Trial Outcomes & Findings for Effect of Secukinumab on Radiographic Progression in Ankylosing Spondylitis as Compared to GP2017 (Adalimumab Biosimilar) (NCT NCT03259074)

NCT ID: NCT03259074

Last Updated: 2023-08-21

Results Overview

Radiographic progression was based on scores from the modified Stoke Ankylosing Spondylitis Spine Score (mSASSS). The mSASSS is the sum of scores assessing the vertebral corners of the lumbar and cervical spine as 0 (normal), 1 (erosion, sclerosis, or squaring), 2 (syndesmophyte), or 3 (bridging syndesmophyte) with a total range from 0-72. No radiographic progression was defined as the change from baseline in mSASSS score \<= 0.5.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 859 participants
• Primary outcome timeframe: Baseline and at Week 104
• Results posted on: 2023-08-21

Participant Flow

A total of 859 subjects were randomized to treatment at 171 sites in 30 countries in Europe, North America, South America, and Asia

Participant milestones

Measure	AIN457 150 mg/Placebo AIN457 150 mg and a matching placebo was administered subcutaneously via pre-filled syringes at Baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks until Week 104	AIN457 300 mg AIN457 300 mg (2 x 150 mg) was administered subcutaneously via pre-filled syringes at Baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks until Week 104	GP2017 40mg GP2017 (adalimumab biosimilar) 40 mg was administered subcutaneously via pre-filled syringes at Baseline followed by dosing every 2 weeks until Week 104
Overall Study STARTED	287	286	286
Overall Study COMPLETED	254	237	243
Overall Study NOT COMPLETED	33	49	43

Reasons for withdrawal

Measure	AIN457 150 mg/Placebo AIN457 150 mg and a matching placebo was administered subcutaneously via pre-filled syringes at Baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks until Week 104	AIN457 300 mg AIN457 300 mg (2 x 150 mg) was administered subcutaneously via pre-filled syringes at Baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks until Week 104	GP2017 40mg GP2017 (adalimumab biosimilar) 40 mg was administered subcutaneously via pre-filled syringes at Baseline followed by dosing every 2 weeks until Week 104
Overall Study Adverse Event	9	12	8
Overall Study Death	1	1	3
Overall Study Lost to Follow-up	2	4	3
Overall Study New Therapy For Study Indication	1	2	2
Overall Study Physician Decision	4	12	10
Overall Study Pregnancy	1	1	0
Overall Study Progressive Disease	1	0	0
Overall Study Protocol Deviation	1	1	3
Overall Study Subject/Guardian Decision	13	16	14

Baseline Characteristics

The baseline mSASSS was determined only from those participants who provided evaluable baseline X-ray images.

Baseline characteristics by cohort

Measure	AIN457 150 mg/Placebo n=287 Participants AIN457 150 mg and a matching placebo was administered subcutaneously via pre-filled syringes at Baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks until Week 104	AIN457 300 mg n=286 Participants AIN457 300 mg (2 x 150 mg) was administered subcutaneously via pre-filled syringes at Baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks until Week 104	GP2017 40mg n=286 Participants GP2017 (adalimumab biosimilar) 40 mg was administered subcutaneously via pre-filled syringes at Baseline followed by dosing every 2 weeks until Week 104	Total n=859 Participants Total of all reporting groups
Age, Continuous	42.1 years STANDARD_DEVIATION 11.99 • n=287 Participants	42.2 years STANDARD_DEVIATION 12.47 • n=286 Participants	41.9 years STANDARD_DEVIATION 12.68 • n=286 Participants	42.1 years STANDARD_DEVIATION 12.37 • n=859 Participants
Sex: Female, Male Female	57 Participants n=287 Participants	63 Participants n=286 Participants	65 Participants n=286 Participants	185 Participants n=859 Participants
Sex: Female, Male Male	230 Participants n=287 Participants	223 Participants n=286 Participants	221 Participants n=286 Participants	674 Participants n=859 Participants
Race/Ethnicity, Customized White	225 Participants n=287 Participants	227 Participants n=286 Participants	228 Participants n=286 Participants	680 Participants n=859 Participants
Race/Ethnicity, Customized Black or African American	1 Participants n=287 Participants	2 Participants n=286 Participants	0 Participants n=286 Participants	3 Participants n=859 Participants
Race/Ethnicity, Customized Asian	40 Participants n=287 Participants	39 Participants n=286 Participants	50 Participants n=286 Participants	129 Participants n=859 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	19 Participants n=287 Participants	15 Participants n=286 Participants	7 Participants n=286 Participants	41 Participants n=859 Participants
Race/Ethnicity, Customized Other	1 Participants n=287 Participants	0 Participants n=286 Participants	0 Participants n=286 Participants	1 Participants n=859 Participants
Race/Ethnicity, Customized Multiple	1 Participants n=287 Participants	3 Participants n=286 Participants	1 Participants n=286 Participants	5 Participants n=859 Participants
Modified Stoke Ankylosing Spondylitis Spine Score (mSASSS) scores	17.602 score on a scale STANDARD_DEVIATION 21.3286 • n=283 Participants • The baseline mSASSS was determined only from those participants who provided evaluable baseline X-ray images.	16.527 score on a scale STANDARD_DEVIATION 20.8153 • n=280 Participants • The baseline mSASSS was determined only from those participants who provided evaluable baseline X-ray images.	15.695 score on a scale STANDARD_DEVIATION 19.4955 • n=283 Participants • The baseline mSASSS was determined only from those participants who provided evaluable baseline X-ray images.	16.609 score on a scale STANDARD_DEVIATION 20.5506 • n=846 Participants • The baseline mSASSS was determined only from those participants who provided evaluable baseline X-ray images.

PRIMARY outcome

Timeframe: Baseline and at Week 104

Population: Full analysis set

Radiographic progression was based on scores from the modified Stoke Ankylosing Spondylitis Spine Score (mSASSS). The mSASSS is the sum of scores assessing the vertebral corners of the lumbar and cervical spine as 0 (normal), 1 (erosion, sclerosis, or squaring), 2 (syndesmophyte), or 3 (bridging syndesmophyte) with a total range from 0-72. No radiographic progression was defined as the change from baseline in mSASSS score <= 0.5.

Outcome measures

Measure	AIN457 150 mg/Placebo n=287 Participants AIN457 150 mg and a matching placebo was administered subcutaneously via pre-filled syringes at Baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks until Week 104	AIN457 300 mg n=286 Participants AIN457 300 mg (2 x 150 mg) was administered subcutaneously via pre-filled syringes at Baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks until Week 104	GP2017 40mg n=286 Participants GP2017 (adalimumab biosimilar) 40 mg was administered subcutaneously via pre-filled syringes at Baseline followed by dosing every 2 weeks until Week 104
Percentage of Participants With no Radiographic Progression at Week 104 (Multiple Imputation) (Full Analysis Set)	66.1 Percentage of participants	66.9 Percentage of participants	65.6 Percentage of participants

SECONDARY outcome

Timeframe: Baseline and at Week 104

Population: Full analysis set

Radiographic changes in the spine were based on the change in score of the modified Stoke Ankylosing Spondylitis Spinal Score (mSASSS) from baseline to Week 104.

The mSASSS is the sum of scores assessing the vertebral corners of the lumbar and cervical spine as 0 (normal), 1 (erosion, sclerosis, or squaring), 2 (syndesmophyte), or 3 (bridging syndesmophyte) with a total range from 0-72.

