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

Slides:

Advertisements

Similar presentations

The effect of secukinumab on moderate-to-severe scalp psoriasis: Results of a 24- week, randomized, double-blind, placebo-controlled phase 3b study Jerry.

Advertisements

Copyright © 2003 American Medical Association. All rights reserved.

Secukinumab sustains early patient-reported outcome benefits through 1 year: Results from 2 phase III randomized placebo-controlled clinical trials comparing.

Secukinumab is superior to ustekinumab in clearing skin of subjects with moderate to severe plaque psoriasis: CLEAR, a randomized controlled trial Diamant.

Secukinumab is superior to ustekinumab in clearing skin of subjects with moderate-to- severe plaque psoriasis up to 1 year: Results from the CLEAR study

Sublingual immunotherapy for peanut allergy: A randomized, double-blind, placebo- controlled multicenter trial David M. Fleischer, MD, A. Wesley Burks,

ATX-101 for reduction of submental fat: A phase III randomized controlled trial Shannon Humphrey, MD, Jonathan Sykes, MD, Jonathan Kantor, MD, MSCE, MA,

The XTEND-CIU study: Long-term use of omalizumab in chronic idiopathic urticaria Marcus Maurer, MD, Allen Kaplan, MD, Karin Rosén, MD, PhD, Michael Holden,

Thomas B. Casale, MD, Patrick H. Win, MD, Jonathan A

OBSERVE-5: Observational postmarketing safety surveillance registry of etanercept for the treatment of psoriasis final 5-year results Alexa B. Kimball,

Image registration of sequential transparent photographs to localize and detect new versus recurrent tumors in dermatologic and Mohs micrographic surgery

Efficacy of simvastatin in plaque psoriasis: A pilot study

ATX-101 for reduction of submental fat: A phase III randomized controlled trial Shannon Humphrey, MD, Jonathan Sykes, MD, Jonathan Kantor, MD, MSCE, MA,

Short- and long-term safety outcomes with ixekizumab from 7 clinical trials in psoriasis: Etanercept comparisons and integrated data Bruce Strober, MD,

Elana Putterman, BS, Leslie Castelo-Soccio, MD, PhD

Deficiency of serum concentration of 25-hydroxyvitamin D correlates with severity of disease in chronic plaque psoriasis Federica Ricceri, MD, Leonardo.

Efficacy and safety of guselkumab, an anti-interleukin-23 monoclonal antibody, compared with adalimumab for the treatment of patients with moderate to.

OPA-15406, a novel, topical, nonsteroidal, selective phosphodiesterase-4 (PDE4) inhibitor, in the treatment of adult and adolescent patients with mild.

Two randomized, double-blind, placebo-controlled studies of fluticasone propionate lotion 0.05% for the treatment of atopic dermatitis in subjects from.

The impact of secukinumab treatment on the prevalence of human papillomavirus in patients with psoriasis: A pilot study Hsien-Yi Chiu, MD, Tsen-Fang.

A double-blind, placebo-controlled, phase-II clinical trial to evaluate oral simvastatin as a treatment for vitiligo Stefan G. Vanderweil, MD, Shinya.

Treatment of notalgia paresthetica with botulinum toxin A: A double-blind randomized controlled trial Catherine Maari, MD, FRCPC, Philippe Marchessault,

A randomized, double-blind, vehicle-controlled, bilateral comparison trial of bexarotene gel 1% versus vehicle gel in combination with narrowband UVB.

Long-term safety and tolerability of apremilast in patients with psoriasis: Pooled safety analysis for ≥156 weeks from 2 phase 3, randomized, controlled.

Inflammatory bowel disease among patients with psoriasis treated with ixekizumab: A presentation of adjudicated data from an integrated database of 7.

The efficacy of multiple courses of alefacept in patients with moderate to severe chronic plaque psoriasis Alan Menter, MD, Jennifer C. Cather, MD, Diane.

