Presented at Winter Clinical Dermatology Conference 2019 | Hawaii | 18–23 Jan 2019

The Efficacy of Certolizumab Pegol Re-Treatment on Plaque Psoriasis 
Following a Blinded Treatment Break: Results from the CIMPACT Trial
M. Lebwohl,1 V. Piguet,2 H. Sofen,3 A. Blauvelt,4 C. Arendt,5 S. Kavanagh,6 M. Boehnlein,7 M. Augustin8
1Icahn School of Medicine at Mount Sinai, New York, NY; 2Cardiff University and University Hospital of Wales, Cardiff, UK; 3UCLA, Los Angeles, CA; 
4Oregon Medical Research Center, Portland, OR; 5UCB Pharma, Brussels, Belgium; 6UCB Pharma, Raleigh, NC; 7UCB Pharma, Monheim, Germany; 
8IVDP, UKE, Hamburg, Germany

References
1. Certolizumab Pegol Prescribing information. Available at http://www.accessdata.fda.gov;  
2. Certolizumab Pegol Summary of Product Characteristics. Available at http://www.ema.europa.eu/
ema; 3. 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: ML, VP, HS, AB, CA, SK, MB, MA; Drafting of the publication, or revising it critically 
for important intellectual content: ML, VP, HS, AB, CA, SK, MB, MA; Final approval of the 
publication: ML, VP, HS, AB, CA, SK, MB, MA. 

Author Disclosures
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/AstraZeneca, Novartis, Pfizer, Valeant, ViDac; VP: AbbVie, 
Almirall, Celgene, Janssen, Novartis, Pfizer, Alliance, Beiersdorf, Biotest, Dermal, Eli Lilly, Galderma, 
Genus Pharma, GlobeMicro, Janssen, LaRoche-Posay, L’Oreal, LEO Pharma, Meda, MSD, Novartis, 
Pfizer, Sinclair Pharma, Spirit, GSK, Samumed, Thornton Ross, TyPham, UCB Pharma; HS: AbbVie, 
Amgen, Boehringer Ingelheim, Celgene, Dermira Inc., Janssen, Eli Lilly, MedImmune, Novartis, 
Pfizer, Sun Pharma, UCB Pharma, Valeant; AB: Scientific adviser and/or clinical study investigator 
for AbbVie, Aclaris, Akros, Allergan, Almirall, Amgen, Arena, Boehringer Ingelheim, Celgene, 
Dermavant, Dermira Inc., Eli Lilly and Company, Galderma, Genentech/Roche, GSK, Janssen, 
Leo, Meiji, Merck Sharp & Dohme, Novartis, Pfizer, Purdue Pharma, Regeneron, Revance, Sandoz, 
Sanofi Genzyme, Sienna Pharmaceuticals, Sun Pharma, UCB Pharma, Valeant, and Vidac. Paid 
speaker for Janssen, Regeneron, and Sanofi Genzyme; CA, SK, MB: Employees of UCB Pharma; 
MA: AbbVie, Almirall, Amgen, Biogen, Boehringer Ingelheim, Celgene, Centocor, Eli Lilly, GSK, 
Hexal, Janssen, LEO Pharma, Medac, Merck, MSD, Mundipharma, Novartis, Pfizer, Sandoz, UCB 
Pharma, Xenoport.

Acknowledgements
The studies were funded by Dermira Inc. in collaboration with UCB Pharma. UCB is the regulatory 
sponsor of cetolizumab 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, Belgium for publication coordination, and Joe Dixon, PhD, 
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 responded to initial treatment, relapsed during a 
treatment break, and were subsequently re-treated.

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

inflammatory disease; treatment options include systemic 
medication, phototherapy and biologic agents.

• Certolizumab pegol (CZP) is a unique, Fc-free, PEGylated, 
anti-tumor necrosis factor (TNF) biologic, approved by 
both the FDA and EMA for the treatment of moderate to 
severe PSO.1,2 

• Here, we assess efficacy of CZP in patients with PSO 
who responded to initial treatment, underwent a blinded 
treatment break, relapsed, and were subsequently re-treated.

