NCT02771210: ACHILLES

Study of Efficacy and Safety of Secukinumab in Psoriatic Arthritis and Axial Spondyloarthritis Patients With Active Enthesitis Including One Achilles Tendon Site

Completed Phase 3 Results posted Last updated 3 May 2021

What this trial tests

Phase 3 trial testing Secukinumab in Psoriatic Arthritis in 204 participants. Completed in 11 December 2019.

Timeline

30 August 2016

Primary endpoint
11 December 2019

11 December 2019

Quick facts

Lead sponsor	Novartis Pharmaceuticals
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	204
Start date	30 August 2016
Primary completion	11 December 2019
Estimated completion	11 December 2019
Sites	55 locations across Italy, Slovakia, Greece, United Kingdom, Germany, Bulgaria, Spain, Czechia

Drugs / interventions tested

• Secukinumab (secukinumab) — full drug profile →
• Secukinumab Placebo — full drug profile →

Conditions studied

• Psoriatic Arthritis — all drugs for Psoriatic Arthritis →
• Axial Spondyloarthritis — all drugs for Axial Spondyloarthritis →
• Enthesitis — all drugs for Enthesitis →

Sponsor

Novartis Pharmaceuticals — full company profile →

Who can join

18 and older, any sex, with Psoriatic Arthritis or Axial Spondyloarthritis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number (%) of Patients With Resolution of Achilles Tendon Enthesitis Primary · Week 24

Number (%) of patients with resolution of Achilles tendon enthesitis (affected foot) as assessed by respective subcomponent of Leeds enthesitis index (LEI) at Week 24. The primary analysis was performed via a logistic regression model with the factors treatment, country, and stratification factor diagnosis (PsA or axSpA); patients with a missing assessment were considered as responders if they had already met the response criterion at the time of last assessment.

Group	Value	95% CI
Secukinumab	43
Placebo	32

Mean Change of Heel Pain Secondary · Week 24

Mean change of heel pain from baseline to Week 24 measured by Numeric Rating Scale (NRS) ranging from 0 to 10, with 0 representing no pain and 10 representing worst pain (e.g. "pain as bad as you can imagine" or "worst pain imaginable").

Group	Value	95% CI
Secukinumab	-2.8	± 2.99
Placebo	-1.9	± 2.69

Number (%) of Patients With Improvement of Bone Marrow Edema Secondary · Week 24

Number (%) of patients with an improvement of bone marrow edema from baseline to Week 24 as assessed by the respective subcomponent of the Psoriatic Arthritis Magnetic Resonance Imaging Score (PsAMRIS) in the affected foot.

Group	Value	95% CI
Secukinumab	17
Placebo	12

Number (%) of Patients With Resolution of Enthesitis as Assessed by LEI Secondary · Week 24

Number (%) of patients with resolution of enthesitis as assessed by the Leeds enthesitis index (LEI) at Week 24.

Group	Value	95% CI
Secukinumab	31
Placebo	21

Mean Change of Physician's Global Assessment of Disease Activity Secondary · Week 24

Mean change of physician's global assessment (PhGA) of disease activity from baseline to Week 24 measured by Visual Analog Scale (VAS) ranging from 0 to 100, with 0 representing not severe and 100 representing very severe.

Group	Value	95% CI
Secukinumab	-34.88	± 25.927
Placebo	-18.93	± 26.257

Mean Change of Patient's Global Assessment of Disease Activity Secondary · Week 24

Mean change of patient's global assessment (PGA) of disease activity from baseline to Week 24 measured by Visual Analog Scale (VAS) ranging from 0 to 100, with 0 representing not severe and 100 representing very severe.

Group	Value	95% CI
Secukinumab	-25.87	± 31.108
Placebo	-16.61	± 29.235

Mean Change of Physician's Assessment of Heel Enthesopathy Activity Secondary · Week 24

Mean change of physician's assessment of heel enthesopathy activity from baseline to Week 24 measured by Visual Analog Scale (VAS) ranging from 0 to 100, with 0 representing not severe and 100 representing very severe.

Group	Value	95% CI
Secukinumab	-38.40	± 24.244
Placebo	-25.19	± 25.250

Mean Change of Patient's Assessment of Heel Enthesopathy Activity Secondary · Week 24

Mean change of patient's assessment of heel enthesopathy activity from baseline to Week 24 measured by Visual Analog Scale (VAS) ranging from 0 to 100, with 0 representing not severe and 100 representing very severe.

