Impact of Baseline Smoking Status and Body Mass Index in Patients with Hidradenitis Suppurativa Treated 
with Adalimumab or Placebo in 2 Phase 3 Studies
Amit Garg,1 Hessel H van der Zee,2 Ziqian Geng,3 Gerit D Mulder3
1Department of Dermatology, Hofstra Northwell School of Medicine, Hempstead, New York, USA; 2Department of Dermatology, Erasmus Medical Center, Rotterdam, the 
Netherlands; 3AbbVie Inc., North Chicago, Illinois, USA

Presented at the Fall Clinical Dermatology Conference - 36th Anniversary • Las Vega, Nevada • October 12 – 15, 2017

INTRODUCTION

• Patients with HS who received treatment with ADA had  
a greater clinical response than patients who received 
placebo, irrespective of baseline smoking status or BMI

 – The clinical response observed with ADA was not 
affected by smoking status or BMI

 – Patients may not have appropriately declared 
themselves as smokers, which may have affected the 
proportion of smokers who achieved clinical response 

• Overall rates of TEAEs were similar in patients who 
received ADA, regardless of smoking status or BMI 

DISCLOSURES

OBJECTIVE

METHODS

RESULTS (CONTINUED)

CONCLUSIONS

REFERENCES

• Hidradenitis suppurativa (HS) is a chronic, inflammatory  
skin disorder associated with painful, deep-seated lesions  
in apocrine gland-bearing regions of the body1–4 

• Patients with HS commonly have a higher body mass 
index (BMI) and a large proportion smoke tobacco, but 
the effect of these factors on treatment outcomes has 
been controversial5 

• Originator adalimumab (ADA) is an anti-tumor necrosis 
factor monoclonal antibody approved for the treatment  
of moderate-to-severe HS6 

 – Results from 2 phase 3, placebo-controlled trials,  
PIONEER I and PIONEER II, demonstrated the efficacy  
and safety of ADA7

• This post hoc analysis evaluated the impact of baseline 
tobacco smoking status and BMI on the efficacy and 
safety of ADA in 2 phase 3, double-blind studies 
(PIONEER I and PIONEER II)

PARTICIPANTS
• Main inclusion criteria 

 – Adults (male and female) ≥ 18 years of age, with a 
diagnosis of HS ≥ 1 year prior to baseline

 – HS lesions present in at least 2 distinct anatomical areas 
(eg, left and right axilla, or left axilla and left inguino-
crural fold), 1 of which was Hurley Stage II or Hurley 
Stage III

 – Abscess and inflammatory nodule (AN) count ≥ 3,  
where the AN count equates to the sum of abscess  
and inflammatory nodules

• Main exclusion criteria 
 – Previous anti-tumor necrosis factor therapy or ADA
 – Other active skin disease or condition (eg, bacterial, 
fungal, or viral infection) that could interfere with 
assessment of HS

 – At baseline visit, draining fistula count > 20
 – Treatment for HS with oral antibiotics within 28 days  
of baseline visit (except for PIONEER II subjects on  
stable doxycycline or minocycline only), or analgesics  
or prescription topical treatment for HS within 14 days  
of baseline visit

STUDY DESIGN AND TREATMENT
• Data were integrated from the first 12 weeks (Period A) of  

2 phase 3 trials: PIONEER I and II
• In both studies, patients were randomized (1:1) to receive 

ADA or matching placebo (Figure 1) 
 – Dose of ADA was 160 mg at week 0, 80 mg at week 
2, and 40 mg weekly starting at week 4 for 12 weeks 
(Period A) 

• In PIONEER II, concomitant doxycycline or minocycline up  
to 100 mg twice daily was permitted if patients took the 
antibiotic for > 28 days before baseline and maintained  
a consistent dosing regimen during the study 

 – Concomitant antibiotic use was not permitted in  
PIONEER I 

Figure 1. Study Design

n = 317 randomized
n = 296 completed 12 weeks

Randomized
N = 633

ADA 40 mg weeklya

Placebo

0 12Week:

n = 316 randomized
n = 300 completed 12 weeksRandomiza!on

Period A Period B

3624

R
e-

ra
nd

om
iz

a!
on

ADA 40 mg weekly

ADA 40 mg every other week

Placebo

Placebo

2 Double-blind, placebo-controlled trials (PIONEER I & II)

aStarting at week 4 following 160 mg at week 0 and 80 mg at week 2.
In PIONEER II, patients who received placebo in period A received ADA 40 mg weekly in period B.
This analysis encompasses only the first 12 weeks, as depicted. ADA = adalimumab.

