Study the Efficacy and Safety of VAY736 and CFZ533 in SLE... | NCT03656562

NCT03656562

ID	Type	Description	Link
2018-001508-12	EudraCT Number

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cohort 1 VAY736	Experimental	Blinded treatment phase: VAY736 administered subcutaneously (s.c.) every 4 weeks as multiple doses of VAY736 150 mg (total dose being VAY736 300 mg) until Week 25 + Standard of Care (SoC) for systemic lupus erythematosus (SLE). Open-label treatment phase: VAY736 administered subcutaneously (s.c.) every 4 weeks as multiple doses of VAY736 150 mg (total dose being VAY736 300 mg) until Week 49.	Drug: VAY736
Cohort 1 VAY736 Placebo	Placebo Comparator	Blinded treatment phase: VAY736 matching placebo administered subcutaneously (s.c.) every 4 weeks as multiple doses of placebo 0 mg until Week 25 + Standard of Care (SoC) for systemic lupus erythematosus (SLE). Open-label treatment phase: VAY736 administered subcutaneously (s.c.) every 4 weeks as multiple doses of VAY736 150 mg (total dose being VAY736 300 mg) until Week 49.	Drug: VAY736 Drug: VAY736 Placebo
Cohort 2 CFZ533	Experimental	Blinded treatment phase: CFZ533 administered intravenously (i.v) every 4 weeks as multiple doses of CFZ533 150 mg, based on body weight (BW) of the patients (10 mg/kg (>= 50 kg BW) and 13 mg/kg (< 50 kg BW)) until Week 25 + Standard of Care (SoC) for systemic lupus erythematosus (SLE). Open-label phase: CFZ533 administered intravenously (i.v) every 4 weeks as multiple doses of CFZ533 150 mg, based on body weight (BW) of the patients (10 mg/kg (>= 50 kg BW) and 13 mg/kg (< 50 kg BW)) until Week 49.	Drug: CFZ533
Cohort 2 CFZ533 Placebo	Placebo Comparator

Interventions

Name	Type	Description	Arm Group Labels	Other Names
VAY736	Drug	150 mg powder in vial for solution for injection; after reconstitution to 150 mg/mL per vial, a dose of 300 mg	Cohort 1 VAY736 Cohort 1 VAY736 Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants With SLE Responder Index (SRI)-4 Response Status at Week 29 With Reduced Steroid Dose Maintained Between Weeks 17 and 29	The primary endpoint was a composite of SRI-4 response at Week 29 with sustained reduction in oral corticosteroid from Week 17 through Week 29. Patients taking other rescue medication or prohibited medication or drop out before Week 29 were considered non-responders. SRI-4 response is defined as below: having >= 4 points reduction from baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score (score is 0 to 105; a higher score indicating more severe disease) AND no new British Isles Lupus Activity Group (BILAG)-2004 A organ domain score and no more than one new BILAG-2004 B organ domain scores compared with baseline AND <10 mm point increase from baseline with scale 0 to 100 mm in the physician's global assessment from baseline Sustained reduction in oral corticosteroid is defined as below: =< 5 mg/day or less than or equal to baseline dose, whichever was lower at Week 17 AND no increase of that dose from Week 17 through Week 29	Baseline, Week 17 to Week 29

Secondary Outcomes

Measure	Description	Time Frame
Changes Between Baseline and Week 29 in the Physicians' Global Assessment (PhGA) Visual Analog Scale (VAS) Assessing Patient's Overall Disease Activity	The Physician's global assessment (PhGA-VAS) of disease activity was performed using 100 mm VAS ranging from "no disease activity" (score 0) to "maximal disease activity" (score 100), after the question on how well the patient was doing with the disease considering all aspects affected by the disease. The investigator was then measuring the distance in mm from the left edge of the scale and entering the value.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Written informed consent must be obtained before any assessment is performed
Fulfill ≥4 of the 11 American College of Rheumatology 1997 classification criteria for SLE
Patient diagnosed with SLE for at least 6 months prior to screening
Elevated serum titers at screening of ANA (≥1:80) of a pattern consistent with an SLE diagnosis, including at a minimum either anti-double stranded DNA (anti-ds DNA) or anti-Ro (SSA) or anti-La (SSB) or anti-nuclear ribonucleoprotein (anti-RNP) or anti-Smith (anti-Sm)
Currently receiving corticosteroids and/or anti-malarial and/or thalidomide treatment and/or another DMARD on a stable dose according to protocol requirements
SLEDAI-2K score of ≥6 at screening
BILAG 2004 score of one "A" score either in the mucocutaneous or in the musculoskeletal domain or one "B" score in either the mucocutaneous or musculoskeletal domain and at least one "A" or "B" score in a second domain at screening
Weigh at least 40 kg at screening

Exclusion Criteria:

Cohort 2 (CFZ533/Placebo) only:

Patients who are at significant risk for thromboembolic events based on the following:
History of either thrombosis or 3 or more spontaneous abortions
Presence of lupus anticoagulant or significantly prolonged activated partial thromboplastin time (aPTT) consistent with co-existent anti-phospholipid syndrome and without concurrent prophylactic treatment with aspirin or anticoagulants as per local standard of care

All Cohorts:

History of receiving prior to screening:
Within 12 weeks: i.v. corticosteroids, calcineurin inhibitors or other oral DMARD
Within 24 weeks: cyclophosphamide or biologics such as intravenous Ig, plasmapheresis, anti-TNF-a mAb, CTLA4-Fc Ig (abatacept) or BAFF targeting agents (e.g., belimumab)
Any B-cell depleting therapies (e.g., anti-CD20 mAb, anti-CD22 mAb, anti-CD52 mAb) or TACI-Ig (atacicept) administered within 52 weeks prior to screening, and a B-cell count <50 cells/μ at the time of screening
Evidence of past exposure to tuberculosis as assessed by Quantiferon testing at screening
Presence of human immunodeficiency virus (HIV) infection at screening
Severe organ dysfunction or life threatening disease; ECOG performance status > 1 at screening
Presence of WHO Class III-IV renal involvement with proliferative disease Presence of severe lupus kidney disease as defined by proteinuria above 6 g/day or equivalent using spot urine protein creatinine ratio, or serum creatinine greater than 2.5 mg/dL (221.05 μmol/L), or requiring immune suppressive induction or maintenance treatment exceeding protocol defined limits
Active viral, bacterial or other infections at the time of screening or enrollment
Receipt of live/attenuated vaccine within a 2-month period before first dosing
Uncontrolled, co-existing serious disease, e.g., uncontrolled hypertension, heart failure, type I diabetes, thyroid disease within 3 months prior to first dosing, or significant, unresolved illness within 2 weeks prior to first dosing
History of hypersensitivity to drugs of similar chemical class
Chronic infection with hepatitis B (HBV) or hepatitis C (HCV). Subjects who are HBsAg negative and HBcAb positive are excluded unless negative for HBV DNA. Once past screening and enrolled into study, requirements for monitoring and antiviral treatment are enacted.

