Psoriatic Arthritis
Conditions
Brief summary
The purpose of this study is to determine an optimal abatacept dosing regimen for the treatment of active arthritis due to psoriatic arthritis in patients who have had a prior inadequate response to disease-modifying antirheumatic drugs, including methotrexate and tumor necrosis factor alpha-blockade compounds.
Interventions
DRUGAbatacept
Solution, intravenous, monthly, short-term = 24 weeks (6 months)
DRUGPlacebo
Solution, intravenous, placebo (double dummy), monthly, short-term = 24 weeks (6 months)
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Meeting classification criteria for psoriatic arthritis for a duration of disease of at least 3 months * Prior failure (inefficacy or intolerance) of therapy with disease-modifying antirheumatic drugs; if patient had prior failure of methotrexate, he or she must have been taking at least 15 mg per week for at least 2 months * If recent failure(inefficacy or intolerance) of a tumor necrosis factor α-blockade compound, participant must be washed out prior to first dose: 56 days for infliximab and 28 days for etanercept and adalimumab * Disease activity as defined by a tender joint count of ≥3, swollen joint count of ≥3, and clinically detectable synovitis at screening and Day 01 (prior to infusion) * Active psoriasis with a qualifying target lesion ≥2 cm in diameter * Able to undergo magnetic resonance imaging * Use of appropriate birth control by women of child bearing potential (WOCBP) Key
Exclusion criteria
* WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 10 weeks after the last dose of investigational product * Women who are pregnant or breastfeeding or who plan to become pregnant or to start breastfeeding during the duration of the study * Women with a positive pregnancy test on enrollment or prior to investigational product administration. * Participants scheduled for or anticipating joint replacement surgery. * Those with a recent history of clinically significant drug or alcohol abuse * Concomitant illness that in the investigator's opinion is likely to require systemic glucocorticosteroid therapy during the study (for example: moderate to severe asthma) * Current symptoms of severe, progressive, or uncontrolled renal, hepatic, hematologic, pulmonary, cardiac, neurologic, ophthalmologic, or cerebral disease. * Unwillingness or inability to undergo screening based on current local or country guidelines/standards to evaluate the presence of cancer * Cancer within the last 5 years * Current malignancy or signs of possible malignancy detected by screening procedures for which the workup to exclude malignancy has not been completed or malignancy cannot be excluded * At risk for or history (within 3 years) of tuberculosis * Any serious bacterial infection within the last 3 months, not treated and resolved with antibiotics, or any chronic bacterial infection (such as, but not limited to, chronic pyelonephritis, osteomyelitis, and bronchiectasis) * Evidence of active or latent bacterial or viral infection infections at the time of potential enrollment * Herpes zoster or cytomegalovirus resolving less than 2 months prior to signing informed consent * Receipt of any live vaccines within 3 months of the anticipated first dose of study medication or anticipation of the need for a live vaccine at any time during and for 3 months after the duration of the study Long-term period participants: Must have met eligibility criteria for short-term period and completed short-term (24-week) period of the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Long-term Period: Number of Participants With Death As Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, SAEs Leading to Discontinuation, Adverse Events (AEs), Drug-related AEs, AEs Leading to Discontinuation, and AEs of Interest | From Day 169 to Day 729 | Presp=prespecified; acute= ≤1 hour after start of infusion; periinfusional= ≤24 hours after start of infusion. AE=any new unfavorable symptom or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=an unfavorable medical event that at any dose results in death, significant disability, drug dependency/abuse, hospitalization or prolonged hospitalization; is life-threatening, an important medical event, or a congenital anomaly/birth defect. Drug-related=possibly, probably, or certainly related and of unknown relationship to study drug. |
| Short-term Period: Number of Participants With ACR 20 Response at Day 169 | At Day 169 from Baseline | An ACR 20 responder was a participant who had a reduction of 20% or more from baseline in scores for both tender and swollen joints and had a reduction from baseline of 20% or more in 3 out of the following 5 assessments: participant's assessment of disease activity, participant's global assessment of disease activity, investigator's global assessment of disease activity, participant's assessment of physical function by HAQ-DI, and Disease Activity Score 28-C reactive protein. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Long-term Period: Mean Percentage of Change From Baseline in Target Lesion Score at Days 365 and 729 | From Baseline to Days 365 and 729 | Target lesion score is a measurement of the degree of erythema, induration, and scale of a psoriatic lesion, at least 2 cm in diameter, selected as a target for response throughout the study period. The scores assigned were 0=clear, 1=almost clear, 2=mild clear, 3=moderate disease, 4=severe. Percent improvement from baseline was computed using the ratio of improvement from baseline to the baseline value. |
| Long-term Period: Mean Change From Baseline in the Short-form 36 (SF-36), Version 2, Domain and Component Scores at Days 365 and 729 | At Days 365 and 729 from baseline | PCS=physical component score; MCS=mental component score. The SF-36 is a 36-item instrument with physical and mental components and covers quality of life (QoL) domains: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health. Responses are used to derive physical and mental component summary scores, ranging from 0 to 100, with higher scores indicating better QoL. Mean change from baseline=postbaseline value-baseline value; a higher value signifies improvement. |
| Long-term Period: Number of Participants Achieving A Reduction of At Least 0.3 Unit From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Days 365 and 729 | Days 365 and 729 from baseline | Per the HAQ-DI, participants assessed their own ability to perform the following tasks: dress/groom, arise, eat, walk, reach, grip, maintain hygiene, and maintain daily activity over a period by marking their responses on a questionnaire. Scoring of the HAQ-DI: 0=without any difficulty; 1=with some difficulty; 2=with much difficulty); and 3=unable to do. Greater score=greater disability. Responders with a \>= 0.3 unit decrease in index scores from baseline to days 365 and 729 were considered to be improved. |
| Short-term Period: Number of Participants With Marked Abnormalities in Hematology | From Baseline to Day 169 | LLN=lower limit of normal; ULN=upper limit of normal; pre-Rx=pretreatment. Marked abnormalities are laboratory measurements marked as abnormal, per predefined study criteria, at any study time point. Criteria: Hemoglobin \>3 g/dL decrease from pre-Rx value; hematocrit \<0.75\*pre-Rx value; erythrocytes \<0.75\*pre-Rx value; platelets \<0.67\*LLN (or, if pre-Rx value \<LLN, \<0.5\*pre-Rx value and \<100000/mm\^3) or \>1.5\*ULN. |
| Short-term Period: Number of Participants With Marked Abnormalities in Hematology (Continued) | From Baseline to Day 169 | LLN=lower limit of normal; ULN=upper limit of normal; pre-Rx=pretreatment. Laboratory measurements are marked as abnormal per predefined study criteria, at any study time point. Criteria for the data presented. Leukocytes \<0.75\*LLN or \>1.25\*ULN (or, if pre-Rx value \<LLN, \<0.8\*pre-Rx or \>ULN. If pre-Rx value \>ULN, \>1.2\*pre-Rx or \<LLN); neutrophils+bands (absolute) \<1.00\*10\^3 c/uL; lymphocytes (absolute) \<0.75\*10\^3 c/uL or \>7.50\*10\^3 c/uL; monocytes (absolute) \>2000/mm\^3; basophils (absolute) \>0.40\*10\^3 c/uL; eosinophils (absolute) \>0.75\*10\^3 c/uL. |
| Short-term Period: Number of Participants With Marked Abnormalities in Serum Chemistry | Baseline to Day 169 | ULN=upper limit of normal; pre-Rx=pretreatment. Marked abnormality criteria: Alkaline phosphatase (ALP), gamma-glutamyltransferase (GGT) \>2\*ULN (if pre-Rx \>ULN, \>3\*pre-Rx); aspartate aminotransferase (AST), alanine transaminase (ALT) \>3\*ULN (if pre-Rx \>ULN, \>4\*pre-Rx); bilirubin (total) \>2\*ULN (if pre-Rx \>ULN, \>4\*pre-Rx); blood urea nitrogen (BUN) \>2\*pre-Rx; creatinine \>1.5\*pre-Rx. |
| Short-term Period: Number of Participants With Marked Abnormalities in Serum Chemistry (Continued) | Baseline to Day 169 | LLN=lower limit of normal; ULN=upper limit of normal; pre-Rx=pretreatment. Marked abnormality criteria: Sodium \<0.95\*LLN or \>1.05\*ULN (if pre-Rx\<LLN, \<0.95\*pre-Rx or \>ULN. If pre-Rx \>ULN,\>1.05\* pre-Rx or \<LLN); potassium, chloride \<0.9\*LLN or \>1.1\*ULN (if pre-Rx \<LLN, \<0.9\*pre-Rx or \>ULN. If pre-Rx \>ULN, \>1.1\*pre-Rx or \<LLN); calcium \<0.8\*LLN or \>1.2\*ULN (if pre-Rx \<LLN,\<0.75\* pre-Rx or \>ULN. If pre-Rx \>ULN, \>1.25\* pre-Rx or \<LLN); phosphorous \<0.75\*LLN or \>1.25\*ULN (if pre-Rx \<LLN, \<0.67\*pre-Rx or \>ULN. If pre-Rx \>ULN, \>1.33\*pre-Rx or \<LLN. |
| Short-term Period: Number of Participants With Marked Abnormalities in Urinalysis | From Baseline to Day 169 | Pre-Rx=pretreatment. Criteria for marked abnormality: Protein, glucose, blood, leukocyte esterase, red blood cells (RBC), white blood cells (WBC) \>=2+ (or, if value \>=4, or if pre-Rx value=0 or 0.5, \>= 2\* or if pre-RX value =1, \>=3, or if pre-Rx =2 or 3, \>=4). |
| Short-term Period: Number of Participants Who Died and With SAEs, AEs, AEs Leading to Discontinuation, SAEs Leading to Discontinuation, Drug-related AEs, and Drug-related SAEs | From Baseline to Day 169 | An AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. An SAE is any unfavorable medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency or abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Drug-related=possibly, probably, or certainly related to and of unknown relationship to study treatment. |
