Developed by Infomedica – Medical Education & Information

2019 EADV Annual Congress content is made available to an international audience through a
licensing agreement between Infomedica and the European Academy of Dermatology and SUPPORTED BY AN UNRESTRICTED
Venereology. Infomedica is an independent medical education provider that delivers medical EDUCATIONAL SPONSORSHIP FROM
information to healthcare professionals through conference coverage and online educational
programs and activities.
EADV 2019 OFFICIAL HIGHLIGHTS

24-week results from a multicentre, randomised study evaluating

ixekizumab versus adalimumab in psoriatic arthritis patients with
psoriasis of ≥10% or <10% body surface area involvement at baseline

Presented by
Prof. Saxon Smith
Dermatology Centre, Hospital CUF Descobertas, Lisbon, Portugal

Developed by Infomedica – Medical Education & Information

2019 EADV Annual Congress content is made available to an international audience through a licensing agreement
between Infomedica and the European Academy of Dermatology and Venereology. Infomedica is an independent medical
education provider that delivers medical information to healthcare professionals through conference coverage and online
educational programs and activities.
Overview and objectives

• The selective interleukin-17A inhibitor ixekizumab (IXE) is approved for the

treatment of active psoriatic arthritis (PsA) and moderate-to-severe plaque
psoriasis (PsO).
• The SPIRIT-H2H study evaluated the efficacy and safety of IXE versus adalimumab
(ADA), another biologic disease-modifying antirheumatic drug (bDMARD),
approved in patients with PsA and PsO.
• This post-hoc subgroup analysis evaluated various 24-week efficacy outcomes
from SPIRIT-H2H in patients with high or low PsO body surface area (BSA)
involvement at baseline.

EADV HIGHLIGHTS 2019

Study design
• SPIRIT-H2H was a multicentre, open-label, rater-blinded, parallel-group study in which bDMARD-naïve patients
(N=566) with PsA and active PsO (≥3% BSA involvement) were randomised to IXE or ADA for 52 weeks.
• Dosing was based on the baseline severity of PsO:
• Moderate-to-severe PsO was defined as PASI score ≥12, sPGA ≥3 and BSA involvement ≥10%.
• Patients with moderate-to-severe PsO received:
• IXE (160 mg at week 0, 80 mg Q2W up to week 12 then Q4W). or
• ADA (80 mg at week 0, 40 mg Q2W starting at week 1).

• Patients not fulfilling the criteria for moderate-to-severe PsO received:

• IXE (160 mg at week 0, 80 mg Q4W), or
• ADA (40 mg at week 0, 40 mg Q2W),

• The primary endpoint was the proportion of patients achieving simultaneous improvement of ≥50% in American
College of Rheumatology criteria (ACR50) and 100% in PASI score (PASI100) at week 24.
• In this post-hoc subgroup analysis, efficacy outcomes at week 24 were compared between IXE and ADA in
patients with baseline BSA involvement of ≥10% or <10%.

EADV HIGHLIGHTS 2019

Principal findings (i)

• At baseline, patients with BSA ≥10% (N=217) consistently showed higher arthritis-
and skin-related clinical assessment scores, and worse patient-reported
outcomes, than patients with BSA <10% (N=349).
• With regards to the simultaneous achievement of ACR50 and PASI100 at week 24,
consistent response rates across baseline BSA levels were observed among IXE-
treated patients (37.2%, and 35.3% for high and low BSA, respectively)
• Among ADA-treated patients, a lower response rate was observed in the high
compared to the low BSA subgroup (21.2% vs 31.8%), resulting in a significant
difference versus IXE.

EADV HIGHLIGHTS 2019

Patients achieving simultaneous improvement of ≥50% in American College
of Rheumatology criteria (ACR50) and 100% in PASI score (PASI100) at
week 24

BSA <10% BSA ≥10%

Response Rate (%) 100 100

80 80

60 60

40 40
35.3 37.2
31.8 20
20
21.2 *
0 0
ADA IXE ADA IXE
(N=179) (N=170) (N=104) (N=113)
*P ≤0.05 vs ADA.
ACR50, ≥50% improvement in American College of Rheumatology criteria; ADA, adalimumab; BSA, body surface area; ITT, intention-to-treat; IXE, ixekizumab; NRI, nonresponder
imputation; PASI100, 100% improvement in Psoriasis Area and Severity Index score.

Adapted from Smith S. EADV 2019.

Principal findings (ii)

• PASI100 and PASI90 responses were significantly higher for IXE than ADA in both
subgroups.
• PASI75 responses were significantly higher for IXE only in the subgroup with BSA
<10%.
• For ACR50, responses were similar for IXE versus ADA in both subgroups.
Remission rates based on Disease Activity in Psoriatic Arthritis scores and
Minimal Disease Activity (MDA6) were significantly higher for IXE than ADA in the
BSA ≥10% subgroup.
• Dermatology Life Quality Index (0,1) responses were also significantly higher for
IXE than ADA in the BSA ≥10% subgroup.

EADV HIGHLIGHTS 2019

Conclusions and clinical perspectives

• IXE was associated with higher levels of response than ADA for skin and joint
outcomes in bDMARD-naïve patients with active PsA and concomitant PsO,
regardless of BSA involvement at baseline.
• For patients with ≥10% BSA involvement, IXE was associated with a statistically
significant better efficacy outcome than ADA with respect to the primary endpoint.
• Data from this post-hoc analysis are consistent with the findings of the SPIRIT-H2H
study.
• In bDMARD-naïve patients with PsA and concomitant PsO, IXE was associated with
higher levels of response than ADA on skin and joint outcomes, irrespective of
baseline BSA involvement.

EADV HIGHLIGHTS 2019