Subjects with a positive HCV antibody test should have HCV RNA levels measured. Subjects with positive (detectable) HCV RNA should be excluded.

Contacts/Locations Module

Name	Affiliation	Role
Novartis Pharmaceuticals	Novartis Pharmaceuticals	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Novartis Investigative Site		Caba		C1015ABO	Argentina
Novartis Investigative Site

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Cohort 1 VAY736	Blinded treatment phase: VAY736 administered subcutaneously (s.c.) every 4 weeks as multiple doses of VAY736 150 mg (total dose being VAY736 300 mg) until Week 25 + Standard of Care (SoC) for systemic lupus erythematosus (SLE). Open-label treatment phase: VAY736 administered subcutaneously (s.c.) every 4 weeks as multiple doses of VAY736 150 mg (total dose being VAY736 300 mg) until Week 49.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Feb 11, 2025	Apr 20, 2026

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

Blinded treatment phase:

CFZ533 matching placebo administered intravenously (i.v) every 4 weeks as multiple doses of placebo 0 mg, based on body weight (BW) of the patients (10 mg/kg (>= 50 kg BW) and 13 mg/kg (< 50 kg BW)) until Week 25 + Standard of Care (SoC) for systemic lupus erythematosus (SLE).

Open-label phase:

CFZ533 administered intravenously (i.v) every 4 weeks as multiple doses of CFZ533 150 mg, based on body weight (BW) of the patients (10 mg/kg (>= 50 kg BW) and 13 mg/kg (< 50 kg BW)) until Week 49.

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	Cohort 1 VAY736	Blinded treatment phase: VAY736 administered subcutaneously (s.c.) every 4 weeks as multiple doses of VAY736 150 mg (total dose being VAY736 300 mg) until Week 25 + Standard of Care (SoC) for systemic lupus erythematosus (SLE). Open-label treatment phase: VAY736 administered subcutaneously (s.c.) every 4 weeks as multiple doses of VAY736 150 mg (total dose being VAY736 300 mg) until Week 49.
BG001	Cohort 1 VAY736 Placebo	Blinded treatment phase: VAY736 matching placebo administered subcutaneously (s.c.) every 4 weeks as multiple doses of placebo 0 mg until Week 25 + Standard of Care (SoC) for systemic lupus erythematosus (SLE). Open-label treatment phase: VAY736 administered subcutaneously (s.c.) every 4 weeks as multiple doses of VAY736 150 mg (total dose being VAY736 300 mg) until Week 49.
BG002	Cohort 2 CFZ533	Blinded treatment phase: CFZ533 administered intravenously (i.v) every 4 weeks as multiple doses of CFZ533 150 mg, based on body weight (BW) of the patients (10 mg/kg (>= 50 kg BW) and 13 mg/kg (< 50 kg BW)) until Week 25 + Standard of Care (SoC) for systemic lupus erythematosus (SLE). Open-label phase: CFZ533 administered intravenously (i.v) every 4 weeks as multiple doses of CFZ533 150 mg, based on body weight (BW) of the patients (10 mg/kg (>= 50 kg BW) and 13 mg/kg (< 50 kg BW)) until Week 49.
BG003	Cohort 2 CFZ533 Placebo	Blinded treatment phase: CFZ533 matching placebo administered intravenously (i.v) every 4 weeks as multiple doses of placebo 0 mg, based on body weight (BW) of the patients (10 mg/kg (>= 50 kg BW) and 13 mg/kg (< 50 kg BW)) until Week 25 + Standard of Care (SoC) for systemic lupus erythematosus (SLE). Open-label phase: CFZ533 administered intravenously (i.v) every 4 weeks as multiple doses of CFZ533 150 mg, based on body weight (BW) of the patients (10 mg/kg (>= 50 kg BW) and 13 mg/kg (< 50 kg BW)) until Week 49.
BG004	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

Years

Title

Denominators

Categories

Title	Measurements
	BG00042.0± 10.91 BG00139.2± 10.46 BG00237.4± 11.34 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00032 BG00127 BG002

Race/Ethnicity, Customized

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Asian	BG0009 BG00112 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Percentage of Participants With SLE Responder Index (SRI)-4 Response Status at Week 29 With Reduced Steroid Dose Maintained Between Weeks 17 and 29

The primary endpoint was a composite of SRI-4 response at Week 29 with sustained reduction in oral corticosteroid from Week 17 through Week 29. Patients taking other rescue medication or prohibited medication or drop out before Week 29 were considered non-responders.

SRI-4 response is defined as below:

having >= 4 points reduction from baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score (score is 0 to 105; a higher score indicating more severe disease) AND
no new British Isles Lupus Activity Group (BILAG)-2004 A organ domain score and no more than one new BILAG-2004 B organ domain scores compared with baseline AND
<10 mm point increase from baseline with scale 0 to 100 mm in the physician's global assessment from baseline

Sustained reduction in oral corticosteroid is defined as below:

=< 5 mg/day or less than or equal to baseline dose, whichever was lower at Week 17 AND
no increase of that dose from Week 17 through Week 29

Pharmacodynamic analysis set (PD analysis set)

