Effect of ixekizumab treatment on work productivity for patients with moderate-to-severe plaque psoriasis: Analysis of results from 3 randomized phase 3 clinical trials

April W. Armstrong, Charles W. Lynde, Sandy R. McBride, Mona Ståhle, Emily Edson-Heredia, Baojin Zhu, David Amato, Enkeleida Nikaï, Fan Emily Yang, Kenneth B. Gordon

Research output: Contribution to journalArticle

23 Citations (Scopus)

Abstract

IMPORTANCE: Therapies that reduce psoriasis symptoms may improve work productivity. OBJECTIVE: To assess the effect of ixekizumab therapy on work productivity, measured by the Work Productivity and Activity Impairment-Psoriasis (WPAI-PSO). DESIGN, SETTING, AND PARTICIPANTS: Three multicenter, randomized double-blind phase 3 trials conducted during the following periods: December 2011 through August 2014 (UNCOVER-1), May 2012 through April 2015 (UNCOVER-2), and August 2012 through July 2014 (UNCOVER-3). Adult outpatients with moderate-to-severe chronic plaque psoriasis were included. INTERVENTIONS: In UNCOVER-1, patients were randomized 1:1:1 to subcutaneous placebo or 80 mg ixekizumab every 2 weeks (Q2W) or every 4 weeks (Q4W) for 12 weeks; UNCOVER-2 and UNCOVER-3 also had an etanercept arm (50 mg twice weekly). Maintenance of initial ixekizumab response was evaluated in UNCOVER-1 and UNCOVER-2 during a randomized withdrawal period following week 12 through week 60. The WPAI-PSO questionnaire was administered at baseline and week 12 for all patients and at weeks 24, 36, 52, and 60 for patients in UNCOVER-1 and UNCOVER-2. MAIN OUTCOMES AND MEASURES: Change in work productivity from baseline as measured by WPAI-PSO scores. RESULTS: Across trials, 5101 patients consented; 3866 were randomized (mean [SD] age, UNCOVER-1, 45.7 [12.9] y, 68.1% male; UNCOVER-2: 45.0 [13.0] y, 67.1% male; UNCOVER-3: 45.8 [13.1] y, 68.2% male). At week 12 in UNCOVER-1, the ixekizumab Q4W and ixekizumab Q2W groups showed significantly greater improvements in WPAI-PSO scores (least squares mean change from baseline [SE]) relative to placebo: absenteeism (-3.5 [0.87], P < .001; -2.6 [0.84], P = .003, respectively, vs 0.2 [0.88]), presenteeism (-18.8 [1.28], P < .001; -18.3 [1.24], P < .001, vs 0.5 [1.30]), work productivity loss (-20.6 [1.38], P < .001; -19.8 [1.33], P < .001, vs -0.8 [1.40]), and activity impairment (-24.5 [1.18], P < .001; -25.2 [1.15], P < .001, vs 0.8 [1.18]). Similar results were obtained for UNCOVER-2 and UNCOVER-3, with the exception of absenteeism with ixekizumab Q4W in UNCOVER-2. Additionally, ixekizumab-treated patients showed significantly greater improvements in WPAI-PSO scores vs etanercept-treated patients: UNCOVER-2: presenteeism, work productivity loss, activity impairment (P < .001 both doses), UNCOVER-3: activity impairment (ie, regular activities outside of work) (ixekizumab Q2W; P = .009). Improvements in WPAI-PSO scores at week 12 were sustained to at least week 60. CONCLUSIONS AND RELEVANCE: Ixekizumab-treated patients reported short- and long-term improvements in work productivity, which could lead to reduced productivity-related cost burden in patients with psoriasis. TRIAL REGISTRATION: clinicaltrials.gov Identifiers: NCT01474512, NCT01597245, NCT01646177.