METHODS
Study Design
• Patients were enrolled in the ongoing phase 3 trial  

CIMPACT (NCT02346240); the full study design has been 
published previously.3

• Patients included in this analysis received treatment 
according to Figure 1.

• We focus on CZP-treated patients who achieved a 75% 
improvement from baseline in Psoriasis Area Severity Index 
(PASI 75) at the end of the initial period (Week 16), were  
re-randomized to placebo every two weeks (Q2W) for up 
to 32 weeks of double-blind maintenance treatment and 
subsequently relapsed (did not demonstrate a PASI 50 
response [50% improvement from baseline]).

• Upon relapse, patients entered the 96-week open-label 
extension and received open-label CZP 400 mg Q2W.

CONCLUSIONS
• Following re-treatment with open-label CZP  

400 mg Q2W, all patients re-achieved or improved 
upon their initial treatment response. 

• The results shown here indicate that CZP may be 
an appropriate treatment option for patients who 
require a treatment break.

• Analyses using larger sample sizes would further 
validate these findings.

aCZP 400 mg loading dose at Weeks 0, 2 and 4. BMI: body mass index; BSA: body 
surface area; CZP: certolizumab pegol; DLQI: Dermatology Life Quality Index;  
IL: interleukin; PASI: Psoriasis Area Severity Index; PGA: physician’s global assessment; 
PSO: plaque psoriasis; Q2W: every two weeks; SD: standard deviation; TNF: tumor 
necrosis factor.

Table 1.  Demographics and baseline 
characteristics 

Figure 2.  Mean absolute PASI through the initial treatment, withdrawal, and  
open-label re-treatment periods

Observed case (there were no missing data). Standard deviations are shown in parentheses. All patients were re-randomized to placebo at Week 16, and subsequently received open-label CZP 
400 mg Q2W at relapse (OLE Week 0). aCombined CZP 200 mg Q2W and CZP 400 mg Q2W; bCZP 400 mg loading dose at Weeks 0, 2 and 4. CZP: certolizumab pegol; OLE: open-label 
extension; PASI: Psoriasis Area Severity Index; Q2W: every two weeks.

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

≥10% body surface area affected, Physician’s Global 
Assessment ≥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; current or history of chronic or 
recurrent viral, bacterial or fungal infections. 

Figure 1. Treatment arms included in this analysis

Patients were enrolled in the phase 3 CIMPACT trial. Only study arms relevant to this analysis are shown. aLoading dose of CZP 400 mg Q2W at Weeks 0, 2 and 4; bDosing adjustment was at the 
Investigator’s discretion based on PASI response. CZP: certolizumab pegol; LD: loading dose; PASI: Psoriasis Area Severity Index; Q2W: every two weeks.

Open-label treatmentInitial treatment period (double-blind) Maintenance period (double-blind)

N=165

Randomization Re-randomization

0 16
Week

44403632 4828

96 Week open-label CZP 400 mg Q2W

< PASI 75 - Escape arm

< PASI 75 - Escape arm
CZP 400 mg Q2W

Placebo Q2W (N=18)LDa CZP 200 mg Q2W
N=8
≥PASI 75

N=10
≥PASI 75

< PASI 50

< PASI 50 - Withdrawn

CZP 200 mg Q2W

Open-label dose switchingbN=167

SUMMARY

Due to patient circumstances, physicians may recommend that 
individuals receiving biologic therapy take a treatment break.

Following re-treatment, all patients re-gained the same level of 
clinical response achieved after 16 weeks of initial treatment. 

