Presented at Fall Clinical Dermatology | Las Vegas, Nevada | October 18–21, 2018. Previously presented at EADV 2018

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25.0%

8.3%

100.0%
100.0%

68.0%
78.0%

16.7%
4.2%37.5%

30.0%

80.0%
72.0%

12.5%
4.2%

50.0%

64.0%

≥PASI 75 at Week 16

Clinical Response in Plaque Psoriasis Patients Switching from Etanercept 
to Certolizumab Pegol in a Phase 3, Randomized, Controlled Study
M. Augustin,1 J. Węgłowska,2 M. Lebwohl,3 C. Paul,4 V. Piguet,5,6,7 H. Sofen,8 A. Blauvelt,9 L. Peterson,10 C. Arendt,11 R. Rolleri10

1Institute for Health Services Research in Dermatology and Nursing (IVDP), University Medical Center Hamburg-Eppendorf (UKE), Hamburg, Germany; 2Niepubliczny Zakład Opieki Zdrowotnej 
multiMedica, Wrocław, Poland; 3Icahn School of Medicine at Mount Sinai, New York, NY; 4Paul Sabatier University, Toulouse, France; 5Cardiff University and University Hospital of Wales, Cardiff, UK; 
6Division of Dermatology, Department of Medicine, University of Toronto, Toronto, Canada; 7Division of Dermatology, Women’s College Hospital, Toronto, Canada; 8David Geffen School of Medicine at 
UCLA, Los Angeles, CA; 9Oregon Medical Research Center, Portland, OR; 10UCB Pharma, Raleigh, NC; 11UCB Pharma, Brussels, Belgium

References: 1. Armstrong AW. et al. JAMA Dermatol 2013;149:1180–5; 2. Costa L. et al. Drugs R D 
2017;17:509;https://doi.org/10.1007/s40268-017-0215-7; 3. Certolizumab Pegol Prescribing information. 
Available at http://www.accessdata.fda.gov; 4. Certolizumab Pegol Summary of Product Characteristics. 
Available at http://www.ema.europa.eu/ema; 5. Gottlieb AB. et al. J Am Acad Dermatol 2018;79:302—14.e6;  
6. Lebwohl M. et al. J Am Acad Dermatol 2018;79:266—76.e5.

Author Contributions: Substantial contributions to study conception/design, or acquisition/
analysis/interpretation of data: MA, JW, ML, CP, VP, HS, AB, LP, CA, RR; Drafting of the publication, or 
revising it critically for important intellectual content: MA, JW, ML, CP, VP, HS, AB, LP, CA, RR; Final approval 
of the publication: MA, JW, ML, CP, VP, HS, AB, LP, CA, RR.

Author Disclosures: MA: AbbVie, Almirall, Amgen, Biogen, Boehringer Ingelheim, Celgene, 
Centocor, Eli Lilly, GlaxoSmithKline, Hexal, Janssen, LEO Pharma, Medac, Merck, MSD, Mundipharma, 
Novartis, Pfizer, Sandoz, UCB Pharma, Xenoport; JW: Amgen, Celgene, Coherus, Dermira Inc., Eli Lilly, 
Galderma, Janssen, LEO Pharma, Merck, Pfizer, Regeneron, Sandoz, UCB Pharma; ML: Allergan, Aqua 
LEO Pharma, Promius. Employee of Mount Sinai which receives research funds from Abbvie, Amgen, 
Boehringer Ingelheim, Celgene, Eli Lilly, Janssen/Johnson & Johnson, Kadmon, Medimmune/Astra 
Zeneca, Novartis, Pfizer, Valeant, ViDac; CP: AbbVie, Almirall, Amgen, Boehringer Ingelheim, Celgene, 
GlaxoSmithKline, Janssen Cilag, LEO Pharma, Eli Lilly, Novartis, Pierre Fabre, Pfizer, Sanofi Regeneron, UCB 
Pharma; VP: AbbVie, Amgen, Boehringer Ingelheim, Celgene, Dermira Inc., Janssen, Eli Lilly, Medimmune, 
Novartis, Pfizer, Sun Pharma, UCB Pharma, Valeant; HS: AbbVie, Amgen, Boehringer Ingelheim, Celgene, 
Dermira Inc., Janssen, Eli Lilly, Medimmune, Novartis, Pfizer, Sun Pharma, UCB Pharma, Valeant; AB: 
AbbVie, Aclaris, Almirall, Amgen, Boehringer Ingelheim, Celgene, Dermavant, Dermira Inc., Eli Lilly, 
Genentech/ Roche, GlaxoSmithKline, Janssen, LEO Pharma, Meiji, Merck, Novartis, Pfizer, Purdue Pharma, 
Regeneron, Sandoz, Sanofi Genzyme, Sienna Pharmaceuticals, Sun Pharma, UCB Pharma, Valeant, Vidac. 
LP, CA, RR: Employees of UCB Pharma. 

