Phase 3
Completed N=397
Efficacy at 24 Weeks With Long Term Safety, Tolerability and Efficacy up to 5 Years of Secukinumab in Patients of Active Psoriatic Arthritis
Source: ClinicalTrials.gov NCT01752634 ↗Enrolled (actual)
397
Serious AEs
14.0%
Results posted
May 2020
Primary outcomePrimary: Number of Participants Achieving American College of Rheumatology 20 (ACR20) Response Criteria — 29; 51; 54; 15 Participants — p=0.0200
◆ Published Evidence
Established
39citations · ~7 / year
Long-term efficacy and safety of secukinumab in patients with psoriatic arthritis: 5-year (end-of-study) results from the phase 3 FUTURE 2 study.
Summary
This study was to provide 24 - 52 week efficacy, safety and tolerability data to support the registration of the secukinumab (AIN457) prefilled syringe (PFS) for subcutaneous self administration in subjects with active PsA despite current or previous NSAID, DMARD and/or anti-TNFα therapy. An additional 4 years of long-term efficacy and safety data were collected during the post Week 52 period of the study.
Linked Publications (5)
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Long-term efficacy and safety of secukinumab in patients with psoriatic arthritis: 5-year (end-of-study) results from the phase 3 FUTURE 2 study.
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Secukinumab Immunogenicity over 52 Weeks in Patients with Psoriatic Arthritis and Ankylosing Spondylitis.
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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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Secukinumab efficacy on resolution of enthesitis in psoriatic arthritis: pooled analysis of two phase 3 studies.
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Comparative Effectiveness of Bimekizumab and Secukinumab in Patients with Psoriatic Arthritis at 52 Weeks Using a Matching-Adjusted Indirect Comparison.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Achieving American College of Rheumatology 20 (ACR20) Response Criteria |
29; 51; 54; 15 | 0.0200 sig |
| SECONDARY Number of Participants Achieving a PASI75 Response in the Subgroup of Subjects Who Have ≥3% Skin Involvement With Psoriasis |
14; 28; 26; 7 | 0.1650 |
| SECONDARY Number of Participants Achieving a PASI90 Response in the Subgroup of Subjects Who Have ≥3% Skin Involvement With Psoriasis |
6; 19; 20; 4 | 0.6421 |
| SECONDARY Change From Baseline in DAS28-CRP |
-1.12; -1.58; -1.61; -0.96 | 0.3763 |
| SECONDARY Change From Baseline in SF36-Physical Component Score |
4.38; 6.39; 7.25; 1.95 | 0.0482 sig |
| SECONDARY Change From Baseline in Stanford Health Assessment Questionnaire Disability Index (HAQ-DI) |
-0.32; -0.48; -0.56; -0.31 | 0.9195 |
| SECONDARY Number of Participants Achieving American College of Rheumatology 50 (ACR50) Response Criteria |
18; 35; 35; 7 | 0.0245 sig |
| SECONDARY Number of Participants With Dactylitis in the Subset of Subjects Who Had Dactylitis at Baseline |
23; 16; 20; 23 | 0.3149 |
| SECONDARY Number of Participants With Enthesitis in the Subset of Subjects Who Had Enthesitis at Baseline |
46; 37; 29; 51 | 0.1678 |
Eligibility Criteria
Inclusion Criteria:Patients eligible for inclusion in this study have to fulfill all of the following 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 Baseline ≥3 tender joints out of 78 and ≥3 swollen out of 76 (dactylitis of a digit counts as one joint each)
- Rheumatoid factor and anti-CCP antibodies negative at screening
- Diagnosis of active plaque psoriasis or nail changes consistent with psoriasis or 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 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.
Exclusion Criteria:Patients fulfilling any of the following criteria are not eligible for inclusion in this study:
- Chest X-ray or chest MRI with evidence of ongoing infectious or malignant process, obtained within 3 months prior to screening and evaluated by a qualified physician
- Subjects taking high potency opioid analgesics (e.g. methadone, hydromorphone, morphine)
- 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. The following wash out periods need to be observed:
- Oral or topical retinoids 4 weeks
- Photochemotherapy (e.g. PUVA) 4 weeks
- Phototherapy (UVA or UVB) 2 weeks
- Topical skin treatments (except in face, scalp and genital area during screening, only corticosteroids with mild to moderate potency) 2 weeks
- 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 (e.g., CAMPATH, anti-CD4, anti-CD5, anti-CD3, anti-CD19)
Data sourced from ClinicalTrials.gov (NCT01752634) 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.