METHODS (CONTINUED)

RESULTS

PATIENT ASSESSMENT
• Patients were assessed in clinic at weeks 0, 2, 4, 8, and 12
• Data from both trials were integrated to evaluate  

the effect of baseline smoking status (yes or no) or  
BMI (< 30 or ≥ 30 kg/m2)

• The primary endpoint in both studies was HS clinical 
response (HiSCR)

 – Defined as ≥ 50% reduction in AN count with no 
increase in abscess or draining fistula counts relative to 
baseline8 

• Adverse events and overall rates of treatment-emergent 
adverse events (TEAEs) were also reported 

STATISTICAL ANALYSIS
• All randomized patients were included in the integrated 

efficacy analyses 
• Treatment difference for the proportion of patients 

achieving HiSCR was calculated using the Cochrane-
Mantel-Haenszel test (2 tailed, α = .05) 

 – Adjusted for study and baseline Hurley stage
• Treatment by subgroup interaction, was calculated using 

a logistic regression with HiSCR at week 12 as response 
variable, and treatment, subgroup, Hurley Stage, and 
treatment by subgroup interaction as factors 

PARTICIPANTS: BASELINE SMOKING AND BMI
• This integrated analysis included 633 randomized patients 

(Table 1) 
 – Of these, 596 patients completed the first 12 weeks of 
the study (ADA, n = 300; placebo, n = 296) 

 – 2 patients in the placebo group discontinued without 
receiving a dose 

• At baseline, the majority of patients reported smoking or 
had a BMI ≥ 30 (Table 1)

Table 1. Baseline Demographics and Disease 
Characteristics

Characteristic
ADA

(n = 316)
Placebo
(n = 317)

Total
(N = 633)

Age, years

 Mean (SD)  35.5 (10.4)  37.0 (11.8) 36.2 (11.1)

Sex, n (%)

 Female   199 (63.0)   218 (68.8)  417 (65.9)

 Male   117 (37.0)    99 (31.2)  216 (34.1)

Duration of HS, n (median)

 < 9.18 years   163 (51.6)   153 (48.3)  316 (49.9)

 ≥ 9.18 years   153 (48.4)   164 (51.7)  317 (50.1)

Lesion counts, mean (SD)

 AN  12.4 (10.3)  13.1 (13.0) 12.8 (11.7)

 Abscesses  2.4 (3.1)  2.6 (3.5) 2.5 (3.3)

 Inflammatory nodules 10.0 (9.2)  10.5 (11.9) 10.3 (10.6)

 Non-draining fistulas   5.5 (11.7)  5.9 (8.5)  5.7 (10.2)

 Draining fistulas  3.8 (4.7)  3.8 (4.8) 3.8 (4.8)

Hurley Stage, n (%)

 II   166 (52.5)   170 (53.6)  336 (53.1)

 III   150 (47.5)   147 (46.4)  297 (46.9)

Modified Sartorius score, 
mean (SD)  128.6 (109.9) 134.6 (93.2) 131.6 (101.8)

BMI, kg/m2, N (%)

 < 30   133 (42.1)   113 (35.6)  246 (38.9)

 ≥ 30   182 (57.6)   202 (63.7)  384 (60.7)

 Missing    1 (0.3)    2 (0.6)   3 (0.5)

Smoking Status, N (%)

 Yes   186 (58.9)   201 (63.4)  387 (61.1)

 No   130 (41.1)   115 (36.3)  245 (38.7)

 Unknown  0 (0)    1 (0.3)   1 (0.2)
ADA = adalimumab; AN = sum of inflammatory nodules and abscesses; BMI = body mass index;  
HS = hidradenitis suppurativa; SD = standard deviation.

ACHIEVEMENT OF HiSCR BY SMOKING STATUS
• Among those patients who smoked, a significantly greater 

proportion of patients who received ADA achieved HiSCR 
compared with patients who received placebo (91/186 vs 
56/201, respectively; P < .001) (Figure 2) 

• Among nonsmokers, a significantly greater percentage  
of patients who received ADA achieved HiSCR compared 
with patients who received placebo (69/130 vs 29/115, 
respectively; P < .001) (Figure 2) 

• The treatment effect is consistent across smoking 
subgoups with no significant treatment-by-subgroup 
interactions (P = .343) 

Figure 2. Achievement of HiSCR in Both Smokers 
and Nonsmokers Who Received ADA 

†P < .001.