Acknowledgements: The studies were funded by Dermira Inc. in collaboration with UCB Pharma. 
UCB is the regulatory sponsor of certolizumab pegol in psoriasis. We thank the patients and their caregivers in 
addition to the investigators and their teams who contributed to this study. The authors acknowledge Bartosz 
Łukowski, MSc, UCB Pharma, Brussels, Beligum for publication coordination and Amelia Frizell-Armitage, PhD, 
and Helen Chambers, DPhil, Costello Medical, Cambridge, UK for medical writing and editorial assistance. All 
costs associated with development of this poster were funded by UCB Pharma.

OBJECTIVE
• To assess the efficacy of certolizumab pegol in patients with 

moderate to severe plaque psoriasis who initially received 12 
weeks of treatment with the anti-TNF etanercept. 

BACKGROUND 
• Plaque psoriasis (PSO) is an immune-mediated, inflammatory disease.

• Treatment options for PSO include topicals, phototherapy or systemic  
medications (including biologics).

• Certolizumab pegol (CZP) is a unique, Fc-free, PEGylated, anti-tumor 
necrosis factor (TNF), approved by both the FDA and EMA for the 
treatment of moderate to severe PSO.3,4 

• In phase 3 trials, CZP has shown clinical improvements maintained 
over 48 weeks, and a safety profile consistent with the anti-TNF class, 
in adults with PSO.5,6

• Here, we assessed clinical outcomes in patients with moderate to 
severe PSO who switched to CZP following 12 weeks of etanercept 
(ETN) treatment and a 4-week washout period.

METHODS 
Study Design
• Patients in the ongoing phase 3 trial CIMPACT (NCT02346240) were 

randomized to placebo, CZP 400 mg every two weeks (Q2W), CZP  
200 mg Q2W for 16 weeks, or ETN 50 mg twice weekly for 12 weeks 
(Figure 1).

• At Week 16, following a 4-week washout, ETN-randomized patients 
received treatment to Week 48 according to their initial response. This 
analysis focuses on:

 – Patients who did not achieve a 50% improvement from baseline in 
Psoriasis Area Severity Index (PASI 50) at Week 12 and entered an 
escape arm where they received open-label CZP 400 mg Q2W.

 – Patients who achieved a 75% improvement from baseline in PASI 
(PASI 75) at Week 16 following the washout period and were  
re-randomized 2:1 to double-blind CZP 200 mg Q2W or placebo 
(PBO) Q2W. 

Patients
• ≥18 years of age with PSO for ≥6 months with PASI ≥12, ≥10% body 

surface area affected, physician’s global assessment (PGA) ≥3 on a 
5-point scale. 

• Candidates for systemic PSO therapy, phototherapy and/or 
photochemotherapy. 