| Long-term Period: Percentage of Participants Achieving American College of Rheumatology (ACR) 20, ACR 50, ACR 70, ACR 90 Responses at Days 365 and 729 | At Days 365 and 729 from Baseline | An ACR 20 (50, 70, 90) responder was a participant whose counts for both tender and swollen joints was reduced by 20% (50%, 70%, 90%, respectively) or more from baseline and who had a reduction of 20% (50%, 70%, 90%, respectively) or more from baseline in 3 of the following assessments: participant's assessment of disease activity, participant's global assessment of disease activity, Investigators Global Response, participant's assessment of physical function by Health Assessment Questionnaire Disability Index, and Disease Activity Score 28 based on C-reactive protein. |
| Short-term Period: Mean Percentage of Change From Baseline in Target Lesion Score at Day 169 | At Day 169 from Baseline | Target lesion score measures the degree of erythema, induration, and scale of a psoriatic lesion with a diameter of at least 2 cm, selected as a target for response throughout the study period. Scores: 0=clear, 1=almost clear, 2=mild clear, 3=moderate disease, 4=severe. Percent improvement from baseline was computed using the ratio of improvement from baseline to the baseline value. |
| Short-term Period: Number of Participants With Positive Responses for Serum Levels of Abatacept-specific Antibodies (Anti-Abatacept-C) | From Baseline to Day 169 | Meso Scale Discovery electrochemiluminescence, a validated, sensitive immunoassay technique (anti-abatacept assay C) was used to measure serum levels of abatacept-specific antibodies against the whole molecule (both the CTLA4 and possibly immunoglobulin G portion \[anti-abatacept antibody\]. |
| Short-term Period: Mean Change From Baseline in the Mental Component Summary Score as Measured by the Short-form 36 at Day 169 | At Day 169 from Baseline | PCS=physical component score; MCS=mental component score. The Short-form 36 is a 36-item instrument with physical and mental components and covers quality of life (QoL) domains: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health. Responses are used to derive physical and mental component summary scores, ranging from 0 to 100, with higher scores indicating better QoL. Mean change from baseline=postbaseline value-baseline value; a higher value signifies improvement. |
| Short-term Period: Mean Serum Concentrations of Abatacept | Days 1, 15, 29, 57, 85, 113, 141, and 169 | Abatacept was assayed using a validated enzyme linked immunosorbent assay method (ELISA). Serum concentration versus time data was analyzed in the descriptive pharmacokinetic (PK) analysis. |
| Short-term Period: Mean Serum Trough Concentrations (Cmin) of Abatacept | Days 1, 15, 29, 57, 85, 113, 141, and 169 | Abatacept was assayed using a validated ELISA method. Cmin of abatacept was obtained from concentration versus time data. |
| Short-term Period: Population Pharmacokinetic (POPPK) Analysis of the Pharmacokinetic (PK) Parameters | Days 1, 15, 29, 57, 85, 113, 141, and 169 | PK data: summaries of concentrations and concentration versus time plots were obtained. These data were to be used to develop a POPPK model using a nonlinear mixed-effects model. Prediction of PK data for each of the 3 abatacept treatment groups using POPPK methodology was not performed, because it would not provide any relevant information over the observed PK data. |
| Short-term Period: Mean Change From Baseline in Physical Component Summary Score as Measured by the Short-form 36 at Day 169 | At Day 169 from Baseline | PCS=physical component score; MCS=mental component score. The Short-form 36 is a 36-item instrument with physical and mental components and covers quality of life (QoL) domains: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health. Responses are used to derive physical and mental component summary scores, ranging from 0 to 100, with higher scores indicating better QoL. Mean change from baseline=postbaseline value-baseline value; a higher value signifies improvement. |
| Short-term Period: Number of Participants Achieving a Reduction of At Least 0.3 Unit From Baseline in HAQ-DI Scores at Day 169 | At Day 169 from Baseline | The HAQ-DI assesses a participant's ability to perform the following tasks: dress/groom; arise; eat; walk; reach; grip; maintain hygiene; and maintain daily activity over a period by marking their response on a questionnaire. Responses/scores range from: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=to unable to do. Higher total score=greater disability. |
| Short-term Period: Number of Participants With an IGA Score of Clear or Almost Clear at Day 169 | At Day 169 from Baseline | Score indicates lesion induration, scaling, and erythema: 0 = clear (no signs of plaque psoriasis except for residual discoloration); 1 = almost clear (just perceptible erythema, no induration to very slightly elevated above normal skin levels, limited amount of very fine scaling); 2 = mild disease (mild erythema, mild induration, mainly fine scaling predominates); 3 = moderate disease (moderate erythema \[most plaques are red\], moderate induration and/or coarse scale predominates); 4=severe (severe erythema, marked to very marked elevation of lesions, coarse thick scale predominates). |
| Long-term Period: Number of Participants With an Investigators Global Assessment (IGA) Score of Clear or Almost Clear at Days 365 and 729 | From Day 169 to Days 365 and 729 | IGA score indicates lesion induration, scaling, and erythema: 0=clear (no signs of plaque psoriasis except for residual discoloration); 1=almost clear (just perceptible erythema, no induration to very slightly elevated above normal skin levels, limited amount of very fine scaling); 2=mild disease (mild erythema, mild induration, mainly fine scaling predominates); 3=moderate disease (moderate erythema \[most plaques are red\], moderate induration and/or coarse scale predominates); 4=severe (severe erythema, marked to very marked elevation of lesions, coarse thick scale predominates). |
Countries
Argentina, Australia, Belgium, Canada, France, Germany, Italy, Netherlands, Norway, South Africa, Spain, United States
Participant flow
Pre-assignment details
191 participants were enrolled and 21 were not randomized. Reasons for this included: adverse events (AEs) (2); participant withdrew consent (5); lost to follow up (1); participant no longer meets study criteria (13).
Participants by arm
| Arm | Count |
|---|---|
| Abatacept 30/10 Participants were administered intravenous (iv) infusions of abatacept (30 mg/kg - calculated dose) over approximately 30 minutes on Days 1 and 15, followed by 10 mg/kg (fixed dose) abatacept infusion on Day 29 and every 28 days thereafter up to and including Day 141. All participants received a calculated dose on Day 1 and 15 followed by fixed dose based on their screening visit weight i.e. for participants weighing \< 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg and participants weighing \> 100 kg received 1000 mg. | 43 |
| Abatacept 10/10 Participants were administered iv infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 141. All participants received a dose based on their screening visit weight as per rheumatoid arthritis label (participants weighing \< 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg and participants weighing \> 100 kg received 1000mg). | 40 |
| Abatacept 3/3 Participants were administered iv infusions of abatacept (3 mg/kg - calculated dose) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 141. All participants received calculated dose based on their screening visit weight. | 45 |
| Placebo Participants were administered iv infusions of either dextrose 5% solution or 0.9% sodium chloride solution at a constant rate over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 141. | 42 |
| Total | 170 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Long-term Period | Administrative reason by sponsor | 17 | 15 | 26 | 18 |
| Long-term Period | Adverse Event | 2 | 1 | 0 | 1 |
| Long-term Period | Lack of Efficacy | 14 | 10 | 14 | 12 |
| Long-term Period | Lost to Follow-up | 1 | 2 | 0 | 0 |
| Long-term Period | No longer meets study criteria | 0 | 1 | 0 | 0 |
| Long-term Period | Other | 1 | 2 | 2 | 2 |
| Long-term Period | Poor compliance/noncompliance | 0 | 1 | 1 | 0 |
| Long-term Period | Withdrawal by Subject | 2 | 2 | 0 | 0 |
| Short-term Period | Adverse Event | 1 | 2 | 1 | 3 |
| Short-term Period | Lack of Efficacy | 3 | 4 | 0 | 3 |
| Short-term Period | Participant not meeting study criteria | 0 | 0 | 0 | 1 |
| Short-term Period | Participant withdrew consent | 2 | 0 | 0 | 2 |
| Short-term Period | Pregnancy | 0 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Abatacept 10/10 | Abatacept 3/3 | Abatacept 30/10 | Placebo | Total |
|---|---|---|---|---|---|
| Age Continuous | 51.5 years | 51.0 years | 54.0 years | 53.0 years | 52.0 years |
| Race/Ethnicity, Customized Asian | 2 participants | 1 participants | 0 participants | 0 participants | 3 participants |
| Race/Ethnicity, Customized Pacific | 0 participants | 0 participants | 0 participants | 1 participants | 1 participants |
| Race/Ethnicity, Customized White | 38 participants | 44 participants | 43 participants | 41 participants | 166 participants |
| Sex: Female, Male Female | 14 Participants | 23 Participants | 23 Participants | 19 Participants | 79 Participants |
| Sex: Female, Male Male | 26 Participants | 22 Participants | 20 Participants | 23 Participants | 91 Participants |
| Weight | 85.0 kilograms STANDARD_DEVIATION 17.9 | 85.0 kilograms STANDARD_DEVIATION 19.1 | 92.9 kilograms STANDARD_DEVIATION 21.3 | 96.0 kilograms STANDARD_DEVIATION 19.4 | 89.7 kilograms STANDARD_DEVIATION 19.9 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 16 / 40 | 15 / 45 | 16 / 43 | 73 / 147 | 19 / 42 |
| serious Total, serious adverse events | 2 / 40 | 1 / 45 | 4 / 43 | 20 / 147 | 1 / 42 |
Outcome results
Primary
Long-term Period: Number of Participants With Death As Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, SAEs Leading to Discontinuation, Adverse Events (AEs), Drug-related AEs, AEs Leading to Discontinuation, and AEs of Interest
Presp=prespecified; acute= ≤1 hour after start of infusion; periinfusional= ≤24 hours after start of infusion. AE=any new unfavorable symptom or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=an unfavorable medical event that at any dose results in death, significant disability, drug dependency/abuse, hospitalization or prolonged hospitalization; is life-threatening, an important medical event, or a congenital anomaly/birth defect. Drug-related=possibly, probably, or certainly related and of unknown relationship to study drug.
