changes in mean SF-36 Physical and Mental Component Summary (PCS and MCS) and domain scores and proportions of patients reporting improvements ≥ minimal important differences in SF-36 scores were compared between groups.

Results

At Week 12, ixekizumab-treated patients (both dose groups in UNCOVER-1, -2, and -3) reported statistically significantly greater improvements in mean SF-36 PCS and MCS and all 8 SF-36 domain scores versus placebo. Further, more ixekizumab-treated patients than placebo-treated patients reported at least minimal treatment responses in SF-36 PCS and MCS scores and domain scores. Overall improvements in SF-36 PCS and MCS scores were maintained through Week 60.

Conclusions

Ixekizumab-treated patients reported statistically significant improvements in HRQoL at 12 weeks that persisted through 1 year.
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Literatuur
1.
go back to reference De Arruda, L. H. F., & De Moraes, A. P. F. (2001). The impact of psoriasis on quality of life. British Journal of Dermatology,144(Suppl 58), 33–36.CrossRef De Arruda, L. H. F., & De Moraes, A. P. F. (2001). The impact of psoriasis on quality of life. British Journal of Dermatology,144(Suppl 58), 33–36.CrossRef
2.
go back to reference Fried, R. G., Friedman, S., Paradis, C., Hatch, M., Lynfield, Y., Duncanson, C., et al. (1995). Trivial or terrible? The psychosocial impact of psoriasis. International Journal of Dermatology,34(2), 101–105.CrossRef Fried, R. G., Friedman, S., Paradis, C., Hatch, M., Lynfield, Y., Duncanson, C., et al. (1995). Trivial or terrible? The psychosocial impact of psoriasis. International Journal of Dermatology,34(2), 101–105.CrossRef
3.
go back to reference Krueger, G., Koo, J., Lebwohl, M., Menter, A., Stern, R. S., & Rolstad, T. (2001). The impact of psoriasis on quality of life: Results of a 1998 National Psoriasis Foundation patient-membership survey. Archives of Dermatology,137(3), 280–284.PubMed Krueger, G., Koo, J., Lebwohl, M., Menter, A., Stern, R. S., & Rolstad, T. (2001). The impact of psoriasis on quality of life: Results of a 1998 National Psoriasis Foundation patient-membership survey. Archives of Dermatology,137(3), 280–284.PubMed
4.
go back to reference Nash, A. S., McAteer, H., Schofield, J., Penzer, P., & Gilbert, A. K. (2015). Psoriasis today: Experiences of healthcare and impact on quality of life in a major UK cohort. Primary Health Care Research & Development,16(4), 415–423.CrossRef Nash, A. S., McAteer, H., Schofield, J., Penzer, P., & Gilbert, A. K. (2015). Psoriasis today: Experiences of healthcare and impact on quality of life in a major UK cohort. Primary Health Care Research & Development,16(4), 415–423.CrossRef
5.
go back to reference Kimball, A. B., Jacobson, C., Weiss, S., Vreeland, M. G., & Wu, Y. (2005). The psychosocial burden of psoriasis. American Journal of Clinical Dermatology,6(6), 383–392.CrossRef Kimball, A. B., Jacobson, C., Weiss, S., Vreeland, M. G., & Wu, Y. (2005). The psychosocial burden of psoriasis. American Journal of Clinical Dermatology,6(6), 383–392.CrossRef
6.
go back to reference Molina-Leyva, A., Jiménez-Moleón, J. J., Naranjo-Sintes, R., & Ruiz-Carrascosa, J. C. (2015). Sexual dysfunction in psoriasis: A systematic review. Journal of the European Academy of Dermatology and Venereology,29(4), 649–655.CrossRef Molina-Leyva, A., Jiménez-Moleón, J. J., Naranjo-Sintes, R., & Ruiz-Carrascosa, J. C. (2015). Sexual dysfunction in psoriasis: A systematic review. Journal of the European Academy of Dermatology and Venereology,29(4), 649–655.CrossRef
7.