• Exclusion criteria: previous treatment with CZP, ETN or ≥2 biologics; 
history of primary failure to any biologic or secondary failure to >1 
biologic; erythrodermic, guttate or generalized PSO types; history of 
current, chronic or recurrent viral, bacterial or fungal infections. 

• ETN primary non-response was defined post-hoc as failure to achieve 
a PASI 50 response at Week 12. 

CONCLUSIONS
• Patients with moderate to severe PSO who did not achieve 

a clinical response after 12 weeks of ETN therapy (<PASI 50) 
showed improvements following switch to CZP 400 mg Q2W.

• The proportion of patients who did achieve a clinical response 
with ETN therapy (≥PASI 75) was maintained or further 
improved following switch to CZP 200 mg Q2W. 

• CZP may be an effective treatment option for patients who do 
not primarily respond to ETN or require treatment switch.

Table 1. Demographics and baseline characteristics 

BMI: body mass index; BSA: body surface area; BW: twice weekly; CZP: certolizumab pegol; ETN: etanercept; IL: interleukin; OL: open-label; PASI: Psoriasis Area Severity 
Index; PGA: physician’s global assessment; PSO; plaque psoriasis; Q2W: every two weeks; SD: standard deviation; TNF: tumor necrosis factor.

All patients  
(N=559)

ETN 50 mg BW 
(n=170)

ETN → OL  
CZP 400 mg Q2W 

(n=35)

ETN →  
CZP 200 mg Q2W 

(n=50)

ETN →  
Placebo Q2W 

(n=24)

Age, years, mean (SD) 45.7 (13.3) 44.6 (14.1) 46.4 (15.4) 43.3 (12.9) 47.2 (13.5)
Male, n (%) 381 (68.2) 127 (74.7) 29 (82.9) 37 (74.0) 18 (75.0)
BMI, kg/m2, mean (SD) 29.6 (6.4) 29.5 (6.3) 31.4 (6.3) 28.4 (4.7) 29.8 (5.7)
Prior biologic use, n (%) 154 (27.5) 51 (30.0) 12 (34.3) 15 (30.0) 10 (41.7)

Anti-TNF 21 (3.8) 8 (4.7) 0 2 (4.0) 2 (8.3)
Anti-IL-17 122 (21.8) 41 (24.1) 11 (31.4) 13 (26.0) 7 (29.2)
Anti-IL-12/IL-23 32 (5.7) 10 (5.9) 2 (5.7) 2 (4.0) 2 (8.3)

PSO duration, years, mean (SD) 18.3 (12.3) 17.4 (12.0) 14.9 (10.0) 18.6 (12.8) 16.3 (14.2)
PASI, mean (SD) 20.9 (8.1) 21.0 (8.2) 21.6 (8.3) 20.9 (9.0) 22.4 (7.9)
BSA affected, %, mean (SD) 27.4 (15.6) 27.5 (15.5) 30.2 (15.5) 26.6 (15.8) 28.9 (16.1)
PGA score, n (%)

3 (moderate) 382 (68.3) 115 (67.6) 18 (51.4) 37 (74.0) 17 (70.8)
4 (severe) 177 (31.7) 55 (32.4) 17 (48.6) 13 (26.0) 7 (29.2)

Figure 1. CIMPACT study design

BW: twice weekly (last dose of ETN received at Week 11.5); CZP: certolizumab 
pegol; ETN: etanercept; LD: 400 mg CZP at Weeks 0,2 and 4 or 16, 18 and 
20; PASI: Psoriasis Area Severity Index; Q2W: every two weeks. 

Study Assessments
• Patients were assessed through Weeks 16–48 for:

 – PASI 75

 – PASI 90 (≥90% reduction from baseline)

 – PGA 0/1 (“clear” or “almost clear” with ≥2 category improvement 
from baseline)

Statistical Analyses
• Patients who did not achieve PASI 50 at Week 32 or later were treated 

as non-responders at subsequent time points. 

• Missing data and patients withdrawn during Weeks 16–48 were 
imputed as non-responders.