Time frame: From Day 169 to Day 729
Population: All participants who received at least 1 infusion of abatacept during the long-term period.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Treated Participants | Long-term Period: Number of Participants With Death As Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, SAEs Leading to Discontinuation, Adverse Events (AEs), Drug-related AEs, AEs Leading to Discontinuation, and AEs of Interest | Deaths | 0 Participants |
| All Treated Participants | Long-term Period: Number of Participants With Death As Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, SAEs Leading to Discontinuation, Adverse Events (AEs), Drug-related AEs, AEs Leading to Discontinuation, and AEs of Interest | SAEs | 20 Participants |
| All Treated Participants | Long-term Period: Number of Participants With Death As Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, SAEs Leading to Discontinuation, Adverse Events (AEs), Drug-related AEs, AEs Leading to Discontinuation, and AEs of Interest | Drug-related SAEs | 4 Participants |
| All Treated Participants | Long-term Period: Number of Participants With Death As Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, SAEs Leading to Discontinuation, Adverse Events (AEs), Drug-related AEs, AEs Leading to Discontinuation, and AEs of Interest | SAEs leading to discontinuation | 0 Participants |
| All Treated Participants | Long-term Period: Number of Participants With Death As Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, SAEs Leading to Discontinuation, Adverse Events (AEs), Drug-related AEs, AEs Leading to Discontinuation, and AEs of Interest | AEs | 123 Participants |
| All Treated Participants | Long-term Period: Number of Participants With Death As Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, SAEs Leading to Discontinuation, Adverse Events (AEs), Drug-related AEs, AEs Leading to Discontinuation, and AEs of Interest | Drug-related AEs | 58 Participants |
| All Treated Participants | Long-term Period: Number of Participants With Death As Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, SAEs Leading to Discontinuation, Adverse Events (AEs), Drug-related AEs, AEs Leading to Discontinuation, and AEs of Interest | AES leading to discontinuation | 4 Participants |
| All Treated Participants | Long-term Period: Number of Participants With Death As Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, SAEs Leading to Discontinuation, Adverse Events (AEs), Drug-related AEs, AEs Leading to Discontinuation, and AEs of Interest | AEs of Interest (AEI): Infections | 83 Participants |
| All Treated Participants | Long-term Period: Number of Participants With Death As Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, SAEs Leading to Discontinuation, Adverse Events (AEs), Drug-related AEs, AEs Leading to Discontinuation, and AEs of Interest | AEI: Malignancy | 2 Participants |
| All Treated Participants | Long-term Period: Number of Participants With Death As Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, SAEs Leading to Discontinuation, Adverse Events (AEs), Drug-related AEs, AEs Leading to Discontinuation, and AEs of Interest | AEI: Autoimmune disorders (presp) | 5 Participants |
| All Treated Participants | Long-term Period: Number of Participants With Death As Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, SAEs Leading to Discontinuation, Adverse Events (AEs), Drug-related AEs, AEs Leading to Discontinuation, and AEs of Interest | AEI: Infusion reactions (presp): Acute | 4 Participants |
| All Treated Participants | Long-term Period: Number of Participants With Death As Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, SAEs Leading to Discontinuation, Adverse Events (AEs), Drug-related AEs, AEs Leading to Discontinuation, and AEs of Interest | AEI: Infusion reactions (presp): Periinfusional | 11 Participants |
Primary
Short-term Period: Number of Participants With ACR 20 Response at Day 169
An ACR 20 responder was a participant who had a reduction of 20% or more from baseline in scores for both tender and swollen joints and had a reduction from baseline of 20% or more in 3 out of the following 5 assessments: participant's assessment of disease activity, participant's global assessment of disease activity, investigator's global assessment of disease activity, participant's assessment of physical function by HAQ-DI, and Disease Activity Score 28-C reactive protein.
Time frame: At Day 169 from Baseline
Population: All randomized participants who received at least 1 infusion of study medication in the double-blind (short-term) period. Missing response values were imputed as nonresponders for participants who discontinued early after receiving study medication.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Treated Participants | Short-term Period: Number of Participants With ACR 20 Response at Day 169 | 18 Participants |
| Abatacept 10/10 | Short-term Period: Number of Participants With ACR 20 Response at Day 169 | 19 Participants |
| Abatacept 3/3 | Short-term Period: Number of Participants With ACR 20 Response at Day 169 | 15 Participants |
| Placebo | Short-term Period: Number of Participants With ACR 20 Response at Day 169 | 8 Participants |
p-value: 0.02295% CI: [4, 41.8]Cochran-Mantel-Haenszel
p-value: 0.00695% CI: [9.4, 48]Cochran-Mantel-Haenszel
p-value: 0.12195% CI: [-3.5, 32.6]Cochran-Mantel-Haenszel
Secondary
Long-term Period: Mean Change From Baseline in the Short-form 36 (SF-36), Version 2, Domain and Component Scores at Days 365 and 729
PCS=physical component score; MCS=mental component score. The SF-36 is a 36-item instrument with physical and mental components and covers quality of life (QoL) domains: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health. Responses are used to derive physical and mental component summary scores, ranging from 0 to 100, with higher scores indicating better QoL. Mean change from baseline=postbaseline value-baseline value; a higher value signifies improvement.
Time frame: At Days 365 and 729 from baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Treated Participants | Long-term Period: Mean Change From Baseline in the Short-form 36 (SF-36), Version 2, Domain and Component Scores at Days 365 and 729 | Day 365 PCS (n=34, 32, 37,29) | 1.73 Units on a scale | Standard Error 1.1 |
| All Treated Participants | Long-term Period: Mean Change From Baseline in the Short-form 36 (SF-36), Version 2, Domain and Component Scores at Days 365 and 729 | Day 365 MCS (n=34,32, 37,29) | 2.73 Units on a scale | Standard Error 1.6 |
| All Treated Participants | Long-term Period: Mean Change From Baseline in the Short-form 36 (SF-36), Version 2, Domain and Component Scores at Days 365 and 729 | Day 729 PCS (n=20,18, 26,18) | 5.59 Units on a scale | Standard Error 1.43 |
| All Treated Participants | Long-term Period: Mean Change From Baseline in the Short-form 36 (SF-36), Version 2, Domain and Component Scores at Days 365 and 729 | Day 729 MCS (n=20,18, 26,18) | 5.89 Units on a scale | Standard Error 1.84 |
| Abatacept 10/10 | Long-term Period: Mean Change From Baseline in the Short-form 36 (SF-36), Version 2, Domain and Component Scores at Days 365 and 729 | Day 365 MCS (n=34,32, 37,29) | 1.07 Units on a scale | Standard Error 2 |
| Abatacept 10/10 | Long-term Period: Mean Change From Baseline in the Short-form 36 (SF-36), Version 2, Domain and Component Scores at Days 365 and 729 | Day 729 PCS (n=20,18, 26,18) | 7.97 Units on a scale | Standard Error 2 |
| Abatacept 10/10 | Long-term Period: Mean Change From Baseline in the Short-form 36 (SF-36), Version 2, Domain and Component Scores at Days 365 and 729 | Day 729 MCS (n=20,18, 26,18) | -0.17 Units on a scale | Standard Error 2.71 |
| Abatacept 10/10 | Long-term Period: Mean Change From Baseline in the Short-form 36 (SF-36), Version 2, Domain and Component Scores at Days 365 and 729 | Day 365 PCS (n=34, 32, 37,29) | 7.59 Units on a scale | Standard Error 1.36 |
| Abatacept 3/3 | Long-term Period: Mean Change From Baseline in the Short-form 36 (SF-36), Version 2, Domain and Component Scores at Days 365 and 729 | Day 729 PCS (n=20,18, 26,18) | 6.74 Units on a scale | Standard Error 1.95 |
| Abatacept 3/3 | Long-term Period: Mean Change From Baseline in the Short-form 36 (SF-36), Version 2, Domain and Component Scores at Days 365 and 729 | Day 365 MCS (n=34,32, 37,29) | 4.95 Units on a scale | Standard Error 2.1 |
| Abatacept 3/3 | Long-term Period: Mean Change From Baseline in the Short-form 36 (SF-36), Version 2, Domain and Component Scores at Days 365 and 729 | Day 729 MCS (n=20,18, 26,18) | 1.85 Units on a scale | Standard Error 2.11 |
| Abatacept 3/3 | Long-term Period: Mean Change From Baseline in the Short-form 36 (SF-36), Version 2, Domain and Component Scores at Days 365 and 729 | Day 365 PCS (n=34, 32, 37,29) | 4.86 Units on a scale | Standard Error 1.67 |
| Placebo | Long-term Period: Mean Change From Baseline in the Short-form 36 (SF-36), Version 2, Domain and Component Scores at Days 365 and 729 | Day 729 MCS (n=20,18, 26,18) | 4.35 Units on a scale | Standard Error 2.29 |
| Placebo | Long-term Period: Mean Change From Baseline in the Short-form 36 (SF-36), Version 2, Domain and Component Scores at Days 365 and 729 | Day 365 MCS (n=34,32, 37,29) | 4.40 Units on a scale | Standard Error 2 |
| Placebo | Long-term Period: Mean Change From Baseline in the Short-form 36 (SF-36), Version 2, Domain and Component Scores at Days 365 and 729 | Day 365 PCS (n=34, 32, 37,29) | 3.59 Units on a scale | Standard Error 1.19 |
| Placebo | Long-term Period: Mean Change From Baseline in the Short-form 36 (SF-36), Version 2, Domain and Component Scores at Days 365 and 729 | Day 729 PCS (n=20,18, 26,18) | 4.45 Units on a scale | Standard Error 1.14 |
Secondary
Long-term Period: Mean Percentage of Change From Baseline in Target Lesion Score at Days 365 and 729
Target lesion score is a measurement of the degree of erythema, induration, and scale of a psoriatic lesion, at least 2 cm in diameter, selected as a target for response throughout the study period. The scores assigned were 0=clear, 1=almost clear, 2=mild clear, 3=moderate disease, 4=severe. Percent improvement from baseline was computed using the ratio of improvement from baseline to the baseline value.
