CONFERENCE UPDATE: EULAR 2023

SEC and SDZ-ADL show similarly low radiographic progression in axSpA patients

RHEUMATOLOGY
11 Jul 2023

STUDY DESIGN

The prevention of potentially irreversible structural damage is an important goal in the management of axial spondylarthritis (axSpA).1 Currently, there are limited data regarding the effects of biologic disease-modifying anti-rheumatic drugs (bDMARDs) on slowing radiographic progression in patients with radiographic axSpA (r-axSpA).1 The MEASURE 1 trial showed low rates of radiographic progression after 2 years in r-axSpA patients being treated with secukinumab (SEC).1 A head-to-head study, SURPASS, was carried out to compare the effects of SEC and adalimumab biosimilar (SDZ-ADL) on radiographic progression.1

SURPASS was a 2-year, partially blinded, randomized, active-controlled, phase 3b trial that involved 859 biologic-naïve patients with active r-axSpA who had a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) spinal pain score ≥4, total back pain score ≥40mm, high-sensitivity C-reactive protein (hs-CPR) ≥5mg/L and/or ≥1 syndesmophyte(s).1 In this trial, patients were aware of the treatment, while physicians were blinded to it.1 Patients were randomized 1:1:1 to receive SEC 150mg, SEC 300mg, or SDZ-ADL 40mg subcutaneously (SC).1

The findings showed that the proportion of patients with no radiographic progression, as defined by the modified Stoke Ankylosing Spondylitis Spinal Score (mSASSS) ≤0.5, was similar across all groups.1 The change from baseline (CFB)-mSASSS at week 104 was consistently low across all groups.1 Also, consistencies across all groups were the cumulative distribution of CFB-mSASSS, the proportion of patients without new syndesmophytes at week 104, as well as the reduction and distribution in the sacroiliac joint oedema score and the spine oedema score.1 The frequency of most adverse events (AEs) was similar and no new safety signals were observed.

FINDINGS

Primary endpoint:
  • The primary endpoint was the proportion of patients with no radiographic progression, defined as CFB-mSASSS ≤0.5, on SEC vs. SDZ-ADL at week 1041
  • The proportion of patients with no radiographic progression was similar across all groups, with 66.1% in SEC 150mg, 66.9% in SEC 300mg, and 65.6% in SDZ-ADL 40mg, showing no progression1

Secondary endpoints:
  • The key secondary endpoints included CFB-mSASSS by week 104, the proportion of patients with ≥1 syndesmophyte(s) with no new syndesmophytes at week 104, the CFB-magnetic resonance imaging (MRI) Berlin sacroiliac joint (SIJ) oedema score and the CFB-ankylosing spondylitis spine MRI-activity (ASspiMRI-a) Berlin modification score1
  • CFB-mSASSS at week 104 was low and similar across all groups, with a least square mean of 0.54 in SEC 150mg, 0.55 in SEC 300mg, and 0.72 in SDZ-ADL 40mg. The cumulative distribution of CFB-mSASSS was also similar across the groups1
  • The proportion of patients without new syndesmophytes was similar across the groups, with 56.9% in SEC 150mg, 53.8% in SEC 300mg, and 53.3% in SDZ-ADL 40mg1
  • The reduction in the SIJ oedema score at weeks 16 and 104 were comparable across all groups. At week 104, the SEC 150mg group decreased from the 2.22 baseline to 0.53, the SEC 300mg group from 2.26 to 0.69, and the SDZ-ADL group from 1.64 to 0.281
  • The reduction in the ASspiMRI-a Berlin modification score was comparable across all groups at weeks 16 and 104. At week 104, the SEC 150mg group decreased from the baseline of 3.67 to 2.13, the SEC 300mg group from 2.50 to 1.08, and the SDZ-ADL group from 2.90 to 0.861
  • The cumulative distributions of the SIJ oedema score and the spine oedema score were similar across all groups1

Safety:
  • About 79.7% of patients in SEC 150mg, 81.8% in SEC 300mg, and 84.2% in SDZ-ADL experienced AEs, with 14.0%, 10.2% and 11.2% of patients experiencing serious AEs, respectively1
  • The frequency of AEs was similar across groups except for Crohn’s disease, ulcerative colitis, uveitis, and pulmonary tuberculosis1
  • No new safety signals were observed1

 

"Spinal radiographic progression over 2 years was low with no significant difference between SEC and SDZ-ADL."

Dr. Xenofon Baraliakos
Ruhr-Universität Bochum, Bochum,
Rheumazentrum Ruhrgebiet, Herne,
Germany

 

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