Posted

Count of Participants

Participants

Baseline, Week 17 to Week 29

ID	Title	Description
OG000	Cohort 1 VAY736	Blinded treatment phase: VAY736 administered subcutaneously (s.c.) every 4 weeks as multiple doses of VAY736 150 mg (total dose being VAY736 300 mg) until Week 25 + Standard of Care (SoC) for systemic lupus erythematosus (SLE). Open-label treatment phase: VAY736 administered subcutaneously (s.c.) every 4 weeks as multiple doses of VAY736 150 mg (total dose being VAY736 300 mg) until Week 49.
OG001	Cohort 1 VAY736 Placebo	Blinded treatment phase: VAY736 matching placebo administered subcutaneously (s.c.) every 4 weeks as multiple doses of placebo 0 mg until Week 25 + Standard of Care (SoC) for systemic lupus erythematosus (SLE). Open-label treatment phase: VAY736 administered subcutaneously (s.c.) every 4 weeks as multiple doses of VAY736 150 mg (total dose being VAY736 300 mg) until Week 49.
OG002	Cohort 2 CFZ533	Blinded treatment phase: CFZ533 administered intravenously (i.v) every 4 weeks as multiple doses of CFZ533 150 mg, based on body weight (BW) of the patients (10 mg/kg (>= 50 kg BW) and 13 mg/kg (< 50 kg BW)) until Week 25 + Standard of Care (SoC) for systemic lupus erythematosus (SLE). Open-label phase: CFZ533 administered intravenously (i.v) every 4 weeks as multiple doses of CFZ533 150 mg, based on body weight (BW) of the patients (10 mg/kg (>= 50 kg BW) and 13 mg/kg (< 50 kg BW)) until Week 49.
OG003	Cohort 2 CFZ533 Placebo	Blinded treatment phase: CFZ533 matching placebo administered intravenously (i.v) every 4 weeks as multiple doses of placebo 0 mg, based on body weight (BW) of the patients (10 mg/kg (>= 50 kg BW) and 13 mg/kg (< 50 kg BW)) until Week 25 + Standard of Care (SoC) for systemic lupus erythematosus (SLE). Open-label phase: CFZ533 administered intravenously (i.v) every 4 weeks as multiple doses of CFZ533 150 mg, based on body weight (BW) of the patients (10 mg/kg (>= 50 kg BW) and 13 mg/kg (< 50 kg BW)) until Week 49.

Units	Counts
Participants	OG00034 OG00133 OG00220 OG003

Title

Denominators

Categories

Title	Measurements
	OG00015 OG0013 OG0028 OG003

Secondary

Changes Between Baseline and Week 29 in the Physicians' Global Assessment (PhGA) Visual Analog Scale (VAS) Assessing Patient's Overall Disease Activity

The Physician's global assessment (PhGA-VAS) of disease activity was performed using 100 mm VAS ranging from "no disease activity" (score 0) to "maximal disease activity" (score 100), after the question on how well the patient was doing with the disease considering all aspects affected by the disease. The investigator was then measuring the distance in mm from the left edge of the scale and entering the value.

Pharmacodynamic analysis set (PD analysis set). Only participants with a value at both Baseline and post-baseline visit included.

Posted

Mean

Standard Deviation

Unit on a scale

Baseline, Week 5, Week 9, Week 13, Week 17, Week 21, Week 25, Week 29

ID	Title	Description
OG000	Cohort 1 VAY736	Blinded treatment phase: VAY736 administered subcutaneously (s.c.) every 4 weeks as multiple doses of VAY736 150 mg (total dose being VAY736 300 mg) until Week 25 + Standard of Care (SoC) for systemic lupus erythematosus (SLE). Open-label treatment phase: VAY736 administered subcutaneously (s.c.) every 4 weeks as multiple doses of VAY736 150 mg (total dose being VAY736 300 mg) until Week 49.
OG001	Cohort 1 VAY736 Placebo	Blinded treatment phase: VAY736 matching placebo administered subcutaneously (s.c.) every 4 weeks as multiple doses of placebo 0 mg until Week 25 + Standard of Care (SoC) for systemic lupus erythematosus (SLE). Open-label treatment phase: VAY736 administered subcutaneously (s.c.) every 4 weeks as multiple doses of VAY736 150 mg (total dose being VAY736 300 mg) until Week 49.

Secondary

Changes Between Baseline and Week 29 in the Patient's Global Assessment (PGA) Visual Analog Scale (VAS) Assessing Patient's Global Disease Activity

The patient's global assessment of disease activity was performed using a Visual Analogue Scale (VAS) of 100 mm ranging from "no disease activity" (score 0) to "severe disease activity" (score 100), after the question on how well the patient was doing with the disease considering all aspects affected by the disease. The investigator was then measuring the distance in mm from the left edge of the scale and entering the value.

Pharmacodynamic analysis set (PD analysis set). Only participants with a value at both Baseline and post-baseline visit included.

Posted

Mean

Standard Deviation

Unit on a scale

Baseline, Week 5, Week 9, Week 13, Week 17, Week 21, Week 25, Week 29

ID	Title	Description
OG000	Cohort 1 VAY736	Blinded treatment phase: VAY736 administered subcutaneously (s.c.) every 4 weeks as multiple doses of VAY736 150 mg (total dose being VAY736 300 mg) until Week 25 + Standard of Care (SoC) for systemic lupus erythematosus (SLE). Open-label treatment phase: VAY736 administered subcutaneously (s.c.) every 4 weeks as multiple doses of VAY736 150 mg (total dose being VAY736 300 mg) until Week 49.
OG001	Cohort 1 VAY736 Placebo	Blinded treatment phase: VAY736 matching placebo administered subcutaneously (s.c.) every 4 weeks as multiple doses of placebo 0 mg until Week 25 + Standard of Care (SoC) for systemic lupus erythematosus (SLE). Open-label treatment phase: VAY736 administered subcutaneously (s.c.) every 4 weeks as multiple doses of VAY736 150 mg (total dose being VAY736 300 mg) until Week 49.

Secondary

Percentage of Participants With Flare

Flare was defined as one new 'A' score or two or more 'B' scores using the British Isles Lupus Assessment Group Index (BILAG -2004).