Time frame: From Baseline to Days 365 and 729
Population: All participants who received at least 1 infusion of abatacept in the long-term (open-label) period.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Treated Participants | Long-term Period: Mean Percentage of Change From Baseline in Target Lesion Score at Days 365 and 729 | Day 365 | 27.51 Percentage of change | Standard Deviation 7.92 |
| All Treated Participants | Long-term Period: Mean Percentage of Change From Baseline in Target Lesion Score at Days 365 and 729 | Day 729 | 49.14 Percentage of change | Standard Deviation 9.13 |
| Abatacept 10/10 | Long-term Period: Mean Percentage of Change From Baseline in Target Lesion Score at Days 365 and 729 | Day 729 | 45.07 Percentage of change | Standard Deviation 7.98 |
| Abatacept 10/10 | Long-term Period: Mean Percentage of Change From Baseline in Target Lesion Score at Days 365 and 729 | Day 365 | 41.97 Percentage of change | Standard Deviation 7.9 |
| Abatacept 3/3 | Long-term Period: Mean Percentage of Change From Baseline in Target Lesion Score at Days 365 and 729 | Day 365 | 20.32 Percentage of change | Standard Deviation 8.59 |
| Abatacept 3/3 | Long-term Period: Mean Percentage of Change From Baseline in Target Lesion Score at Days 365 and 729 | Day 729 | 44.79 Percentage of change | Standard Deviation 9.09 |
| Placebo | Long-term Period: Mean Percentage of Change From Baseline in Target Lesion Score at Days 365 and 729 | Day 365 | 33.82 Percentage of change | Standard Deviation 7.52 |
| Placebo | Long-term Period: Mean Percentage of Change From Baseline in Target Lesion Score at Days 365 and 729 | Day 729 | 34.41 Percentage of change | Standard Deviation 8.98 |
Secondary
Long-term Period: Number of Participants Achieving A Reduction of At Least 0.3 Unit From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Days 365 and 729
Per the HAQ-DI, participants assessed their own ability to perform the following tasks: dress/groom, arise, eat, walk, reach, grip, maintain hygiene, and maintain daily activity over a period by marking their responses on a questionnaire. Scoring of the HAQ-DI: 0=without any difficulty; 1=with some difficulty; 2=with much difficulty); and 3=unable to do. Greater score=greater disability. Responders with a \>= 0.3 unit decrease in index scores from baseline to days 365 and 729 were considered to be improved.
Time frame: Days 365 and 729 from baseline
Population: All participants who received at least 1 infusion of abatacept in the long-term (open-label) period. (n=number of participants with responses available)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Treated Participants | Long-term Period: Number of Participants Achieving A Reduction of At Least 0.3 Unit From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Days 365 and 729 | Day 365 (n=3, 28, 32, 23) | 12 Participants |
| All Treated Participants | Long-term Period: Number of Participants Achieving A Reduction of At Least 0.3 Unit From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Days 365 and 729 | Day 729 (n=9, 11, 13, 10) | 9 Participants |
| Abatacept 10/10 | Long-term Period: Number of Participants Achieving A Reduction of At Least 0.3 Unit From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Days 365 and 729 | Day 729 (n=9, 11, 13, 10) | 11 Participants |
| Abatacept 10/10 | Long-term Period: Number of Participants Achieving A Reduction of At Least 0.3 Unit From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Days 365 and 729 | Day 365 (n=3, 28, 32, 23) | 16 Participants |
| Abatacept 3/3 | Long-term Period: Number of Participants Achieving A Reduction of At Least 0.3 Unit From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Days 365 and 729 | Day 365 (n=3, 28, 32, 23) | 17 Participants |
| Abatacept 3/3 | Long-term Period: Number of Participants Achieving A Reduction of At Least 0.3 Unit From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Days 365 and 729 | Day 729 (n=9, 11, 13, 10) | 13 Participants |
| Placebo | Long-term Period: Number of Participants Achieving A Reduction of At Least 0.3 Unit From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Days 365 and 729 | Day 365 (n=3, 28, 32, 23) | 12 Participants |
| Placebo | Long-term Period: Number of Participants Achieving A Reduction of At Least 0.3 Unit From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Days 365 and 729 | Day 729 (n=9, 11, 13, 10) | 10 Participants |
Secondary
Long-term Period: Number of Participants With an Investigators Global Assessment (IGA) Score of Clear or Almost Clear at Days 365 and 729
IGA score indicates lesion induration, scaling, and erythema: 0=clear (no signs of plaque psoriasis except for residual discoloration); 1=almost clear (just perceptible erythema, no induration to very slightly elevated above normal skin levels, limited amount of very fine scaling); 2=mild disease (mild erythema, mild induration, mainly fine scaling predominates); 3=moderate disease (moderate erythema \[most plaques are red\], moderate induration and/or coarse scale predominates); 4=severe (severe erythema, marked to very marked elevation of lesions, coarse thick scale predominates).
Time frame: From Day 169 to Days 365 and 729
Population: All participants who received at least 1 infusion of abatacept in the long-term (open-label) period. (n=number of participants with a response)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Treated Participants | Long-term Period: Number of Participants With an Investigators Global Assessment (IGA) Score of Clear or Almost Clear at Days 365 and 729 | Day 365 (n=30, 29, 34, 23) | 13 Participants |
| All Treated Participants | Long-term Period: Number of Participants With an Investigators Global Assessment (IGA) Score of Clear or Almost Clear at Days 365 and 729 | Day 729 (n=20, 17, 26, 18) | 10 Participants |
| Abatacept 10/10 | Long-term Period: Number of Participants With an Investigators Global Assessment (IGA) Score of Clear or Almost Clear at Days 365 and 729 | Day 729 (n=20, 17, 26, 18) | 7 Participants |
| Abatacept 10/10 | Long-term Period: Number of Participants With an Investigators Global Assessment (IGA) Score of Clear or Almost Clear at Days 365 and 729 | Day 365 (n=30, 29, 34, 23) | 10 Participants |
| Abatacept 3/3 | Long-term Period: Number of Participants With an Investigators Global Assessment (IGA) Score of Clear or Almost Clear at Days 365 and 729 | Day 365 (n=30, 29, 34, 23) | 19 Participants |
| Abatacept 3/3 | Long-term Period: Number of Participants With an Investigators Global Assessment (IGA) Score of Clear or Almost Clear at Days 365 and 729 | Day 729 (n=20, 17, 26, 18) | 16 Participants |
| Placebo | Long-term Period: Number of Participants With an Investigators Global Assessment (IGA) Score of Clear or Almost Clear at Days 365 and 729 | Day 365 (n=30, 29, 34, 23) | 10 Participants |
| Placebo | Long-term Period: Number of Participants With an Investigators Global Assessment (IGA) Score of Clear or Almost Clear at Days 365 and 729 | Day 729 (n=20, 17, 26, 18) | 8 Participants |
Secondary
Long-term Period: Percentage of Participants Achieving American College of Rheumatology (ACR) 20, ACR 50, ACR 70, ACR 90 Responses at Days 365 and 729
An ACR 20 (50, 70, 90) responder was a participant whose counts for both tender and swollen joints was reduced by 20% (50%, 70%, 90%, respectively) or more from baseline and who had a reduction of 20% (50%, 70%, 90%, respectively) or more from baseline in 3 of the following assessments: participant's assessment of disease activity, participant's global assessment of disease activity, Investigators Global Response, participant's assessment of physical function by Health Assessment Questionnaire Disability Index, and Disease Activity Score 28 based on C-reactive protein.
Time frame: At Days 365 and 729 from Baseline
Population: All participants who received at least 1 infusion of abatacept in the long-term (open-label) period. (n=number of participants with a response)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Treated Participants | Long-term Period: Percentage of Participants Achieving American College of Rheumatology (ACR) 20, ACR 50, ACR 70, ACR 90 Responses at Days 365 and 729 | ACR 20, Day 365 (n=34, 29, 36, 32) | 50.0 Percentage of participants |
| All Treated Participants | Long-term Period: Percentage of Participants Achieving American College of Rheumatology (ACR) 20, ACR 50, ACR 70, ACR 90 Responses at Days 365 and 729 | ACR 20, Day 729 (n=21, 18, 26, 18) | 81 Percentage of participants |
| All Treated Participants | Long-term Period: Percentage of Participants Achieving American College of Rheumatology (ACR) 20, ACR 50, ACR 70, ACR 90 Responses at Days 365 and 729 | ACR 50, Day 365 (n=34, 29, 36, 32) | 23.5 Percentage of participants |
| All Treated Participants | Long-term Period: Percentage of Participants Achieving American College of Rheumatology (ACR) 20, ACR 50, ACR 70, ACR 90 Responses at Days 365 and 729 | ACR 50, Day 729 (n=21, 18, 26, 18) | 57.1 Percentage of participants |
| All Treated Participants | Long-term Period: Percentage of Participants Achieving American College of Rheumatology (ACR) 20, ACR 50, ACR 70, ACR 90 Responses at Days 365 and 729 | ACR 70, Day 365 (n=34, 29, 36, 32) | 5.9 Percentage of participants |
| All Treated Participants | Long-term Period: Percentage of Participants Achieving American College of Rheumatology (ACR) 20, ACR 50, ACR 70, ACR 90 Responses at Days 365 and 729 | ACR 70, Day 729 (n=21, 18, 26, 18) | 23.8 Percentage of participants |
| All Treated Participants | Long-term Period: Percentage of Participants Achieving American College of Rheumatology (ACR) 20, ACR 50, ACR 70, ACR 90 Responses at Days 365 and 729 | ACR 90, Day 365 (n=34, 29, 36, 32) | 0 Percentage of participants |
| All Treated Participants | Long-term Period: Percentage of Participants Achieving American College of Rheumatology (ACR) 20, ACR 50, ACR 70, ACR 90 Responses at Days 365 and 729 | ACR 90, Day 729 (n=21, 18, 26, 18) | 0 Percentage of participants |
| Abatacept 10/10 | Long-term Period: Percentage of Participants Achieving American College of Rheumatology (ACR) 20, ACR 50, ACR 70, ACR 90 Responses at Days 365 and 729 | ACR 70, Day 729 (n=21, 18, 26, 18) | 16.7 Percentage of participants |
| Abatacept 10/10 | Long-term Period: Percentage of Participants Achieving American College of Rheumatology (ACR) 20, ACR 50, ACR 70, ACR 90 Responses at Days 365 and 729 | ACR 70, Day 365 (n=34, 29, 36, 32) | 17.2 Percentage of participants |
