Presented at Fall Clinical Dermatology | Las Vegas, Nevada | October 18–21, 2018. Previously presented at The 5th World Psoriasis and Psoriatic Arthritis Conference 2018

OBJECTIVE
• To understand the frequency of inadequate response to  

first-line biologic therapies in patients with psoriasis, and the 
reasons underlying this lack of response, in a real-world setting.

Frequency of Inadequate Response to Treatment Among  
Psoriasis Patients on First-Line Biologics
A. Sheahan,1 E. Lee,2 L. Pisenti,2 M. Yassine,2 R. Suruki1

1UCB Pharma, Raleigh, NC; 2UCB Pharma, Smyrna, GA

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

affecting around 3% of adults in the United States1,2 and 2–6% 
in Europe.3 

• PSO can have a substantial impact on patients’ quality of life, with 
psychosocial and emotional effects such as depression and fatigue in 
addition to physical symptoms.4 

• Whilst treatment of patients with moderate to severe disease with 
biologic agents such as tumor necrosis factor inhibitors (anti-TNFs), 
anti-interleukin (IL)-17s and anti-IL12/13s is well-established, sub-
optimal efficacy or adverse events may require switching to another 
biologic to improve patient outcomes.

• However, studies describing the occurrence of inadequate 
response (IR) to biologic treatments in the real-world setting are 
currently lacking.

• An understanding of the frequency and reasons underlying IR may help 
to identify and address unmet treatment needs.

METHODS 
Study Design and Inclusion Criteria
• A retrospective analysis of a commercial US healthcare claims database 

was conducted, including claims data from 2012–2016. 

• Included patients had:

 – A qualifying PSO ICD-9/10 code

 – Initiated treatment with an anti-TNF approved for PSO, secukinumab, 
ustekinumab or apremilast (index date)

 – ≥1 year of database enrollment both before and after the index date

• Patients with prior biologic exposure in the year prior to the index date 
were excluded.

Definition of IR
• IR was defined as:

1. ≥1 claim with a biologic dose >110% of the label-recommended dose 
for ≥30 days (“Above-label dosing”)

2. Cessation (>2 months with no treatment) of a 1st line biologic  
(“Non-switch discontinuation”)

3. Cessation of a 1st line biologic followed by initiation of a new biologic 
within 2 months (“Switch to another biologic”)

4. Addition of a corticosteroid, immunosuppressant, or biologic with ≥30 
days’ supply overlap (“Add-on treatment”) 

RESULTS
Treatment Response Outcomes
• Of 13,995 patients who met the inclusion criteria, 10,213 (73.0%) 

experienced an IR event in the 12-month follow-up period. 

 – The most common IR event was non-switch discontinuation 
(Figure 1)

%, unless otherwise stated
Inadequate 
response 

(N=10,213)

No inadequate 
response 
(N=3,782)

Age (years), mean 46.2 47.0

Female 52.1 46.7

History of systemic 
treatment

56.1 54.4

Index biologic

Adalimumab 44.4 37.3

Etanercept 27.5 23.7

Apremilast 12.7 18.8

Ustekinumab 11.7 13.9

Infliximab 1.9 3.7

Secukinumab 0.7 1.2

Golimumab 0.7 0.9

Certolizumab pegol 0.4 0.5

Most frequent comorbidities and those of interest

Psoriatic arthritis 30.7 31.1

Hypertension 30.6 31.3

Hyperlipidemia 29.7 31.3

Anxiety 9.8 8.9

Depression 13.5 11.1

Table 1.  Patient demographics and index  
biologic use

Systemic treatment: any prescribed non-biologic therapy indicated for the 
management of PSO.

Figure 1.  Distribution of response outcomes 
across index biologics

IR: inadequate response.

References: 1. Rachakonda TD. et al. J Am Acad Dermatol 2014;70:512–6; 2. Kurd SK. et al. J Am 
Acad Dermatol 2009;60:218–24; 3. Danielsen K. et al. Br J Dermatol 2013;168:1303–10; 4. Langley RG. et al. 
Ann Rheum Dis 2005; 64:ii18–23.

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

Author Disclosures: AS, EL, LP, MY, RS are employees of UCB Pharma.

Acknowledgements: This study was funded by UCB Pharma. The authors would like to thank 
David Friesen (Hays Pharma) and Paul Murray (Hays Pharma) for assistance with data analysis, Mylene Serna, 
PhD, UCB Pharma, Smyrna, USA, for publication coordination 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.

CONCLUSIONS
• Inadequate response in first line PSO biologic treatment is 

common, with non-switch discontinuation being the most 
frequent type.