Original languageEnglish (US)
Pages (from-to)661-669
Number of pages9
JournalJAMA Dermatology
Volume152
Issue number6
DOIs
StatePublished - Jun 1 2016
Externally publishedYes

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LY2439821
Phase III Clinical Trials
Psoriasis
Randomized Controlled Trials
Therapeutics
Efficiency
Absenteeism
Placebos

ASJC Scopus subject areas

  • Dermatology

Cite this

Effect of ixekizumab treatment on work productivity for patients with moderate-to-severe plaque psoriasis : Analysis of results from 3 randomized phase 3 clinical trials. / Armstrong, April W.; Lynde, Charles W.; McBride, Sandy R.; Ståhle, Mona; Edson-Heredia, Emily; Zhu, Baojin; Amato, David; Nikaï, Enkeleida; Yang, Fan Emily; Gordon, Kenneth B.

In: JAMA Dermatology, Vol. 152, No. 6, 01.06.2016, p. 661-669.

Research output: Contribution to journalArticle

Armstrong, AW, Lynde, CW, McBride, SR, Ståhle, M, Edson-Heredia, E, Zhu, B, Amato, D, Nikaï, E, Yang, FE & Gordon, KB 2016, 'Effect of ixekizumab treatment on work productivity for patients with moderate-to-severe plaque psoriasis: Analysis of results from 3 randomized phase 3 clinical trials', JAMA Dermatology, vol. 152, no. 6, pp. 661-669. https://doi.org/10.1001/jamadermatol.2016.0269
Armstrong, April W. ; Lynde, Charles W. ; McBride, Sandy R. ; Ståhle, Mona ; Edson-Heredia, Emily ; Zhu, Baojin ; Amato, David ; Nikaï, Enkeleida ; Yang, Fan Emily ; Gordon, Kenneth B. / Effect of ixekizumab treatment on work productivity for patients with moderate-to-severe plaque psoriasis : Analysis of results from 3 randomized phase 3 clinical trials. In: JAMA Dermatology. 2016 ; Vol. 152, No. 6. pp. 661-669.
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abstract = "IMPORTANCE: Therapies that reduce psoriasis symptoms may improve work productivity. OBJECTIVE: To assess the effect of ixekizumab therapy on work productivity, measured by the Work Productivity and Activity Impairment-Psoriasis (WPAI-PSO). DESIGN, SETTING, AND PARTICIPANTS: Three multicenter, randomized double-blind phase 3 trials conducted during the following periods: December 2011 through August 2014 (UNCOVER-1), May 2012 through April 2015 (UNCOVER-2), and August 2012 through July 2014 (UNCOVER-3). Adult outpatients with moderate-to-severe chronic plaque psoriasis were included. INTERVENTIONS: In UNCOVER-1, patients were randomized 1:1:1 to subcutaneous placebo or 80 mg ixekizumab every 2 weeks (Q2W) or every 4 weeks (Q4W) for 12 weeks; UNCOVER-2 and UNCOVER-3 also had an etanercept arm (50 mg twice weekly). Maintenance of initial ixekizumab response was evaluated in UNCOVER-1 and UNCOVER-2 during a randomized withdrawal period following week 12 through week 60. The WPAI-PSO questionnaire was administered at baseline and week 12 for all patients and at weeks 24, 36, 52, and 60 for patients in UNCOVER-1 and UNCOVER-2. MAIN OUTCOMES AND MEASURES: Change in work productivity from baseline as measured by WPAI-PSO scores. RESULTS: Across trials, 5101 patients consented; 3866 were randomized (mean [SD] age, UNCOVER-1, 45.7 [12.9] y, 68.1{\%} male; UNCOVER-2: 45.0 [13.0] y, 67.1{\%} male; UNCOVER-3: 45.8 [13.1] y, 68.2{\%} male). At week 12 in UNCOVER-1, the ixekizumab Q4W and ixekizumab Q2W groups showed significantly greater improvements in WPAI-PSO scores (least squares mean change from baseline [SE]) relative to placebo: absenteeism (-3.5 [0.87], P < .001; -2.6 [0.84], P = .003, respectively, vs 0.2 [0.88]), presenteeism (-18.8 [1.28], P < .001; -18.3 [1.24], P < .001, vs 0.5 [1.30]), work productivity loss (-20.6 [1.38], P < .001; -19.8 [1.33], P < .001, vs -0.8 [1.40]), and activity impairment (-24.5 [1.18], P < .001; -25.2 [1.15], P < .001, vs 0.8 [1.18]). Similar results were obtained for UNCOVER-2 and UNCOVER-3, with the exception of absenteeism with ixekizumab Q4W in UNCOVER-2. Additionally, ixekizumab-treated patients showed significantly greater improvements in WPAI-PSO scores vs etanercept-treated patients: UNCOVER-2: presenteeism, work productivity loss, activity impairment (P < .001 both doses), UNCOVER-3: activity impairment (ie, regular activities outside of work) (ixekizumab Q2W; P = .009). Improvements in WPAI-PSO scores at week 12 were sustained to at least week 60. CONCLUSIONS AND RELEVANCE: Ixekizumab-treated patients reported short- and long-term improvements in work productivity, which could lead to reduced productivity-related cost burden in patients with psoriasis. TRIAL REGISTRATION: clinicaltrials.gov Identifiers: NCT01474512, NCT01597245, NCT01646177.",
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T1 - Effect of ixekizumab treatment on work productivity for patients with moderate-to-severe plaque psoriasis

