Long-term efficacy of certolizumab pegol for the treatment of plaque psoriasis: 3-year results from two randomized phase III trials (CIMPASI-1 and CIMPASI-2)

K. B. Gordon; R. B. Warren; A. B. Gottlieb; A. Blauvelt; D. Thaçi; C. Leonardi; Y. Poulin; M. Boehnlein; F. Brock; C. Ecoffet; K. Reich

doi:10.1111/bjd.19393

Long-term efficacy of certolizumab pegol for the treatment of plaque psoriasis: 3-year results from two randomized phase III trials (CIMPASI-1 and CIMPASI-2)

K. B. Gordon^*, R. B. Warren, A. B. Gottlieb, A. Blauvelt, D. Thaçi, C. Leonardi, Y. Poulin, M. Boehnlein, F. Brock, C. Ecoffet, K. Reich

^*Corresponding author for this work

Institute of Inflammation Medicine

21 Citations (Scopus)

Abstract

Background: Certolizumab pegol (CZP) is an Fc-free, PEGylated anti-tumour necrosis factor biologic. Objectives: To report the 3-year efficacy of CZP in plaque psoriasis, pooled from the CIMPASI-1 (NCT02326298) and CIMPASI-2 (NCT02326272) phase III trials. Methods: Adults with moderate-to-severe psoriasis for ≥ 6 months were randomized 2 : 2 : 1 to CZP 200 mg, CZP 400 mg or placebo, every 2 weeks (Q2W) for up to 48 weeks. Patients entering the open-label period (weeks 48–144) from double-blinded CZP initially received CZP 200 mg Q2W. Patients not achieving ≥ 50% improvement in Psoriasis Area and Severity Index (PASI 50) at week 16 entered an open-label CZP 400 mg Q2W escape arm (weeks 16–144). Dose adjustments based on PASI response were permitted during open-label treatment. Outcomes included PASI 75, PASI 90 and Physician’s Global Assessment (PGA) 0/1 responder rates, based on a logistic regression model (missing data imputed using Markov Chain Monte Carlo methodology). Results: In total, 186 patients were randomized to CZP 200 mg Q2W and 175 to CZP 400 mg Q2W. At week 48, PASI 75/90 was achieved by 72·7%/51·3% of patients randomized to CZP 200 mg and 84·4%/62·7% randomized to CZP 400 mg. Patients entering the open-label period at week 48, from blinded treatment, received CZP 200 mg Q2W. At week 144, PASI 75/90 was achieved by 70·6%/48·7% patients randomized to CZP 200 mg and 72·9%/42·7% randomized to CZP 400 mg. At week 16, 72 placebo-randomized patients entered the CZP 400 mg Q2W escape arm; 75.7%/58.5% achieved PASI 75/90 at week 144. Conclusions: Both CZP 200 mg and 400 mg Q2W demonstrated sustained, durable efficacy, with numerically higher responses for some outcomes with 400 mg Q2W.

Original language	English
Journal	British Journal of Dermatology
ISSN	0007-0963
DOIs	https://doi.org/10.1111/bjd.19393
Publication status	Published - 11.07.2020

