Phase 3
N=204
Study of Efficacy and Safety of Secukinumab in Psoriatic Arthritis and Axial Spondyloarthritis Patients With Active Enthesitis Including One Achilles Tendon Site
Psoriatic Arthritis · Axial Spondyloarthritis · Enthesitis
Bottom Line
View on ClinicalTrials.gov: NCT02771210 ↗Enrolled (actual)
204
Serious AEs
6.4%
Results posted
Jan 2021
Primary outcome: Primary: Number (%) of Patients With Resolution of Achilles Tendon Enthesitis — 43; 32 Participants — p=0.136
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Secukinumab (Biological); Secukinumab Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Dec 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number (%) of Patients With Resolution of Achilles Tendon Enthesitis |
43; 32 | 0.136 |
| SECONDARY Mean Change of Heel Pain |
-2.8; -1.9 | — |
| SECONDARY Number (%) of Patients With Improvement of Bone Marrow Edema |
17; 12 | — |
| SECONDARY Number (%) of Patients With Resolution of Enthesitis as Assessed by LEI |
31; 21 | — |
| SECONDARY Mean Change of Physician's Global Assessment of Disease Activity |
-34.88; -18.93 | — |
| SECONDARY Mean Change of Patient's Global Assessment of Disease Activity |
-25.87; -16.61 | — |
| SECONDARY Mean Change of Physician's Assessment of Heel Enthesopathy Activity |
-38.40; -25.19 | — |
| SECONDARY Mean Change of Patient's Assessment of Heel Enthesopathy Activity |
-31.05; -20.77 | — |
| SECONDARY Mean Change in Short Form-36 (SF-36) v2 |
8.29; 5.28 | — |
| SECONDARY Percentage of Patients With Resolution of Achilles Tendon Enthesitis After Switching From Placebo to Secukinumab |
43; 32; 66; 55 | — |
| SECONDARY Mean Change of Heel Pain After Switching From Placebo to Secukinumab |
-0.70; -1.43 | — |
Summary
The purpose of this study was to demonstrate efficacy, including effects on inflammation by magnetic resonance imaging (MRI) assessments, of secukinumab on Achilles tendon enthesitis for up to 1 year with a primary focus at Week 24, in patients with active Psoriatic Arthritis and axial Spondyloarthritis despite current or previous non-steroidal anti-inflammatory drugs (NSAID) and/or disease modifying anti-rheumatic drug (DMARD) and/or anti-TNFα therapy.
Eligibility Criteria
Key Inclusion Criteria
- Patients with Psoriatic arthritis: Diagnosis of Psoriatic arthritis as per the Classification criteria for Psoriatic Arthritis (CASPAR criteria) with symptoms for at least 6 months and active Psoriatic arthritis as assessed by ≥ 1 tender joints out of 78 and ≥ 1 swollen joints out of 76 at Baseline (dactylitis of a digit counts as one joint each).
- Patients with Axial Spondyloarthritis: Diagnosis of Axial Spondyloarthritis as per the classification of the Assessment of Spondyloarthritis International Society axial Spondyloarthritis (ASAS) criteria and objective signs of inflammation at Screening (magnetic resonance imaging (MRI) or definite radiographic sacroilitis and/or abnormal C-Reactive Protein) and active disease assessed by total Bath ankylosing spondylitis disease activity index (BASDAI) ≥ 4 (0-10) at Baseline.
- Diagnosis of Achilles tendon enthesitis according to swelling and tenderness at the insertional site of the Achilles tendon into the calcaneus.
- Onset of heel pain ≥ 1 month at Baseline.
- Heel enthesitis that is magnetic resonance imaging (MRI)-positive according to the investigator's judgement.
- Patients who have been exposed to up to two TNFα inhibitors.
Key Exclusion Criteria
- Chest X-ray or chest magnetic resonance imaging (MRI) with evidence of ongoing infectious or malignant process.
- Previous exposure to secukinumab or other biologic drug directly targeting Interleukin (IL)-17 or Interleukin (IL)-17 receptor.
- Ongoing use of psoriasis treatments / medications (e.g. topical corticosteroids, ultraviolet (UV) therapy) at randomization.
- Patients who have previously been exposed to more than two Tumor necrosis factor (TNF) inhibitors (investigational or approved).
- Patients who have ever received biologic immunomodulating agents (investigational or approved), except those targeting Tumor necrosis factor (TNF) inhibitors.
- Pregnant or nursing (lactating) women.
- History of ongoing, chronic or recurrent infectious disease or evidence of tuberculosis infection.
Data sourced from ClinicalTrials.gov (NCT02771210). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.