Phase 3
Completed N=996
Study to Demonstrate the Efficacy (Including Inhibition of Structural Damage), Safety and Tolerability up to 2 Years of Secukinumab in Active Psoriatic Arthritis
Source: ClinicalTrials.gov NCT02404350 ↗Enrolled (actual)
996
Serious AEs
3.3%
Results posted
Jun 2019
Primary outcomePrimary: Percentage of Participants With Active Psoriatic Arthritis (PsA) Achieving an American College of Rheumatology Response 20 (ACR20) at Week 16 — 59.5; 55.5; 62.6; 27.4 percentage of participants — p=<0.0001
◆ Published Evidence
Highly cited
299citations · ~37 / year
Secukinumab improves active psoriatic arthritis symptoms and inhibits radiographic progression: primary results from the randomised, double-blind, phase III FUTURE 5 study.
Summary
The purpose of this study was to demonstrate efficacy including effect on inhibition of progression of structural damage, safety and tolerability up to 2 years with primary focus at Week 16 (week 24 for structural damage), to support the use of secukinumab pre-filled syringe (PFS) by subcutaneous (s.c.) self-administration with or without loading regimen in subjects with active Psoriatic Arthritis (PsA) despite current or previous NSAID, DMARD therapy and/or previous anti-TNFα therapy. Long term efficacy up to 2 years was based on signs and symptoms of joint/bone structure preservation (X-ray) and improvement in physical function measured by Health Assessment Questionnaire - Disability Index (HAQ-DI©), as well as skin and nail improvement for psoriasis signs.
Linked Publications (5)
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Secukinumab improves active psoriatic arthritis symptoms and inhibits radiographic progression: primary results from the randomised, double-blind, phase III FUTURE 5 study.
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Secukinumab provides sustained improvement in signs and symptoms and low radiographic progression in patients with psoriatic arthritis: 2-year (end-of-study) results from the FUTURE 5 study.
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Clinically relevant patient clusters identified by machine learning from the clinical development programme of secukinumab in psoriatic arthritis.
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Comparative Effectiveness of Bimekizumab and Secukinumab in Patients with Psoriatic Arthritis at 52 Weeks Using a Matching-Adjusted Indirect Comparison.
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Relationship of radiographic progression status to low disease activity in patients with PsA receiving secukinumab treatment for 2 years.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Active Psoriatic Arthritis (PsA) Achieving an American College of Rheumatology Response 20 (ACR20) at Week 16 |
59.5; 55.5; 62.6; 27.4 | <0.0001 sig |
| SECONDARY Change From Baseline to Week 24 With Secukinumab Compared With Placebo for Joint/Bone Structural Damage (Using Van Der Heijde Modified Total Sharp Score (mTSS)) |
15.25; 13.50; 12.90; 14.95; -0.10; 0.13 | 0.0061 sig |
| SECONDARY Count and Percentage of Patients Achieving Psoriatic Area and Severity Index 75 (PASI75) Response |
68; 75; 77; 20 | <0.0001 sig |
| SECONDARY Count and Percentage of Patients Achieving Psoriatic Area and Severity Index 90 (PASI90) Response |
37; 46; 59; 15 | <0.0001 sig |
| SECONDARY Count and Percentage of Patients Achieving an ACR50 Response |
71; 79; 88; 27 | <0.0001 sig |
| SECONDARY Change From Baseline in HAQ-DI© Score |
-0.45; -0.44; -0.55; -0.21 | <0.0001 sig |
| SECONDARY Change From Baseline in Disease Activity Score for 28 Joints (DAS28-CRP) (Utilizing High Sensitivity C-Reactive Protein (hsCRP)) |
-1.29; -1.29; -1.49; -0.63 | <0.0001 sig |
| SECONDARY Count and Percentage of Patients With Enthesitis in the Subset of Patients Who Had Enthesitis at Baseline |
75; 64; 62; 124 | 0.2250 |
| SECONDARY Count and Percentage of Participants With Dactylitis in the Subset of Patients Who Have Dactylitis at Baseline |
45; 34; 28; 84 | 0.0004 sig |
Eligibility Criteria
Inclusion Criteria
Diagnosis of PsA classified by CASPAR criteria and with symptoms for at least 6 months with moderate to severe PsA who must have at BSL ≥3 tender joints out of 78 and ≥3 swollen joints out of 76 (dactylitis of a digit counts as one joint each).
- Rheumatoid factor (RF) and anti-cyclic citrullinated peptide (anti-CCP) antibodies negative at screening.
- Diagnosis of active plaque psoriasis or nail changes consistent with psoriasis or a documented history of plaque psoriasis.
- Subjects with PsA should have taken NSAIDs for at least 4 weeks prior to randomization with inadequate control of symptoms or at least one dose if stopped due to intolerance to NSAIDs.-Subjects who are regularly taking NSAIDs as part of their PsA therapy are required to be on a stable dose for at least 2 weeks before study randomization and should remain on a stable dose up to Week 24.
- Subjects taking corticosteroids must be on a stable dose of ≤10 mg/day prednisone or equivalent for at least 2 weeks before randomization and should remain on a stable dose up to Week 24.
- Subjects taking MTX (≤ 25 mg/week) are allowed to continue their medication if the dose is stable for at least 4 weeks before randomization and should remain on a stable dose up to Week 52.
- Subjects on MTX must be on folic acid supplementation at randomization.
- Subjects who are on a DMARD other than MTX must discontinue the DMARD 4 weeks prior to randomization visit except for leflunomide, which has to be discontinued for 8 weeks prior to randomization unless a cholestyramine wash-out has been performed.
- Subjects who have been on a TNFα inhibitor must have experienced an inadequate response to previous or current treatment with a TNFα inhibitor given at an approved dose for at least 3 months or have stopped treatment due to safety/tolerability problems after at least one administration of a TNFα inhibitor.
- Subjects who have previously been treated with TNFα inhibitors (investigational or approved) will be allowed entry into study after appropriate wash-out period prior to randomization
Exclusion Criteria
Chest X-ray or chest MRI with evidence of ongoing infectious or malignant process. - Subjects taking high potency opioid analgesics.
- Previous exposure to secukinumab or other biologic drug directly targeting IL-17 or IL-17 receptor. - Ongoing use of prohibited psoriasis treatments / medications (e.g., topical corticosteroids, UV therapy) at randomization.
- Any intramuscular or intravenous or intra-articular corticosteroid treatment within 4 weeks before randomization.
- Subjects who have ever received biologic immunomodulating agents except for those targeting TNFα (investigational or approved).
- Previous treatment with any cell-depleting therapies including but not limited to anti- CD20, investigational agents
- Other protocol-defined exclusion criteria do apply
Data sourced from ClinicalTrials.gov (NCT02404350) and the linked publication. 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. Informational only — not medical advice.