Funding

The authors thank the patients and the investigators and their teams who took part in these studies. The authors also acknowledge Catherine Arendt, MD PharmD, of UCB Pharma, Brussels, Belgium, for critical review during the development of this manuscript; Sarah Kavanagh, MPH, for statistical analysis; Joe Dixon, PhD, of Costello Medical, Cambridge, UK, for medical writing and editorial assistance in preparing this manuscript for publication, based on the authors’ input and direction; and Susanne Wiegratz, Dipl.‐Biol., MSc, of UCB Pharma, Monheim, Germany, for publication coordination. Richard Warren is supported by the Manchester NIHR Biomedical Research Centre. K.B.G. has received honoraria and/or research support from AbbVie, Almirall, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Dermira Inc., Eli Lilly, Janssen, Novartis, Pfizer, Sun Pharma and UCB Pharma. R.B.W. has served as a speaker, advisor and/or clinical study investigator for AbbVie, Almirall, Arena Pharmaceuticals, Avillion, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly and Company, Janssen, LEO Pharma, Novartis, Ortho, Sanofi Genzyme, Sun Pharma and UCB Pharma. A.B.G. has current consulting or advisory board agreements with AbbVie, Allergan, Avotres Therapeutics, Beiersdorf, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Dermira Inc., Dr. Reddy’s Laboratories, Eli Lilly, Incyte, Janssen, LEO Pharma, Novartis, Sun Pharma, UCB Pharma, Valeant and XBiotech (no personal compensation); and has received research and educational grants from Boehringer Ingelheim, Incyte, Janssen, Novartis, UCB Pharma and XBiotech. A.B. has served as a scientific adviser and/or clinical study investigator for AbbVie, Aclaris, Allergan, Almirall, Athenex, Boehringer Ingelheim, Bristol Myers Squibb, Dermavant, Dermira Inc., Eli Lilly and Company, FLX Bio, Forte, Galderma, Janssen, LEO Pharma, Novartis, Ortho, Pfizer, Regeneron, Sandoz, Sanofi Genzyme, Sun Pharma and UCB Pharma; and as a paid speaker for AbbVie. D.T. has received honoraria for participation on ad boards, as a speaker or for consultancy from AbbVie, Almirall, Amgen, Boehringer Ingelheim, Celgene, Dignity, Dr. Reddy’s Laboratories, Eli Lilly, Galapagos, GSK, Janssen, LEO Pharma, Morphosis, MSD, Novartis, Pfizer, Sandoz‐Hexal, Pfizer, Regeneron/Sanofi and UCB Pharma; and research grants from Celgene and Novartis. C.L. is treasurer of the International Psoriasis Council; a Fellow of the American Academy of Dermatology; a Member of the American Dermatological Association and Adjunct Professor of Dermatology at St Louis University School of Medicine; has a private practice in St Louis, MO; has received consulting and advisory board honoraria from AbbVie, Amgen, Boehringer Ingelheim, Dermira Inc., Eli Lilly, Janssen, LEO Pharma, Pfizer, Sandoz, UCB Pharma and Vitae; has acted as an investigator for AbbVie, Actavis, Amgen, Boehringer Ingelheim, Celgene, Coherus, Corrona, Dermira Inc., Eli Lilly, Galderma, Glenmark, Janssen, LEO Pharma, Merck, Novartis, Novella, Pfizer, Sandoz, Stiefel and Wyeth; and has acted as a speaker (with honoraria) for AbbVie, Celgene, Eli Lilly and Novartis. Y.P. has acted as an investigator (research grants) for AbbVie, Baxter, Boehringer Ingelheim, Celgene, Centocor/Janssen, Eli Lilly, EMD Serono, GSK, LEO Pharma, MedImmune, Merck, Novartis, Pfizer, Regeneron, Takeda and UCB Pharma; and as a speaker (with honoraria) for AbbVie, Celgene, Janssen, Eli Lilly, LEO Pharma, Novartis, Regeneron and Sanofi Genzyme. M.B., F.B. and C.E. are employees of UCB Pharma. K.R. has served as an advisor and/or paid speaker for and/or participated in clinical trials sponsored by AbbVie, Affibody, Almirall, Amgen, Avillion, Biogen, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Centocor, Covagen, Dermira Inc., Eli Lilly, Forward Pharma, Fresenius Medical Care, Galapagos, GSK, Janssen‐Cilag, Kyowa Kirin, LEO Pharma, Medac, Merck Sharp & Dohme, Miltenyi Biotec, Novartis, Ocean Pharma, Pfizer, Regeneron, Samsung Bioepis, Sanofi, Sun Pharma, Takeda, UCB Pharma, Valeant and Xenoport.

