Phase 3
Completed N=270
Efficacy and Safety of Tofacitinib in Subjects With Active Ankylosing Spondylitis (AS)
Source: ClinicalTrials.gov NCT03502616 ↗Enrolled (actual)
270
Serious AEs
2.2%
Results posted
Jan 2021
Primary outcomePrimary: Percentage of Participants Achieving Assessment of SpondyloArthritis International Society (ASAS)20 Response at Week 16 — 56.39; 29.41 Percentage of participants — p=<0.0001
◆ Published Evidence
Emerging
6citations · ~3 / year
Integrated safety analysis of tofacitinib from Phase 2 and 3 trials of patients with ankylosing spondylitis.
Summary
The purpose of this study is to determine if tofacitinib is safe and effective in subjects with active ankylosing spondylitis.
Linked Publications (5)
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Integrated safety analysis of tofacitinib from Phase 2 and 3 trials of patients with ankylosing spondylitis.
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Improvement of Fatigue in Patients with Ankylosing Spondylitis Receiving Tofacitinib: Analyses of a Phase 3 Randomized Controlled Trial.
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Tofacitinib Efficacy/Safety in Patients with Ankylosing Spondylitis by Baseline Body Mass Index: A Post Hoc Analysis of Phase 2/3 Trials.
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Efficacy and Safety of Tofacitinib in Patients with Psoriatic Arthritis or Ankylosing Spondylitis by Cigarette Smoking Status.
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Exhaustion-Resistant CD8 <sup>+</sup> T Cells in Ankylosing Spondylitis: A Proposed Three-Axis Model.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving Assessment of SpondyloArthritis International Society (ASAS)20 Response at Week 16 |
56.39; 29.41 | <0.0001 sig |
| SECONDARY Percentage of Participants Achieving Ankylosing Spondylitis (ASAS)40 Response at Week 16 |
40.60; 12.50 | <0.0001 sig |
| SECONDARY Number of Participants With Treatment Emergent Adverse Events (AEs) |
73; 70; 103; 93 | — |
| SECONDARY Number of Participants With Treatment Emergent Adverse Events (AEs) by Severity |
53; 52; 18; 18; 2; 0 | — |
| SECONDARY Number of Participants With Laboratory Abnormalities (Without Regard to Baseline Abnormality) |
106; 129; 126; 131 | — |
| SECONDARY Number of Participants With Vital Signs Abnormalities |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Abnormalities in Physical Examination |
2; 1; 1; 2; 1; 1 | — |
| SECONDARY Number of Participants With Electrocardiogram (ECG) Abnormalities |
0; 0; 0; 1; 1; 1 | — |
| SECONDARY Percentage of Participants Achieving ASAS20 Response at Weeks 2, 4, 8, 12, 24, 32, 40 and 48 |
28.57; 10.29; 51.13; 19.85; 57.14; 25.00 | 0.0001 sig |
| SECONDARY Percentage of Participants Achieving ASAS40 Response at Weeks 2, 4, 8, 12, 24, 32, 40 and 48 |
10.53; 4.41; 27.07; 3.68; 34.59; 5.88 | 0.0548 |
| SECONDARY Change From Baseline in Ankylosing Spondylitis Disease Activity Score Using C-Reactive Protein (ASDAS[CRP]) at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 |
-0.88; -0.17; -1.14; -0.24; -1.30; -0.24 | <0.0001 sig |
| SECONDARY Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP) at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 |
-1.07; -0.14; -1.06; -0.14; -1.05; -0.03 | <0.0001 sig |
| SECONDARY Change From Baseline in Ankylosing Spondylitis Quality of Life (ASQoL) Score at Weeks 16 and 48 |
-4.03; -2.01; -5.97; -4.70 | 0.0001 sig |
| SECONDARY Change From Baseline in Short-Form-36 Health Survey-Version 2 Acute (SF-36v2) Score at Weeks 16 and 48 |
5.52; 3.29; 6.13; 3.13; 7.93; 3.47 | 0.0088 sig |
| SECONDARY Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) Scores: Cervical Rotation Angle at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 |
2.25; 0.95; 3.63; 2.07; 6.26; 2.44 | 0.1513 |
| SECONDARY Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) Scores: Intermalleolar Distance at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 |
2.29; 0.90; 3.62; 0.84; 4.68; 1.36 | 0.1410 |
| SECONDARY Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) Scores: Lateral Spinal Flexion at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 |
0.60; -0.21; 0.96; -0.10; 1.34; 0.15 | 0.0018 sig |
| SECONDARY Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) Scores: Lumbar Flexion (Modified Schober) at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 |
0.30; -0.07; 0.41; -0.11; 0.32; -0.17 | 0.0047 sig |
| SECONDARY Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) Scores: Tragus-to-wall Distance at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 |
-0.19; -0.24; -0.48; -0.07; -0.51; 0.36 | 0.7291 |
| SECONDARY Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) Linear Method Total Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 |
-0.25; -0.03; -0.39; -0.06; -0.49; -0.03 | 0.0001 sig |
| SECONDARY Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Total Scores at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 |
3.16; 0.32; 4.80; 1.19; 6.46; 1.03 | <0.0001 sig |
| SECONDARY Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Experience Domain Scores at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 |
