16 Week Efficacy and 5 Year Long Term Efficacy, Safety and Tolerability of Secukinumab in Patients With Active Ankylosing Spondylitis

Conditions

Anklyosing Spondylitis

Keywords

Ankylosing spondylitis, AS, Chronic inflammatory disease, Inflammatory back pain, Secukinumab, Prefilled syringe, PFS, Subcutaneous injection, AIN457, AIN457F, AIN457F2310, adult

Brief summary

This study assessed the efficacy and safety of secukinumab in patients with active ankylosing spondylitis who were tolerant to or had an inadequate response to NSAIDs, DMARDs and / or TNFα inhibitor

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10.3389/fimmu.2020.561748

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BMJ Open2020-09-018 citations

10.1136/bmjopen-2020-039059

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Lara D. Veeken2020-04-01

10.1093/rheumatology/keaa109.036

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The Journal of Rheumatology2019-06-1529 citations

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European Journal of Rheumatology2018-10-3014 citations

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Marzo-Ortega H, Sieper J, Kivitz A, Blanco R, Cohen M, Delicha EM, Rohrer S, Richards H.

2017-12-2845 citations

10.1136/rmdopen-2017-000592

Efficacy and safety of secukinumab in Asian patients with active ankylosing spondylitis: 52-week pooled results from two phase 3 studies.

Wei JC, Baeten D, Sieper J, Deodhar A, Bhosekar V, Martin R, Porter B.

2017-05-2528 citations

10.1111/1756-185x.13094

Secukinumab efficacy in anti-TNF-naive and anti-TNF-experienced subjects with active ankylosing spondylitis: results from the MEASURE 2 Study.

Sieper J, Deodhar A, Marzo-Ortega H, Aelion JA, Blanco R, Jui-Cheng T, Andersson M, Porter B, Richards HB, MEASURE 2 Study Group.

2016-08-31118 citations

10.1136/annrheumdis-2016-210023

Secukinumab, an Interleukin-17A Inhibitor, in Ankylosing Spondylitis

Dominique Baeten, Joachim Sieper, Jürgen Braun, Xenofon Baraliakos, Maxime Dougados et al. (12 authors)

New England Journal of Medicine2015-12-23973 citations

10.1056/nejmoa1505066

Interventions

DRUGSecukinumab (75 mg)

Secukinumab 75 mg s.c.

DRUGPlacebo

Placebo

DRUGSecukinumab (150 mg)

Secukinumab 150 mg s.c.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

Inclusion criteria

* Male or non-pregnant, non-lactating female patients * Diagnosis of moderate to severe AS with prior documented radiologic evidence (x-ray) fulfilling the Modified New York criteria for AS (1984) * Patients should have been on NSAIDs with an inadequate response * Patients who were regularly taking NSAIDs as part of their AS therapy are required to be on a stable dose * Patients who had been on an anti-TNFα agent (not more than one) must have experienced an inadequate response

Exclusion criteria

* Chest X-ray (or MRI) with evidence of ongoing infectious or malignant process * Patients with total ankylosis of the spine * Patients previously treated with any biological immunomodulating agents except for those targeting TNFα * Previous treatment with any cell-depleting therapies

Design outcomes

Primary

Measure	Time frame	Description
Percentage of Participants Achieving ASAS 20 (SpondyloArthritis International Society Criteria) Response at Week 16	Baseline up to 16 weeks	ASAS 20 response is a validated composite assessment reflecting the percentage of treated patients who achieve within a defined timeframe an improvement of 20% and ≥1 unit on a scale of 1 to 10 in at least three of the four ASAS main domains and no worsening of ≥20% and ≥1 unit in the remaining domain. ASAS 20 is used to assess the efficacy of at least one dose of secukinumab against placebo.

Secondary

Measure	Time frame	Description
Change From Baseline at Week 16 in Serum hsCRP	Baseline up to 16 weeks	The change from baseline in hsCRP is expressed as a ratio of post-baseline to baseline values. With the ratio normalized to 1.0 at baseline, ratios less than 1.0 represent decreased post-baseline values, whereas ratios greater than 1.0 represent increased post-baseline values. Blood levels of C-reactive protein (CRP), an acute phase reactant, are indicative of inflammation and of its severity, and can be used to monitor treatment response. A high sensitvity CRP (hsCRP) test is implemented in this study to assess the efficacy of at least one dose of secukinumab versus placebo in reducing AS elicited systemic inflammation over time.
Percentage of Participants Achieving ASAS 5/6 (SpondyloArthritis International Society Criteria) Response at Week 16	Baseline up to 16 weeks	ASAS 5/6 response is a validated composite assessment, reflecting the percentage of treated patients who achieve within a defined timeframe at least 20% improvement in score in at least 5 of a conventional set of 6 clinical domains relevant to AS (pain, patient global assessment, function, inflammation, spinal mobility, C-reative protein) without deterioration in the 6th domain. In this study, ASAS 5/6 is used to assess the efficacy of at least one dose of secukinumab against placebo.
Change From Baseline at Week 16 for Total Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)	Baseline up to 16 weeks	BASDAI is a validated assessment tool using 1 through 10 scales (1 indicating no problem and 10 indicating worst problem), to characterize six clinical domains (fatigue, spinal pain, joint pain/selling, localized tenderness, morning stiffness duration, morning stiffness severity) pertaining to five major symptoms of AS perceived by the patients. Computed composite scores of 4 or greater indicate suboptimal disease control. In this study, the BASDAI is used to assess the efficacy of at least one dose of secukinumab verus placebo.
Percentage of Participants Achieving ASAS 40 (SpondyloArthritis International Society Criteria) Response	Baseline up to 16 weeks	ASAS 40 response is a validated composite assessment, reflecting the proportion of treated patients who achieve within a defined timeframe an improvement of ≥40% and ≥2 units on a scale of 0 to 10 (0 being worse and 10 being better) in at least three of the four ASAS main domains (patient global, pain, function and inflammation) and no worsening at all in the remaining domain. ASAS 40 is used to assess the efficacy of at least one dose of secukinumab against placebo.
Change From Baseline at Week 16 in ASQoL	Baseline up to 16 weeks	ASQoL is an 18 item questionnaire that assesses disease-specific quality of life (QoL), consisting of statements that are relevant to the physical and mental conditions for a participant with AS: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each statement is answered by the participant as a 'Yes' (scored as 1) or 'No' (scored as 0). All item scores are summed to give a total score. Total score can range from 0 (good QoL) to 18 (poor QoL). In this study, ASQoL is used to assess improvement from baseline of at least one dose of secukinumab versus placebo.
Percentage of Participants Achieving ASAS Partial Remission at Week 16	Baseline up to 16 weeks	ASAS partial remission is a composite assessment, reflecting the proportion of treated patients who achieve within a defined time frame a value not above 2 units in each of the 4 ASAS domains on a scale 0 to 10. In this study ASAS partial remission is used to assess the efficacy of at least one dose of secukinumab versus placebo.
Change From Baseline at Week 16 in Physical Function Component Summary (PCS) of the Medical Outcomes Study Questionnaire Short-form Health Survey (SF-36)	Baseline up to 16 weeks	Physical Function Component Summary (PCS) is only 1 component of SF-36. This scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.

Countries

Austria, Canada, Czechia, Finland, Germany, Italy, Netherlands, Russia, Singapore, Spain, Switzerland, United Kingdom, United States

Participant flow

Participants by arm

Arm	Count
Secukinumab 75 mg Secukinumab 75 mg subcutaneous injection once weekly at baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks.	73
Secukinumab 150 mg Secukinumab 150 mg subcutaneous injection once weekly at baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks	72
Placebo Placebo subcutaneous injection once weekly at baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks up to week 16	74
Total	219

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002	FG003	FG004
Up to Week 16	Adverse Event	2	5	4	0	0
Up to Week 16	Death	1	0	0	0	0
Up to Week 16	Lack of Efficacy	0	0	1	0	0
Up to Week 16	Physician Decision	0	0	1	0	0
Up to Week 16	Withdrawal by Subject	2	1	2	0	0
Week 16 up to Week 260	Adverse Event	5	2	0	3	2
Week 16 up to Week 260	Death	1	1	0	0	0
Week 16 up to Week 260	Lack of Efficacy	7	4	0	4	2
Week 16 up to Week 260	Non-compliance	0	1	0	1	0
Week 16 up to Week 260	Physician Decision	0	2	0	0	0
Week 16 up to Week 260	Technical issues	0	1	0	1	0
Week 16 up to Week 260	Withdrawal by Subject	7	2	0	3	1

Baseline characteristics

Characteristic	Secukinumab 75 mg	Secukinumab 150 mg	Placebo	Total
Age, Customized >= 65 to 74 years	2 participants	2 participants	1 participants	5 participants
Age, Customized < 65 years	70 participants	70 participants	72 participants	212 participants
Age, Customized >= 75 years	1 participants	0 participants	1 participants	2 participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 participants	1 participants	0 participants	1 participants
Race/Ethnicity, Customized Asian	3 participants	2 participants	4 participants	9 participants
Race/Ethnicity, Customized White	70 participants	69 participants	70 participants	209 participants
Sex: Female, Male Female	22 Participants	26 Participants	18 Participants	66 Participants
Sex: Female, Male Male	51 Participants	46 Participants	56 Participants	153 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk
deaths Total, all-cause mortality	2 / 105	1 / 155	0 / 74
other Total, other adverse events	76 / 105	99 / 155	26 / 74
serious Total, serious adverse events	25 / 105	31 / 155	4 / 74

Outcome results

Primary

Percentage of Participants Achieving ASAS 20 (SpondyloArthritis International Society Criteria) Response at Week 16

ASAS 20 response is a validated composite assessment reflecting the percentage of treated patients who achieve within a defined timeframe an improvement of 20% and ≥1 unit on a scale of 1 to 10 in at least three of the four ASAS main domains and no worsening of ≥20% and ≥1 unit in the remaining domain. ASAS 20 is used to assess the efficacy of at least one dose of secukinumab against placebo.

Time frame: Baseline up to 16 weeks

Arm	Measure	Value (NUMBER)
Secukinumab 75 mg	Percentage of Participants Achieving ASAS 20 (SpondyloArthritis International Society Criteria) Response at Week 16	41.1 percentage of participants
Secukinumab 150 mg	Percentage of Participants Achieving ASAS 20 (SpondyloArthritis International Society Criteria) Response at Week 16	61.1 percentage of participants
Placebo	Percentage of Participants Achieving ASAS 20 (SpondyloArthritis International Society Criteria) Response at Week 16	28.4 percentage of participants

p-value: 0.096795% CI: [0.9, 3.67]Regression, Logistic

p-value: <0.000195% CI: [2.14, 8.96]Regression, Logistic

Secondary

Change From Baseline at Week 16 for Total Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)

BASDAI is a validated assessment tool using 1 through 10 scales (1 indicating no problem and 10 indicating worst problem), to characterize six clinical domains (fatigue, spinal pain, joint pain/selling, localized tenderness, morning stiffness duration, morning stiffness severity) pertaining to five major symptoms of AS perceived by the patients. Computed composite scores of 4 or greater indicate suboptimal disease control. In this study, the BASDAI is used to assess the efficacy of at least one dose of secukinumab verus placebo.

Time frame: Baseline up to 16 weeks

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Secukinumab 75 mg	Change From Baseline at Week 16 for Total Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)	-1.92 scores on a scale	Standard Error 0.249
Secukinumab 150 mg	Change From Baseline at Week 16 for Total Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)	-2.19 scores on a scale	Standard Error 0.248
Placebo	Change From Baseline at Week 16 for Total Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)	-0.85 scores on a scale	Standard Error 0.252

p-value: <0.000195% CI: [-1.77, -0.37]Mixed Models Analysis

p-value: 0.000295% CI: [-2.04, -0.65]Mixed Models Analysis

Secondary

Change From Baseline at Week 16 in ASQoL

ASQoL is an 18 item questionnaire that assesses disease-specific quality of life (QoL), consisting of statements that are relevant to the physical and mental conditions for a participant with AS: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each statement is answered by the participant as a 'Yes' (scored as 1) or 'No' (scored as 0). All item scores are summed to give a total score. Total score can range from 0 (good QoL) to 18 (poor QoL). In this study, ASQoL is used to assess improvement from baseline of at least one dose of secukinumab versus placebo.

Time frame: Baseline up to 16 weeks

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Secukinumab 75 mg	Change From Baseline at Week 16 in ASQoL	-3.33 scores on a scale	Standard Error 0.537
Secukinumab 150 mg	Change From Baseline at Week 16 in ASQoL	-4.00 scores on a scale	Standard Error 0.528
Placebo	Change From Baseline at Week 16 in ASQoL	-1.37 scores on a scale	Standard Error 0.53

p-value: 0.009695% CI: [-3.43, -0.48]Mixed Models Analysis

p-value: 0.000595% CI: [-4.09, -1.16]Mixed Models Analysis

Secondary

Change From Baseline at Week 16 in Physical Function Component Summary (PCS) of the Medical Outcomes Study Questionnaire Short-form Health Survey (SF-36)

Physical Function Component Summary (PCS) is only 1 component of SF-36. This scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.

Time frame: Baseline up to 16 weeks

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Secukinumab 75 mg	Change From Baseline at Week 16 in Physical Function Component Summary (PCS) of the Medical Outcomes Study Questionnaire Short-form Health Survey (SF-36)	4.77 scores on a scale	Standard Error 0.798
Secukinumab 150 mg	Change From Baseline at Week 16 in Physical Function Component Summary (PCS) of the Medical Outcomes Study Questionnaire Short-form Health Survey (SF-36)	6.06 scores on a scale	Standard Error 0.784
Placebo	Change From Baseline at Week 16 in Physical Function Component Summary (PCS) of the Medical Outcomes Study Questionnaire Short-form Health Survey (SF-36)	1.92 scores on a scale	Standard Error 0.786

p-value: 0.01195% CI: [0.66, 5.03]Mixed Models Analysis

p-value: 0.000295% CI: [1.96, 6.32]Mixed Models Analysis

Secondary

Change From Baseline at Week 16 in Serum hsCRP

The change from baseline in hsCRP is expressed as a ratio of post-baseline to baseline values. With the ratio normalized to 1.0 at baseline, ratios less than 1.0 represent decreased post-baseline values, whereas ratios greater than 1.0 represent increased post-baseline values. Blood levels of C-reactive protein (CRP), an acute phase reactant, are indicative of inflammation and of its severity, and can be used to monitor treatment response. A high sensitvity CRP (hsCRP) test is implemented in this study to assess the efficacy of at least one dose of secukinumab versus placebo in reducing AS elicited systemic inflammation over time.

Time frame: Baseline up to 16 weeks

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Secukinumab 75 mg	Change From Baseline at Week 16 in Serum hsCRP	0.61 mg/L	Standard Error 1.103
Secukinumab 150 mg	Change From Baseline at Week 16 in Serum hsCRP	0.55 mg/L	Standard Error 1.104
Placebo	Change From Baseline at Week 16 in Serum hsCRP	1.13 mg/L	Standard Error 1.105

p-value: <0.000195% CI: [0.41, 0.71]Mixed Models Analysis

p-value: <0.000195% CI: [0.37, 0.64]Mixed Models Analysis

Secondary

Percentage of Participants Achieving ASAS 40 (SpondyloArthritis International Society Criteria) Response

ASAS 40 response is a validated composite assessment, reflecting the proportion of treated patients who achieve within a defined timeframe an improvement of ≥40% and ≥2 units on a scale of 0 to 10 (0 being worse and 10 being better) in at least three of the four ASAS main domains (patient global, pain, function and inflammation) and no worsening at all in the remaining domain. ASAS 40 is used to assess the efficacy of at least one dose of secukinumab against placebo.