We report the clinical outcomes of patients who:Certolizumab pegol (CZP)

1 Fab’
Had a successful initial 

treatment period 
with CZP

Were withdrawn 
from treatment

Relapsed
Were re-treated with 
CZP dosed at 400 mg 

every two weeks

All CZP 
(N=18)

CZP 400 mg 
Q2W 

(N=10)

CZP 200 mg 
Q2Wa 
(N=8)

Age, years, mean (SD) 42.6 (13.1) 41.4 (8.7) 44.0 (17.7)

Male, n (%) 9 (50.0) 4 (40.0) 5 (62.5)

BMI, kg/m2, mean (SD) 28.6 (4.1) 26.7 (1.8) 30.9 (5.0)

Prior biologic use, n (%) 6 (33.3) 4 (40.0) 2 (25.0)

Anti-TNF 0 0 0

Anti-IL-17 5 (27.8) 3 (30.0) 2 (25.0)

Anti-IL-12/IL-23 1 (5.6) 0 1 (12.5)

PSO duration, years, 
mean (SD)

23.0 (16.6) 19.4 (15.9) 27.6 (17.4)

PASI, mean (SD) 23.4 (8.9) 24.0 (7.3) 22.6 (11.2)

BSA affected, %,  
mean (SD)

33.3 (17.7) 34.3 (17.8) 32.0 (18.6)

PGA score, n (%)

3 (moderate) 15 (83.3) 8 (80.0) 7 (87.5)

4 (severe) 3 (16.7) 2 (20.0) 1 (12.5)

DLQI, mean (SD) 11.8 (9.2) 13.8 (9.7) 9.3 (8.5)

Study Assessments and Statistical Analyses
• Patients were assessed throughout the initial, maintenance 

and open-label periods for:

 – Absolute PASI

 – PASI 75 and PASI 90 (90% improvement from baseline)

• Observed data are reported.

• During re-treatment, time to achieve a 75% or 90% 
improvement in PASI from Week 16 response was 
estimated using Kaplan-Meier analysis.

RESULTS 
Patient Population
• Of the patients who were initially randomized to either 

CZP 400 mg Q2W or CZP 200 mg Q2W, achieved  
PASI 75 at Week 16, and were re-randomized to placebo 
Q2W for maintenance treatment, 18 relapsed and 
received open-label CZP 400 mg Q2W. 

• Baseline demographics are shown in Table 1. 

• Mean PASI reduced rapidly over the initial 16 weeks of CZP 
treatment (Figure 2).

• At Week 16, in addition to PASI 75, 61% of patients (11/18) 
also achieved PASI 90. 

Clinical Response to Withdrawal  
and Re-Treatment
• Following re-randomization to placebo, median time to 

relapse was 142 days (Figure 2).

• After 12 weeks of re-treatment with open-label CZP  
400 mg Q2W, mean absolute PASI was comparable to 
that achieved after the initial 16 weeks (Figure 2).

• Over the course of the re-treatment period and follow-up, 
all patients who had attained a PASI 75 or PASI 90 response 
at Week 16 regained the same level of response.

• A high proportion of patients achieved further 
improvements in PASI during re-treatment, compared 
to their Week 16 score:

 – 83% of patients (15/18) achieved a further 75% 
improvement on their Week 16 PASI in a median time 
of 127 days (95% confidence interval: 76–171) from 
re-treatment

 – 67% of patients (12/18) achieved a further 90% 
improvement on their Week 16 PASI, in a median time 
of 169 days (95% confidence interval: 85–337) from 
re-treatment.

0

5

10

15

20

25

30

40

Baseline Week 16 OLE Week 0 OLE Week 12

Time (Weeks)

M
e

a
n

 A
b

so
lu

te
 P

A
S

I

Double-blind CZP treatment Treatment withdrawal
placebo Q2W

Open-label re-treatment 
CZP 400 mg Q2W

24.0 (7.3)

23.4 (8.9)

22.6 (11.2)

2.8 (2.8)
2.5 (2.5)

2.2 (2.2)

16.7 (6.4) 16.1 (6.7)

15.5 (7.4)
5.4 (5.2)

4.8 (4.6)

3.9 (4.0)

All CZPa (N=18) CZP 200 mg Q2Wb (N=8)CZP 400 mg Q2W (N=10)

Median time 
to relapse:
142 days 

(relapse)

Randomization group: