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Certolizumab pegol for the treatment of chronic plaque psoriasis: Results through 48 weeks of a phase 3, multicenter, randomized, double-blind, etanercept- and placebo- controlled study (CIMPACT) Mark Lebwohl, MD, Andrew Blauvelt, MD, MBA, Carle Paul, MD, PhD, Howard Sofen, MD, Jolanta Węgłowska, MD, Vincent Piguet, MD, Daniel Burge, MD, Robert Rolleri, PharmD, Janice Drew, MPH, Luke Peterson, MS, Matthias Augustin, MD Journal of the American Academy of Dermatology Volume 79, Issue 2, Pages e5 (August 2018) DOI: /j.jaad Copyright © 2018 American Academy of Dermatology, Inc. Terms and Conditions
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Fig 1 Study design. BW, Biweekly; CZP, certolizumab pegol; ETN, etanercept; LD, loading dose of CZP 400 mg at weeks 0, 2, and 4 or weeks 16, 18, and 20; PASI, Psoriasis Area and Severity Index; PASI 50, ≥50% reduction in PASI from baseline PASI; PASI 75, ≥75% reduction in PASI from baseline PASI; Q2W, every 2 weeks; Q4W, every 4 weeks. Journal of the American Academy of Dermatology , e5DOI: ( /j.jaad ) Copyright © 2018 American Academy of Dermatology, Inc. Terms and Conditions
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Fig 2 Patient disposition. ∗Patients received a loading dose of 400 mg at weeks 0, 2, and 4. †PASI 75 nonresponders at week 16 entered the escape arm for treatment with CZP 400 mg every 2 weeks. ‡ETN-treated PASI 75 responders rerandomized to CZP 200 mg every 2 weeks received an initial loading dose of 400 mg at weeks 16, 18, and 20. §Represents the CZP 400 mg every 4 weeks treatment group. ‖Two patients completed week 16 but did not enter the maintenance period (1 lost to follow-up; 1 consent withdrawn). CZP, Certolizumab pegol; ETN, etanercept; PASI, Psoriasis Area and Severity Index; PASI 75, ≥75% reduction in PASI from baseline PASI; Q2W, every 2 weeks; Q4W, every 4 weeks, w/d, withdrawn. Journal of the American Academy of Dermatology , e5DOI: ( /j.jaad ) Copyright © 2018 American Academy of Dermatology, Inc. Terms and Conditions
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Fig 3 PASI 75 responder rate of randomized patients through week 12 (primary endpoint) and week 16, by visit. Analysis of the responder rate was based on the logistic regression model. Patients receiving CZP 200 mg every 2 weeks also received loading doses of CZP 400 mg at weeks 0, 2, and 4. ∗P < .05 versus placebo (controlled for multiplicity at weeks 12 and 16). †P < .0001 versus placebo (controlled for multiplicity at weeks 12 and 16). ‡Superior to ETN (P = .0152). §Noninferior to ETN (95% confidence interval –2.9 to 18.9). CZP, Certolizumab pegol; ETN, etanercept; PASI, Psoriasis Area and Severity Index; PASI 75, ≥75% reduction in PASI from baseline PASI; Q2W, every 2 weeks. Journal of the American Academy of Dermatology , e5DOI: ( /j.jaad ) Copyright © 2018 American Academy of Dermatology, Inc. Terms and Conditions
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Fig 4 PGA 0/1 responder rate of randomized patients through week 12 and week 16, by visit. Analysis of the responder rate was based on the logistic regression model. Inferential statistical comparisons of CZP and ETN were not performed. Patients who received CZP 200 mg every 2 weeks also received loading doses of CZP 400 mg at weeks 0, 2, and 4. ∗P < .05 versus placebo (controlled for multiplicity at weeks 12 and 16). †P < .0001 versus placebo (controlled for multiplicity at weeks 12 and 16). CZP, Certolizumab pegol; ETN, etanercept; PGA 0/1, Physician's Global Assessment clear/almost clear, with ≥2-category improvement from baseline Physician's Global Assessment; Q2W, every 2 weeks. Journal of the American Academy of Dermatology , e5DOI: ( /j.jaad ) Copyright © 2018 American Academy of Dermatology, Inc. Terms and Conditions
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Fig 5 PASI 90 responder rate of randomized patients through week 12 and week 16, by visit. Analysis of the responder rate was based on the logistic regression model. Inferential statistical comparisons of CZP and ETN were not performed. Patients who received CZP 200 mg every 2 weeks also received loading doses of CZP 400 mg at weeks 0, 2, and 4. ∗P < .05 versus placebo (controlled for multiplicity at weeks 12 and 16). †P < .0001 versus placebo (controlled for multiplicity at weeks 12 and 16). CZP, Certolizumab pegol; ETN, etanercept; PASI, Psoriasis Area and Severity Index; PASI 90, ≥90% reduction in PASI from baseline PASI; Q2W, every 2 weeks. Journal of the American Academy of Dermatology , e5DOI: ( /j.jaad ) Copyright © 2018 American Academy of Dermatology, Inc. Terms and Conditions
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Fig 6 PASI 75 responder rate of maintenance set from week 16 through week 48, by visit. Analysis involved the imputation of data from nonresponders. CZP, Certolizumab pegol; PASI, Psoriasis Area and Severity Index; PASI 75, ≥75% reduction in PASI from baseline PASI; Q2W, every 2 weeks; Q4W, every 4 weeks. Journal of the American Academy of Dermatology , e5DOI: ( /j.jaad ) Copyright © 2018 American Academy of Dermatology, Inc. Terms and Conditions
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Supplemental Fig 1 PGA 0/1 responder rate of maintenance set from week 16 through week 48, by visit. Analysis involved the imputation of data from nonresponders. CZP, Certolizumab pegol; PGA 0/1, Physician's Global Assessment of clear or almost clear with ≥2-category improvement from PGA baseline; Q2W, every 2 weeks; Q4W, every 4 weeks. Journal of the American Academy of Dermatology , e5DOI: ( /j.jaad ) Copyright © 2018 American Academy of Dermatology, Inc. Terms and Conditions
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Supplemental Fig 2 PASI 90 responder rate of maintenance set from week 16 through week 48, by visit. Analysis involved the imputation of data from nonresponders. CZP, Certolizumab pegol; PASI, Psoriasis Area and Severity Index; PASI 90, ≥90% reduction in PASI from baseline PASI; Q2W, every 2 weeks; Q4W, every 4 weeks. Journal of the American Academy of Dermatology , e5DOI: ( /j.jaad ) Copyright © 2018 American Academy of Dermatology, Inc. Terms and Conditions
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