Outcome measures

Measure	AIN457 150 mg/Placebo n=287 Participants AIN457 150 mg and a matching placebo was administered subcutaneously via pre-filled syringes at Baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks until Week 104	AIN457 300 mg n=286 Participants AIN457 300 mg (2 x 150 mg) was administered subcutaneously via pre-filled syringes at Baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks until Week 104	GP2017 40mg n=286 Participants GP2017 (adalimumab biosimilar) 40 mg was administered subcutaneously via pre-filled syringes at Baseline followed by dosing every 2 weeks until Week 104
Change From Baseline in mSASSS at Week 104 (Multiple Imputation) (Full Analysis Set)	0.54 mSASSS scores Standard Error 0.175	0.55 mSASSS scores Standard Error 0.180	0.72 mSASSS scores Standard Error 0.177

SECONDARY outcome

Timeframe: Baseline and at Week 104

Population: Syndesmophyte subset only included participants who had a syndesmophyte at baseline as measured on the mSASSS scale.

Syndesmophytes are bony growths that develop on corner of the vertebrae of the spine which are indicators of AS. A participant was considered to have a syndesmophyte if at least one reader assessed vertebral corner as >= 2 at on the mSASSS scale at baseline. Only participants with a syndesmophyte at baseline were evaluated at Week 104 for new syndesmophytes. A new syndesmophyte was a syndesmophyte present at Week 104 which was not present at baseline. Absence of new syndesmophyte was defined as having individual vertebral score < 2 on the mSASSS scale for all interpretable locations that had no syndesmophyte at baseline. Missing responses for subjects without new syndesmophyte at Week 104 were imputed by multiple imputation (MCMC).

Outcome measures

Measure	AIN457 150 mg/Placebo n=211 Participants AIN457 150 mg and a matching placebo was administered subcutaneously via pre-filled syringes at Baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks until Week 104	AIN457 300 mg n=204 Participants AIN457 300 mg (2 x 150 mg) was administered subcutaneously via pre-filled syringes at Baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks until Week 104	GP2017 40mg n=212 Participants GP2017 (adalimumab biosimilar) 40 mg was administered subcutaneously via pre-filled syringes at Baseline followed by dosing every 2 weeks until Week 104
Percentage of Participants Without New Syndesmophytes by mSASSS Between Baseline and Week 104 (Multiple Imputation) (Syndesmophyte Subset)	56.9 Percentage of participants	53.8 Percentage of participants	53.3 Percentage of participants

SECONDARY outcome

Timeframe: Baseline and at Week 104

Population: MRI subset only included participants who had an MRI performed at selected centers

Magnetic Resonance Images (MRI) of the Sacroiliac Joint (SIJ) were assessed for the presence and severity of SIJ bone marrow edema according to the Berlin Active Inflammatory Lesions Scoring with a minimum score of 0 and a maximum score of 24. Higher scores indicate more inflammation.

Outcome measures

Measure	AIN457 150 mg/Placebo n=137 Participants AIN457 150 mg and a matching placebo was administered subcutaneously via pre-filled syringes at Baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks until Week 104	AIN457 300 mg n=137 Participants AIN457 300 mg (2 x 150 mg) was administered subcutaneously via pre-filled syringes at Baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks until Week 104	GP2017 40mg n=144 Participants GP2017 (adalimumab biosimilar) 40 mg was administered subcutaneously via pre-filled syringes at Baseline followed by dosing every 2 weeks until Week 104
Change From Baseline in MRI Berlin Sacroiliac (SI) Joint Edema Score (Observed Data) (MRI Subset)	-1.527 scores on a scale Standard Error 0.1057	-1.378 scores on a scale Standard Error 0.1097	-1.710 scores on a scale Standard Error 0.1087

SECONDARY outcome

Timeframe: Baseline and at Week 104

Population: MRI subset only included participants who had an MRI performed at selected centers

Magnetic Resonance Images (MRI) of the spine were assessed for the presence and severity of bone marrow edema in the spinal vertebrae according to the Berlin modification of the ASspiMRI-a edema score with a score range of 0 to 69. Higher scores indicate more inflammation.

