Presented at Winter Clinical Dermatology Conference 2020 | Hawaii | Jan 17–22 2020 Previously presented at 28th EADV Congress 2019

Durability of Response in Patients with Psoriatic Arthritis Treated with 
Certolizumab Pegol over 216 Weeks: Post-Hoc Analyses from the 
RAPID-PsA Study
A. B. Gottlieb,1 P. Gisondi,2 J. Eells,3 L. Peterson,4 A. Kavanaugh5

1Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, NY; 2University of Verona, Verona, Italy;  
3UCB Pharma, Slough, UK; 4UCB Pharma, Raleigh, NC; 5University of California, San Diego, CA

References
1. Certolizumab Pegol Prescribing Information. Available at  
www.fda.gov/drugs; 2. Certolizumab Pegol Summary of Product 
Characteristics. Available at www.ema.europa.eu/ema; 3. van der Heijde 
D. RMD Open 2018;4:e000582; 4. van der Heijde D. EULAR 2018;  
5. Gordon K. EADV 2019;870; 6. Gordon K. EADV 2019;1556;  
7. Gordon K. AAD 2019; 8. Coates LC. Ann Rheum Dis 2010;69:48–53.

Author Contributions
Substantial contributions to study conception/design, or acquisition/
analysis/interpretation of data: ABG, PG, JE, LP, AK; Drafting of the 
publication, or revising it critically for important intellectual content: 
ABG, PG, JE, LP, AK; Final approval of the publication: ABG, PG, 
JE, LP, AK.

Author Disclosures
ABG: Research/educational grants: Allergan, Eli Lilly, Incyte, Janssen, 
LEO Pharma and Novartis. Current consulting/advisory board 
agreements/speakers bureau: AbbVie, Allergan, Beiersdorf Inc.,  
Bristol-Myers Squibb, Celgene Corp., Dermira, Eli Lilly, Incyte, Janssen 
Inc, Novartis, Reddy Labs, Sienna, Sun Pharmaceutical Industries, 
UCB Pharma, Valeant; PG: Consultant for AbbVie, Abiogen, Almirall, 
Celgene, Eli Lilly, Janssen, Leo Pharma, Merck, MSD, Novartis, Otsuka, 
Pfizer, Pierre Fabre, Sanofi, UCB Pharma; JE, LP: Employees of UCB 
Pharma; AK: Research grants from Abbott, Amgen, Bristol-Myers Squibb, 
Janssen, Pfizer, Roche, and UCB Pharma.

Acknowledgements
The study was funded by UCB Pharma. 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 
Ruth Le Fevre, 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 durability of response in patients  

with psoriatic arthritis who were treated with 
certolizumab pegol over 216 weeks.

BACKGROUND
• Certolizumab pegol (CZP) is a unique, Fc-free, PEGylated 

anti-tumour necrosis factor (TNF) that is approved 
by the FDA and EMA for the treatment of psoriatic 
arthritis (PsA).1,2

• In the 4-year, phase 3 RAPID-PsA trial (NCT01087788), 
substantial proportions of CZP-treated patients achieved 
targets such as minimal disease activity (MDA) and 
very low disease activity (VLDA), consistent with other 
biologics, including anti-TNFs.3,4

• In phase 3 trials in plaque psoriasis (PSO), CZP-treated 
patients showed clinical improvements, which were 
sustained over three years of treatment.5

• Responder rates observed at Weeks 16 and 48 were 
durable over time.6,7

• Here, we assess the durability of the initial clinical 
response to CZP in patients with PsA.

METHODS
Study Design
• RAPID-PsA was a 4-year, phase 3 trial, double-blind and 

placebo-controlled to Week 24, dose-blind to Week 48 
and open-label to Week 216. 

• Patients with PsA were randomised 1:1:1 to CZP 200 mg 
every two weeks (Q2W), CZP 400 mg every four weeks 
(Q4W) or placebo; 

 – All patients randomised to CZP received CZP 400 mg 
loading dose at Weeks 0, 2 and 4, and continued their 
assigned dose during the open-label period to  
Week 216 (Figure 1).

Patients
• Included patients were aged ≥18 years with a diagnosis 

of active PsA of ≥6 months’ duration, and had failed 
treatment with ≥1 disease-modifying anti-rheumatic 
drug (DMARD). 

CONCLUSIONS
• Of patients with PsA who initially responded to  

CZP treatment and achieved an MDA response at 
Week 24 and completed treatment to Week 216, 
>85% maintained this clinical response after four 
years of treatment.

• Even at the more stringent VLDA threshold, >80%  
of Week 24 responders who completed to Week 216 
maintained their response to four years.

• These findings highlight the long-term durability 
of the clinical response to CZP in patients 
with moderate to severe PsA, with substantial 
proportions of patients reaching and maintaining 
stringent treatment targets.

BMI: body mass index; BSA: body surface area; CRP: C-reactive protein;  
CZP: certolizumab pegol; DMARD: disease modifying anti-rheumatic drug; HLA-B27: 
human leukocyte antigen B27; SD: standard deviation; TNF: tumour necrosis factor.

Table 1. Patient baseline characteristics

Figure 2. Durability of response through Weeks 24–216

Data are observed case. Data are pooled for patients treated with CZP 200 mg Q2W and CZP 400 mg Q4W. aMDA plus BSA ≤3% responses are reported in patients who had BSA ≥3% at 
baseline. BSA: body surface area; CZP: certolizumab pegol; MDA: minimal disease activity; Q2W: every two weeks; Q4W: every four weeks; VLDA: very low disease activity.

• Patients with prior exposure to >2 biologic agents  
(>1 anti-TNF) for the treatment of PsA or PSO were excluded.