go back to reference Dalgard, F. J., Gieler, U., Tomas-Aragones, L., Lien, L., Poot, F., Jemec, G. B., et al. (2015). The psychological burden of skin diseases: A cross-sectional multicenter study among dermatological out-patients in 13 European countries. Journal of Investigative Dermatology,135(4), 984–991.CrossRef Dalgard, F. J., Gieler, U., Tomas-Aragones, L., Lien, L., Poot, F., Jemec, G. B., et al. (2015). The psychological burden of skin diseases: A cross-sectional multicenter study among dermatological out-patients in 13 European countries. Journal of Investigative Dermatology,135(4), 984–991.CrossRef
8.
go back to reference Kurd, S. K., Troxel, A. B., Crits-Christoph, P., & Gelfand, J. M. (2010). The risk of depression, anxiety, and suicidality in patients with psoriasis: A population-based cohort study. Archives of Dermatology,146(8), 891–895.PubMedPubMedCentral Kurd, S. K., Troxel, A. B., Crits-Christoph, P., & Gelfand, J. M. (2010). The risk of depression, anxiety, and suicidality in patients with psoriasis: A population-based cohort study. Archives of Dermatology,146(8), 891–895.PubMedPubMedCentral
9.
go back to reference Sampogna, F., Tabolli, S., Abeni, D., IDI Multipurpose Psoriasis Research on Vital Experiences (IMPROVE) investigators, et al. (2012). Living with psoriasis: prevalence of shame, anger, worry, and problems in daily activities and social life. Acta Dermato-Venereologica,92(3), 299–303.CrossRef Sampogna, F., Tabolli, S., Abeni, D., IDI Multipurpose Psoriasis Research on Vital Experiences (IMPROVE) investigators, et al. (2012). Living with psoriasis: prevalence of shame, anger, worry, and problems in daily activities and social life. Acta Dermato-Venereologica,92(3), 299–303.CrossRef
10.
go back to reference Rapp, S. R., Feldman, S. R., Exum, M. L., Fleischer, A. B., Jr., & Reboussin, D. M. (1999). Psoriasis causes as much disability as other major medical diseases. Journal of the American Academy of Dermatology,41(3 Pt 1), 401–407.CrossRef Rapp, S. R., Feldman, S. R., Exum, M. L., Fleischer, A. B., Jr., & Reboussin, D. M. (1999). Psoriasis causes as much disability as other major medical diseases. Journal of the American Academy of Dermatology,41(3 Pt 1), 401–407.CrossRef
11.
go back to reference Warren, R. B., Kleyn, C. E., & Gulliver, W. P. (2011). Cumulative life course impairment in psoriasis: Patient perception of disease-related impairment throughout the life course. British Journal of Dermatology,164(Suppl 1), 1–14.CrossRef Warren, R. B., Kleyn, C. E., & Gulliver, W. P. (2011). Cumulative life course impairment in psoriasis: Patient perception of disease-related impairment throughout the life course. British Journal of Dermatology,164(Suppl 1), 1–14.CrossRef
12.
go back to reference Feldman, S. R., Gordon, K. B., Bala, M., Evans, R., Li, S., Dooley, L. T., et al. (2005). Infliximab treatment results in significant improvement in the quality of life of patients with severe psoriasis: A double-blind placebo-controlled trial. British Journal of Dermatology,152(5), 954–960.CrossRef Feldman, S. R., Gordon, K. B., Bala, M., Evans, R., Li, S., Dooley, L. T., et al. (2005). Infliximab treatment results in significant improvement in the quality of life of patients with severe psoriasis: A double-blind placebo-controlled trial. British Journal of Dermatology,152(5), 954–960.CrossRef
13.