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Academic Focus: Center for Infection and Inflammation Research (ZIEL)

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10.1111/bjd.19393

Cite this

Gordon, K. B., Warren, R. B., Gottlieb, A. B., Blauvelt, A., Thaçi, D., Leonardi, C., Poulin, Y., Boehnlein, M., Brock, F., Ecoffet, C., & Reich, K. (2020). Long-term efficacy of certolizumab pegol for the treatment of plaque psoriasis: 3-year results from two randomized phase III trials (CIMPASI-1 and CIMPASI-2). British Journal of Dermatology. https://doi.org/10.1111/bjd.19393

@article{8a0607bc7b6242ff895dd03a09f1797e,

title = "Long-term efficacy of certolizumab pegol for the treatment of plaque psoriasis: 3-year results from two randomized phase III trials (CIMPASI-1 and CIMPASI-2)",

abstract = "Background: Certolizumab pegol (CZP) is an Fc-free, PEGylated anti-tumour necrosis factor biologic. Objectives: To report the 3-year efficacy of CZP in plaque psoriasis, pooled from the CIMPASI-1 (NCT02326298) and CIMPASI-2 (NCT02326272) phase III trials. Methods: Adults with moderate-to-severe psoriasis for ≥ 6 months were randomized 2 : 2 : 1 to CZP 200 mg, CZP 400 mg or placebo, every 2 weeks (Q2W) for up to 48 weeks. Patients entering the open-label period (weeks 48–144) from double-blinded CZP initially received CZP 200 mg Q2W. Patients not achieving ≥ 50\% improvement in Psoriasis Area and Severity Index (PASI 50) at week 16 entered an open-label CZP 400 mg Q2W escape arm (weeks 16–144). Dose adjustments based on PASI response were permitted during open-label treatment. Outcomes included PASI 75, PASI 90 and Physician{\textquoteright}s Global Assessment (PGA) 0/1 responder rates, based on a logistic regression model (missing data imputed using Markov Chain Monte Carlo methodology). Results: In total, 186 patients were randomized to CZP 200 mg Q2W and 175 to CZP 400 mg Q2W. At week 48, PASI 75/90 was achieved by 72·7\%/51·3\% of patients randomized to CZP 200 mg and 84·4\%/62·7\% randomized to CZP 400 mg. Patients entering the open-label period at week 48, from blinded treatment, received CZP 200 mg Q2W. At week 144, PASI 75/90 was achieved by 70·6\%/48·7\% patients randomized to CZP 200 mg and 72·9\%/42·7\% randomized to CZP 400 mg. At week 16, 72 placebo-randomized patients entered the CZP 400 mg Q2W escape arm; 75.7\%/58.5\% achieved PASI 75/90 at week 144. Conclusions: Both CZP 200 mg and 400 mg Q2W demonstrated sustained, durable efficacy, with numerically higher responses for some outcomes with 400 mg Q2W.",

author = "Gordon, \{K. B.\} and Warren, \{R. B.\} and Gottlieb, \{A. B.\} and A. Blauvelt and D. Tha{\c c}i and C. Leonardi and Y. Poulin and M. Boehnlein and F. Brock and C. Ecoffet and K. Reich",

year = "2020",

month = jul,

day = "11",

doi = "10.1111/bjd.19393",

language = "English",

journal = "British Journal of Dermatology",

issn = "0007-0963",

publisher = "Oxford University Press",

}

TY - JOUR

T1 - Long-term efficacy of certolizumab pegol for the treatment of plaque psoriasis: 3-year results from two randomized phase III trials (CIMPASI-1 and CIMPASI-2)

AU - Gordon, K. B.

AU - Warren, R. B.

AU - Gottlieb, A. B.

AU - Blauvelt, A.

AU - Thaçi, D.

AU - Leonardi, C.

AU - Poulin, Y.

AU - Boehnlein, M.

AU - Brock, F.

AU - Ecoffet, C.

AU - Reich, K.