Outcome measures

Measure	AIN457 150 mg/Placebo n=137 Participants AIN457 150 mg and a matching placebo was administered subcutaneously via pre-filled syringes at Baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks until Week 104	AIN457 300 mg n=137 Participants AIN457 300 mg (2 x 150 mg) was administered subcutaneously via pre-filled syringes at Baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks until Week 104	GP2017 40mg n=144 Participants GP2017 (adalimumab biosimilar) 40 mg was administered subcutaneously via pre-filled syringes at Baseline followed by dosing every 2 weeks until Week 104
Change From Baseline in Berlin Modification of ASspiMRI-a Edema Score (MRI Subset)	-1.224 Berlin mod. of ASspiMRI-a edema scores Standard Error 0.2306	-1.683 Berlin mod. of ASspiMRI-a edema scores Standard Error 0.2373	-2.101 Berlin mod. of ASspiMRI-a edema scores Standard Error 0.2378

SECONDARY outcome

Timeframe: Week 104

Population: Full analysis set for the population to be analyzed in this secondary outcome: AIN457 150 mg and AIN457 300 mg arms.

Assessment of SpondyloArthritis International Society criteria (ASAS) consist of 4 domains measured on visual analog scales (VAS): 1. Patient's global assessment; 2. Patient's assessment of back pain; 3. Function represented by Bath Ankylosing Spondylitis Functional Index (BASFI) average of 10 questions; 4. Inflammation represented by mean duration and severity of morning stiffness, on the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI). ASAS 20 response is defined as an improvement of ≥20% and ≥1 unit on a scale of 10 in at least three of the four main domains and no worsening of ≥20% and ≥1 unit on a scale of 10 in the remaining domain. A higher score on the VAS signifies higher severity.

Outcome measures

Measure	AIN457 150 mg/Placebo n=287 Participants AIN457 150 mg and a matching placebo was administered subcutaneously via pre-filled syringes at Baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks until Week 104	AIN457 300 mg n=286 Participants AIN457 300 mg (2 x 150 mg) was administered subcutaneously via pre-filled syringes at Baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks until Week 104	GP2017 40mg GP2017 (adalimumab biosimilar) 40 mg was administered subcutaneously via pre-filled syringes at Baseline followed by dosing every 2 weeks until Week 104
Percentage of Responders for Assessment of SpondyloArthritis International Society 20 (ASAS20)	83.1 Percentage of participants Interval 77.8 to 87.4	82.9 Percentage of participants Interval 77.3 to 87.4	—

SECONDARY outcome

Timeframe: Week 104

Population: Full analysis set for the population to be analyzed in this secondary outcome: AIN457 150 mg and AIN457 300 mg arms.

Assessment of SpondyloArthritis International Society criteria (ASAS) consist of 4 domains measured on visual analog scales (VAS): 1. Patient's global assessment; 2. Patient's assessment of back pain; 3. Function represented by Bath Ankylosing Spondylitis Functional Index (BASFI) average of 10 questions; 4. Inflammation represented by mean duration and severity of morning stiffness, on the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI). ASAS40 response is defined as an improvement of ≥40% and ≥2 units on a scale of 10 in at least three of the four ASAS main domains and no worsening at all in the remaining domain. A higher score on the VAS signifies higher severity.

Outcome measures

Measure	AIN457 150 mg/Placebo n=287 Participants AIN457 150 mg and a matching placebo was administered subcutaneously via pre-filled syringes at Baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks until Week 104	AIN457 300 mg n=286 Participants AIN457 300 mg (2 x 150 mg) was administered subcutaneously via pre-filled syringes at Baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks until Week 104	GP2017 40mg GP2017 (adalimumab biosimilar) 40 mg was administered subcutaneously via pre-filled syringes at Baseline followed by dosing every 2 weeks until Week 104
Percentage of Responders for Assessment of SpondyloArthritis International Society 40 (ASAS 40)	69.9 Percentage of participants Interval 63.7 to 75.4	73.5 Percentage of participants Interval 67.3 to 78.9	—

SECONDARY outcome

Timeframe: Week 104

Population: Full analysis set for the population to be analyzed in this secondary outcome: AIN457 150 mg and AIN457 300 mg arms.