Pharmacodynamic analysis set (PD analysis set)

Posted

Number

percentage of participants

Up to 69 weeks

ID	Title	Description
OG000	Cohort 1 VAY736	Blinded treatment phase: VAY736 administered subcutaneously (s.c.) every 4 weeks as multiple doses of VAY736 150 mg (total dose being VAY736 300 mg) until Week 25 + Standard of Care (SoC) for systemic lupus erythematosus (SLE). Open-label treatment phase: VAY736 administered subcutaneously (s.c.) every 4 weeks as multiple doses of VAY736 150 mg (total dose being VAY736 300 mg) until Week 49.
OG001	Cohort 1 VAY736 Placebo	Blinded treatment phase: VAY736 matching placebo administered subcutaneously (s.c.) every 4 weeks as multiple doses of placebo 0 mg until Week 25 + Standard of Care (SoC) for systemic lupus erythematosus (SLE). Open-label treatment phase: VAY736 administered subcutaneously (s.c.) every 4 weeks as multiple doses of VAY736 150 mg (total dose being VAY736 300 mg) until Week 49.
OG002	Cohort 2 CFZ533	Blinded treatment phase: CFZ533 administered intravenously (i.v) every 4 weeks as multiple doses of CFZ533 150 mg, based on body weight (BW) of the patients (10 mg/kg (>= 50 kg BW) and 13 mg/kg (< 50 kg BW)) until Week 25 + Standard of Care (SoC) for systemic lupus erythematosus (SLE). Open-label phase: CFZ533 administered intravenously (i.v) every 4 weeks as multiple doses of CFZ533 150 mg, based on body weight (BW) of the patients (10 mg/kg (>= 50 kg BW) and 13 mg/kg (< 50 kg BW)) until Week 49.

Secondary

Time to First Flare

Time to first flare, with flare defined as one new 'A' score or two or more 'B' score using BILAG -2004

PD analysis set. Number analyzed is the number of patients with data available at the specified time point.

Posted

Mean

Standard Deviation

days

Up to 69 weeks

ID	Title	Description
OG000	Cohort 1 VAY736	Blinded treatment phase: VAY736 administered subcutaneously (s.c.) every 4 weeks as multiple doses of VAY736 150 mg (total dose being VAY736 300 mg) until Week 25 + Standard of Care (SoC) for systemic lupus erythematosus (SLE). Open-label treatment phase: VAY736 administered subcutaneously (s.c.) every 4 weeks as multiple doses of VAY736 150 mg (total dose being VAY736 300 mg) until Week 49.
OG001	Cohort 1 VAY736 Placebo	Blinded treatment phase: VAY736 matching placebo administered subcutaneously (s.c.) every 4 weeks as multiple doses of placebo 0 mg until Week 25 + Standard of Care (SoC) for systemic lupus erythematosus (SLE). Open-label treatment phase: VAY736 administered subcutaneously (s.c.) every 4 weeks as multiple doses of VAY736 150 mg (total dose being VAY736 300 mg) until Week 49.
OG002	Cohort 2 CFZ533	Blinded treatment phase: CFZ533 administered intravenously (i.v) every 4 weeks as multiple doses of CFZ533 150 mg, based on body weight (BW) of the patients (10 mg/kg (>= 50 kg BW) and 13 mg/kg (< 50 kg BW)) until Week 25 + Standard of Care (SoC) for systemic lupus erythematosus (SLE). Open-label phase: CFZ533 administered intravenously (i.v) every 4 weeks as multiple doses of CFZ533 150 mg, based on body weight (BW) of the patients (10 mg/kg (>= 50 kg BW) and 13 mg/kg (< 50 kg BW)) until Week 49.

Secondary

Pharmacokinetics (PK) Cohort 1 - VAY736 Free Serum Concentration

Note: End of study (EoS) was a floating timepoint and did not represent a uniform timepoint across the study.

PK analysis set. Number analyzed is the number of patients with data available at the specified time point.

Posted

Mean

Standard Deviation

μg/mL

Weeks 29, 53, 69, and EoS (up to 69 weeks), pre-dose

ID	Title	Description
OG000	Cohort 1 VAY736	Blinded treatment phase: VAY736 administered subcutaneously (s.c.) every 4 weeks as multiple doses of VAY736 150 mg (total dose being VAY736 300 mg) until Week 25 + Standard of Care (SoC) for systemic lupus erythematosus (SLE). Open-label treatment phase: VAY736 administered subcutaneously (s.c.) every 4 weeks as multiple doses of VAY736 150 mg (total dose being VAY736 300 mg) until Week 49.
OG001	Cohort 1 VAY736 Placebo	Blinded treatment phase: VAY736 matching placebo administered subcutaneously (s.c.) every 4 weeks as multiple doses of placebo 0 mg until Week 25 + Standard of Care (SoC) for systemic lupus erythematosus (SLE). Open-label treatment phase: VAY736 administered subcutaneously (s.c.) every 4 weeks as multiple doses of VAY736 150 mg (total dose being VAY736 300 mg) until Week 49.

Secondary

PK Cohort 2 - Free CFZ533 Concentration in Plasma

PK analysis set. Number analyzed is the number of patients with data available at the specified time point.

Posted

Mean

Standard Deviation

μg/mL

Weeks 29, 53, and 69, pre-dose

ID	Title	Description
OG000	Cohort 2 CFZ533	Blinded treatment phase: CFZ533 administered intravenously (i.v) every 4 weeks as multiple doses of CFZ533 150 mg, based on body weight (BW) of the patients (10 mg/kg (>= 50 kg BW) and 13 mg/kg (< 50 kg BW)) until Week 25 + Standard of Care (SoC) for systemic lupus erythematosus (SLE). Open-label phase: CFZ533 administered intravenously (i.v) every 4 weeks as multiple doses of CFZ533 150 mg, based on body weight (BW) of the patients (10 mg/kg (>= 50 kg BW) and 13 mg/kg (< 50 kg BW)) until Week 49.
OG001	Cohort 2 CFZ533 Placebo	Blinded treatment phase: CFZ533 matching placebo administered intravenously (i.v) every 4 weeks as multiple doses of placebo 0 mg, based on body weight (BW) of the patients (10 mg/kg (>= 50 kg BW) and 13 mg/kg (< 50 kg BW)) until Week 25 + Standard of Care (SoC) for systemic lupus erythematosus (SLE). Open-label phase: CFZ533 administered intravenously (i.v) every 4 weeks as multiple doses of CFZ533 150 mg, based on body weight (BW) of the patients (10 mg/kg (>= 50 kg BW) and 13 mg/kg (< 50 kg BW)) until Week 49.