PY - 2020/7/11

Y1 - 2020/7/11

N2 - Background: Certolizumab pegol (CZP) is an Fc-free, PEGylated anti-tumour necrosis factor biologic. Objectives: To report the 3-year efficacy of CZP in plaque psoriasis, pooled from the CIMPASI-1 (NCT02326298) and CIMPASI-2 (NCT02326272) phase III trials. Methods: Adults with moderate-to-severe psoriasis for ≥ 6 months were randomized 2 : 2 : 1 to CZP 200 mg, CZP 400 mg or placebo, every 2 weeks (Q2W) for up to 48 weeks. Patients entering the open-label period (weeks 48–144) from double-blinded CZP initially received CZP 200 mg Q2W. Patients not achieving ≥ 50% improvement in Psoriasis Area and Severity Index (PASI 50) at week 16 entered an open-label CZP 400 mg Q2W escape arm (weeks 16–144). Dose adjustments based on PASI response were permitted during open-label treatment. Outcomes included PASI 75, PASI 90 and Physician’s Global Assessment (PGA) 0/1 responder rates, based on a logistic regression model (missing data imputed using Markov Chain Monte Carlo methodology). Results: In total, 186 patients were randomized to CZP 200 mg Q2W and 175 to CZP 400 mg Q2W. At week 48, PASI 75/90 was achieved by 72·7%/51·3% of patients randomized to CZP 200 mg and 84·4%/62·7% randomized to CZP 400 mg. Patients entering the open-label period at week 48, from blinded treatment, received CZP 200 mg Q2W. At week 144, PASI 75/90 was achieved by 70·6%/48·7% patients randomized to CZP 200 mg and 72·9%/42·7% randomized to CZP 400 mg. At week 16, 72 placebo-randomized patients entered the CZP 400 mg Q2W escape arm; 75.7%/58.5% achieved PASI 75/90 at week 144. Conclusions: Both CZP 200 mg and 400 mg Q2W demonstrated sustained, durable efficacy, with numerically higher responses for some outcomes with 400 mg Q2W.

AB - Background: Certolizumab pegol (CZP) is an Fc-free, PEGylated anti-tumour necrosis factor biologic. Objectives: To report the 3-year efficacy of CZP in plaque psoriasis, pooled from the CIMPASI-1 (NCT02326298) and CIMPASI-2 (NCT02326272) phase III trials. Methods: Adults with moderate-to-severe psoriasis for ≥ 6 months were randomized 2 : 2 : 1 to CZP 200 mg, CZP 400 mg or placebo, every 2 weeks (Q2W) for up to 48 weeks. Patients entering the open-label period (weeks 48–144) from double-blinded CZP initially received CZP 200 mg Q2W. Patients not achieving ≥ 50% improvement in Psoriasis Area and Severity Index (PASI 50) at week 16 entered an open-label CZP 400 mg Q2W escape arm (weeks 16–144). Dose adjustments based on PASI response were permitted during open-label treatment. Outcomes included PASI 75, PASI 90 and Physician’s Global Assessment (PGA) 0/1 responder rates, based on a logistic regression model (missing data imputed using Markov Chain Monte Carlo methodology). Results: In total, 186 patients were randomized to CZP 200 mg Q2W and 175 to CZP 400 mg Q2W. At week 48, PASI 75/90 was achieved by 72·7%/51·3% of patients randomized to CZP 200 mg and 84·4%/62·7% randomized to CZP 400 mg. Patients entering the open-label period at week 48, from blinded treatment, received CZP 200 mg Q2W. At week 144, PASI 75/90 was achieved by 70·6%/48·7% patients randomized to CZP 200 mg and 72·9%/42·7% randomized to CZP 400 mg. At week 16, 72 placebo-randomized patients entered the CZP 400 mg Q2W escape arm; 75.7%/58.5% achieved PASI 75/90 at week 144. Conclusions: Both CZP 200 mg and 400 mg Q2W demonstrated sustained, durable efficacy, with numerically higher responses for some outcomes with 400 mg Q2W.

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U2 - 10.1111/bjd.19393

DO - 10.1111/bjd.19393

M3 - Journal articles

C2 - 32652544

AN - SCOPUS:85090447727

SN - 0007-0963

JO - British Journal of Dermatology

JF - British Journal of Dermatology

ER -

Long-term efficacy of certolizumab pegol for the treatment of plaque psoriasis: 3-year results from two randomized phase III trials (CIMPASI-1 and CIMPASI-2)

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