| Abatacept 10/10 | Long-term Period: Percentage of Participants Achieving American College of Rheumatology (ACR) 20, ACR 50, ACR 70, ACR 90 Responses at Days 365 and 729 | ACR 20, Day 729 (n=21, 18, 26, 18) | 66.7 Percentage of participants |
| Abatacept 10/10 | Long-term Period: Percentage of Participants Achieving American College of Rheumatology (ACR) 20, ACR 50, ACR 70, ACR 90 Responses at Days 365 and 729 | ACR 90, Day 729 (n=21, 18, 26, 18) | 5.6 Percentage of participants |
| Abatacept 10/10 | Long-term Period: Percentage of Participants Achieving American College of Rheumatology (ACR) 20, ACR 50, ACR 70, ACR 90 Responses at Days 365 and 729 | ACR 90, Day 365 (n=34, 29, 36, 32) | 6.9 Percentage of participants |
| Abatacept 10/10 | Long-term Period: Percentage of Participants Achieving American College of Rheumatology (ACR) 20, ACR 50, ACR 70, ACR 90 Responses at Days 365 and 729 | ACR 50, Day 729 (n=21, 18, 26, 18) | 27.8 Percentage of participants |
| Abatacept 10/10 | Long-term Period: Percentage of Participants Achieving American College of Rheumatology (ACR) 20, ACR 50, ACR 70, ACR 90 Responses at Days 365 and 729 | ACR 50, Day 365 (n=34, 29, 36, 32) | 37.9 Percentage of participants |
| Abatacept 10/10 | Long-term Period: Percentage of Participants Achieving American College of Rheumatology (ACR) 20, ACR 50, ACR 70, ACR 90 Responses at Days 365 and 729 | ACR 20, Day 365 (n=34, 29, 36, 32) | 62.1 Percentage of participants |
| Abatacept 3/3 | Long-term Period: Percentage of Participants Achieving American College of Rheumatology (ACR) 20, ACR 50, ACR 70, ACR 90 Responses at Days 365 and 729 | ACR 90, Day 365 (n=34, 29, 36, 32) | 5.6 Percentage of participants |
| Abatacept 3/3 | Long-term Period: Percentage of Participants Achieving American College of Rheumatology (ACR) 20, ACR 50, ACR 70, ACR 90 Responses at Days 365 and 729 | ACR 50, Day 365 (n=34, 29, 36, 32) | 33.3 Percentage of participants |
| Abatacept 3/3 | Long-term Period: Percentage of Participants Achieving American College of Rheumatology (ACR) 20, ACR 50, ACR 70, ACR 90 Responses at Days 365 and 729 | ACR 50, Day 729 (n=21, 18, 26, 18) | 42.3 Percentage of participants |
| Abatacept 3/3 | Long-term Period: Percentage of Participants Achieving American College of Rheumatology (ACR) 20, ACR 50, ACR 70, ACR 90 Responses at Days 365 and 729 | ACR 70, Day 365 (n=34, 29, 36, 32) | 13.9 Percentage of participants |
| Abatacept 3/3 | Long-term Period: Percentage of Participants Achieving American College of Rheumatology (ACR) 20, ACR 50, ACR 70, ACR 90 Responses at Days 365 and 729 | ACR 70, Day 729 (n=21, 18, 26, 18) | 23.1 Percentage of participants |
| Abatacept 3/3 | Long-term Period: Percentage of Participants Achieving American College of Rheumatology (ACR) 20, ACR 50, ACR 70, ACR 90 Responses at Days 365 and 729 | ACR 90, Day 729 (n=21, 18, 26, 18) | 11.5 Percentage of participants |
| Abatacept 3/3 | Long-term Period: Percentage of Participants Achieving American College of Rheumatology (ACR) 20, ACR 50, ACR 70, ACR 90 Responses at Days 365 and 729 | ACR 20, Day 365 (n=34, 29, 36, 32) | 61.1 Percentage of participants |
| Abatacept 3/3 | Long-term Period: Percentage of Participants Achieving American College of Rheumatology (ACR) 20, ACR 50, ACR 70, ACR 90 Responses at Days 365 and 729 | ACR 20, Day 729 (n=21, 18, 26, 18) | 65.4 Percentage of participants |
| Placebo | Long-term Period: Percentage of Participants Achieving American College of Rheumatology (ACR) 20, ACR 50, ACR 70, ACR 90 Responses at Days 365 and 729 | ACR 50, Day 365 (n=34, 29, 36, 32) | 34.4 Percentage of participants |
| Placebo | Long-term Period: Percentage of Participants Achieving American College of Rheumatology (ACR) 20, ACR 50, ACR 70, ACR 90 Responses at Days 365 and 729 | ACR 50, Day 729 (n=21, 18, 26, 18) | 55.6 Percentage of participants |
| Placebo | Long-term Period: Percentage of Participants Achieving American College of Rheumatology (ACR) 20, ACR 50, ACR 70, ACR 90 Responses at Days 365 and 729 | ACR 20, Day 729 (n=21, 18, 26, 18) | 72.2 Percentage of participants |
| Placebo | Long-term Period: Percentage of Participants Achieving American College of Rheumatology (ACR) 20, ACR 50, ACR 70, ACR 90 Responses at Days 365 and 729 | ACR 20, Day 365 (n=34, 29, 36, 32) | 46.9 Percentage of participants |
| Placebo | Long-term Period: Percentage of Participants Achieving American College of Rheumatology (ACR) 20, ACR 50, ACR 70, ACR 90 Responses at Days 365 and 729 | ACR 70, Day 365 (n=34, 29, 36, 32) | 18.8 Percentage of participants |
| Placebo | Long-term Period: Percentage of Participants Achieving American College of Rheumatology (ACR) 20, ACR 50, ACR 70, ACR 90 Responses at Days 365 and 729 | ACR 90, Day 729 (n=21, 18, 26, 18) | 0 Percentage of participants |
| Placebo | Long-term Period: Percentage of Participants Achieving American College of Rheumatology (ACR) 20, ACR 50, ACR 70, ACR 90 Responses at Days 365 and 729 | ACR 90, Day 365 (n=34, 29, 36, 32) | 6.3 Percentage of participants |
| Placebo | Long-term Period: Percentage of Participants Achieving American College of Rheumatology (ACR) 20, ACR 50, ACR 70, ACR 90 Responses at Days 365 and 729 | ACR 70, Day 729 (n=21, 18, 26, 18) | 11.1 Percentage of participants |
Secondary
Short-term Period: Mean Change From Baseline in Physical Component Summary Score as Measured by the Short-form 36 at Day 169
PCS=physical component score; MCS=mental component score. The Short-form 36 is a 36-item instrument with physical and mental components and covers quality of life (QoL) domains: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health. Responses are used to derive physical and mental component summary scores, ranging from 0 to 100, with higher scores indicating better QoL. Mean change from baseline=postbaseline value-baseline value; a higher value signifies improvement.
Time frame: At Day 169 from Baseline
Population: All randomized participants who received treatment and with baseline and postbaseline measurements at Day 169. Missing values were imputed by Last Observation Carried Forward, except for participants with only baseline observations.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Treated Participants | Short-term Period: Mean Change From Baseline in Physical Component Summary Score as Measured by the Short-form 36 at Day 169 | 7.30 Units on a scale | Standard Error 1.85 |
| Abatacept 10/10 | Short-term Period: Mean Change From Baseline in Physical Component Summary Score as Measured by the Short-form 36 at Day 169 | 9.27 Units on a scale | Standard Error 1.91 |
| Abatacept 3/3 | Short-term Period: Mean Change From Baseline in Physical Component Summary Score as Measured by the Short-form 36 at Day 169 | 6.32 Units on a scale | Standard Error 1.82 |
| Placebo | Short-term Period: Mean Change From Baseline in Physical Component Summary Score as Measured by the Short-form 36 at Day 169 | 0.15 Units on a scale | Standard Error 1.87 |
95% CI: [1.97, 12.33]ANCOVA
95% CI: [3.83, 14.41]ANCOVA
95% CI: [1.01, 11.32]ANCOVA
Secondary
Short-term Period: Mean Change From Baseline in the Mental Component Summary Score as Measured by the Short-form 36 at Day 169
PCS=physical component score; MCS=mental component score. The Short-form 36 is a 36-item instrument with physical and mental components and covers quality of life (QoL) domains: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health. Responses are used to derive physical and mental component summary scores, ranging from 0 to 100, with higher scores indicating better QoL. Mean change from baseline=postbaseline value-baseline value; a higher value signifies improvement.
Time frame: At Day 169 from Baseline
Population: All randomized and treated participants with baseline and postbaseline measurements at Day 169. Missing values were imputed by Last Observation Carried Forward, except for participants with only baseline observations.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Treated Participants | Short-term Period: Mean Change From Baseline in the Mental Component Summary Score as Measured by the Short-form 36 at Day 169 | 4.50 Units on a scale | Standard Error 2.45 |
| Abatacept 10/10 | Short-term Period: Mean Change From Baseline in the Mental Component Summary Score as Measured by the Short-form 36 at Day 169 | 4.42 Units on a scale | Standard Error 2.5 |
| Abatacept 3/3 | Short-term Period: Mean Change From Baseline in the Mental Component Summary Score as Measured by the Short-form 36 at Day 169 | 3.16 Units on a scale | Standard Error 2.41 |
| Placebo | Short-term Period: Mean Change From Baseline in the Mental Component Summary Score as Measured by the Short-form 36 at Day 169 | 2.41 Units on a scale | Standard Error 2.47 |
95% CI: [-4.79, 8.96]ANCOVA
95% CI: [-4.94, 8.95]ANCOVA
95% CI: [-6.08, 7.58]ANCOVA
Secondary
Short-term Period: Mean Percentage of Change From Baseline in Target Lesion Score at Day 169
Target lesion score measures the degree of erythema, induration, and scale of a psoriatic lesion with a diameter of at least 2 cm, selected as a target for response throughout the study period. Scores: 0=clear, 1=almost clear, 2=mild clear, 3=moderate disease, 4=severe. Percent improvement from baseline was computed using the ratio of improvement from baseline to the baseline value.
Time frame: At Day 169 from Baseline
Population: All randomized participants who received at least 1 infusion of study drug in double-blind (short-term) period. Only participants with both baseline and postbaseline values included. Missing values at Day 169 were imputed using the last observation carried forward values, except for participants with only baseline value.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Treated Participants | Short-term Period: Mean Percentage of Change From Baseline in Target Lesion Score at Day 169 | 19.39 Percentage of change | Standard Error 9.16 |
| Abatacept 10/10 | Short-term Period: Mean Percentage of Change From Baseline in Target Lesion Score at Day 169 | 22.96 Percentage of change | Standard Error 9.46 |
| Abatacept 3/3 | Short-term Period: Mean Percentage of Change From Baseline in Target Lesion Score at Day 169 | 31.11 Percentage of change | Standard Error 8.98 |
| Placebo | Short-term Period: Mean Percentage of Change From Baseline in Target Lesion Score at Day 169 | 0.63 Percentage of change | Standard Error 9.35 |
95% CI: [-7.02, 44.56]ANCOVA
95% CI: [-3.93, 48.6]ANCOVA
95% CI: [4.82, 56.15]ANCOVA
Secondary
Short-term Period: Mean Serum Concentrations of Abatacept
Abatacept was assayed using a validated enzyme linked immunosorbent assay method (ELISA). Serum concentration versus time data was analyzed in the descriptive pharmacokinetic (PK) analysis.