• Analysis of the longer-term outcomes of non-switch 
discontinuation patients may help to better characterize 
the reasons these patients are not persistent on the first line 
biologic; currently it is difficult to determine why patients 
would discontinue without initiating an alternate biologic.

• This highlights an opportunity to optimize available treatment 
options, and better understand patient needs.

• Therapeutic options with improved durability may help 
optimize the management of PSO, but further analysis is 
necessary to identify underlying causes of IR.

0.8

0.6

0.4

0.2

0.0

1.0

P
ro

b
a
b

ili
ty

 o
f 

re
m

a
in

in
g

 in
 f

o
llo

w
-u

p

0 2 4 6 8 10 12

Time to IR event (months)

IR (all qualifying events)

Above-label dosing

Switch to other biologic

Non-switch discontinuation

Add-on treatment

Time to IR event 
(months)

All IR events 
(n=10,213)

Above-label dosing 
(n=2,144)

Switch to another 
biologic (n=1,324)

Non-switch 
discontinuation 

(n=5,901)

Add-on treatment 
(n=844)

Mean (SD) 4.6 (3.1) 4.6 (2.7) 5.5 (2.9) 4.4 (3.2) 4.1 (3.3)

Median

(Q1–Q3)

3.8

(2.0–6.6)

3.7

(2.8–6.3)

5.1

(3.2–7.6)

3.7

(1.8–6.5)

3.3

(1.4–6.3)

Figure 3. Time to IR events

IR: inadequate response; SD: standard deviation; Q1–Q3: interquartile range.

Figure 2.  Response outcomes by index biologic

Above-label dosing was not assessed for infliximab and ustekinumab (due to weight-based dosing). IR: inadequate response.

Figure 4.  Treatment persistence in patients switching 
to another biologic

Figure 5.  Add-on treatments by baseline therapy

Non-switch
discontinuation

42%

Non-IR
27%

Above-label 
dosing

15%

Switch to
another biologic

10%

Add-on treatment
6%

80

60

40

20

100

0

%
 P

at
ie

n
ts

Etanercept
(n=3708)

Certolizumab
pegol (n=64)

Ustekinumab
(n=1719)

Golimumab
(n=102)

Apremilast
(n=2013)

Secukinumab
(n=117)

Infliximab
(n=330)

Adalimumab
(n=5942)

42.4

6.7

23.6

27.3

37.6

19.7

29.1

5.1

33.3

44.1

12.7

24.2

10.8

18.0

41.2

23.8

10.7

35.6

24.3

30.5

62.1

29.7

46.9

10.9

35.4

49.8

Non-IR Above-label dosing Switch to another biologicNon-switch discontinuation Add-on treatment

5.5 3.9 5.9 5.6

8.5

9.0 6.9
2.9

3.5
12.50.2

Not
persistent

30%
Persistent

70%

Not
persistent

47%
Persistent

53%

3 months after switch

6 months after switch

90

80

70

60

50

40

30

20

10

100

0

%
 P

at
ie

n
ts

Overall

15.4

63.9

BL Biologic
monotherapy

BL Concomitant 
systemic

corticosteroid

BL Concomitant
immunosuppressive

Biologic Immunosuppressive Systemic corticosteroid

20.7
15.6

19.0

65.4

3.9

11.8

84.3

0.9

47.4
51.8

Treatment at baseline

• Demographics and characteristics, including the distribution of  
index biologics, were similar in patients who did and did not  
experience IR (Table 1).

• The proportion of IR by index biologic ranged from 76.2% in 
adalimumab to 57.6% in infliximab (Figure 2).

Time to Inadequate Response 
• Across all IR groups, mean time from initiation of 1st line biologic to  

IR was 4.6 months (standard deviation [SD] =3.1).

• Time to IR tended to be numerically higher in patients switching to 
another biologic (mean=5.5 months, SD=2.9) (Figure 3).

Biologic Switch Patients
• Among patients switching to another biologic, 70.5% of patients  

were persistent on the new biologic after 3 months, vs 53.5% after  
6 months (Figure 4).

• Most frequently used biologics after treatment switch were 
ustekinumab (29.7% of switch patients) and adalimumab (28.7% of 
switch patients).

Add-on Treatment Patients
• Overall, most frequent add-on therapies were immunosuppressive 

drugs (63.9%) followed by systemic corticosteroids (20.7%) and 
biologics (15.4%) (Figure 5).

• 73.3% of these patients subsequently discontinued the add-on therapy 
before discontinuing their biologic.