NCT02070978

Long-term Safety and Tolerability of Atacicept (Long-term Follow-Up of Participant Who Participated in ADDRESS II)

Terminated Phase 2 Results posted Last updated 21 March 2019

What this trial tests

Phase 2 trial testing Atacicept 75 mg in Lupus Erythematosus, Systemic in 253 participants. Terminated before completion.

Timeline

29 July 2014

Primary endpoint
5 April 2016

9 February 2018

Quick facts

Lead sponsor	EMD Serono
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	253
Start date	29 July 2014
Primary completion	5 April 2016
Estimated completion	9 February 2018
Sites	84 locations across Italy, South Africa, Russia, Peru, Chile, United Kingdom, Germany, Poland

Drugs / interventions tested

• Atacicept 75 mg — full drug profile →
• Atacicept 150 mg — full drug profile →
• Atacicept 150 mg — full drug profile →

Conditions studied

• Lupus Erythematosus, Systemic — all drugs for Lupus Erythematosus, Systemic →

Sponsor

EMD Serono — full company profile →

Who can join

18 and older, any sex, with Lupus Erythematosus, Systemic. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

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

Number of Participants With at Least One Serious Adverse Event (SAE) During the Treatment Period Primary · Baseline (LTE Day 1) up to maximum treatment duration of 143.7 weeks

An Adverse event (AE) was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease associated with the use of study drug, whether or not considered related to the study drug or worsening of pre-existing medical condition, whether or not related to study drug. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important

Group	Value	95% CI
Placebo/Atacicept 150 mg	13
Atacicept 75 mg	10
Atacicept 150 mg	9

Number of Participants Who Prematurely Discontinued the Treatment Due to Adverse Event (AE) Primary · Baseline (Day 1 of Core study) up to maximum duration of 167.7 weeks

An Adverse event (AE) was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease associated with the use of study drug, whether or not considered related to the study drug or worsening of pre-existing medical condition, whether or not related to study drug. TEAEs were defined as events with an onset date on or after the date of first dose of study treatment in the core study and ongoing at the 024 LTE study entry, occurring during the 024 LTE study and the Safety follow-up Period.

Group	Value	95% CI
Placebo/Atacicept 150 mg	9
Atacicept 75 mg	4
Atacicept 150 mg	5

Change From Baseline in Systemic Lupus International Collaborating Clinics/American College of Rheumatology (SLICC/ACR) Damage Index Organ Damage Scores Secondary · Baseline: Day 1 (Core Study), Day 1 (LTE Study), Week 24, Week 48, Week 72 and Week 96

SLICC/ACR score or damage index evaluates cumulative damage in Systemic Lupus Erythematosus (SLE). These changes may or may not be related to SLE. Most items are scored only if they have been present for at least 6 months. Scores range from 0 to 47 points, with higher scores indicating greater cumulative damage. Baseline was defined as Day 1 of Core study.

Baseline; Day 1 (Core Study)

Group	Value	95% CI
Placebo/Atacicept 150 mg	1	± 1.0
Atacicept 75 mg	1	± 1.2
Atacicept 150 mg	0	± 0.8

Change at LTE Day 1

Group	Value	95% CI
Placebo/Atacicept 150 mg	0	± 0.0
Atacicept 75 mg	0	± 0.1
Atacicept 150 mg	0	± 0.0

Change at LTE Week 24

Group	Value	95% CI
Placebo/Atacicept 150 mg	0	± 0.1
Atacicept 75 mg	0	± 0.1
Atacicept 150 mg	0	± 0.2

Change at LTE Week 48

Group	Value	95% CI
Placebo/Atacicept 150 mg	0	± 0.2
Atacicept 75 mg	0	± 0.2
Atacicept 150 mg	0	± 0.3

Change at LTE Week 72

Group	Value	95% CI
Placebo/Atacicept 150 mg	0	± 0.3
Atacicept 75 mg	0	± 0.3
Atacicept 150 mg	0	± 0.2

Change at LTE Week 96

Group	Value	95% CI
Placebo/Atacicept 150 mg	0	± 0.3
Atacicept 75 mg	0	± 0.3
Atacicept 150 mg	0	± 0.0

Change From Baseline in Disease Activity as Measured by British Isles Lupus Assessment Group (BILAG) 2004 Score Secondary · Baseline: Core study Screening, LTE Day 1, Week 24, Week 48, Week 72 and Week 96

BILAG Disease Activity Index evaluates systemic lupus erythematosus (SLE) activity in 8 organ system domains: General, mucocutaneous, neurological, musculoskeletal, cardiorespiratory, vasculitis, renal, and hematologic using a separate alphabetic score (A to E) assigned to each organ system defined as follows. BILAG A: Severe disease activity; BILAG B: moderate disease activity; BILAG C: mild disease; BILAG D: system previously affected but now inactive; BILAG E: system never involved. BILAG evaluated by scoring each of a list of signs and symptoms as: improving (1); same (2); worse (3); new (

Baseline: Core study Screening

Group	Value	95% CI
Placebo/Atacicept 150 mg	15	± 7.1
Atacicept 75 mg	14	± 7.2
Atacicept 150 mg	16	± 6.1

Change at LTE Day 1

Group	Value	95% CI
Placebo/Atacicept 150 mg	-8	± 6.9
Atacicept 75 mg	-9	± 7.2
Atacicept 150 mg	-10	± 6.8

Change at LTE Week 24

Group	Value	95% CI
Placebo/Atacicept 150 mg	-8	± 8.3
Atacicept 75 mg	-10	± 7.5
Atacicept 150 mg	-12	± 7.2

Change at LTE Week 48

Group	Value	95% CI
Placebo/Atacicept 150 mg	-9	± 7.7
Atacicept 75 mg	-8	± 7.5
Atacicept 150 mg	-11	± 7.4

Change at LTE Week 72

Group	Value	95% CI
Placebo/Atacicept 150 mg	-9	± 7.9
Atacicept 75 mg	-10	± 6.2
Atacicept 150 mg	-11	± 8.2

Change at LTE Week 96

Group	Value	95% CI
Placebo/Atacicept 150 mg	-14	± 12.9
Atacicept 75 mg	-8	± 6.3
Atacicept 150 mg	-12	± 6.8

Change From Baseline in Disease Activity as Measured by Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) Score Secondary · Baseline: Screening Visit (Core Study); LTE Day 1, Week 24, Week 48, Week 72 and Week 96

SLEDAI-2K is an activity index that measures disease activity and records feature of active lupus as present or not present. SLEDAI-2K uses a weighted checklist to assign a numerical score based on the presence or absence of 24 symptoms. Each symptom present is assigned between 1 and 8 points based on its usual clinical importance, yielding a total score that ranges from 0 points (no symptoms) to 105 points (presence of all defined symptoms). Baseline was defined as core study screening visit.

Baseline: Screening Visit (Core Study)

Group	Value	95% CI
Placebo/Atacicept 150 mg	10	± 2.9
Atacicept 75 mg	10	± 3.4
Atacicept 150 mg	10	± 3.0

Change at LTE Day 1

Group	Value	95% CI
Placebo/Atacicept 150 mg	-4	± 4.1
Atacicept 75 mg	-5	± 4.5
Atacicept 150 mg	-5	± 3.9

Change at LTE Week 24

Group	Value	95% CI
Placebo/Atacicept 150 mg	-5	± 4.3
Atacicept 75 mg	-6	± 4.1
Atacicept 150 mg	-6	± 3.9

Change at LTE Week 48

Group	Value	95% CI
Placebo/Atacicept 150 mg	-6	± 3.4
Atacicept 75 mg	-6	± 4.6
Atacicept 150 mg	-7	± 4.3

Change at LTE Week 72

Group	Value	95% CI
Placebo/Atacicept 150 mg	-5	± 3.8
Atacicept 75 mg	-6	± 3.7
Atacicept 150 mg	-7	± 3.9

Change at LTE Week 96

Group	Value	95% CI
Placebo/Atacicept 150 mg	-7	± 5.0
Atacicept 75 mg	-6	± 4.9
Atacicept 150 mg	-8	± 2.7

Change From Baseline in Disease Activity as Measured by Physician's Global Assessment (PGA) Score Secondary · Baseline: Screening Visit (Core Study); LTE Day1, Week 24, Week 48, Week 72 and Week 96

The PGA was used to quantify disease activity and was measured using an anchored visual analog scale (VAS). The participant's current disease activity assessed by investigator in the score range of 0 to 3. Where 0=none; 1=mild; 2=moderate; 3=severe. The assessment made relative not to the participant's most severe state, but the most severe state of systemic lupus erythematosus (SLE) per the investigator's assessment. Baseline was defined as core study screening visit.

Baseline: Screening Visit (Core Study)

Group	Value	95% CI
Placebo/Atacicept 150 mg	1.56	± 0.424
Atacicept 75 mg	1.46	± 0.509
Atacicept 150 mg	1.47	± 0.460

Change at LTE Day 1

Group	Value	95% CI
Placebo/Atacicept 150 mg	-0.76	± 0.559
Atacicept 75 mg	-0.77	± 0.559
Atacicept 150 mg	-0.77	± 0.614

Change at LTE Week 24

Group	Value	95% CI
Placebo/Atacicept 150 mg	-0.91	± 0.620
Atacicept 75 mg	-0.85	± 0.555
Atacicept 150 mg	-0.94	± 0.547

Change at LTE Week 48

Group	Value	95% CI
Placebo/Atacicept 150 mg	-1.01	± 0.647
Atacicept 75 mg	-0.86	± 0.522
Atacicept 150 mg	-0.99	± 0.557

Change at LTE Week 72

Group	Value	95% CI
Placebo/Atacicept 150 mg	-0.90	± 0.758
Atacicept 75 mg	-0.84	± 0.503
Atacicept 150 mg	-1.03	± 0.580

Change at LTE Week 96

Group	Value	95% CI
Placebo/Atacicept 150 mg	-1.17	± 0.518
Atacicept 75 mg	-0.72	± 0.579
Atacicept 150 mg	-1.21	± 0.411

Number of Participants Who Achieved SLE Responder Index (SRI-4) Response (a Disease Activity Composite Index) Secondary · Baseline: Core study Screening; LTE Day 1, Week 24, Week 48, Week 72 and Week 96

SRI-4 response was defined as greater than or equal to 4-point reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) total score, no new British Isles Lupus Assessment Group (BILAG) A and no more than 1 new BILAG B domain score and no worsening (less than 10 percent increase) from baseline Physician's Global Assessment of Disease Activity (PGA). SLEDAI-2K is an activity index that measures disease activity and records feature of active lupus as present or not present. SLEDAI-2K uses a weighted checklist to assign a numerical score based on the presence or absence of

LTE Day 1

Group	Value	95% CI
Placebo/Atacicept 150 mg	42
Atacicept 75 mg	52
Atacicept 150 mg	57

LTE Week 24

Group	Value	95% CI
Placebo/Atacicept 150 mg	43
Atacicept 75 mg	57
Atacicept 150 mg	60

LTE Week 48

Group	Value	95% CI
Placebo/Atacicept 150 mg	44
Atacicept 75 mg	46
Atacicept 150 mg	51

LTE Week 72

Group	Value	95% CI
Placebo/Atacicept 150 mg	21
Atacicept 75 mg	23
Atacicept 150 mg	23

LTE Week 96

Group	Value	95% CI
Placebo/Atacicept 150 mg	6
Atacicept 75 mg	9
Atacicept 150 mg	12