go back to reference Kimball, A. B., Bensimon, A. G., Guerin, A., Yu, A. P., Wu, E. Q., Okun, M. M., et al. (2011). Efficacy and safety of adalimumab among patients with moderate to severe psoriasis with co-morbidities: Subanalysis of results from a randomized, double-blind, placebo-controlled, phase III trial. American Journal of Clinical Dermatology,12(1), 51–62.CrossRef Kimball, A. B., Bensimon, A. G., Guerin, A., Yu, A. P., Wu, E. Q., Okun, M. M., et al. (2011). Efficacy and safety of adalimumab among patients with moderate to severe psoriasis with co-morbidities: Subanalysis of results from a randomized, double-blind, placebo-controlled, phase III trial. American Journal of Clinical Dermatology,12(1), 51–62.CrossRef
14.
go back to reference Krueger, G. G., Langley, R. G., Finlay, A. Y., Griffiths, C. E., Woolley, J. M., Lalla, D., et al. (2005). Patient-reported outcomes of psoriasis improvement with etanercept therapy: Results of a randomized phase III trial. British Journal of Dermatology,153(6), 1192–1199.CrossRef Krueger, G. G., Langley, R. G., Finlay, A. Y., Griffiths, C. E., Woolley, J. M., Lalla, D., et al. (2005). Patient-reported outcomes of psoriasis improvement with etanercept therapy: Results of a randomized phase III trial. British Journal of Dermatology,153(6), 1192–1199.CrossRef
15.
go back to reference Langley, R. G., Elewski, B. E., Lebwohl, M., Reich, K., Griffiths, C. E., Papp, K., et al. (2014). Secukinumab in plaque psoriasis–results of two phase 3 trials. New England Journal of Medicine,371(4), 326–338.CrossRef Langley, R. G., Elewski, B. E., Lebwohl, M., Reich, K., Griffiths, C. E., Papp, K., et al. (2014). Secukinumab in plaque psoriasis–results of two phase 3 trials. New England Journal of Medicine,371(4), 326–338.CrossRef
16.
go back to reference Langley, R. G., Feldman, S. R., Han, C., Schenkel, B., Szapary, P., Hsu, M. C., et al. (2010). Ustekinumab significantly improves symptoms of anxiety, depression, and skin-related quality of life in patients with moderate-to-severe psoriasis: Results from a randomized, double-blind, placebo-controlled phase III trial. Journal of the American Academy of Dermatology,63(3), 457–465.CrossRef Langley, R. G., Feldman, S. R., Han, C., Schenkel, B., Szapary, P., Hsu, M. C., et al. (2010). Ustekinumab significantly improves symptoms of anxiety, depression, and skin-related quality of life in patients with moderate-to-severe psoriasis: Results from a randomized, double-blind, placebo-controlled phase III trial. Journal of the American Academy of Dermatology,63(3), 457–465.CrossRef
17.
go back to reference Lebwohl, M., Papp, K., Han, C., Schenkel, B., Yeilding, N., Wang, Y., et al. (2010). Ustekinumab improves health-related quality of life in patients with moderate-to-severe psoriasis: results from the PHOENIX 1 trial. British Journal of Dermatology,162(1), 137–146.CrossRef Lebwohl, M., Papp, K., Han, C., Schenkel, B., Yeilding, N., Wang, Y., et al. (2010). Ustekinumab improves health-related quality of life in patients with moderate-to-severe psoriasis: results from the PHOENIX 1 trial. British Journal of Dermatology,162(1), 137–146.CrossRef
18.
go back to reference Revicki, D. A., Willian, M. K., Menter, A., Gordon, K. B., Kimball, A. B., Leonardi, C. L., et al. (2007). Impact of adalimumab treatment on patient-reported outcomes: Results from a Phase III clinical trial in patients with moderate to severe plaque psoriasis. Journal of Dermatological Treatment,18(6), 341–350.CrossRef Revicki, D. A., Willian, M. K., Menter, A., Gordon, K. B., Kimball, A. B., Leonardi, C. L., et al. (2007). Impact of adalimumab treatment on patient-reported outcomes: Results from a Phase III clinical trial in patients with moderate to severe plaque psoriasis. Journal of Dermatological Treatment,18(6), 341–350.CrossRef
19.