Secondary

PD Cohort 2 (CFZ533): Total Soluble CD40

PD analysis set

Posted

Mean

Standard Deviation

ng/mL

Weeks 29, 53, and 69

ID	Title	Description
OG000	Cohort 2 CFZ533	Blinded treatment phase: CFZ533 administered intravenously (i.v) every 4 weeks as multiple doses of CFZ533 150 mg, based on body weight (BW) of the patients (10 mg/kg (>= 50 kg BW) and 13 mg/kg (< 50 kg BW)) until Week 25 + Standard of Care (SoC) for systemic lupus erythematosus (SLE). Open-label phase: CFZ533 administered intravenously (i.v) every 4 weeks as multiple doses of CFZ533 150 mg, based on body weight (BW) of the patients (10 mg/kg (>= 50 kg BW) and 13 mg/kg (< 50 kg BW)) until Week 49.
OG001	Cohort 2 CFZ533 Placebo	Blinded treatment phase: CFZ533 matching placebo administered intravenously (i.v) every 4 weeks as multiple doses of placebo 0 mg, based on body weight (BW) of the patients (10 mg/kg (>= 50 kg BW) and 13 mg/kg (< 50 kg BW)) until Week 25 + Standard of Care (SoC) for systemic lupus erythematosus (SLE). Open-label phase: CFZ533 administered intravenously (i.v) every 4 weeks as multiple doses of CFZ533 150 mg, based on body weight (BW) of the patients (10 mg/kg (>= 50 kg BW) and 13 mg/kg (< 50 kg BW)) until Week 49.

Units	Counts

Secondary

Percentage of Participants With Anti-drug Antibodies (ADAs)

ADAs were measured in plasma for CFZ533 and in serum for VAY736. Note: End of study (EoS) was a floating timepoint and did not represent a uniform timepoint across the study.

Safety set. Number analyzed is the number of patients with data available at the specified time point.

Posted

Number

percentage of participants

Baseline, Weeks 29, 53, 69, and EoS (up to 69 weeks)

ID	Title	Description
OG000	Cohort 1 VAY736	Blinded treatment phase: VAY736 administered subcutaneously (s.c.) every 4 weeks as multiple doses of VAY736 150 mg (total dose being VAY736 300 mg) until Week 25 + Standard of Care (SoC) for systemic lupus erythematosus (SLE). Open-label treatment phase: VAY736 administered subcutaneously (s.c.) every 4 weeks as multiple doses of VAY736 150 mg (total dose being VAY736 300 mg) until Week 49.
OG001	Cohort 1 VAY736 Placebo	Blinded treatment phase: VAY736 matching placebo administered subcutaneously (s.c.) every 4 weeks as multiple doses of placebo 0 mg until Week 25 + Standard of Care (SoC) for systemic lupus erythematosus (SLE). Open-label treatment phase: VAY736 administered subcutaneously (s.c.) every 4 weeks as multiple doses of VAY736 150 mg (total dose being VAY736 300 mg) until Week 49.
OG002	Cohort 2 CFZ533

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	VAY736	Blinded treatment phase: VAY736 administered subcutaneously (s.c.) every 4 weeks as multiple doses of VAY736 150 mg (total dose being VAY736 300 mg) until Week 25 + Standard of Care (SoC) for systemic lupus erythematosus (SLE).	34	1	34	21	34
EG001	VAY736 Placebo	Blinded treatment phase: VAY736 matching placebo administered subcutaneously (s.c.) every 4 weeks as multiple doses of placebo 0 mg until Week 25 + Standard of Care (SoC) for systemic lupus erythematosus (SLE).	33	4	33	21	33
EG002	CFZ533	Blinded treatment phase: CFZ533 administered intravenously (i.v) every 4 weeks as multiple doses of CFZ533 150 mg, based on body weight (BW) of the patients (10 mg/kg (>= 50 kg BW) and 13 mg/kg (< 50 kg BW)) until Week 25 + Standard of Care (SoC) for systemic lupus erythematosus (SLE).	20	0	20	9	20
EG003	CFZ533 Placebo	Blinded treatment phase: CFZ533 matching placebo administered intravenously (i.v) every 4 weeks as multiple doses of placebo 0 mg, based on body weight (BW) of the patients (10 mg/kg (>= 50 kg BW) and 13 mg/kg (< 50 kg BW)) until Week 25 + Standard of Care (SoC) for systemic lupus erythematosus (SLE).	20	1	20	11	20
EG004	Total (Double-blind)	Total (Double-blind)	107	6	107	62	107
EG005	VAY736/VAY736	Open-label treatment phase: VAY736 administered subcutaneously (s.c.) every 4 weeks as multiple doses of VAY736 150 mg (total dose being VAY736 300 mg) until Week 49.	33	3	33	15	33
EG006	VAY736 Placebo/VAY736	Open-label treatment phase: VAY736 administered subcutaneously (s.c.) every 4 weeks as multiple doses of VAY736 150 mg (total dose being VAY736 300 mg) until Week 49.	32	1	32	21	32
EG007	CFZ533/CFZ533	Open-label phase: CFZ533 administered intravenously (i.v) every 4 weeks as multiple doses of CFZ533 150 mg, based on body weight (BW) of the patients (10 mg/kg (>= 50 kg BW) and 13 mg/kg (< 50 kg BW)) until Week 49.	20	0	20	7	20
EG008	CFZ533 Placebo/CFZ533	Open-label phase: CFZ533 administered intravenously (i.v) every 4 weeks as multiple doses of CFZ533 150 mg, based on body weight (BW) of the patients (10 mg/kg (>= 50 kg BW) and 13 mg/kg (< 50 kg BW)) until Week 49.	16	2	16	14	16
EG009	Total (Open-label)	Total (Open-label)	101	6	101	57	101
EG010	VAY736/VAY736 (Post-treatment Follow-up)	Post-treatment follow-up	32	1	32	4	32
EG011	VAY736 Placebo/VAY736 (Post-treatment Follow-up)	Post-treatment follow-up	30	1	30	6	30
EG012	CFZ533/CFZ533 (Post-treatment Follow-up)	Post-treatment follow-up	20	0	20	2	20
EG013	CFZ533 Placebo/CFZ533 (Post-treatment Follow-up)	Post-treatment follow-up	16	2	16	5	16
EG014	Total (Post-treatment Follow-up)	Total (post-treatment follow-up)	98	4	98	17	98
EG015	VAY736/VAY736 (Secondary Post-treatment Follow-up)	Secondary post-treatment follow-up	29	1	29	8	29
EG016	VAY736 Placebo/VAY736 (Secondary Post-treatment Follow-up)	Secondary post-treatment follow-up	25	1	25	5	25
EG017	Total (Secondary Post-treatment Follow-up)	Total (secondary post-treatment follow-up)	54	2	54	13	54