1.35; 0.11; 2.30; 0.60; 2.72; 0.53 | 0.0005 sig |
| SECONDARY Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Impact Domain Scores at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 |
1.79; 0.17; 2.47; 0.55; 3.73; 0.46 | 0.0002 sig |
| SECONDARY Change From Baseline in Patient's Global Assessment of Disease (PGA) at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 |
-1.21; -0.32; -1.85; -0.63; -2.14; -0.42 | <0.0001 sig |
| SECONDARY Change From Baseline in Patient's Assessment of Spinal Pain: Total Back Pain at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 |
-1.28; -0.38; -2.05; -0.71; -2.51; -0.53 | <0.0001 sig |
| SECONDARY Change From Baseline in Patient's Assessment of Spinal Pain: Nocturnal Spinal Pain at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 |
-1.24; -0.32; -2.15; -0.56; -2.61; -0.59 | <0.0001 sig |
| SECONDARY Change From Baseline in in Bath Ankylosing Spondylitis Functional Index (BASFI) at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 |
-0.87; -0.45; -1.35; -0.58; -1.79; -0.69 | 0.0089 sig |
| SECONDARY Change From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Inflammation (Morning Stiffness) Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 |
-1.33; -0.49; -2.08; -0.60; -2.52; -0.91 | <0.0001 sig |
| SECONDARY Percentage of Participants Achieving ASAS 5/6 Response at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 |
16.54; 2.94; 35.34; 6.62; 41.35; 8.09 | 0.0001 sig |
| SECONDARY Percentage of Participants Achieving ASAS Partial Remission at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 |
2.26; 0; 4.51; 0; 7.52; 1.47 | 0.1692 |
| SECONDARY Change From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 |
-1.25; -0.52; -1.95; -0.67; -2.32; -0.82 | <0.0001 sig |
| SECONDARY Percentage of Participants Achieving Bath Ankylosing Spondylitis Disease Activity Index 50 (BASDAI50) Response at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 |
12.03; 3.68; 29.32; 6.62; 39.85; 11.03 | 0.0116 sig |
| SECONDARY Percentage of Participants With Ankylosing Spondylitis Disease Activity Score Using C-Reactive Protein (ASDAS[CRP]) Clinically Important Improvement Response at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 |
39.39; 6.62; 53.03; 12.50; 59.85; 14.71 | <0.0001 sig |
| SECONDARY Percentage of Participants Ankylosing Spondylitis Disease Activity Score Using C-Reactive Protein (ASDAS[CRP]) Major Improvement Response at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 |
8.94; 0.00; 17.89; 1.55; 22.76; 2.33 | 0.0013 sig |
| SECONDARY Percentage of Participants Ankylosing Spondylitis Disease Activity Score Using C-Reactive Protein (ASDAS[CRP]) Inactive Disease Response at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 |
0.75; 0.00; 3.76; 0.00; 6.02; 0.74 | 0.5518 |
| SECONDARY Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) at Weeks 4, 8, 12, 16, 24, 32, 40 and 48 |
-1.42; -0.59; -2.02; -1.28; -1.89; -1.17 | 0.0099 sig |
| SECONDARY Change From Baseline in Swollen Joint Count (SJC) at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 |
-1.71; -2.09; -1.90; -2.23; -2.39; -2.45 | 0.4379 |
| SECONDARY Change From Baseline in Spinal Mobility (Chest Expansion ) at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 |
0.22; -0.09; 0.25; -0.07; 0.46; 0.22 | 0.0043 sig |
| SECONDARY Change From Baseline in EuroQol 5 Dimensions 3 Levels (EQ-5D-3L) Score at Weeks 16 and 48 |
-0.23; -0.06; -0.21; -0.20; -0.18; -0.09 | 0.0030 sig |
| SECONDARY Change From Baseline in EuroQol Visual Analogue Scale (EQ-VAS) Score (mm) at Weeks 16 and 48 |
13.00; 2.89; 20.64; 18.00 | <0.0001 sig |
| SECONDARY Change From Baseline in Work Productivity and Activity Impairment (WPAI): Percent Work Time Missed Due to Health Problem at Weeks 16 and 48 |
-3.65; 0.88; -8.10; -5.79 | 0.1784 |
| SECONDARY Change From Baseline in Work Productivity and Activity Impairment (WPAI): Percent Impairment While Working Due to Health Problem at Weeks 16 and 48 |
-19.83; -6.94; -25.35; -23.00 | <0.0001 sig |
| SECONDARY Change From Baseline in Work Productivity and Activity Impairment (WPAI): Percent Overall Work Impairment Due to Health Problem at Weeks 16 and 48 |
-21.49; -7.64; -27.63; -23.22 | <0.0001 sig |
| SECONDARY Change From Baseline in Work Productivity and Activity Impairment (WPAI): Percent Activity Impairment Due to Health Problem at Weeks 16 and 48 |
-19.03; -5.63; -27.37; -19.77 | <0.0001 sig |
Eligibility Criteria
Inclusion Criteria
- Has a diagnosis of Ankylosing Spondylitis (AS) based on the Modified New York Criteria for AS (1984).
- Must have a radiograph of SI joints (AP Pelvis) documenting diagnosis of AS.
- Has active disease despite nonsteroidal anti-inflammatory drug (NSAID) therapy or intolerant to NSAIDs.
Exclusion Criteria
- History of known or suspected complete ankylosis of the spine.
- History of allergies, intolerance or hypersensitivity to lactose or tofacitinib.
- History of any other rheumatic disease.
- Any subject with condition affecting oral drug absorption.
Data sourced from ClinicalTrials.gov (NCT03502616) 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.