The Assessment of SpondyloArthritis International Society (ASAS) partial remission response criteria consisted of the following assessment domains measured on visual analogue scales (VAS): 1. Patient's global assessment; 2. Patient's assessment of back pain; 3. Function represented by BASFI average of 10 questions regarding ability to perform specific tasks; 4. Inflammation represented by mean duration and severity of morning stiffness, on the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI). The ASAS partial remission criteria was defined as a value not above 2 units in each of the four domains on a scale of 10.

Outcome measures

Measure	AIN457 150 mg/Placebo n=287 Participants AIN457 150 mg and a matching placebo was administered subcutaneously via pre-filled syringes at Baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks until Week 104	AIN457 300 mg n=286 Participants AIN457 300 mg (2 x 150 mg) was administered subcutaneously via pre-filled syringes at Baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks until Week 104	GP2017 40mg GP2017 (adalimumab biosimilar) 40 mg was administered subcutaneously via pre-filled syringes at Baseline followed by dosing every 2 weeks until Week 104
Percentage of Responders for Assessment of SpondyloArthritis International Society With a Partial Remission Response (Full Analysis Set)	31.5 Percentage participants Interval 25.9 to 37.7	30.2 Percentage participants Interval 24.5 to 36.6	—

SECONDARY outcome

Timeframe: Week 104

Population: Full analysis set for the population to be analyzed in this secondary outcome: AIN457 150 mg and AIN457 300 mg arms.

The Ankylosing Spondylitis Disease Activity Score (ASDAS) is a composite index to assess disease activity in AS. Parameters used for the ASDAS include spinal pain (BASDAI question 2), the patient's global assessment of disease activity, peripheral pain/swelling (BASDAI question 3), duration of morning stiffness (BASDAI question 6) and C-reactive protein (CRP) in mg/L (Sieper 2009, Lukas 2009). Disease activity states are inactive disease, moderate disease activity, high disease activity, and very high disease activity. The 3 values selected to separate these states were < 1.3 between inactive disease and moderate disease activity, < 2.1 between moderate disease activity and high disease activity, and > 3.5 between high disease activity and very high disease activity. Selected cutoffs for improvement scores were a change ≥ 1.1 unit for "minimal clinically important improvement" and a change ≥ 2.0 units for "major improvement" (Machado 2011).

Outcome measures

Measure	AIN457 150 mg/Placebo n=287 Participants AIN457 150 mg and a matching placebo was administered subcutaneously via pre-filled syringes at Baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks until Week 104	AIN457 300 mg n=286 Participants AIN457 300 mg (2 x 150 mg) was administered subcutaneously via pre-filled syringes at Baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks until Week 104	GP2017 40mg GP2017 (adalimumab biosimilar) 40 mg was administered subcutaneously via pre-filled syringes at Baseline followed by dosing every 2 weeks until Week 104
Percentage of Participants With Assessment of SpondyloArthritis International Society for Inactive Disease Response (Observed Data) (Full Analysis Set)	31.1 Percentage of participants Interval 25.5 to 37.4	31.7 Percentage of participants Interval 25.7 to 38.3	—