Number of Participants Who Achieved BILAG-based Combined Lupus Assessment (BICLA) Response (a Disease Activity Composite Index) Secondary · Baseline: Core study Screening; LTE Day 1, Week 24, Week 48, Week 72 and Week 96

The BICLA response was defined as BILAG-2004 improvement (all screening visit BILAG A improving to B/C/D, all screening visit BILAG B to C/D, and less than or equal to (\<=1) new BILAG B and no new BILAG A); no deterioration in SLEDAI total score; PGA increase by less than (\<) 0 percentage (%) (defined as less then (\<)0.3 point increase for the statistical analyses) and no non-permitted medication/treatment. Baseline was defined as core study screening visit.

LTE Day 1

Group	Value	95% CI
Placebo/Atacicept 150 mg	43
Atacicept 75 mg	43
Atacicept 150 mg	50

LTE Week 24

Group	Value	95% CI
Placebo/Atacicept 150 mg	40
Atacicept 75 mg	45
Atacicept 150 mg	53

LTE Week 48

Group	Value	95% CI
Placebo/Atacicept 150 mg	35
Atacicept 75 mg	34
Atacicept 150 mg	43

LTE Week 72

Group	Value	95% CI
Placebo/Atacicept 150 mg	16
Atacicept 75 mg	17
Atacicept 150 mg	21

LTE Week 96

Group	Value	95% CI
Placebo/Atacicept 150 mg	4
Atacicept 75 mg	7
Atacicept 150 mg	9

Percent Change From Baseline in Prednisone-equivalent Corticosteroid Dose Secondary · Baseline: Screening Visit (Core Study); LTE Day 1, Week 24, Week 48, Week 72 and Week 96

Percent Change at LTE Day 1

Group	Value	95% CI
Placebo/Atacicept 150 mg	-11.04	± 31.139
Atacicept 75 mg	-5.25	± 55.697
Atacicept 150 mg	-11.54	± 26.117

Percent Change at LTE Week 24

Group	Value	95% CI
Placebo/Atacicept 150 mg	-11.89	± 41.411
Atacicept 75 mg	-4.79	± 59.371
Atacicept 150 mg	-1.21	± 94.677

Percent Change at LTE Week 48

Group	Value	95% CI
Placebo/Atacicept 150 mg	-9.19	± 54.364
Atacicept 75 mg	-6.01	± 45.605
Atacicept 150 mg	-17.97	± 37.040

Percent Change at LTE Week 72

Group	Value	95% CI
Placebo/Atacicept 150 mg	-19.32	± 38.157
Atacicept 75 mg	-8.69	± 28.112
Atacicept 150 mg	-22.34	± 36.058

Percent Change at LTE Week 96

Group	Value	95% CI
Placebo/Atacicept 150 mg	-36.67	± 58.146
Atacicept 75 mg	-12.40	± 73.793
Atacicept 150 mg	-28.57	± 43.080

Change From Baseline in the Short-Form (SF-36) Health Survey Physical Component Score and Mental Component Score Secondary · Baseline (Core Study Day 1); LTE Day 1, Week 24, Week 48, Week 72 and Week 96

The 36-Item Short-Form Health Survey (SF-36) is a standardized survey evaluating 8 aspects of functional health and well-being. These eight subscales were summarized as relating to either physical health or mental health. Physical component summary (PCS) is based primarily on physical functioning, role-physical, bodily pain, and general health scales and mental component summary (MCS) encompasses vitality, social functioning, role-emotional, and mental health scales. Score from mental health, role emotional, social functioning, and vitality domains were averaged to calculate MCS. Total score r

PCS: Baseline (Core Study Day 1)

Group	Value	95% CI
Placebo/Atacicept 150 mg	37.7	± 9.20
Atacicept 75 mg	37.8	± 10.56
Atacicept 150 mg	38.8	± 9.27

PCS: Change at LTE Day 1

Group	Value	95% CI
Placebo/Atacicept 150 mg	4.8	± 10.00
Atacicept 75 mg	4.8	± 8.30
Atacicept 150 mg	4.0	± 7.46