Apremilast, an oral phosphodiesterase 4 (PDE4) inhibitor, in patients with moderate to severe plaque psoriasis: Results of a phase III, randomized, controlled.

Pharmacy costs of specialty medications for plaque psoriasis in the United States Eric J. Yang, BS, Kristen M. Beck, MD, Sahil Sekhon, MD, Tina Bhutani,

Secukinumab is superior to ustekinumab in clearing skin of subjects with moderate to severe plaque psoriasis: CLEAR, a randomized controlled trial Diamant.

Effect of psoriatic arthritis on ixekizumab clinical outcomes in moderate-to-severe psoriasis patients: A post hoc analysis Alice B. Gottlieb, MD, PhD,

Amy S. Paller, MD, Elaine C. Siegfried, MD, David M

Seasonal variation of acne and psoriasis: A 3-year study using the Physician Global Assessment severity scale Vanessa Lindsay Pascoe, MD, Alexandra Boer.

A novel topical minocycline foam for the treatment of moderate-to-severe acne vulgaris: Results of 2 randomized, double-blind, phase 3 studies Linda.

Olumacostat glasaretil, a novel topical sebum inhibitor, in the treatment of acne vulgaris: A phase IIa, multicenter, randomized, vehicle-controlled study

Safety and efficacy of hydrogen peroxide topical solution, 40% (w/w), in patients with seborrheic keratoses: Results from 2 identical, randomized, double-blind,

Lip edema Journal of the American Academy of Dermatology

A Phase III, Randomized, Controlled Trial of the Fully Human IL-12/23 mAb Briakinumab in Moderate-to-Severe Psoriasis Kenneth B. Gordon, Richard G. Langley,

Apremilast, an oral phosphodiesterase 4 inhibitor, in patients with difficult-to-treat nail and scalp psoriasis: Results of 2 phase III randomized, controlled.

Comment on “Quantitative Evaluation of Biologic Therapy Options for Psoriasis: A Systematic Review and Network Meta-Analysis” Kristian Reich, Craig Leonardi,

Efficacy and safety of lebrikizumab (an anti-IL-13 monoclonal antibody) in adults with moderate-to-severe atopic dermatitis inadequately controlled by.

Pruritus severity in patients with psoriasis is not correlated with psoriasis disease severity David Roblin, MD, FRCP, Ro Wickramasinghe, PhD, MBA, Gil.

Serlopitant reduced pruritus in patients with prurigo nodularis in a phase 2, randomized, placebo-controlled trial Sonja Ständer, MD, Paul Kwon, MD,

Certolizumab pegol for the treatment of chronic plaque psoriasis: Results through 48 weeks of a phase 3, multicenter, randomized, double-blind, etanercept-

Efficacy and safety of guselkumab, an anti-interleukin-23 monoclonal antibody, compared with adalimumab for the continuous treatment of patients with.

Safety and efficacy of a fixed combination of halobetasol and tazarotene in the treatment of moderate-to-severe plaque psoriasis: Results of 2 phase 3.

Rapid onset of action in patients with moderate-to-severe psoriasis treated with brodalumab: A pooled analysis of data from two phase 3 randomized clinical.

Ulrich Mrowietz, MD, Hervé Bachelez, MD, PhD, A

Long-term efficacy and safety of itolizumab in patients with moderate-to-severe chronic plaque psoriasis: A double-blind, randomized-withdrawal, placebo-controlled.

Jennifer L. Hundley, MD, Christie L

The effect of secukinumab on moderate-to-severe scalp psoriasis: Results of a 24- week, randomized, double-blind, placebo-controlled phase 3b study Jerry.