T2 - Analysis of results from 3 randomized phase 3 clinical trials

AU - Armstrong, April W.

AU - Lynde, Charles W.

AU - McBride, Sandy R.

AU - Ståhle, Mona

AU - Edson-Heredia, Emily

AU - Zhu, Baojin

AU - Amato, David

AU - Nikaï, Enkeleida

AU - Yang, Fan Emily

AU - Gordon, Kenneth B.

PY - 2016/6/1

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N2 - IMPORTANCE: Therapies that reduce psoriasis symptoms may improve work productivity. OBJECTIVE: To assess the effect of ixekizumab therapy on work productivity, measured by the Work Productivity and Activity Impairment-Psoriasis (WPAI-PSO). DESIGN, SETTING, AND PARTICIPANTS: Three multicenter, randomized double-blind phase 3 trials conducted during the following periods: December 2011 through August 2014 (UNCOVER-1), May 2012 through April 2015 (UNCOVER-2), and August 2012 through July 2014 (UNCOVER-3). Adult outpatients with moderate-to-severe chronic plaque psoriasis were included. INTERVENTIONS: In UNCOVER-1, patients were randomized 1:1:1 to subcutaneous placebo or 80 mg ixekizumab every 2 weeks (Q2W) or every 4 weeks (Q4W) for 12 weeks; UNCOVER-2 and UNCOVER-3 also had an etanercept arm (50 mg twice weekly). Maintenance of initial ixekizumab response was evaluated in UNCOVER-1 and UNCOVER-2 during a randomized withdrawal period following week 12 through week 60. The WPAI-PSO questionnaire was administered at baseline and week 12 for all patients and at weeks 24, 36, 52, and 60 for patients in UNCOVER-1 and UNCOVER-2. MAIN OUTCOMES AND MEASURES: Change in work productivity from baseline as measured by WPAI-PSO scores. RESULTS: Across trials, 5101 patients consented; 3866 were randomized (mean [SD] age, UNCOVER-1, 45.7 [12.9] y, 68.1% male; UNCOVER-2: 45.0 [13.0] y, 67.1% male; UNCOVER-3: 45.8 [13.1] y, 68.2% male). At week 12 in UNCOVER-1, the ixekizumab Q4W and ixekizumab Q2W groups showed significantly greater improvements in WPAI-PSO scores (least squares mean change from baseline [SE]) relative to placebo: absenteeism (-3.5 [0.87], P < .001; -2.6 [0.84], P = .003, respectively, vs 0.2 [0.88]), presenteeism (-18.8 [1.28], P < .001; -18.3 [1.24], P < .001, vs 0.5 [1.30]), work productivity loss (-20.6 [1.38], P < .001; -19.8 [1.33], P < .001, vs -0.8 [1.40]), and activity impairment (-24.5 [1.18], P < .001; -25.2 [1.15], P < .001, vs 0.8 [1.18]). Similar results were obtained for UNCOVER-2 and UNCOVER-3, with the exception of absenteeism with ixekizumab Q4W in UNCOVER-2. Additionally, ixekizumab-treated patients showed significantly greater improvements in WPAI-PSO scores vs etanercept-treated patients: UNCOVER-2: presenteeism, work productivity loss, activity impairment (P < .001 both doses), UNCOVER-3: activity impairment (ie, regular activities outside of work) (ixekizumab Q2W; P = .009). Improvements in WPAI-PSO scores at week 12 were sustained to at least week 60. CONCLUSIONS AND RELEVANCE: Ixekizumab-treated patients reported short- and long-term improvements in work productivity, which could lead to reduced productivity-related cost burden in patients with psoriasis. TRIAL REGISTRATION: clinicaltrials.gov Identifiers: NCT01474512, NCT01597245, NCT01646177.