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Acute myocardial infarction	Cardiac disorders	MedDRA (28.0)	Systematic Assessment	EG0000 affected34 at risk EG0010 affected33 at risk EG0020 affected20 at risk EG0030 affected20 at risk EG0040 affected107 at risk EG0051 affected33 at risk EG0060 affected32 at risk EG0070 affected20 at risk EG0080 affected16 at risk EG0091 affected101 at risk EG0100 affected32 at risk EG0110 affected30 at risk EG0120 affected20 at risk EG0130 affected16 at risk EG0140 affected98 at risk EG0150 affected29 at risk EG0160 affected25 at risk EG0170 affected54 at risk
Vertigo positional	Ear and labyrinth disorders	MedDRA (28.0)	Systematic Assessment	EG0000 affected34 at risk EG0010 affected33 at risk EG0020 affected20 at risk EG003
Pancreatitis	Gastrointestinal disorders	MedDRA (28.0)	Systematic Assessment	EG0000 affected34 at risk EG0010 affected33 at risk EG0020 affected20 at risk EG003
Cytomegalovirus viraemia	Infections and infestations	MedDRA (28.0)	Systematic Assessment	EG0000 affected34 at risk EG0010 affected33 at risk EG0020 affected20 at risk EG003
Herpes zoster	Infections and infestations	MedDRA (28.0)	Systematic Assessment	EG0000 affected34 at risk EG0011 affected33 at risk EG0020 affected20 at risk EG003
Pneumocystis jirovecii pneumonia	Infections and infestations	MedDRA (28.0)	Systematic Assessment	EG0000 affected34 at risk EG0010 affected33 at risk EG0020 affected20 at risk EG003
Pneumonia	Infections and infestations	MedDRA (28.0)	Systematic Assessment	EG0000 affected34 at risk EG0010 affected33 at risk EG0020 affected20 at risk EG003
Pneumonia bacterial	Infections and infestations	MedDRA (28.0)	Systematic Assessment	EG0000 affected34 at risk EG0010 affected33 at risk EG0020 affected20 at risk EG003
Pneumonia cytomegaloviral	Infections and infestations	MedDRA (28.0)	Systematic Assessment	EG0000 affected34 at risk EG0010 affected33 at risk EG0020 affected20 at risk EG003
Pyelonephritis	Infections and infestations	MedDRA (28.0)	Systematic Assessment	EG0000 affected34 at risk EG0011 affected33 at risk EG0020 affected20 at risk EG003
Salmonella bacteraemia	Infections and infestations	MedDRA (28.0)	Systematic Assessment	EG0000 affected34 at risk EG0011 affected33 at risk EG0020 affected20 at risk EG003
Compression fracture	Injury, poisoning and procedural complications	MedDRA (28.0)	Systematic Assessment	EG0000 affected34 at risk EG0010 affected33 at risk EG0020 affected20 at risk EG003
Head injury	Injury, poisoning and procedural complications	MedDRA (28.0)	Systematic Assessment	EG0000 affected34 at risk EG0010 affected33 at risk EG0020 affected20 at risk EG003
Jaw fracture	Injury, poisoning and procedural complications	MedDRA (28.0)	Systematic Assessment	EG0000 affected34 at risk EG0010 affected33 at risk EG0020 affected20 at risk EG003
Meniscus injury	Injury, poisoning and procedural complications	MedDRA (28.0)	Systematic Assessment	EG0000 affected34 at risk EG0010 affected33 at risk EG0020 affected20 at risk EG003
Spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA (28.0)	Systematic Assessment	EG0000 affected34 at risk EG0010 affected33 at risk EG0020 affected20 at risk EG003
Carcinoid tumour of the stomach	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (28.0)	Systematic Assessment	EG0000 affected34 at risk EG0010 affected33 at risk EG0020 affected20 at risk EG003
Central nervous system vasculitis	Nervous system disorders	MedDRA (28.0)	Systematic Assessment	EG0000 affected34 at risk EG0010 affected33 at risk EG0020 affected20 at risk EG003
Syncope	Nervous system disorders	MedDRA (28.0)	Systematic Assessment	EG0000 affected34 at risk EG0010 affected33 at risk EG0020 affected20 at risk EG003
Renal impairment	Renal and urinary disorders	MedDRA (28.0)	Systematic Assessment	EG0001 affected34 at risk EG0010 affected33 at risk EG0020 affected20 at risk EG003
Ovarian cyst	Reproductive system and breast disorders	MedDRA (28.0)	Systematic Assessment	EG0000 affected34 at risk EG0011 affected33 at risk EG0020 affected20 at risk EG003
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (28.0)	Systematic Assessment	EG0000 affected34 at risk EG0010 affected33 at risk EG0020 affected20 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA (28.0)	Systematic Assessment	EG0000 affected34 at risk EG0011 affected33 at risk EG0020 affected20 at risk EG0030 affected20 at risk EG0041 affected107 at risk EG0050 affected33 at risk EG0060 affected32 at risk EG0070 affected20 at risk EG0080 affected16 at risk EG0090 affected101 at risk EG0100 affected32 at risk EG0110 affected30 at risk EG0120 affected20 at risk EG0131 affected16 at risk EG0141 affected98 at risk EG0150 affected29 at risk EG0161 affected25 at risk EG0171 affected54 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA (28.0)	Systematic Assessment	EG0000 affected34 at risk EG0010 affected33 at risk EG0020 affected20 at risk EG003
Neutropenia	Blood and lymphatic system disorders	MedDRA (28.0)	Systematic Assessment	EG0000 affected34 at risk EG0012 affected33 at risk EG0020 affected20 at risk EG003
Vertigo	Ear and labyrinth disorders	MedDRA (28.0)	Systematic Assessment	EG0001 affected34 at risk EG0010 affected33 at risk EG0020 affected20 at risk EG003
Cataract	Eye disorders	MedDRA (28.0)	Systematic Assessment	EG0001 affected34 at risk EG0010 affected33 at risk EG0020 affected20 at risk EG003
Dry eye	Eye disorders	MedDRA (28.0)	Systematic Assessment	EG0000 affected34 at risk EG0010 affected33 at risk EG0020 affected20 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA (28.0)	Systematic Assessment	EG0000 affected34 at risk EG0010 affected33 at risk EG0020 affected20 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA (28.0)	Systematic Assessment	EG0000 affected34 at risk EG0012 affected33 at risk EG0021 affected20 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA (28.0)	Systematic Assessment	EG0000 affected34 at risk EG0010 affected33 at risk EG0020 affected20 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA (28.0)	Systematic Assessment	EG0000 affected34 at risk EG0010 affected33 at risk EG0020 affected20 at risk EG003