Adverse Events

AIN457 150 mg/Placebo

Serious events: 40 serious events

Other events: 106 other events

Deaths: 1 deaths

AIN457 300 mg

Serious events: 29 serious events

Other events: 107 other events

Deaths: 1 deaths

GP2017 40 mg

Serious events: 32 serious events

Other events: 99 other events

Deaths: 3 deaths

Serious adverse events

Measure	AIN457 150 mg/Placebo n=286 participants at risk AIN457 150 mg and a matching placebo was administered subcutaneously via pre-filled syringes at Baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks until Week 104	AIN457 300 mg n=285 participants at risk AIN457 300 mg (2 x 150 mg) was administered subcutaneously via pre-filled syringes at Baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks until Week 104	GP2017 40 mg n=285 participants at risk GP2017 (adalimumab biosimilar) 40 mg was administered subcutaneously via pre-filled syringes at Baseline followed by dosing every 2 weeks until Week 104
Cardiac disorders Cardiac failure	0.00% 0/286 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.00% 0/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.35% 1/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.
Cardiac disorders Coronary artery disease	0.35% 1/286 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.00% 0/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.00% 0/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.
Cardiac disorders Myocardial infarction	0.35% 1/286 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.00% 0/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.00% 0/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.
Eye disorders Iridocyclitis	0.70% 2/286 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.35% 1/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.00% 0/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.
Eye disorders Retinal detachment	0.00% 0/286 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.00% 0/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.35% 1/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.
Eye disorders Retinal vein occlusion	0.00% 0/286 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.00% 0/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.35% 1/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.
Gastrointestinal disorders Chronic gastrointestinal bleeding	0.00% 0/286 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.35% 1/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.00% 0/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.
Gastrointestinal disorders Colitis	1.0% 3/286 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.00% 0/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.00% 0/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.
Gastrointestinal disorders Colitis ulcerative	0.35% 1/286 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.00% 0/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.00% 0/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.
Gastrointestinal disorders Crohn's disease	0.70% 2/286 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	1.1% 3/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.00% 0/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.
Gastrointestinal disorders Diarrhoea	0.35% 1/286 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.00% 0/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.00% 0/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.
Gastrointestinal disorders Duodenal ulcer haemorrhage	0.00% 0/286 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.35% 1/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.00% 0/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.
Gastrointestinal disorders Gastroenteritis eosinophilic	0.00% 0/286 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.35% 1/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.00% 0/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.
Gastrointestinal disorders Gastrointestinal disorder	0.00% 0/286 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.35% 1/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.00% 0/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/286 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.00% 0/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.35% 1/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.
Gastrointestinal disorders Haemorrhoids	0.00% 0/286 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.00% 0/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.35% 1/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.
Gastrointestinal disorders Ileal ulcer	0.00% 0/286 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.35% 1/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.00% 0/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.
Gastrointestinal disorders Large intestine perforation	0.00% 0/286 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.35% 1/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.00% 0/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.
Gastrointestinal disorders Pancreatitis acute	0.35% 1/286 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.00% 0/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.70% 2/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.
Gastrointestinal disorders Umbilical hernia	0.00% 0/286 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.00% 0/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.35% 1/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.
General disorders Death	0.00% 0/286 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.35% 1/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.00% 0/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.
General disorders Drug intolerance	0.35% 1/286 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.00% 0/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.00% 0/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.
General disorders Medical device pain	0.35% 1/286 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.00% 0/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.00% 0/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.
General disorders Non-cardiac chest pain	0.00% 0/286 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.00% 0/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.35% 1/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.
General disorders Sudden death	0.00% 0/286 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.00% 0/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.35% 1/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.
Hepatobiliary disorders Cholangitis	0.00% 0/286 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.00% 0/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.35% 1/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.
Hepatobiliary disorders Cholecystitis	0.35% 1/286 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.00% 0/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.00% 0/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.
Hepatobiliary disorders Cholelithiasis	0.00% 0/286 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.00% 0/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.35% 1/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.
Hepatobiliary disorders Cholestasis	0.35% 1/286 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.00% 0/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.00% 0/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.
Immune system disorders Immunosuppression	0.00% 0/286 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.35% 1/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.00% 0/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.
Infections and infestations Abscess intestinal	0.00% 0/286 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.35% 1/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.00% 0/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.
Infections and infestations Anal abscess	0.35% 1/286 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.00% 0/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.00% 0/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.
Infections and infestations Appendicitis	0.35% 1/286 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.35% 1/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.35% 1/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.
Infections and infestations COVID-19	0.35% 1/286 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.00% 0/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.35% 1/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.
Infections and infestations COVID-19 pneumonia	0.35% 1/286 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.00% 0/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.00% 0/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.
Infections and infestations Cellulitis	0.35% 1/286 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.00% 0/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.35% 1/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.
Infections and infestations Diverticulitis	0.00% 0/286 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.35% 1/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.00% 0/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.
Infections and infestations Epididymitis	0.35% 1/286 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.00% 0/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.00% 0/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.
Infections and infestations Erysipelas	0.35% 1/286 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.00% 0/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.00% 0/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.
Infections and infestations Myelitis	0.00% 0/286 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.35% 1/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.00% 0/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.
Infections and infestations Oral herpes	0.35% 1/286 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.00% 0/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.00% 0/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.
Infections and infestations Pneumonia	0.00% 0/286 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.35% 1/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.70% 2/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.
Infections and infestations Pulmonary tuberculosis	0.00% 0/286 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.00% 0/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.35% 1/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.
Infections and infestations Pyelonephritis	0.00% 0/286 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.70% 2/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.00% 0/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.
