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Certolizumab pegol for the treatment of chronic plaque psoriasis: Results through 48 weeks from 2 phase 3, multicenter, randomized, double-blinded, placebo-controlled.

Published byMilo Morris Modified over 6 years ago

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Presentation on theme: "Certolizumab pegol for the treatment of chronic plaque psoriasis: Results through 48 weeks from 2 phase 3, multicenter, randomized, double-blinded, placebo-controlled."— Presentation transcript:

1 Certolizumab pegol for the treatment of chronic plaque psoriasis: Results through 48 weeks from 2 phase 3, multicenter, randomized, double-blinded, placebo-controlled studies (CIMPASI-1 and CIMPASI-2)  Alice B. Gottlieb, MD, PhD, Andrew Blauvelt, MD, MBA, Diamant Thaçi, MD, Craig L. Leonardi, MD, Yves Poulin, MD, Janice Drew, MPH, Luke Peterson, MS, Catherine Arendt, MD, PharmD, Daniel Burge, MD, Kristian Reich, MD  Journal of the American Academy of Dermatology  Volume 79, Issue 2, Pages e6 (August 2018) DOI: /j.jaad Copyright © 2018 American Academy of Dermatology, Inc. Terms and Conditions

2 Fig 1 Study design. CZP, Certolizumab pegol; LD, loading dose 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 50-75, ≥50% but <75% reduction in PASI from baseline PASI; PASI 75, ≥75% reduction in PASI from baseline PASI; Q2W, every 2 weeks. Journal of the American Academy of Dermatology  , e6DOI: ( /j.jaad ) Copyright © 2018 American Academy of Dermatology, Inc. Terms and Conditions

3 Fig 2 Patient disposition to week 48. ∗Upon entering maintenance period, placebo-treated PASI 75 responders (≥75% reduction in PASI from baseline PASI) continued blinded placebo treatment; PASI responders (≥50% but <75% reduction in PASI from baseline PASI) received CZP 200 mg every 2 weeks. †PASI 50 nonresponders at week 16 received open-label CZP 400 mg every 2 weeks in the escape arm of the study. ‡Two patients completed week 16 but did not enter maintenance period due to adverse events. §Two patients completed week 16 but did not enter maintenance period: 1 was lost to follow-up and 1 withdrew consent. Patients randomized to CZP 200 mg every 2 weeks received a loading dose of CZP 400 mg at weeks 0, 2, and 4. CZP, Certolizumab pegol; PASI, Psoriasis Area and Severity Index; PASI 50, ≥50% reduction in PASI from baseline PASI; Q2W, every 2 weeks; w/d, withdrawn. Journal of the American Academy of Dermatology  , e6DOI: ( /j.jaad ) Copyright © 2018 American Academy of Dermatology, Inc. Terms and Conditions

4 Fig 3 PASI 75 responder rates of randomized patients through week 48, by visit. Patients randomized to CZP 200 mg every 2 weeks received loading doses of CZP 400 mg at weeks 0, 2, and 4. The responder rate analysis was based on the logistic regression model. *P < .05 versus placebo (controlled for multiplicity at week 16 in CIMPASI-1 and CIMPASI-2). †P < .0001 versus placebo (controlled for multiplicity at week 16 in CIMPASI-1 and CIMPASI-2). CZP, Certolizumab pegol; 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  , e6DOI: ( /j.jaad ) Copyright © 2018 American Academy of Dermatology, Inc. Terms and Conditions

5 Fig 4 PASI 90 responder rates of randomized patients through week 48, by visit. Patients randomized to CZP 200 mg every 2 weeks received loading doses of CZP 400 mg at weeks 0, 2, and 4. The responder rate analysis was based on the logistic regression model.*P < .05 versus placebo (controlled for multiplicity at week 16 in CIMPASI-1 and CIMPASI-2). †P < .0001 versus placebo (controlled for multiplicity at week 16 in CIMPASI-1 and CIMPASI-2). CZP, Certolizumab pegol; 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  , e6DOI: ( /j.jaad ) Copyright © 2018 American Academy of Dermatology, Inc. Terms and Conditions

6 Supplemental Fig 1 PGA 0/1 responder rates of randomized patients through week 48, by visit. Patients randomized to CZP 200 mg every 2 weeks received loading doses of CZP 400 mg at weeks 0, 2, and 4. Responder rates were based on the logistic regression model.*P < .05 versus placebo (controlled for multiplicity at week 16 in CIMPASI-1 and CIMPASI-2). †P < .0001 versus placebo (controlled for multiplicity at week 16 in CIMPASI-1 and CIMPASI-2). CZP, Certolizumab pegol; PGA 0/1, Physician's Global Assessment clear/almost clear with ≥2-category improvement from baseline; Q2W, every 2 weeks. Journal of the American Academy of Dermatology  , e6DOI: ( /j.jaad ) Copyright © 2018 American Academy of Dermatology, Inc. Terms and Conditions

7 Supplemental Fig 2 Change in DLQI of randomized patients at weeks 16 and 48. Patients randomized to CZP 200 mg every 2 weeks received loading doses of CZP 400 mg at weeks 0, 2, and 4. The analysis of covariance model was used. ∗P < .0001 vs placebo (controlled for multiplicity at week 16). BL, Baseline; CfB, change from baseline; CZP, certolizumab pegol; DLQI, Dermatology Life Quality Index; Q2W, every 2 weeks. Journal of the American Academy of Dermatology  , e6DOI: ( /j.jaad ) Copyright © 2018 American Academy of Dermatology, Inc. Terms and Conditions

8 Supplemental Fig 3 DLQI 0/1 responder rates through week 48. Patients randomized to CZP 200 mg every 2 weeks received loading doses of CZP 400 mg at weeks 0, 2, and 4. Responder rates were based on the percentage of participants with DLQI 0/1 at each given time point (no modeling performed). CZP, Certolizumab pegol; DLQI, Dermatology Life Quality Index; Q2W, every 2 weeks. Journal of the American Academy of Dermatology  , e6DOI: ( /j.jaad ) Copyright © 2018 American Academy of Dermatology, Inc. Terms and Conditions

9 Supplemental Fig 4 Fixed-sequence testing procedure. CZP, Certolizumab pegol; DLQI, Dermatology Life Quality Index; PASI, Psoriasis Area and Severity Index; PASI 75, ≥75% reduction in PASI from baseline PASI; PASI 90, ≥90% reduction in PASI from baseline PASI; PGA, Physician's Global Assessment; Q2W, every 2 week. Journal of the American Academy of Dermatology  , e6DOI: ( /j.jaad ) Copyright © 2018 American Academy of Dermatology, Inc. Terms and Conditions

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