ACHIEVEMENT OF HiSCR BY BMI
• For patients with BMIs < 30, HiSCR was achieved by 

a significantly greater proportion of patients who 
received ADA compared with placebo (72/133 vs 36/113, 
respectively; P < .001) (Figure 3) 

• For patients with BMIs ≥ 30, HiSCR was achieved by 
significantly more ADA-treated patients when compared 
with placebo (88/182 vs 48/202, respectively; P < .001) 
(Figure 3) 

• The treatment effect is consistent across BMI subgroups 
with no significant treatment-by-subgroup interactions  
(P = .522) 

Figure 3. Achievement of HiSCR in Patients with 
BMI < 30 and BMI ≥ 30 Who Received ADA

†P < .001.

TREATMENT-EMERGENT ADVERSE EVENTS
• The most frequently reported TEAEs in the ADA 

population were hidradenitis, followed by headache, 
upper respiratory tract infections, and nasopharyngitis 

• Patients who received ADA reported fewer TEAEs than 
patients who received placebo, regardless of smoking 
status (Table 2) or BMI category (Table 3)

• Overall rates of TEAEs were similar in patients who 
received ADA, regardless of smoking status or BMI 

Table 2. Treatment-Emergent Adverse Event 
Rates in Smokers and Nonsmokers

Characteristic

Yes No
ADA 

(n = 186) 
n (%)

Placebo 
(n = 201) 

n (%)

ADA 
(n = 130) 

n (%)

Placebo 
(n = 113) 

n (%)

Any AE 105 (56.5) 135 (67.2) 70 (53.8) 67 (59.3)

Any SAE  4 (2.2)  7 (3.5) 2 (1.5) 4 (3.5)

Any AE leading to  
discontinuation of study drug  4 (2.2)  2 (1.0) 1 (0.8) 8 (7.1)

Any Severe AE 11 (5.9) 15 (7.5) 6 (4.6) 4 (3.5)

Any infection  50 (26.9)  68 (33.8) 29 (22.3) 28 (24.8)

Any serious infection  1 (0.5)  1 (0.5) 1 (0.8) 1 (0.9)
AE = adverse event; SAE = serious adverse event.

Table 3. Treatment-Emergent Adverse Event 
Rates by BMI Category (< 30 and ≥ 30)

Characteristic

< 30 ≥ 30
ADA 

(n = 133) 
n (%)

Placebo 
(n = 113) 

n (%)

ADA 
(n = 182) 

n (%)

Placebo 
(n = 200) 

n (%)

Any AE 70 (52.6) 64 (56.6) 105 (57.7) 138 (69.0)

Any SAE 2 (1.5) 3 (2.7)  4 (2.2)  8 (4.0)

Any AE leading to  
discontinuation of study drug 2 (1.5) 5 (4.4)  3 (1.6)  5 (2.5)

Any severe AE 6 (4.5) 7 (6.2) 11 (6.0) 12 (6.0)

Any infection 35 (26.3) 30 (26.5)  44 (24.2)  65 (32.5)

Any serious infection 1 (0.8) 1 (0.9)  1 (0.5)  1 (0.5)
AE = adverse event; SAE = serious adverse event.

A Garg has served as a consultant for AbbVie Inc., Eli Lilly, Janssen, and Pfizer. H van der Zee has served as a consultant for AbbVie and InflaRx. Z Geng and 
GD Mulder are full-time employees of AbbVie, and may own stock and/or stock options. AbbVie, funded this study and participated in the study design, 
study research, data collection, analysis and interpretation of data, and writing, reviewing, and approving this poster for presentation. All authors had 
access to the data; participated in the development, review, and approval of the poster; and agreed to submit the abstract and subsequent poster to 
EADV for consideration. Editorial assistance, funded by AbbVie, provided by Kristy A Grabowski, PhD, of JB Ashtin.

1. Danby FW, Margesson LJ. Dermatol Clin. 2010;28:779–93.
2. Hessam S, et al. J Am Acad Dermatol. 2015;73:998–1005.
3. Woodruff CM, et al. Mayo Clin Proc. 2015;90:1679–93.
4. Zouboulis CC, et al. Dermatology. 2015;231:184–90.
5. Zouboulis CC, et al. JEADV. 2015;29:619–44.
6. Humira [package insert]. North Chicago, IL: AbbVie Inc; 2016.
7. Kimball AB, et al. N Engl J Med. 2016;375:422-34.
8. Kimball AB, et al. Br J Dermatol. 2014;171:1434–42.


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