RESULTS 
Patient Demographics and Baseline Characteristics
• 170 patients were randomized to ETN at Week 0; 159 were still in the 

study at Week 16. 

• 35/159 failed to achieve a PASI 50 response following 12 weeks of ETN 
treatment and entered the open-label CZP 400 mg Q2W escape arm 
at Week 16. 

• 77/159 patients demonstrated a PASI 75 response at Week 16, 74 of 
whom entered the double-blind maintenance period; 50 patients were 
re-randomized to CZP 200 mg Q2W and 24 to placebo Q2W. 

• Baseline characteristics are shown in Table 1. 

Clinical Response to CZP in ETN PASI 50  
Non-Responders
• At Week 32 following 16 weeks of CZP 400 mg Q2W:

 – 60.0% of ETN non-responders achieved a PASI 75 response  
(Figure 2A)

 – 25.7% achieved a PASI 90 response (Figure 2B)

 – 42.9% achieved a PGA 0/1 response (Figure 2C)

• At Week 48 (after 32 weeks of CZP 400 mg Q2W) these proportions 
were maintained or further increased (Figure 2).

Clinical Response to CZP in ETN PASI 75 Responders
• For ETN responders who switched to CZP 200 mg Q2W at Week 16:

 – 82.0% still achieved a PASI 75 response at Week 48 (Figure 3A)

 – The proportion of PASI 90 responders increased to Week 48  
(Figure 3B)

 – The proportion achieving a PGA 0/1 response remained high  
(Figure 3C)

• The PASI 75, PASI 90 and PGA 0/1 responder rate declined through 
Weeks 16–48 for ETN patients who switched to placebo (Figure 3). 

Safety
• No new safety signals were identified in patients who initially received 

ETN and switched to CZP treatment at Week 16.

0

Randomization Re-randomization

16 4840 443212 36Week

Initial treatment 
period

(Double-blind)

Maintenance period
(Double-blind)

1:3:3:3

<PASI 
75

<PASI 50 – Open label treatment

<PASI 
75

<PASI 
75

<PASI 
75

Placebo Q2W
Placebo Q2W (n=24)

CZP 400 mg Q4W

CZP 200 mg Q2W (n=50)

ETN 50 mg 
BW (n=170)

Washout

LD

CZP 400 mg Q2W CZP 400 mg Q2W

Escape CZP 400 mg Q2W

(n=74)

LD

<PASI 50 
at Week 12 

(n=35)

<PASI 50 – Withdrawn

≥PASI 75 

CZP 200 mg 
Q2W

Figure 2.  Clinical response in ETN PASI 50  
non-responders following switch to CZP 

A) PASI 75

SUMMARY

These data show that CZP may be an e�ective treatment option in patients 
who require treatment switch from etanercept.

We report patients with psoriasis who received etanercept 50 mg twice weekly for 12 weeks and 
subsequently switched to certolizumab pegol dosed at either 400 mg or 200 mg every two weeks.

Psoriasis patients treated with a biologic may 
require treatment switch to a second agent due to:1,2

Dissatisfaction

Adverse events

Loss of e�cacy

Change of circumstance

Primary non-response

1 Fab’

Certolizumab pegol

C) PGA 0/1

Non-responder imputation. ETN non-response defined as failure to achieve ≥50% reduction from baseline in PASI at Week 12. aCZP 400 mg loading dose at Weeks 16, 18 
and 20. BW: twice weekly (last dose of ETN received at Week 11.5); CZP: certolizumab pegol; ETN: etanercept; OL: open-label; PASI: Psoriasis Area Severity Index; PGA: 
physician’s global assessment; Q2W: every two weeks.

Figure 3.  Clinical response in ETN PASI 75 responders 
re-randomized to CZP and placebo

A) PASI 75

C) PGA 0/1

Placebo Q2W (n=24)

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68.0%
78.0%

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B) PASI 90 B) PASI 90