Injection site reaction	General disorders	MedDRA (28.0)	Systematic Assessment	EG0009 affected34 at risk EG0011 affected33 at risk EG0020 affected20 at risk EG003
Pyrexia	General disorders	MedDRA (28.0)	Systematic Assessment	EG0002 affected34 at risk EG0010 affected33 at risk EG0022 affected20 at risk EG003
Bacteraemia	Infections and infestations	MedDRA (28.0)	Systematic Assessment	EG0000 affected34 at risk EG0010 affected33 at risk EG0020 affected20 at risk EG003
Bronchitis	Infections and infestations	MedDRA (28.0)	Systematic Assessment	EG0001 affected34 at risk EG0012 affected33 at risk EG0020 affected20 at risk EG003
COVID-19	Infections and infestations	MedDRA (28.0)	Systematic Assessment	EG0001 affected34 at risk EG0011 affected33 at risk EG0020 affected20 at risk EG003
Cellulitis	Infections and infestations	MedDRA (28.0)	Systematic Assessment	EG0000 affected34 at risk EG0011 affected33 at risk EG0020 affected20 at risk EG003
Cystitis	Infections and infestations	MedDRA (28.0)	Systematic Assessment	EG0000 affected34 at risk EG0011 affected33 at risk EG0020 affected20 at risk EG003
Cytomegalovirus viraemia	Infections and infestations	MedDRA (28.0)	Systematic Assessment	EG0000 affected34 at risk EG0010 affected33 at risk EG0020 affected20 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA (28.0)	Systematic Assessment	EG0001 affected34 at risk EG0011 affected33 at risk EG0020 affected20 at risk EG003
Herpes zoster	Infections and infestations	MedDRA (28.0)	Systematic Assessment	EG0001 affected34 at risk EG0011 affected33 at risk EG0020 affected20 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA (28.0)	Systematic Assessment	EG0007 affected34 at risk EG0017 affected33 at risk EG0023 affected20 at risk EG003
Oral candidiasis	Infections and infestations	MedDRA (28.0)	Systematic Assessment	EG0000 affected34 at risk EG0010 affected33 at risk EG0020 affected20 at risk EG003
Oral fungal infection	Infections and infestations	MedDRA (28.0)	Systematic Assessment	EG0000 affected34 at risk EG0010 affected33 at risk EG0020 affected20 at risk EG003
Oral herpes	Infections and infestations	MedDRA (28.0)	Systematic Assessment	EG0000 affected34 at risk EG0010 affected33 at risk EG0021 affected20 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA (28.0)	Systematic Assessment	EG0003 affected34 at risk EG0011 affected33 at risk EG0021 affected20 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA (28.0)	Systematic Assessment	EG0001 affected34 at risk EG0012 affected33 at risk EG0021 affected20 at risk EG003
Injection related reaction	Injury, poisoning and procedural complications	MedDRA (28.0)	Systematic Assessment	EG0002 affected34 at risk EG0011 affected33 at risk EG0020 affected20 at risk EG003
Procedural pain	Injury, poisoning and procedural complications	MedDRA (28.0)	Systematic Assessment	EG0000 affected34 at risk EG0010 affected33 at risk EG0020 affected20 at risk EG003
Blood immunoglobulin M decreased	Investigations	MedDRA (28.0)	Systematic Assessment	EG0000 affected34 at risk EG0010 affected33 at risk EG0020 affected20 at risk EG003
Cytomegalovirus test positive	Investigations	MedDRA (28.0)	Systematic Assessment	EG0000 affected34 at risk EG0010 affected33 at risk EG0020 affected20 at risk EG003
Dyslipidaemia	Metabolism and nutrition disorders	MedDRA (28.0)	Systematic Assessment	EG0000 affected34 at risk EG0010 affected33 at risk EG0020 affected20 at risk EG003
Hypertriglyceridaemia	Metabolism and nutrition disorders	MedDRA (28.0)	Systematic Assessment	EG0001 affected34 at risk EG0012 affected33 at risk EG0020 affected20 at risk EG003
Hyperuricaemia	Metabolism and nutrition disorders	MedDRA (28.0)	Systematic Assessment	EG0001 affected34 at risk EG0010 affected33 at risk EG0020 affected20 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (28.0)	Systematic Assessment	EG0001 affected34 at risk EG0010 affected33 at risk EG0020 affected20 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (28.0)	Systematic Assessment	EG0001 affected34 at risk EG0011 affected33 at risk EG0020 affected20 at risk EG003
Dizziness	Nervous system disorders	MedDRA (28.0)	Systematic Assessment	EG0001 affected34 at risk EG0011 affected33 at risk EG0021 affected20 at risk EG003
Headache	Nervous system disorders	MedDRA (28.0)	Systematic Assessment	EG0003 affected34 at risk EG0011 affected33 at risk EG0025 affected20 at risk EG003
Insomnia	Psychiatric disorders	MedDRA (28.0)	Systematic Assessment	EG0001 affected34 at risk EG0010 affected33 at risk EG0020 affected20 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (28.0)	Systematic Assessment	EG0000 affected34 at risk EG0011 affected33 at risk EG0020 affected20 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA (28.0)	Systematic Assessment	EG0000 affected34 at risk EG0010 affected33 at risk EG0020 affected20 at risk EG003
Acne	Skin and subcutaneous tissue disorders	MedDRA (28.0)	Systematic Assessment	EG0000 affected34 at risk EG0010 affected33 at risk EG0020 affected20 at risk EG003
Dermatitis allergic	Skin and subcutaneous tissue disorders	MedDRA (28.0)	Systematic Assessment	EG0000 affected34 at risk EG0010 affected33 at risk EG0020 affected20 at risk EG003
Dermatitis contact	Skin and subcutaneous tissue disorders	MedDRA (28.0)	Systematic Assessment	EG0000 affected34 at risk EG0010 affected33 at risk EG0020 affected20 at risk EG003
Eczema	Skin and subcutaneous tissue disorders	MedDRA (28.0)	Systematic Assessment	EG0000 affected34 at risk EG0011 affected33 at risk EG0020 affected20 at risk EG003
Leukoplakia	Skin and subcutaneous tissue disorders	MedDRA (28.0)	Systematic Assessment	EG0000 affected34 at risk EG0010 affected33 at risk EG0020 affected20 at risk EG003
Hypertension	Vascular disorders	MedDRA (28.0)	Systematic Assessment	EG0002 affected34 at risk EG0010 affected33 at risk EG0020 affected20 at risk EG003