Group	Value	95% CI
Secukinumab	-31.05	± 29.135
Placebo	-20.77	± 30.417

Mean Change in Short Form-36 (SF-36) v2 Secondary · Week 24

Mean change in Short Form-36 (SF-36) v2 as an indicator of overall health status The SF-36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100 Lower scores = more disability, higher scores = less disability

Group	Value	95% CI
Secukinumab	8.29	± 9.759
Placebo	5.28	± 7.285

Percentage of Patients With Resolution of Achilles Tendon Enthesitis After Switching From Placebo to Secukinumab Secondary · Weeks 24 and 52

Percentage of patients with resolution of Achilles tendon enthesitis (affected foot) after switching from placebo to secukinumab at Week 24

Week 24

Group	Value	95% CI
Secukinumab	43
Placebo	32

Week 52

Group	Value	95% CI
Secukinumab	66
Placebo	55

Mean Change of Heel Pain After Switching From Placebo to Secukinumab Secondary · Change from week 24 to week 52

Mean change of heel pain after switching from placebo to secukinumab from Week 24 to week 52 measured by Numeric Rating Scale (NRS) ranging from 0 to 10, with 0 representing no pain and 10 representing worst pain (e.g. "pain as bad as you can imagine" or "worst pain imaginable").

Group	Value	95% CI
Secukinumab	-0.70	± 2.291
Placebo	-1.43	± 2.251

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events were collected from first dose of study treatment until end of study treatment at week 52. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Secukinumab

Serious: 7/102 (7%)

Deaths: 0/102

Placebo-Secukinumab

Serious: 6/102 (6%)

Deaths: 0/102

Serious adverse events (17 terms)

Reaction	System	Secukinumab	Placebo-Secukinumab
Atrial fibrillation	Cardiac disorders	—	—
Goitre	Endocrine disorders	—	—
Abdominal adhesions	Gastrointestinal disorders	—	—
Inflammatory bowel disease	Gastrointestinal disorders	—	—
Large intestinal stenosis	Gastrointestinal disorders	—	—
Cellulitis	Infections and infestations	—	—
Diverticulitis	Infections and infestations	—	—
Pyelonephritis acute	Infections and infestations	—	—
Lower limb fracture	Injury, poisoning and procedural complications	—	—
Stress fracture	Injury, poisoning and procedural complications	—	—
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	—	—
Invasive breast carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—
Uterine cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—
Cauda equina syndrome	Nervous system disorders	—	—
Migraine with aura	Nervous system disorders	—	—
Venous thrombosis limb	Vascular disorders	—	—

Other adverse events (5 terms — click to expand)

Reaction	System	Secukinumab	Placebo-Secukinumab
Nasopharyngitis	Infections and infestations	—	—
Headache	Nervous system disorders	—	—
Diarrhoea	Gastrointestinal disorders	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—
Upper respiratory tract infection	Infections and infestations	—	—

Most-reported serious reactions: Atrial fibrillation, Goitre, Abdominal adhesions, Inflammatory bowel disease, Large intestinal stenosis, Cellulitis, Diverticulitis, Pyelonephritis acute.

Data from ClinicalTrials.gov NCT02771210 adverse events section.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Role of Interleukin- (IL-) 17 in the Pathogenesis and Targeted Therapies in Spondyloarthropathies.
   Chyuan IT, Chen JY. · · 2018 · cited 25× · PMID 29670461 · DOI 10.1155/2018/2403935
2. Magnetic Resonance Imaging of Enthesitis in Spondyloarthritis, Including Psoriatic Arthritis-Status and Recent Advances.
   Mathew AJ, Østergaard M. · · 2020 · cited 24× · PMID 32695789 · DOI 10.3389/fmed.2020.00296
3. Efficacy and safety of secukinumab in patients with spondyloarthritis and enthesitis at the Achilles tendon: results from a phase 3b trial.
   Behrens F, Sewerin P, de Miguel E, Patel Y, et al · · 2022 · cited 20× · PMID 34730795 · DOI 10.1093/rheumatology/keab784
4. Secukinumab efficacy on resolution of enthesitis in psoriatic arthritis: pooled analysis of two phase 3 studies.
   Coates LC, Wallman JK, McGonagle D, Schett GA, et al · · 2019 · cited 16× · PMID 31801620 · DOI 10.1186/s13075-019-2055-z
5. Achilles tendon enthesitis evaluated by MRI assessments in patients with axial spondyloarthritis and psoriatic arthritis: a report of the methodology of the ACHILLES trial.
   Baraliakos X, Sewerin P, de Miguel E, Pournara E, et al · · 2020 · cited 9× · PMID 33220702 · DOI 10.1186/s12891-020-03775-4
6. Magnetic resonance imaging characteristics in patients with spondyloarthritis and clinical diagnosis of heel enthesitis: post hoc analysis from the phase 3 ACHILLES trial.
   Baraliakos X, Sewerin P, de Miguel E, Pournara E, et al · · 2022 · cited 6× · PMID 35578245 · DOI 10.1186/s13075-022-02797-8
7. What does evidence-based medicine tell us about treatments for different subtypes of psoriatic arthritis? A systematic literature review on randomized controlled trials.
   Bakirci Ureyen S, Ivory C, Kalyoncu U, Karsh J, et al · · 2018 · cited 6× · PMID 31431950 · DOI 10.1093/rap/rkx019
8. A Narrative Review of Secukinumab in Spondyloarthritis and Psoriatic Arthritis: Treating the Whole Patient.
   Kaeley GS, Kivitz A, Mease P, Weiss PF, et al · · 2026 · PMID 41854828 · DOI 10.1007/s40744-026-00833-6