Infections and infestations Sepsis	0.00% 0/286 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.00% 0/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.35% 1/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.
Infections and infestations Septic shock	0.00% 0/286 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.00% 0/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.35% 1/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.
Infections and infestations Suspected COVID-19	0.00% 0/286 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.00% 0/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.35% 1/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.
Infections and infestations Urinary tract infection	0.00% 0/286 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.00% 0/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.70% 2/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.
Injury, poisoning and procedural complications Exposure during pregnancy	0.00% 0/286 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.35% 1/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.00% 0/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.
Injury, poisoning and procedural complications Femur fracture	0.35% 1/286 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.00% 0/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.00% 0/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.
Injury, poisoning and procedural complications Hip fracture	0.00% 0/286 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.35% 1/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.35% 1/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.
Injury, poisoning and procedural complications Joint injury	0.35% 1/286 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.00% 0/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.00% 0/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.
Injury, poisoning and procedural complications Post procedural haemorrhage	0.00% 0/286 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.00% 0/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.35% 1/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.
Injury, poisoning and procedural complications Tendon rupture	0.35% 1/286 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.00% 0/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.00% 0/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.
Metabolism and nutrition disorders Dehydration	0.00% 0/286 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.35% 1/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.00% 0/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.
Metabolism and nutrition disorders Hyperglycaemia	0.35% 1/286 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.00% 0/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.00% 0/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.
Metabolism and nutrition disorders Type 1 diabetes mellitus	0.00% 0/286 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.35% 1/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.00% 0/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/286 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.35% 1/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.00% 0/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.00% 0/286 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.35% 1/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.00% 0/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.
Musculoskeletal and connective tissue disorders Osteoarthritis	1.0% 3/286 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.35% 1/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.35% 1/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.
Musculoskeletal and connective tissue disorders Synovial cyst	0.00% 0/286 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.35% 1/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.00% 0/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.35% 1/286 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.35% 1/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.00% 0/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder neoplasm	0.35% 1/286 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.00% 0/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.00% 0/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chloroma	0.35% 1/286 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.00% 0/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.00% 0/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian cancer	0.00% 0/286 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.00% 0/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.35% 1/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Papillary thyroid cancer	0.35% 1/286 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.00% 0/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.00% 0/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.
Nervous system disorders Brain hypoxia	0.00% 0/286 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.00% 0/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.35% 1/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.
Nervous system disorders Facial paresis	0.35% 1/286 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.00% 0/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.00% 0/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.
Nervous system disorders Guillain-Barre syndrome	0.00% 0/286 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.00% 0/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.35% 1/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.
Nervous system disorders Lacunar stroke	0.35% 1/286 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.00% 0/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.00% 0/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.
Nervous system disorders Parkinson's disease	0.00% 0/286 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.00% 0/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.35% 1/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.
Nervous system disorders Subarachnoid haemorrhage	0.35% 1/286 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.00% 0/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.00% 0/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.
Pregnancy, puerperium and perinatal conditions Abortion	0.35% 1/286 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.00% 0/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.00% 0/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.
Product Issues Device dislocation	0.00% 0/286 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.00% 0/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.35% 1/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.
Product Issues Device issue	0.00% 0/286 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.35% 1/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.00% 0/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.
Psychiatric disorders Depression	0.35% 1/286 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.00% 0/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.35% 1/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.
Psychiatric disorders Depression suicidal	0.35% 1/286 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.00% 0/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.00% 0/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.
Renal and urinary disorders Haematuria	0.00% 0/286 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.00% 0/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.35% 1/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.
Renal and urinary disorders Hydronephrosis	0.35% 1/286 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.00% 0/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.35% 1/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.
Renal and urinary disorders Micturition disorder	0.00% 0/286 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.00% 0/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.35% 1/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.
Renal and urinary disorders Renal colic	0.00% 0/286 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.35% 1/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.00% 0/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.
Renal and urinary disorders Ureterolithiasis	0.35% 1/286 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.00% 0/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.35% 1/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.
Reproductive system and breast disorders Endometrial hyperplasia	0.00% 0/286 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.35% 1/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.00% 0/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.
Reproductive system and breast disorders Ovarian cyst	0.35% 1/286 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.00% 0/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.00% 0/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/286 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.00% 0/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.35% 1/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.35% 1/286 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.00% 0/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.35% 1/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.
Respiratory, thoracic and mediastinal disorders Pneumothorax spontaneous	0.00% 0/286 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.35% 1/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.00% 0/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.
Skin and subcutaneous tissue disorders Eczema	0.00% 0/286 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.00% 0/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.35% 1/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.
Skin and subcutaneous tissue disorders Purpura	0.35% 1/286 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.00% 0/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.00% 0/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.
Vascular disorders Iliac artery occlusion	0.00% 0/286 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.35% 1/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.00% 0/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.
Vascular disorders Iliac artery stenosis	0.00% 0/286 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.35% 1/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.00% 0/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.
Vascular disorders Phlebitis	0.00% 0/286 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.35% 1/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.00% 0/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.
Vascular disorders Thrombosis	0.00% 0/286 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.00% 0/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	0.35% 1/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.