PCS: Change at LTE Week 24

Group	Value	95% CI
Placebo/Atacicept 150 mg	5.3	± 8.62
Atacicept 75 mg	5.1	± 8.78
Atacicept 150 mg	5.9	± 7.74

PCS: Change at LTE Week 48

Group	Value	95% CI
Placebo/Atacicept 150 mg	6.4	± 9.56
Atacicept 75 mg	6.2	± 9.67
Atacicept 150 mg	4.6	± 8.23

PCS: Change at LTE Week 72

Group	Value	95% CI
Placebo/Atacicept 150 mg	5.8	± 8.61
Atacicept 75 mg	3.4	± 7.37
Atacicept 150 mg	6.7	± 5.33

PCS: Change at LTE Week 96

Group	Value	95% CI
Placebo/Atacicept 150 mg	13.0	± 9.51
Atacicept 75 mg	3.1	± 9.29
Atacicept 150 mg	8.9	± 6.08

MCS: Baseline (Core Study Day 1)

Group	Value	95% CI
Placebo/Atacicept 150 mg	41.3	± 10.70
Atacicept 75 mg	43.3	± 12.09
Atacicept 150 mg	43.2	± 10.81

MCS: Change at LTE Day 1

Group	Value	95% CI
Placebo/Atacicept 150 mg	2.1	± 11.38
Atacicept 75 mg	2.2	± 12.62
Atacicept 150 mg	1.9	± 9.30

Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score Secondary · Baseline (Core Study Day 1); LTE Day 1, Week 24, Week 48, Week 72, and Week 96

The LupusQoL was a lupus-specific health related QoL (HRQoL) questionnaire consisting of 34 items grouped in 8 domains: physical health, pain, planning, intimate relationships, burden to others, emotional health, body image, and fatigue. Participants indicate their responses on a 5-point Likert response format, where 4 = never, 3 = occasionally, 2 = a good bit of the time, 1 = most of the time, and 0 = all of the time. Summary scores can be calculated for all 8 domains. A LupusQoL score for each domain was reported on a 0 to 100 scale, with greater values indicating better HRQoL. Baseline was

Physical Health: Baseline (Core study Day 1)

Group	Value	95% CI
Placebo/Atacicept 150 mg	60.2	± 23.08
Atacicept 75 mg	62.0	± 27.17
Atacicept 150 mg	61.3	± 27.87

Physical Health: Change at LTE Day 1

Group	Value	95% CI
Placebo/Atacicept 150 mg	8.8	± 21.86
Atacicept 75 mg	7.5	± 17.37
Atacicept 150 mg	8.2	± 16.40

Physical Health: Change at LTE Week 24

Group	Value	95% CI
Placebo/Atacicept 150 mg	10.4	± 21.27
Atacicept 75 mg	10.8	± 18.86
Atacicept 150 mg	10.9	± 18.46

Physical Health: Change at LTE Week 48

Group	Value	95% CI
Placebo/Atacicept 150 mg	9.3	± 22.23
Atacicept 75 mg	11.2	± 24.80
Atacicept 150 mg	12.8	± 20.30

Physical Health: Change at LTE Week 72

Group	Value	95% CI
Placebo/Atacicept 150 mg	8.0	± 19.42
Atacicept 75 mg	5.9	± 17.61
Atacicept 150 mg	11.9	± 20.02

Physical Health: Change at LTE Week 96

Group	Value	95% CI
Placebo/Atacicept 150 mg	25.0	± 21.46
Atacicept 75 mg	12.9	± 17.97
Atacicept 150 mg	14.4	± 10.33

Pain: Baseline (Core study Day 1)

Group	Value	95% CI
Placebo/Atacicept 150 mg	58.7	± 26.77
Atacicept 75 mg	61.2	± 30.27
Atacicept 150 mg	57.7	± 31.52