Time frame: Days 1, 15, 29, 57, 85, 113, 141, and 169
Population: All participants who received at least 1 infusion of study medication and were evaluable for PK analysis during double-blind period. n= number of participants with evaluable PK results in each arm respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Treated Participants | Short-term Period: Mean Serum Concentrations of Abatacept | Day 1 (n= 13, 13, 44) | 0 µg/mL | Standard Deviation 0 |
| All Treated Participants | Short-term Period: Mean Serum Concentrations of Abatacept | Day 15 (n= 43, 38, 42) | 119.99 µg/mL | Standard Deviation 35.3 |
| All Treated Participants | Short-term Period: Mean Serum Concentrations of Abatacept | Day 29 (n= 41, 39, 43) | 186.82 µg/mL | Standard Deviation 62.49 |
| All Treated Participants | Short-term Period: Mean Serum Concentrations of Abatacept | Day 57 (n= 40, 39, 44) | 58.55 µg/mL | Standard Deviation 26.09 |
| All Treated Participants | Short-term Period: Mean Serum Concentrations of Abatacept | Day 85 (n= 37, 35, 41) | 39.00 µg/mL | Standard Deviation 19.37 |
| All Treated Participants | Short-term Period: Mean Serum Concentrations of Abatacept | Day 113 ( n= 35, 33, 43) | 36.30 µg/mL | Standard Deviation 19.94 |
| All Treated Participants | Short-term Period: Mean Serum Concentrations of Abatacept | Day 141 (n= 35, 34, 42) | 26.70 µg/mL | Standard Deviation 9.24 |
| All Treated Participants | Short-term Period: Mean Serum Concentrations of Abatacept | Day 169 (n= 36, 42, 34) | 28.93 µg/mL | Standard Deviation 11.29 |
| Abatacept 10/10 | Short-term Period: Mean Serum Concentrations of Abatacept | Day 29 (n= 41, 39, 43) | 49.70 µg/mL | Standard Deviation 16.79 |
| Abatacept 10/10 | Short-term Period: Mean Serum Concentrations of Abatacept | Day 141 (n= 35, 34, 42) | 25.78 µg/mL | Standard Deviation 9.74 |
| Abatacept 10/10 | Short-term Period: Mean Serum Concentrations of Abatacept | Day 57 (n= 40, 39, 44) | 25.75 µg/mL | Standard Deviation 9.67 |
| Abatacept 10/10 | Short-term Period: Mean Serum Concentrations of Abatacept | Day 85 (n= 37, 35, 41) | 26.29 µg/mL | Standard Deviation 10.59 |
| Abatacept 10/10 | Short-term Period: Mean Serum Concentrations of Abatacept | Day 113 ( n= 35, 33, 43) | 32.69 µg/mL | Standard Deviation 14.08 |
| Abatacept 10/10 | Short-term Period: Mean Serum Concentrations of Abatacept | Day 1 (n= 13, 13, 44) | 0.01 µg/mL | Standard Deviation 0.01 |
| Abatacept 10/10 | Short-term Period: Mean Serum Concentrations of Abatacept | Day 15 (n= 43, 38, 42) | 48.29 µg/mL | Standard Deviation 17.96 |
| Abatacept 10/10 | Short-term Period: Mean Serum Concentrations of Abatacept | Day 169 (n= 36, 42, 34) | 26.34 µg/mL | Standard Deviation 10.75 |
| Abatacept 3/3 | Short-term Period: Mean Serum Concentrations of Abatacept | Day 29 (n= 41, 39, 43) | 16.20 µg/mL | Standard Deviation 4.86 |
| Abatacept 3/3 | Short-term Period: Mean Serum Concentrations of Abatacept | Day 15 (n= 43, 38, 42) | 14.28 µg/mL | Standard Deviation 7.67 |
| Abatacept 3/3 | Short-term Period: Mean Serum Concentrations of Abatacept | Day 1 (n= 13, 13, 44) | 0 µg/mL | Standard Deviation 0 |
| Abatacept 3/3 | Short-term Period: Mean Serum Concentrations of Abatacept | Day 57 (n= 40, 39, 44) | 10.42 µg/mL | Standard Deviation 5.75 |
| Abatacept 3/3 | Short-term Period: Mean Serum Concentrations of Abatacept | Day 141 (n= 35, 34, 42) | 7.66 µg/mL | Standard Deviation 3.13 |
| Abatacept 3/3 | Short-term Period: Mean Serum Concentrations of Abatacept | Day 113 ( n= 35, 33, 43) | 8.85 µg/mL | Standard Deviation 5.01 |
| Abatacept 3/3 | Short-term Period: Mean Serum Concentrations of Abatacept | Day 85 (n= 37, 35, 41) | 8.73 µg/mL | Standard Deviation 3.26 |
| Abatacept 3/3 | Short-term Period: Mean Serum Concentrations of Abatacept | Day 169 (n= 36, 42, 34) | 9.29 µg/mL | Standard Deviation 5.23 |
Secondary
Short-term Period: Mean Serum Trough Concentrations (Cmin) of Abatacept
Abatacept was assayed using a validated ELISA method. Cmin of abatacept was obtained from concentration versus time data.
Time frame: Days 1, 15, 29, 57, 85, 113, 141, and 169
Population: All participants who received at least 1 infusion of study medication and were evaluable for PK analysis during double-blind period. n= number of participants with evaluable PK results in each arm respectively.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| All Treated Participants | Short-term Period: Mean Serum Trough Concentrations (Cmin) of Abatacept | Day 15 (n= 43, 38, 43) | 115.35 µg/mL |
| All Treated Participants | Short-term Period: Mean Serum Trough Concentrations (Cmin) of Abatacept | Day 29 (n= 41, 39, 43) | 176.22 µg/mL |
| All Treated Participants | Short-term Period: Mean Serum Trough Concentrations (Cmin) of Abatacept | Day 57 (n= 40, 39, 44) | 53.08 µg/mL |
| All Treated Participants | Short-term Period: Mean Serum Trough Concentrations (Cmin) of Abatacept | Day 113 (n= 35, 33, 43) | 31.50 µg/mL |
| All Treated Participants | Short-term Period: Mean Serum Trough Concentrations (Cmin) of Abatacept | Day 141 (n= 35, 34, 42) | 25.02 µg/mL |
| All Treated Participants | Short-term Period: Mean Serum Trough Concentrations (Cmin) of Abatacept | Day 169 (n= 36, 34, 42) | 26.65 µg/mL |
| All Treated Participants | Short-term Period: Mean Serum Trough Concentrations (Cmin) of Abatacept | Day 85 (n= 37, 35, 41) | 33.09 µg/mL |
| Abatacept 10/10 | Short-term Period: Mean Serum Trough Concentrations (Cmin) of Abatacept | Day 57 (n= 40, 39, 44) | 23.88 µg/mL |
| Abatacept 10/10 | Short-term Period: Mean Serum Trough Concentrations (Cmin) of Abatacept | Day 85 (n= 37, 35, 41) | 24.36 µg/mL |
| Abatacept 10/10 | Short-term Period: Mean Serum Trough Concentrations (Cmin) of Abatacept | Day 113 (n= 35, 33, 43) | 29.60 µg/mL |
| Abatacept 10/10 | Short-term Period: Mean Serum Trough Concentrations (Cmin) of Abatacept | Day 169 (n= 36, 34, 42) | 24.33 µg/mL |
| Abatacept 10/10 | Short-term Period: Mean Serum Trough Concentrations (Cmin) of Abatacept | Day 15 (n= 43, 38, 43) | 45.10 µg/mL |
| Abatacept 10/10 | Short-term Period: Mean Serum Trough Concentrations (Cmin) of Abatacept | Day 141 (n= 35, 34, 42) | 23.62 µg/mL |
| Abatacept 10/10 | Short-term Period: Mean Serum Trough Concentrations (Cmin) of Abatacept | Day 29 (n= 41, 39, 43) | 46.86 µg/mL |
| Abatacept 3/3 | Short-term Period: Mean Serum Trough Concentrations (Cmin) of Abatacept | Day 29 (n= 41, 39, 43) | 15.43 µg/mL |
| Abatacept 3/3 | Short-term Period: Mean Serum Trough Concentrations (Cmin) of Abatacept | Day 57 (n= 40, 39, 44) | 9.03 µg/mL |
| Abatacept 3/3 | Short-term Period: Mean Serum Trough Concentrations (Cmin) of Abatacept | Day 141 (n= 35, 34, 42) | 6.91 µg/mL |
| Abatacept 3/3 | Short-term Period: Mean Serum Trough Concentrations (Cmin) of Abatacept | Day 85 (n= 37, 35, 41) | 8.15 µg/mL |
| Abatacept 3/3 | Short-term Period: Mean Serum Trough Concentrations (Cmin) of Abatacept | Day 169 (n= 36, 34, 42) | 7.84 µg/mL |
| Abatacept 3/3 | Short-term Period: Mean Serum Trough Concentrations (Cmin) of Abatacept | Day 15 (n= 43, 38, 43) | 12.81 µg/mL |
| Abatacept 3/3 | Short-term Period: Mean Serum Trough Concentrations (Cmin) of Abatacept | Day 113 (n= 35, 33, 43) | 7.56 µg/mL |
Secondary
Short-term Period: Number of Participants Achieving a Reduction of At Least 0.3 Unit From Baseline in HAQ-DI Scores at Day 169
The HAQ-DI assesses a participant's ability to perform the following tasks: dress/groom; arise; eat; walk; reach; grip; maintain hygiene; and maintain daily activity over a period by marking their response on a questionnaire. Responses/scores range from: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=to unable to do. Higher total score=greater disability.