Other adverse events

Measure	AIN457 150 mg/Placebo n=286 participants at risk AIN457 150 mg and a matching placebo was administered subcutaneously via pre-filled syringes at Baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks until Week 104	AIN457 300 mg n=285 participants at risk AIN457 300 mg (2 x 150 mg) was administered subcutaneously via pre-filled syringes at Baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks until Week 104	GP2017 40 mg n=285 participants at risk GP2017 (adalimumab biosimilar) 40 mg was administered subcutaneously via pre-filled syringes at Baseline followed by dosing every 2 weeks until Week 104
Infections and infestations Upper respiratory tract infection	5.9% 17/286 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	8.8% 25/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	6.3% 18/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.
Musculoskeletal and connective tissue disorders Ankylosing spondylitis	3.8% 11/286 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	6.0% 17/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	4.2% 12/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.
Gastrointestinal disorders Diarrhoea	7.0% 20/286 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	7.7% 22/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	3.9% 11/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.
Infections and infestations Nasopharyngitis	16.4% 47/286 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	14.0% 40/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	15.4% 44/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.
Musculoskeletal and connective tissue disorders Arthralgia	5.6% 16/286 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	4.6% 13/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	4.2% 12/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.
Nervous system disorders Headache	5.6% 16/286 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	6.0% 17/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	6.0% 17/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.
Vascular disorders Hypertension	3.8% 11/286 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	3.9% 11/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.	5.3% 15/285 • Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: +1 862 778 8300

Email: Novartis.email@Novartis.com

Results disclosure agreements

• Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
• Publication restrictions are in place

Restriction type: OTHER