Pain: Change at LTE Day 1

Group	Value	95% CI
Placebo/Atacicept 150 mg	11.8	± 24.86
Atacicept 75 mg	11.0	± 23.93
Atacicept 150 mg	13.4	± 21.78

Number of Participants With Patient Global Impression of Change (PGIC) Secondary · Baseline (Core Study Day 1); LTE Day 1, Week 24, Week 48, Week 72 and Week 96

The PGIC is self-rated scale that asks the participant to describe the change in activity limitations, symptoms, emotions, and overall Quality of life (QoL) related to the participant's painful condition on the following scale: 1 (very much improved), 2 (much improved), 3 (minimally improved), 4 (no change), 5 (minimally worse), 6 (much worse) and 7 (very much worse). Number of participants in the PGIC categories of very much improved (1) and much improved (2) are reported.

LTE Day 1: Very much improved

Group	Value	95% CI
Placebo/Atacicept 150 mg	13
Atacicept 75 mg	19
Atacicept 150 mg	25

LTE Day 1: Much improved

Group	Value	95% CI
Placebo/Atacicept 150 mg	29
Atacicept 75 mg	33
Atacicept 150 mg	27

LTE Week 24: Very much improved

Group	Value	95% CI
Placebo/Atacicept 150 mg	18
Atacicept 75 mg	22
Atacicept 150 mg	22

LTE Week 24: Much improved

Group	Value	95% CI
Placebo/Atacicept 150 mg	35
Atacicept 75 mg	29
Atacicept 150 mg	40

LTE Week 48: Very much improved

Group	Value	95% CI
Placebo/Atacicept 150 mg	16
Atacicept 75 mg	20
Atacicept 150 mg	24

LTE Week 48: Much improved

Group	Value	95% CI
Placebo/Atacicept 150 mg	26
Atacicept 75 mg	24
Atacicept 150 mg	30

LTE Week 72: Very much improved

Group	Value	95% CI
Placebo/Atacicept 150 mg	7
Atacicept 75 mg	10
Atacicept 150 mg	10

LTE Week 72: Much improved

Group	Value	95% CI
Placebo/Atacicept 150 mg	13
Atacicept 75 mg	13
Atacicept 150 mg	13

Adverse events — posted to ClinicalTrials.gov

Time frame: Baseline up to maximum duration of 167.7 weeks. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Placebo/Atacicept 150 mg

Serious: 19/83 (23%)

Deaths: 0/83

Atacicept 75 mg

Serious: 13/82 (16%)

Deaths: 0/82

Atacicept 150 mg

Serious: 11/88 (13%)

Deaths: 2/88

Serious adverse events (60 terms)

Reaction	System	Placebo/Atacicept 150 mg	Atacicept 75 mg	Atacicept 150 mg
Herpes zoster	Infections and infestations	—	—	—
Pneumonia	Infections and infestations	—	—	—
Systemic lupus erythematosus	Musculoskeletal and connective tissue disorders	—	—	—
Pleural effusion	Respiratory, thoracic and mediastinal disorders	—	—	—
Lymphadenopathy	Blood and lymphatic system disorders	—	—	—
Meniere's disease	Ear and labyrinth disorders	—	—	—
Gastritis	Gastrointestinal disorders	—	—	—
Cholecystitis	Hepatobiliary disorders	—	—	—
Osteomyelitis	Infections and infestations	—	—	—
Pharyngotonsillitis	Infections and infestations	—	—	—
Pyelonephritis acute	Infections and infestations	—	—	—
Soft tissue infection	Infections and infestations	—	—	—
Subcutaneous abscess	Infections and infestations	—	—	—
Animal bite	Injury, poisoning and procedural complications	—	—	—
Overdose	Injury, poisoning and procedural complications	—	—	—
Radius fracture	Injury, poisoning and procedural complications	—	—	—
Tendon rupture	Injury, poisoning and procedural complications	—	—	—
Hypocalcaemia	Metabolism and nutrition disorders	—	—	—
Hypoglycaemia	Metabolism and nutrition disorders	—	—	—
Embryonal rhabdomyosarcoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—
Thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—
Cerebrovascular accident	Nervous system disorders	—	—	—
Seizure	Nervous system disorders	—	—	—
Pregnancy	Pregnancy, puerperium and perinatal conditions	—	—	—
Disorientation	Psychiatric disorders	—	—	—