go back to reference Strand, V., Sharp, V., Koenig, A. S., Park, G., Shi, Y., Wang, B., et al. (2012). Comparison of health-related quality of life in rheumatoid arthritis, psoriatic arthritis and psoriasis and effects of etanercept treatment. Annals of the Rheumatic Diseases,71(7), 1143–1150.CrossRef Strand, V., Sharp, V., Koenig, A. S., Park, G., Shi, Y., Wang, B., et al. (2012). Comparison of health-related quality of life in rheumatoid arthritis, psoriatic arthritis and psoriasis and effects of etanercept treatment. Annals of the Rheumatic Diseases,71(7), 1143–1150.CrossRef
20.
go back to reference Feldman, S. R., & Krueger, G. G. (2005). Psoriasis assessment tools in clinical trials. Annals of the Rheumatic Diseases,64(Suppl 2), ii65–ii68. (discussion ii69–73).PubMedPubMedCentral Feldman, S. R., & Krueger, G. G. (2005). Psoriasis assessment tools in clinical trials. Annals of the Rheumatic Diseases,64(Suppl 2), ii65–ii68. (discussion ii69–73).PubMedPubMedCentral
21.
go back to reference Mrowietz, U., Kragballe, K., Reich, K., Spuls, P., Griffiths, C. E., Nast, A., et al. (2011). Definition of treatment goals for moderate to severe psoriasis: A European consensus. Archives of Dermatological Research,303(1), 1–10.CrossRef Mrowietz, U., Kragballe, K., Reich, K., Spuls, P., Griffiths, C. E., Nast, A., et al. (2011). Definition of treatment goals for moderate to severe psoriasis: A European consensus. Archives of Dermatological Research,303(1), 1–10.CrossRef
22.
go back to reference Ware, J. E., Jr., & Sherbourne, C. D. (1992). The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Medical Care,30(6), 473–483.CrossRef Ware, J. E., Jr., & Sherbourne, C. D. (1992). The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Medical Care,30(6), 473–483.CrossRef
23.
go back to reference Di Cesare, A., Di Meglio, P., & Nestle, F. O. (2009). The IL-23/Th17 axis in the immunopathogenesis of psoriasis. Journal of Investigative Dermatology,129(6), 1339–1350.CrossRef Di Cesare, A., Di Meglio, P., & Nestle, F. O. (2009). The IL-23/Th17 axis in the immunopathogenesis of psoriasis. Journal of Investigative Dermatology,129(6), 1339–1350.CrossRef
24.
go back to reference Genovese, M. C., Van den Bosch, F., Roberson, S. A., Bojin, S., Biagini, I. M., Ryan, P., et al. (2010). LY2439821, a humanized anti-interleukin-17 monoclonal antibody, in the treatment of patients with rheumatoid arthritis: A phase I randomized, double-blind, placebo-controlled, proof-of-concept study. Arthritis Rheumatology,62(4), 929–939.CrossRef Genovese, M. C., Van den Bosch, F., Roberson, S. A., Bojin, S., Biagini, I. M., Ryan, P., et al. (2010). LY2439821, a humanized anti-interleukin-17 monoclonal antibody, in the treatment of patients with rheumatoid arthritis: A phase I randomized, double-blind, placebo-controlled, proof-of-concept study. Arthritis Rheumatology,62(4), 929–939.CrossRef
25.
go back to reference Leonardi, C., Matheson, R., Zachariae, C., Cameron, G., Li, L., & Edson-Heredia, E. (2012). Anti-interleukin-17 monoclonal antibody ixekizumab in chronic Plaque psoriasis. New England Journal of Medicine,366(13), 1190–1199.CrossRef Leonardi, C., Matheson, R., Zachariae, C., Cameron, G., Li, L., & Edson-Heredia, E. (2012). Anti-interleukin-17 monoclonal antibody ixekizumab in chronic Plaque psoriasis. New England Journal of Medicine,366(13), 1190–1199.CrossRef
26.
