Improvement of Nail Psoriasis 
With Brodalumab in Phase 3 Trials

Mark G. Lebwohl,1 Lawrence Green,2 Sylvia Hsu,3 Shipra Rastogi,4 Tina Lin,5 Radhakrishnan Pillai,6 Robert J. Israel5
1Icahn School of Medicine at Mount Sinai, New York, NY; 2George Washington University School of Medicine, Washington, DC; 3Baylor College of Medicine, Houston, TX; 4Ortho Dermatologics, Bridgewater, NJ;  

5Valeant Pharmaceuticals North America LLC, Bridgewater, NJ; 6Dow Pharmaceutical Sciences (a division of Valeant Pharmaceuticals North America LLC), Petaluma, CA

2017 Fall Clinical Dermatology Conference® • October 12-15, 2017 • Las Vegas, NV

INTRODUCTION
• Psoriasis is a chronic inflammatory condition characterized by thick, scaly patches on the skin

 – Interleukin-17 (IL-17) has been identified to play a significant role in disease pathogenesis1

• Nail involvement occurs in approximately half of all patients with psoriasis and is often 
difficult to treat2 

• Brodalumab is a monoclonal antibody that targets the receptor IL-17RA and has 
demonstrated efficacy and safety in the treatment of plaque psoriasis3,4

OBJECTIVE
• To evaluate the efficacy of brodalumab in nail psoriasis

METHODS
• Brodalumab was evaluated in three phase 3 multicenter, randomized, double-blind,  

placebo-controlled studies in patients with moderate-to-severe psoriasis3,4

• Patients were treated with brodalumab (140 or 210 mg every 2 weeks [Q2W]) or placebo 
during the 12-week induction phase 

• Nail involvement was assessed at baseline using the nail psoriasis severity index (NAPSI)
 – Patients were evaluated by the nail with the highest psoriasis involvement score

• Improvement in NAPSI score was assessed in patients with a baseline NAPSI score ≥6 
• The mean improvement in NAPSI score from baseline was evaluated at week 12
• Comparisons were made by analysis of covariance, adjusting for baseline body weight, prior 

biologic use, geographic region, study, and baseline NAPSI score

RESULTS
Patient demographics and characteristics
• Mean baseline NAPSI scores were similar in all groups (range, 9.5-9.6; Table 1)

Improvement in NAPSI score at week 12
• The improvements observed with both brodalumab doses compared with placebo were 

significant (P<0.001; Figure 1)

• After 12 weeks, improvements from baseline of 11.6%, 37.5%, and 46.3% were observed in 
the placebo, brodalumab 140 mg Q2W, and brodalumab 210 mg Q2W groups, respectively 
(Figure 2)

• After 12 weeks, treatment with brodalumab 210 mg Q2W led to a greater decrease in 
NAPSI score compared with brodalumab 140 mg Q2W relative to placebo (Table 2)

Table 1. Patient Baseline Demographics and Clinical Characteristics (Integrated 
AMAGINE-1/-2/-3 Studies)

Figure 1. NAPSI score at baseline and week 12 (as observed).

N
A

PS
I s

co
re

, m
ea

n 
(S

D
) 

6

0

4

2

10

12

14

8

BL BL

*

BLWeek 12 Week 12 Week 12
Brodalumab

140 mg Q2W
Placebo Brodalumab

210 mg Q2W
261n 466 472

1.1 (3.2)Improvement over baseline(as observed), mean (SD) 3.6 (3.9) 4.4 (3.8)

5.16.08.4 9.59.69.5

*

BL, baseline; NAPSI, nail psoriasis severity index; Q2W, every 2 weeks; SD, standard deviation. *P<0.001 vs BL.

Figure 2. Percent improvement over baseline at week 12 (as observed).

N
A

PS
I s

co
re

 im
pr

ov
em

en
t

ov
er

 b
as

el
in

e,
 %

30

0

20

10

50

60

40

Placebo

11.6%

37.5%

46.3%

Brodalumab
140 mg Q2W

Brodalumab
210 mg Q2W

261 n466 472

NAPSI, nail psoriasis severity index; Q2W, every 2 weeks.

Acknowledgments: This study was sponsored by Ortho Dermatologics. Medical writing support was provided by MedThink SciCom and funded 
by Ortho Dermatologics. 

References: 1. Kim and Krueger. Annu Rev Med. 2017;68:255-269. 2. Crowley et al. JAMA Dermatol. 2015;151:87-94. 3. Lebwohl et al. N Engl J Med. 
2015;373:1318-1328. 4. Papp et al. Br J Dermatol. 2016;175:273-286. 

CONCLUSIONS
• Brodalumab 140 and 210 mg Q2W were associated with significant 

improvements in psoriatic nail symptoms after 12 weeks of treatment 
• Because nail turnover is slower than skin turnover, longer periods  

of brodalumab therapy would be expected to result in continued  
nail improvement 

Brodalumab

 
Placebo
(N=844)

140 mg Q2W
(N=1458)

210 mg Q2W
(N=1458)

Age, mean (SD), y 44.7 (12.9) 44.8 (13.0) 45.1 (12.9)
Male, n (%) 588 (69.7) 1012 (69.4) 1013 (69.5)
White, n (%) 769 (91.1) 1322 (90.7) 1319 (90.5)
Weight, mean (SD), kg 90.2 (22.1) 90.4 (21.6) 90.7 (23.1)
BMI, mean (SD), kg/m2 30.2 (6.8) 30.4 (7.0) 30.5 (7.3)
Duration of psoriasis, mean (SD), y 18.5 (12.0) 18.1 (11.9) 18.7 (12.4)
Psoriatic arthritis (yes), n (%) 173 (20.5) 319 (21.9) 299 (20.5)
BSA, mean (SD), % 27.6 (17.1) 27.8 (17.8) 26.8 (16.8)
PASI score, mean (SD) 20.1 (8.3) 20.2 (8.2) 20.2 (8.0)
sPGA score, n (%)
   3
   4
   5 (very severe)

473 (56.0)
324 (38.4)
47 (5.6)

899 (61.7)
489 (33.5)
70 (4.8)

810 (55.6)
567 (38.9)
81 (5.6)

Prior biologic therapy (yes), n (%) 267 (31.6) 438 (30.0) 439 (30.1)
NAPSI score, mean (SD) 9.5 (3.4) 9.6 (3.9) 9.5 (4.0)
Patients with NAPSI ≥6, n (%) 261 (30.9) 466 (32.0) 472 (32.4)
BMI, body mass index; BSA, body surface area; NAPSI, nail psoriasis severity index; PASI, psoriasis area and severity index; Q2W, every 2 weeks; 
SD, standard deviation; sPGA, static physician’s global assessment.

Table 2. Treatment Differences With Brodalumab vs Placebo at Week 12 (Multiple Imputation) 
Brodalumab

 
Placebo
(N=261)

140 mg Q2W
(N=466)

210 mg Q2W
(N=472)

NAPSI, mean (SE) 8.5 (0.3) 6.0 (0.2) 5.2 (0.2)
Treatment difference vs placebo, least squares mean (95% CI) — 2.5 (2.0, 3.0) 3.3 (2.8, 3.8)
P value vs placebo  <0.001 <0.001
CI, confidence interval; NAPSI, nail psoriasis severity index; Q2W, every 2 weeks; SE, standard error. 

© 2017. All Rights Reserved.

7589_NAPSI (AAD Encore)_M1-1.indd   1 9/22/17   9:41 AM


	FC17PosterValeantLebwohlImprovementNailPsoriasisPhase3.pdf