Other adverse events (13 terms — click to expand)

Reaction	System	Placebo/Atacicept 150 mg	Atacicept 75 mg	Atacicept 150 mg
Injection site reaction	General disorders	—	—	—
Urinary tract infection	Infections and infestations	—	—	—
Upper respiratory tract infection	Infections and infestations	—	—	—
Injection site pain	General disorders	—	—	—
Headache	Nervous system disorders	—	—	—
Bronchitis	Infections and infestations	—	—	—
Nasopharyngitis	Infections and infestations	—	—	—
Sinusitis	Infections and infestations	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—
Pharyngitis	Infections and infestations	—	—	—
Hypertension	Vascular disorders	—	—	—
Injection site erythema	General disorders	—	—	—
Gastritis	Gastrointestinal disorders	—	—	—

Most-reported serious reactions: Herpes zoster, Pneumonia, Systemic lupus erythematosus, Pleural effusion, Lymphadenopathy, Meniere's disease, Gastritis, Cholecystitis.

Data from ClinicalTrials.gov NCT02070978 adverse events section.

Sponsor's own description

This is a multicenter, double-blind, Phase 2b, long-term extension (LTE) to the ADDRESS II core trial (EMR 700461-023) (NCT01972568), to evaluate long-term safety and tolerability of atacicept in participants with systemic lupus erythematosus (SLE). Participants who completed the 24-week core study ADDRESS II core study (NCT01972568) and thus not met any of the discontinuation criteria were invited to enter this long-term extension (LTE) study NCT02070978.

Publications & conference data

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

1. Systemic lupus erythematosus: updated insights on the pathogenesis, diagnosis, prevention and therapeutics.
   Dai X, Fan Y, Zhao X. · · 2025 · cited 78× · PMID 40097390 · DOI 10.1038/s41392-025-02168-0
2. A critical review of clinical trials in systemic lupus erythematosus.
   Mahieu MA, Strand V, Simon LS, Lipsky PE, et al · · 2016 · cited 57× · PMID 27497257 · DOI 10.1177/0961203316652492
3. Systemic lupus erythematosus biomarkers: the challenging quest.
   Arriens C, Wren JD, Munroe ME, Mohan C. · · 2017 · cited 52× · PMID 28013203 · DOI 10.1093/rheumatology/kew407
4. BAFF- and APRIL-targeted therapy in systemic autoimmune diseases.
   Nakayamada S, Tanaka Y. · · 2016 · cited 49× · PMID 29259679 · DOI 10.1186/s41232-016-0015-4
5. Skin-Associated B Cells in the Pathogenesis of Cutaneous Autoimmune Diseases-Implications for Therapeutic Approaches.
   Fetter T, Niebel D, Braegelmann C, Wenzel J. · · 2020 · cited 43× · PMID 33297481 · DOI 10.3390/cells9122627
6. Research and therapeutics-traditional and emerging therapies in systemic lupus erythematosus.
   Davis LS, Reimold AM. · · 2017 · cited 37× · PMID 28375452 · DOI 10.1093/rheumatology/kew417
7. Current and emerging treatment options for ANCA-associated vasculitis: potential role of belimumab and other BAFF/APRIL targeting agents.
   Lenert A, Lenert P. · · 2015 · cited 28× · PMID 25609919 · DOI 10.2147/dddt.s67264
8. B-cell survival factors in autoimmune rheumatic disorders.
   Morais SA, Vilas-Boas A, Isenberg DA. · · 2015 · cited 25× · PMID 26288664 · DOI 10.1177/1759720x15586782