Time frame: At Day 169 from Baseline
Population: All randomized participants who received at least 1 infusion of study medication at any time. Missing response values were imputed as nonresponders for participants who discontinued early after receiving study medication.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Treated Participants | Short-term Period: Number of Participants Achieving a Reduction of At Least 0.3 Unit From Baseline in HAQ-DI Scores at Day 169 | 15 Participants |
| Abatacept 10/10 | Short-term Period: Number of Participants Achieving a Reduction of At Least 0.3 Unit From Baseline in HAQ-DI Scores at Day 169 | 18 Participants |
| Abatacept 3/3 | Short-term Period: Number of Participants Achieving a Reduction of At Least 0.3 Unit From Baseline in HAQ-DI Scores at Day 169 | 16 Participants |
| Placebo | Short-term Period: Number of Participants Achieving a Reduction of At Least 0.3 Unit From Baseline in HAQ-DI Scores at Day 169 | 8 Participants |
95% CI: [-2.5, 34.5]Cochran-Mantel-Haenszel
95% CI: [6.8, 45.5]Cochran-Mantel-Haenszel
95% CI: [-1.8, 34.9]Cochran-Mantel-Haenszel
Secondary
Short-term Period: Number of Participants Who Died and With SAEs, AEs, AEs Leading to Discontinuation, SAEs Leading to Discontinuation, Drug-related AEs, and Drug-related SAEs
An AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. An SAE is any unfavorable medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency or abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Drug-related=possibly, probably, or certainly related to and of unknown relationship to study treatment.
Time frame: From Baseline to Day 169
Population: All participants who received at least 1 infusion of study medication during the double-blind period.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Treated Participants | Short-term Period: Number of Participants Who Died and With SAEs, AEs, AEs Leading to Discontinuation, SAEs Leading to Discontinuation, Drug-related AEs, and Drug-related SAEs | Deaths | 0 Participants |
| All Treated Participants | Short-term Period: Number of Participants Who Died and With SAEs, AEs, AEs Leading to Discontinuation, SAEs Leading to Discontinuation, Drug-related AEs, and Drug-related SAEs | Drug-related AEs | 13 Participants |
| All Treated Participants | Short-term Period: Number of Participants Who Died and With SAEs, AEs, AEs Leading to Discontinuation, SAEs Leading to Discontinuation, Drug-related AEs, and Drug-related SAEs | All SAEs Leading to Discontinuation | 1 Participants |
| All Treated Participants | Short-term Period: Number of Participants Who Died and With SAEs, AEs, AEs Leading to Discontinuation, SAEs Leading to Discontinuation, Drug-related AEs, and Drug-related SAEs | SAEs | 4 Participants |
| All Treated Participants | Short-term Period: Number of Participants Who Died and With SAEs, AEs, AEs Leading to Discontinuation, SAEs Leading to Discontinuation, Drug-related AEs, and Drug-related SAEs | Drug-related SAEs | 1 Participants |
| All Treated Participants | Short-term Period: Number of Participants Who Died and With SAEs, AEs, AEs Leading to Discontinuation, SAEs Leading to Discontinuation, Drug-related AEs, and Drug-related SAEs | AEs | 29 Participants |
| All Treated Participants | Short-term Period: Number of Participants Who Died and With SAEs, AEs, AEs Leading to Discontinuation, SAEs Leading to Discontinuation, Drug-related AEs, and Drug-related SAEs | All AEs Leading to Discontinuation | 1 Participants |
| Abatacept 10/10 | Short-term Period: Number of Participants Who Died and With SAEs, AEs, AEs Leading to Discontinuation, SAEs Leading to Discontinuation, Drug-related AEs, and Drug-related SAEs | Drug-related AEs | 13 Participants |
| Abatacept 10/10 | Short-term Period: Number of Participants Who Died and With SAEs, AEs, AEs Leading to Discontinuation, SAEs Leading to Discontinuation, Drug-related AEs, and Drug-related SAEs | All AEs Leading to Discontinuation | 2 Participants |
| Abatacept 10/10 | Short-term Period: Number of Participants Who Died and With SAEs, AEs, AEs Leading to Discontinuation, SAEs Leading to Discontinuation, Drug-related AEs, and Drug-related SAEs | AEs | 31 Participants |
| Abatacept 10/10 | Short-term Period: Number of Participants Who Died and With SAEs, AEs, AEs Leading to Discontinuation, SAEs Leading to Discontinuation, Drug-related AEs, and Drug-related SAEs | All SAEs Leading to Discontinuation | 0 Participants |
| Abatacept 10/10 | Short-term Period: Number of Participants Who Died and With SAEs, AEs, AEs Leading to Discontinuation, SAEs Leading to Discontinuation, Drug-related AEs, and Drug-related SAEs | Drug-related SAEs | 1 Participants |
| Abatacept 10/10 | Short-term Period: Number of Participants Who Died and With SAEs, AEs, AEs Leading to Discontinuation, SAEs Leading to Discontinuation, Drug-related AEs, and Drug-related SAEs | SAEs | 2 Participants |
| Abatacept 10/10 | Short-term Period: Number of Participants Who Died and With SAEs, AEs, AEs Leading to Discontinuation, SAEs Leading to Discontinuation, Drug-related AEs, and Drug-related SAEs | Deaths | 0 Participants |
| Abatacept 3/3 | Short-term Period: Number of Participants Who Died and With SAEs, AEs, AEs Leading to Discontinuation, SAEs Leading to Discontinuation, Drug-related AEs, and Drug-related SAEs | All AEs Leading to Discontinuation | 1 Participants |
| Abatacept 3/3 | Short-term Period: Number of Participants Who Died and With SAEs, AEs, AEs Leading to Discontinuation, SAEs Leading to Discontinuation, Drug-related AEs, and Drug-related SAEs | Deaths | 0 Participants |
| Abatacept 3/3 | Short-term Period: Number of Participants Who Died and With SAEs, AEs, AEs Leading to Discontinuation, SAEs Leading to Discontinuation, Drug-related AEs, and Drug-related SAEs | SAEs | 0 Participants |
| Abatacept 3/3 | Short-term Period: Number of Participants Who Died and With SAEs, AEs, AEs Leading to Discontinuation, SAEs Leading to Discontinuation, Drug-related AEs, and Drug-related SAEs | AEs | 31 Participants |
| Abatacept 3/3 | Short-term Period: Number of Participants Who Died and With SAEs, AEs, AEs Leading to Discontinuation, SAEs Leading to Discontinuation, Drug-related AEs, and Drug-related SAEs | All SAEs Leading to Discontinuation | 0 Participants |
| Abatacept 3/3 | Short-term Period: Number of Participants Who Died and With SAEs, AEs, AEs Leading to Discontinuation, SAEs Leading to Discontinuation, Drug-related AEs, and Drug-related SAEs | Drug-related AEs | 12 Participants |
| Abatacept 3/3 | Short-term Period: Number of Participants Who Died and With SAEs, AEs, AEs Leading to Discontinuation, SAEs Leading to Discontinuation, Drug-related AEs, and Drug-related SAEs | Drug-related SAEs | 0 Participants |
| Placebo | Short-term Period: Number of Participants Who Died and With SAEs, AEs, AEs Leading to Discontinuation, SAEs Leading to Discontinuation, Drug-related AEs, and Drug-related SAEs | AEs | 30 Participants |
| Placebo | Short-term Period: Number of Participants Who Died and With SAEs, AEs, AEs Leading to Discontinuation, SAEs Leading to Discontinuation, Drug-related AEs, and Drug-related SAEs | Drug-related SAEs | 0 Participants |
| Placebo | Short-term Period: Number of Participants Who Died and With SAEs, AEs, AEs Leading to Discontinuation, SAEs Leading to Discontinuation, Drug-related AEs, and Drug-related SAEs | Drug-related AEs | 7 Participants |
| Placebo | Short-term Period: Number of Participants Who Died and With SAEs, AEs, AEs Leading to Discontinuation, SAEs Leading to Discontinuation, Drug-related AEs, and Drug-related SAEs | SAEs | 1 Participants |
| Placebo | Short-term Period: Number of Participants Who Died and With SAEs, AEs, AEs Leading to Discontinuation, SAEs Leading to Discontinuation, Drug-related AEs, and Drug-related SAEs | Deaths | 0 Participants |
| Placebo | Short-term Period: Number of Participants Who Died and With SAEs, AEs, AEs Leading to Discontinuation, SAEs Leading to Discontinuation, Drug-related AEs, and Drug-related SAEs | All SAEs Leading to Discontinuation | 0 Participants |
| Placebo | Short-term Period: Number of Participants Who Died and With SAEs, AEs, AEs Leading to Discontinuation, SAEs Leading to Discontinuation, Drug-related AEs, and Drug-related SAEs | All AEs Leading to Discontinuation | 3 Participants |
Secondary
Short-term Period: Number of Participants With an IGA Score of Clear or Almost Clear at Day 169
Score indicates lesion induration, scaling, and erythema: 0 = clear (no signs of plaque psoriasis except for residual discoloration); 1 = almost clear (just perceptible erythema, no induration to very slightly elevated above normal skin levels, limited amount of very fine scaling); 2 = mild disease (mild erythema, mild induration, mainly fine scaling predominates); 3 = moderate disease (moderate erythema \[most plaques are red\], moderate induration and/or coarse scale predominates); 4=severe (severe erythema, marked to very marked elevation of lesions, coarse thick scale predominates).
Time frame: At Day 169 from Baseline
Population: All randomized participants who received at least 1 infusion of study medication in double-blind (short-term) period. Missing response values were imputed as nonresponders for participants who discontinued early after receiving study medication.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Treated Participants | Short-term Period: Number of Participants With an IGA Score of Clear or Almost Clear at Day 169 | 9 Participants |
| Abatacept 10/10 | Short-term Period: Number of Participants With an IGA Score of Clear or Almost Clear at Day 169 | 10 Participants |
| Abatacept 3/3 | Short-term Period: Number of Participants With an IGA Score of Clear or Almost Clear at Day 169 | 17 Participants |
| Placebo | Short-term Period: Number of Participants With an IGA Score of Clear or Almost Clear at Day 169 | 11 Participants |
95% CI: [-23, 11]Cochran-Mantel-Haenszel
95% CI: [-18, 17.1]Cochran-Mantel-Haenszel
95% CI: [-7.6, 28.5]Cochran-Mantel-Haenszel
Secondary
Short-term Period: Number of Participants With Marked Abnormalities in Hematology
LLN=lower limit of normal; ULN=upper limit of normal; pre-Rx=pretreatment. Marked abnormalities are laboratory measurements marked as abnormal, per predefined study criteria, at any study time point. Criteria: Hemoglobin \>3 g/dL decrease from pre-Rx value; hematocrit \<0.75\*pre-Rx value; erythrocytes \<0.75\*pre-Rx value; platelets \<0.67\*LLN (or, if pre-Rx value \<LLN, \<0.5\*pre-Rx value and \<100000/mm\^3) or \>1.5\*ULN.