go back to reference Liu, L., Lu, J., Allan, B. W., Tang, Y., Tetreault, J., Chow, C. K., et al. (2016). Generation and characterization of ixekizumab, a humanized monoclonal antibody that neutralizes interleukin-17A. Journal of Inflammation Research,9, 39–50.CrossRef Liu, L., Lu, J., Allan, B. W., Tang, Y., Tetreault, J., Chow, C. K., et al. (2016). Generation and characterization of ixekizumab, a humanized monoclonal antibody that neutralizes interleukin-17A. Journal of Inflammation Research,9, 39–50.CrossRef
27.
go back to reference Griffiths, C. E. M., Reich, K., Lebwohl, M., van der Kerkhof, P., Paul, C., Menter, A., et al. (2015). Comparison of ixekizumab with etanercept or placebo in moderate-to-severe psoriasis (UNCOVER-2 and UNCOVER-3): Results from two phase 3 randomised trials. The Lancet,386(9993), 541–551.CrossRef Griffiths, C. E. M., Reich, K., Lebwohl, M., van der Kerkhof, P., Paul, C., Menter, A., et al. (2015). Comparison of ixekizumab with etanercept or placebo in moderate-to-severe psoriasis (UNCOVER-2 and UNCOVER-3): Results from two phase 3 randomised trials. The Lancet,386(9993), 541–551.CrossRef
28.
go back to reference Gordon, K. B., Blauvelt, A., Papp, K. A., Langley, R. G., Luger, T., Ohtsuki, M., et al. (2016). Phase 3 trials of ixekizumab in moderate-to-severe plaque psoriasis. New England Journal of Medicine,375(4), 345–356.CrossRef Gordon, K. B., Blauvelt, A., Papp, K. A., Langley, R. G., Luger, T., Ohtsuki, M., et al. (2016). Phase 3 trials of ixekizumab in moderate-to-severe plaque psoriasis. New England Journal of Medicine,375(4), 345–356.CrossRef
29.
go back to reference Maruish, M. E. (Ed.). (2011). User’s manual for the SF36v2 Health Survey (3rd ed.). Lincoln, RI: Quality Metric Incorporated. Maruish, M. E. (Ed.). (2011). User’s manual for the SF36v2 Health Survey (3rd ed.). Lincoln, RI: Quality Metric Incorporated.
30.
go back to reference Ixekizumab (TALTZ™) Package Insert. Eli Lilly and Company. Indianapolis, IN USA. Revised January 2017. Ixekizumab (TALTZ™) Package Insert. Eli Lilly and Company. Indianapolis, IN USA. Revised January 2017.
31.
go back to reference Prakash, A., Risser, R. C., & Mallinckrodt, C. H. (2008). The impact of analytic method on interpretation of outcomes in longitudinal clinical trials. International Journal of Clinical Practice,62(8), 1147–1158.CrossRef Prakash, A., Risser, R. C., & Mallinckrodt, C. H. (2008). The impact of analytic method on interpretation of outcomes in longitudinal clinical trials. International Journal of Clinical Practice,62(8), 1147–1158.CrossRef
Metagegevens
Titel
Ixekizumab treatment and the impact on SF-36: results from three pivotal phase III randomised controlled trials in patients with moderate-to-severe plaque psoriasis
Auteurs
Richard G. B. Langley
Kristian Reich
Vibeke Strand
Steven R. Feldman
Carle Paul
Kenneth Gordon
Richard B. Warren
Darryl Toth
Enkeleida Nikaï
Baojin Zhu
Orin Goldblum
Emily Edson-Heredia
Hilde Carlier
Russel Burge
Chen-Yen Lin
Kristin Hollister
Matthias Augustin
Publicatiedatum
26-10-2019
Uitgeverij
Springer International Publishing
Gepubliceerd in
Quality of Life Research / Uitgave 2/2020
Print ISSN: 0962-9343
Elektronisch ISSN: 1573-2649
DOI
https://doi.org/10.1007/s11136-019-02296-5

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