Time frame: Baseline up to 16 weeks

Arm	Measure	Value (NUMBER)
Secukinumab 75 mg	Percentage of Participants Achieving ASAS 40 (SpondyloArthritis International Society Criteria) Response	26.0 percentage of participants
Secukinumab 150 mg	Percentage of Participants Achieving ASAS 40 (SpondyloArthritis International Society Criteria) Response	36.1 percentage of participants
Placebo	Percentage of Participants Achieving ASAS 40 (SpondyloArthritis International Society Criteria) Response	10.8 percentage of participants

p-value: 0.019495% CI: [1.19, 7.48]Regression, Logistic

p-value: <0.000495% CI: [2.06, 12.44]Regression, Logistic

Secondary

Percentage of Participants Achieving ASAS 5/6 (SpondyloArthritis International Society Criteria) Response at Week 16

ASAS 5/6 response is a validated composite assessment, reflecting the percentage of treated patients who achieve within a defined timeframe at least 20% improvement in score in at least 5 of a conventional set of 6 clinical domains relevant to AS (pain, patient global assessment, function, inflammation, spinal mobility, C-reative protein) without deterioration in the 6th domain. In this study, ASAS 5/6 is used to assess the efficacy of at least one dose of secukinumab against placebo.

Time frame: Baseline up to 16 weeks

Arm	Measure	Value (NUMBER)
Secukinumab 75 mg	Percentage of Participants Achieving ASAS 5/6 (SpondyloArthritis International Society Criteria) Response at Week 16	34.2 percentage of participants
Secukinumab 150 mg	Percentage of Participants Achieving ASAS 5/6 (SpondyloArthritis International Society Criteria) Response at Week 16	43.1 percentage of participants
Placebo	Percentage of Participants Achieving ASAS 5/6 (SpondyloArthritis International Society Criteria) Response at Week 16	8.1 percentage of participants

p-value: 0.000395% CI: [2.31, 16.26]Regression, Logistic

p-value: <0.000195% CI: [3.47, 24.12]Regression, Logistic

Secondary

Percentage of Participants Achieving ASAS Partial Remission at Week 16

ASAS partial remission is a composite assessment, reflecting the proportion of treated patients who achieve within a defined time frame a value not above 2 units in each of the 4 ASAS domains on a scale 0 to 10. In this study ASAS partial remission is used to assess the efficacy of at least one dose of secukinumab versus placebo.

Time frame: Baseline up to 16 weeks

Arm	Measure	Value (NUMBER)
Secukinumab 75 mg	Percentage of Participants Achieving ASAS Partial Remission at Week 16	15.1 percentage of participants
Secukinumab 150 mg	Percentage of Participants Achieving ASAS Partial Remission at Week 16	13.9 percentage of participants
Placebo	Percentage of Participants Achieving ASAS Partial Remission at Week 16	4.1 percentage of participants

p-value: 0.032595% CI: [1.13, 16.21]Regression, Logistic

p-value: 0.047195% CI: [1.02, 15.01]Regression, Logistic

16 Week Efficacy and 5 Year Long Term Efficacy, Safety and Tolerability of Secukinumab in Patients With Active Ankylosing Spondylitis

Conditions

Keywords

Brief summary

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Percentage of Participants Achieving ASAS 20 (SpondyloArthritis International Society Criteria) Response at Week 16

Change From Baseline at Week 16 for Total Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)

Change From Baseline at Week 16 in ASQoL

Change From Baseline at Week 16 in Physical Function Component Summary (PCS) of the Medical Outcomes Study Questionnaire Short-form Health Survey (SF-36)

Change From Baseline at Week 16 in Serum hsCRP

Percentage of Participants Achieving ASAS 40 (SpondyloArthritis International Society Criteria) Response

Percentage of Participants Achieving ASAS 5/6 (SpondyloArthritis International Society Criteria) Response at Week 16

Percentage of Participants Achieving ASAS Partial Remission at Week 16