Secukinumab shows significant efficacy in palmoplantar psoriasis: Results from GESTURE, a randomized controlled trial Alice Gottlieb, MD, PhD, John Sullivan,

Christopher T. Cassetty, MD, Andrew F. Alexis, MD, MPH, Jerome L

Ixekizumab treatment shows a neutral impact on cardiovascular parameters in patients with moderate-to-severe plaque psoriasis: Results from UNCOVER-1,

Modification of the nail psoriasis severity index

Topical glycopyrronium tosylate for the treatment of primary axillary hyperhidrosis: Results from the ATMOS-1 and ATMOS-2 phase 3 randomized controlled.

Tofacitinib therapy for children with severe alopecia areata

Tezepelumab, an anti–thymic stromal lymphopoietin monoclonal antibody, in the treatment of moderate to severe atopic dermatitis: A randomized phase 2a.

Adalimumab for nail psoriasis: Efficacy and safety from the first 26 weeks of a phase 3, randomized, placebo-controlled trial Boni E. Elewski, MD, Martin.

Two randomized, double-blind, controlled trials of 2219 subjects to compare the combination clindamycin/tretinoin hydrogel with each agent alone and vehicle.

Comparative effectiveness of biologic agents for the treatment of psoriasis in a real- world setting: Results from a large, prospective, observational.

An open-label study evaluating the efficacy and tolerability of alefacept for the treatment of scalp psoriasis James Krell, MD, FAAD, Candi Nelson, BS,

Gaps in pain management in dermatology: A needs assessment from Canada

Alan Menter, MD, Stephen K

Certolizumab pegol for the treatment of chronic plaque psoriasis: Results through 48 weeks of a phase 3, multicenter, randomized, double-blind, etanercept-

Brittany G. Craiglow, MD, Brett A. King, MD, PhD

Randomized study of topical tacrolimus ointment as possible treatment for resistant idiopathic pruritus ani Erwin Suys, MD Journal of the American Academy.

Apremilast, an oral phosphodiesterase-4 inhibitor, in the treatment of palmoplantar psoriasis: Results of a pooled analysis from phase II PSOR-005 and.

Brodalumab in the treatment of moderate to severe psoriasis in patients when previous anti-interleukin 17A therapies have failed Grace Kimmel, MD, Margot.

Efficacy and safety of ixekizumab for the treatment of moderate-to-severe plaque psoriasis: Results through 108 weeks of a randomized, controlled phase.

Adapalene gel 0.3% for the treatment of acne vulgaris: A multicenter, randomized, double-blind, controlled, phase III trial Diane Thiboutot, MD, David.

Presentation transcript:

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 302-314.e6 (August 2018) DOI: 10.1016/j.jaad.2018.04.012 Copyright © 2018 American Academy of Dermatology, Inc. Terms and Conditions

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 2018 79, 302-314.e6DOI: (10.1016/j.jaad.2018.04.012) Copyright © 2018 American Academy of Dermatology, Inc. Terms and Conditions

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 50-75 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 2018 79, 302-314.e6DOI: (10.1016/j.jaad.2018.04.012) Copyright © 2018 American Academy of Dermatology, Inc. Terms and Conditions

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 2018 79, 302-314.e6DOI: (10.1016/j.jaad.2018.04.012) Copyright © 2018 American Academy of Dermatology, Inc. Terms and Conditions

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 2018 79, 302-314.e6DOI: (10.1016/j.jaad.2018.04.012) Copyright © 2018 American Academy of Dermatology, Inc. Terms and Conditions

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 2018 79, 302-314.e6DOI: (10.1016/j.jaad.2018.04.012) Copyright © 2018 American Academy of Dermatology, Inc. Terms and Conditions

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 2018 79, 302-314.e6DOI: (10.1016/j.jaad.2018.04.012) Copyright © 2018 American Academy of Dermatology, Inc. Terms and Conditions

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 2018 79, 302-314.e6DOI: (10.1016/j.jaad.2018.04.012) Copyright © 2018 American Academy of Dermatology, Inc. Terms and Conditions

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 2018 79, 302-314.e6DOI: (10.1016/j.jaad.2018.04.012) Copyright © 2018 American Academy of Dermatology, Inc. Terms and Conditions