ID	Term
D008180	Lupus Erythematosus, Systemic

ID	Term
C000656267	ianalumab
C000626035	iscalimab

Units	Counts
Participants	OG00020 OG00111

EG0040 affected107 at risk

EG0051 affected33 at risk

EG0060 affected32 at risk

EG0070 affected20 at risk

EG0080 affected16 at risk

EG0091 affected101 at risk

EG0100 affected32 at risk

EG0110 affected30 at risk

EG0120 affected20 at risk

EG0130 affected16 at risk

EG0140 affected98 at risk

EG0150 affected29 at risk

EG0160 affected25 at risk

EG0170 affected54 at risk

EG0040 affected107 at risk

EG0050 affected33 at risk

EG0060 affected32 at risk

EG0070 affected20 at risk

EG0080 affected16 at risk

EG0090 affected101 at risk

EG0100 affected32 at risk

EG0110 affected30 at risk

EG0120 affected20 at risk

EG0130 affected16 at risk

EG0140 affected98 at risk

EG0151 affected29 at risk

EG0160 affected25 at risk

EG0171 affected54 at risk

EG0040 affected107 at risk

EG0050 affected33 at risk

EG0060 affected32 at risk

EG0070 affected20 at risk

EG0080 affected16 at risk

EG0090 affected101 at risk

EG0100 affected32 at risk

EG0110 affected30 at risk

EG0120 affected20 at risk

EG0131 affected16 at risk

EG0141 affected98 at risk

EG0150 affected29 at risk

EG0160 affected25 at risk

EG0170 affected54 at risk

EG0041 affected107 at risk

EG0050 affected33 at risk

EG0060 affected32 at risk

EG0070 affected20 at risk

EG0080 affected16 at risk

EG0090 affected101 at risk

EG0100 affected32 at risk

EG0110 affected30 at risk

EG0120 affected20 at risk

EG0130 affected16 at risk

EG0140 affected98 at risk

EG0150 affected29 at risk

EG0160 affected25 at risk

EG0170 affected54 at risk

EG0040 affected107 at risk

EG0050 affected33 at risk

EG0060 affected32 at risk

EG0070 affected20 at risk

EG0080 affected16 at risk

EG0090 affected101 at risk

EG0100 affected32 at risk

EG0110 affected30 at risk

EG0120 affected20 at risk

EG0131 affected16 at risk

EG0141 affected98 at risk

EG0150 affected29 at risk

EG0160 affected25 at risk

EG0170 affected54 at risk

EG0040 affected107 at risk

EG0050 affected33 at risk

EG0060 affected32 at risk

EG0070 affected20 at risk

EG0080 affected16 at risk

EG0090 affected101 at risk

EG0100 affected32 at risk

EG0110 affected30 at risk

EG0120 affected20 at risk

EG0131 affected16 at risk

EG0141 affected98 at risk

EG0150 affected29 at risk

EG0160 affected25 at risk

EG0170 affected54 at risk

EG0040 affected107 at risk

EG0050 affected33 at risk

EG0060 affected32 at risk

EG0070 affected20 at risk

EG0081 affected16 at risk

EG0091 affected101 at risk

EG0100 affected32 at risk

EG0110 affected30 at risk

EG0120 affected20 at risk

EG0130 affected16 at risk

EG0140 affected98 at risk

EG0150 affected29 at risk

EG0160 affected25 at risk

EG0170 affected54 at risk

EG0040 affected107 at risk

EG0050 affected33 at risk

EG0060 affected32 at risk

EG0070 affected20 at risk

EG0080 affected16 at risk

EG0090 affected101 at risk

EG0100 affected32 at risk

EG0110 affected30 at risk

EG0120 affected20 at risk

EG0131 affected16 at risk

EG0141 affected98 at risk

EG0150 affected29 at risk

EG0160 affected25 at risk

EG0170 affected54 at risk

EG0041 affected107 at risk

EG0050 affected33 at risk

EG0060 affected32 at risk

EG0070 affected20 at risk

EG0080 affected16 at risk

EG0090 affected101 at risk

EG0100 affected32 at risk

EG0110 affected30 at risk

EG0120 affected20 at risk

EG0130 affected16 at risk

EG0140 affected98 at risk

EG0150 affected29 at risk

EG0160 affected25 at risk

EG0170 affected54 at risk

EG0041 affected107 at risk

EG0050 affected33 at risk

EG0060 affected32 at risk

EG0070 affected20 at risk

EG0080 affected16 at risk

EG0090 affected101 at risk

EG0100 affected32 at risk

EG0110 affected30 at risk

EG0120 affected20 at risk

EG0130 affected16 at risk

EG0140 affected98 at risk

EG0150 affected29 at risk

EG0160 affected25 at risk

EG0170 affected54 at risk

EG0040 affected107 at risk

EG0051 affected33 at risk

EG0060 affected32 at risk

EG0070 affected20 at risk

EG0080 affected16 at risk

EG0091 affected101 at risk

EG0100 affected32 at risk

EG0110 affected30 at risk

ID	Term
D003240	Connective Tissue Diseases
D017437	Skin and Connective Tissue Diseases
D001327	Autoimmune Diseases
D007154	Immune System Diseases