AB - IMPORTANCE: Therapies that reduce psoriasis symptoms may improve work productivity. OBJECTIVE: To assess the effect of ixekizumab therapy on work productivity, measured by the Work Productivity and Activity Impairment-Psoriasis (WPAI-PSO). DESIGN, SETTING, AND PARTICIPANTS: Three multicenter, randomized double-blind phase 3 trials conducted during the following periods: December 2011 through August 2014 (UNCOVER-1), May 2012 through April 2015 (UNCOVER-2), and August 2012 through July 2014 (UNCOVER-3). Adult outpatients with moderate-to-severe chronic plaque psoriasis were included. INTERVENTIONS: In UNCOVER-1, patients were randomized 1:1:1 to subcutaneous placebo or 80 mg ixekizumab every 2 weeks (Q2W) or every 4 weeks (Q4W) for 12 weeks; UNCOVER-2 and UNCOVER-3 also had an etanercept arm (50 mg twice weekly). Maintenance of initial ixekizumab response was evaluated in UNCOVER-1 and UNCOVER-2 during a randomized withdrawal period following week 12 through week 60. The WPAI-PSO questionnaire was administered at baseline and week 12 for all patients and at weeks 24, 36, 52, and 60 for patients in UNCOVER-1 and UNCOVER-2. MAIN OUTCOMES AND MEASURES: Change in work productivity from baseline as measured by WPAI-PSO scores. RESULTS: Across trials, 5101 patients consented; 3866 were randomized (mean [SD] age, UNCOVER-1, 45.7 [12.9] y, 68.1% male; UNCOVER-2: 45.0 [13.0] y, 67.1% male; UNCOVER-3: 45.8 [13.1] y, 68.2% male). At week 12 in UNCOVER-1, the ixekizumab Q4W and ixekizumab Q2W groups showed significantly greater improvements in WPAI-PSO scores (least squares mean change from baseline [SE]) relative to placebo: absenteeism (-3.5 [0.87], P < .001; -2.6 [0.84], P = .003, respectively, vs 0.2 [0.88]), presenteeism (-18.8 [1.28], P < .001; -18.3 [1.24], P < .001, vs 0.5 [1.30]), work productivity loss (-20.6 [1.38], P < .001; -19.8 [1.33], P < .001, vs -0.8 [1.40]), and activity impairment (-24.5 [1.18], P < .001; -25.2 [1.15], P < .001, vs 0.8 [1.18]). Similar results were obtained for UNCOVER-2 and UNCOVER-3, with the exception of absenteeism with ixekizumab Q4W in UNCOVER-2. Additionally, ixekizumab-treated patients showed significantly greater improvements in WPAI-PSO scores vs etanercept-treated patients: UNCOVER-2: presenteeism, work productivity loss, activity impairment (P < .001 both doses), UNCOVER-3: activity impairment (ie, regular activities outside of work) (ixekizumab Q2W; P = .009). Improvements in WPAI-PSO scores at week 12 were sustained to at least week 60. CONCLUSIONS AND RELEVANCE: Ixekizumab-treated patients reported short- and long-term improvements in work productivity, which could lead to reduced productivity-related cost burden in patients with psoriasis. TRIAL REGISTRATION: clinicaltrials.gov Identifiers: NCT01474512, NCT01597245, NCT01646177.

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