• In this analysis, data were pooled for patients randomised 
to CZP 200 mg Q2W and CZP 400 mg Q4W. 

Study Assessments and Statistical Analyses
• PsA severity was assessed using seven MDA criteria  

(see Summary box).

Figure 1. RAPID-PsA study design

CZP: certolizumab pegol; LD: loading dose; PsA: psoriatic arthritis; Q2W: every two weeks; Q4W: every four weeks.

• Week 24–216 data are reported for patients who were 
randomised to CZP at Week 0 and who achieved:

 – Week 24 MDA (≥5/7 MDA criteria)

 – Week 24 VLDA (7/7 MDA criteria)

 – Baseline psoriatic BSA ≥3% and Week 24 BSA ≤3% plus 
≥4/6 of the remaining MDA criteria (MDA plus BSA ≤3%)

• Data are shown for patients randomised to CZP at Week 0 
as observed case.

RESULTS 
Patient Disposition
• 273 patients were randomised to CZP 200 mg Q2W 

(N=138) or CZP 400 mg Q4W (N=135) at Week 0 
(Figure 1). 

• Patient baseline characteristics are shown in Table 1.

Week 24 Response
• Of the patients randomised to CZP, at Week 24:

 – 95/273 (34.8%) patients achieved MDA

 – 37/273 (13.6%) achieved VLDA

• At baseline 166/273 patients had BSA ≥3%, 39 (23.5%) of 
whom achieved MDA plus BSA ≤3% at Week 24.

• There was no clear trend observed in the components 
that contributed to failure to achieve VLDA response.

Durability of Response
• Responder rates for all three composite outcome 

measures remained high to Week 216 in patients who 
demonstrated a Week 24 response and completed  
Week 216 (Figure 2).

• Numerically, the greatest durability to Week 216 was seen 
for MDA (Figure 2).

n (%) unless otherwise stated
All CZP

(N=273)

Age, years, mean (SD) 47.7 (11.6)

Male 126 (46.2)

BMI, kg/m2, mean (SD) 30.0 (6.4)

CRP, mean (SD) 14.3 (22.3)

HLA-B27 positivity 41 (15.0)

Psoriasis BSA ≥3% 166 (60.8)

Nail psoriasis 197 (72.2)

Enthesitis 172 (63.0)

Dactylitis 94 (34.4)

Suspected axial involvement 213 (78.0)

Prior use of synthetic DMARDs

 1 165 (60.4)

 ≥2 103 (37.7)

Prior anti-TNF exposure 54 (19.8)
Week 48 96 156 168 180 192 204 216

MDA, % 
(n/N)

85.1 
(80/94)

88.9 
(80/90)

90.7 
(78/86)

89.4 
(76/85)

87.8 
(72/82)

87.7 
(71/81)

92.3 
(72/78)

86.8 
(66/76)

Week 48 96 156 168 180 192 204 216

VLDA, % 
(n/N)

71.4 
(25/35)

88.2 
(30/34)

77.4 
(24/31)

70.0  
(21/30)

66.7  
(20/30)

82.8  
(24/29)

82.1  
(23/28)

81.5 
 (22/27)

Week 48 96 156 168 180 192 204 216

MDA plus 
BSA ≤3% 
(n/N)

73.7 
(28/38)

82.9 
(29/35)

81.8 
(27/33)

71.9 
(23/32)

80.0  
(24/30)

72.4  
(21/29)

78.6  
(22/28)

82.8 
 (24/29)

SUMMARY
We assessed durability of the initial clinical response to certolizumab pegol (CZP) in patients with psoriatic arthritis (PsA)

PsA activity and severity were measured using seven criteria:

Tender joint count ≤1

Swollen joint count ≤1

Psoriasis Area and Severity Index ≤1 or ≤3% body surface area a�ected

Patient pain visual analogue score ≤15

Patient global disease activity visual analogue score ≤20 

Health Assessment Questionnaire Disability Index ≤0.5 

Tender entheseal points ≤1

Proportions of patients at Week 216 who maintained 
their clinical response from Week 24:

MDA: 87% VLDA: 82%

Minimal disease activity (MDA)
≥5/7 MDA criteria8 

Very low disease activity (VLDA)
=7/7 MDA criteria8

Week: 0 16 24 48 216

Screening Double-blind Open-labelDose-blind

LD 400 mg Weeks 0, 2, 4

CZP 200 mg Q2W

CZP 400 mg Q4W

CZP 200 mg Q2W

CZP 400 mg Q4W

CZP 200 mg Q2W

CZP 400 mg Q4W

LD

LD

Placebo

LD 400 mg Weeks 16, 18, 20

LD 400 mg Weeks 24, 26, 28

Adult patients
with active 
PsA N=409

Placebo escape:
Patients who failed to achieve a 10% decrease 
in tender joint count and swollen joint count 
at both Week 14 and Week 16 were randomised 
in a blinded manner to escape treatment from 
Week 16.

Placebo completers:
Patients who completed the double-blind phase 
were randomised to CZP in a dose-blind manner.

N=138

N=135

N=136

n=30

n=29

n=30

n=31

LD

LD

LD

LD

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82.9
(n=29/35)

82.8
(n=24/29)

80

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16814412096724824 216

Week

60

40

100

20

192

80

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16814412096724824 216

Week

P
ro

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 o

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192

86.8
(n=66/76)

88.9
(n=80/90)

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88.2
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81.5
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80

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16814412096724824 216

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60

40

100

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192

A) Week 24 MDA responders (n=95) B) Week 24 VLDA responders (n=37)
C)  Week 24 MDA plus BSA ≤3% 

responders (n=39) in patients 
with baseline BSA ≥3%a