Time frame: From Baseline to Day 169
Population: All participants who received at least 1 infusion of study medication during double-blind period. n=number of participants with evaluable results (each arm respectively).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Treated Participants | Short-term Period: Number of Participants With Marked Abnormalities in Hematology | Hemoglobin (n = 43, 40, 45, 41) | 0 Participants |
| All Treated Participants | Short-term Period: Number of Participants With Marked Abnormalities in Hematology | Hematocrit (n = 43, 40, 45, 41) | 0 Participants |
| All Treated Participants | Short-term Period: Number of Participants With Marked Abnormalities in Hematology | Erythrocytes (n = 43, 40, 45, 41) | 0 Participants |
| All Treated Participants | Short-term Period: Number of Participants With Marked Abnormalities in Hematology | Platelet count (n = 43, 40, 45, 41) | 0 Participants |
| Abatacept 10/10 | Short-term Period: Number of Participants With Marked Abnormalities in Hematology | Hematocrit (n = 43, 40, 45, 41) | 0 Participants |
| Abatacept 10/10 | Short-term Period: Number of Participants With Marked Abnormalities in Hematology | Erythrocytes (n = 43, 40, 45, 41) | 0 Participants |
| Abatacept 10/10 | Short-term Period: Number of Participants With Marked Abnormalities in Hematology | Platelet count (n = 43, 40, 45, 41) | 0 Participants |
| Abatacept 10/10 | Short-term Period: Number of Participants With Marked Abnormalities in Hematology | Hemoglobin (n = 43, 40, 45, 41) | 0 Participants |
| Abatacept 3/3 | Short-term Period: Number of Participants With Marked Abnormalities in Hematology | Erythrocytes (n = 43, 40, 45, 41) | 0 Participants |
| Abatacept 3/3 | Short-term Period: Number of Participants With Marked Abnormalities in Hematology | Hematocrit (n = 43, 40, 45, 41) | 0 Participants |
| Abatacept 3/3 | Short-term Period: Number of Participants With Marked Abnormalities in Hematology | Platelet count (n = 43, 40, 45, 41) | 0 Participants |
| Abatacept 3/3 | Short-term Period: Number of Participants With Marked Abnormalities in Hematology | Hemoglobin (n = 43, 40, 45, 41) | 0 Participants |
| Placebo | Short-term Period: Number of Participants With Marked Abnormalities in Hematology | Platelet count (n = 43, 40, 45, 41) | 0 Participants |
| Placebo | Short-term Period: Number of Participants With Marked Abnormalities in Hematology | Hematocrit (n = 43, 40, 45, 41) | 0 Participants |
| Placebo | Short-term Period: Number of Participants With Marked Abnormalities in Hematology | Hemoglobin (n = 43, 40, 45, 41) | 0 Participants |
| Placebo | Short-term Period: Number of Participants With Marked Abnormalities in Hematology | Erythrocytes (n = 43, 40, 45, 41) | 0 Participants |
Secondary
Short-term Period: Number of Participants With Marked Abnormalities in Hematology (Continued)
LLN=lower limit of normal; ULN=upper limit of normal; pre-Rx=pretreatment. Laboratory measurements are marked as abnormal per predefined study criteria, at any study time point. Criteria for the data presented. Leukocytes \<0.75\*LLN or \>1.25\*ULN (or, if pre-Rx value \<LLN, \<0.8\*pre-Rx or \>ULN. If pre-Rx value \>ULN, \>1.2\*pre-Rx or \<LLN); neutrophils+bands (absolute) \<1.00\*10\^3 c/uL; lymphocytes (absolute) \<0.75\*10\^3 c/uL or \>7.50\*10\^3 c/uL; monocytes (absolute) \>2000/mm\^3; basophils (absolute) \>0.40\*10\^3 c/uL; eosinophils (absolute) \>0.75\*10\^3 c/uL.
Time frame: From Baseline to Day 169
Population: All participants who received at least 1 infusion of study medication during double-blind period. n=number of participants with evaluable results (each arm respectively).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Treated Participants | Short-term Period: Number of Participants With Marked Abnormalities in Hematology (Continued) | Neutrophils+bands (absolute) (n = 43, 40, 45, 41) | 0 Participants |
| All Treated Participants | Short-term Period: Number of Participants With Marked Abnormalities in Hematology (Continued) | Leukocytes (n = 43, 40, 45, 41) | 0 Participants |
| All Treated Participants | Short-term Period: Number of Participants With Marked Abnormalities in Hematology (Continued) | Monocytes (absolute) (n = 43, 40, 45, 41) | 0 Participants |
| All Treated Participants | Short-term Period: Number of Participants With Marked Abnormalities in Hematology (Continued) | Eosinophils (absolute) (n = 43, 40, 45, 41) | 1 Participants |
| All Treated Participants | Short-term Period: Number of Participants With Marked Abnormalities in Hematology (Continued) | Basophils (absolute) (n = 43, 40, 45, 41) | 0 Participants |
| All Treated Participants | Short-term Period: Number of Participants With Marked Abnormalities in Hematology (Continued) | Lymphocytes (absolute) (n = 43, 40, 45, 41) | 2 Participants |
| Abatacept 10/10 | Short-term Period: Number of Participants With Marked Abnormalities in Hematology (Continued) | Neutrophils+bands (absolute) (n = 43, 40, 45, 41) | 0 Participants |
| Abatacept 10/10 | Short-term Period: Number of Participants With Marked Abnormalities in Hematology (Continued) | Eosinophils (absolute) (n = 43, 40, 45, 41) | 1 Participants |
| Abatacept 10/10 | Short-term Period: Number of Participants With Marked Abnormalities in Hematology (Continued) | Leukocytes (n = 43, 40, 45, 41) | 0 Participants |
| Abatacept 10/10 | Short-term Period: Number of Participants With Marked Abnormalities in Hematology (Continued) | Basophils (absolute) (n = 43, 40, 45, 41) | 0 Participants |
| Abatacept 10/10 | Short-term Period: Number of Participants With Marked Abnormalities in Hematology (Continued) | Lymphocytes (absolute) (n = 43, 40, 45, 41) | 0 Participants |
| Abatacept 10/10 | Short-term Period: Number of Participants With Marked Abnormalities in Hematology (Continued) | Monocytes (absolute) (n = 43, 40, 45, 41) | 0 Participants |
| Abatacept 3/3 | Short-term Period: Number of Participants With Marked Abnormalities in Hematology (Continued) | Eosinophils (absolute) (n = 43, 40, 45, 41) | 1 Participants |
| Abatacept 3/3 | Short-term Period: Number of Participants With Marked Abnormalities in Hematology (Continued) | Neutrophils+bands (absolute) (n = 43, 40, 45, 41) | 0 Participants |
| Abatacept 3/3 | Short-term Period: Number of Participants With Marked Abnormalities in Hematology (Continued) | Leukocytes (n = 43, 40, 45, 41) | 2 Participants |
| Abatacept 3/3 | Short-term Period: Number of Participants With Marked Abnormalities in Hematology (Continued) | Basophils (absolute) (n = 43, 40, 45, 41) | 0 Participants |
| Abatacept 3/3 | Short-term Period: Number of Participants With Marked Abnormalities in Hematology (Continued) | Lymphocytes (absolute) (n = 43, 40, 45, 41) | 6 Participants |
| Abatacept 3/3 | Short-term Period: Number of Participants With Marked Abnormalities in Hematology (Continued) | Monocytes (absolute) (n = 43, 40, 45, 41) | 0 Participants |
| Placebo | Short-term Period: Number of Participants With Marked Abnormalities in Hematology (Continued) | Eosinophils (absolute) (n = 43, 40, 45, 41) | 0 Participants |
| Placebo | Short-term Period: Number of Participants With Marked Abnormalities in Hematology (Continued) | Neutrophils+bands (absolute) (n = 43, 40, 45, 41) | 0 Participants |
| Placebo | Short-term Period: Number of Participants With Marked Abnormalities in Hematology (Continued) | Monocytes (absolute) (n = 43, 40, 45, 41) | 0 Participants |
| Placebo | Short-term Period: Number of Participants With Marked Abnormalities in Hematology (Continued) | Lymphocytes (absolute) (n = 43, 40, 45, 41) | 1 Participants |
| Placebo | Short-term Period: Number of Participants With Marked Abnormalities in Hematology (Continued) | Basophils (absolute) (n = 43, 40, 45, 41) | 0 Participants |
| Placebo | Short-term Period: Number of Participants With Marked Abnormalities in Hematology (Continued) | Leukocytes (n = 43, 40, 45, 41) | 0 Participants |
Secondary
Short-term Period: Number of Participants With Marked Abnormalities in Serum Chemistry
ULN=upper limit of normal; pre-Rx=pretreatment. Marked abnormality criteria: Alkaline phosphatase (ALP), gamma-glutamyltransferase (GGT) \>2\*ULN (if pre-Rx \>ULN, \>3\*pre-Rx); aspartate aminotransferase (AST), alanine transaminase (ALT) \>3\*ULN (if pre-Rx \>ULN, \>4\*pre-Rx); bilirubin (total) \>2\*ULN (if pre-Rx \>ULN, \>4\*pre-Rx); blood urea nitrogen (BUN) \>2\*pre-Rx; creatinine \>1.5\*pre-Rx.
Time frame: Baseline to Day 169
Population: All participants who received at least 1 infusion of study medication during the double-blind period. n=number of participants with evaluable results (each arm respectively).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Treated Participants | Short-term Period: Number of Participants With Marked Abnormalities in Serum Chemistry | ALP (n = 43, 40, 45, 41) | 0 Participants |
| All Treated Participants | Short-term Period: Number of Participants With Marked Abnormalities in Serum Chemistry | BUN (n = 43, 40, 45, 41) | 0 Participants |
| All Treated Participants | Short-term Period: Number of Participants With Marked Abnormalities in Serum Chemistry | Bilirubin (total) (n = 43, 40, 45, 41) | 0 Participants |
| All Treated Participants | Short-term Period: Number of Participants With Marked Abnormalities in Serum Chemistry | AST (n = 43, 40, 45, 41) | 0 Participants |
| All Treated Participants | Short-term Period: Number of Participants With Marked Abnormalities in Serum Chemistry | Creatinine (n = 43, 40, 45, 41) | 0 Participants |
| All Treated Participants | Short-term Period: Number of Participants With Marked Abnormalities in Serum Chemistry | ALT (n = 43, 40, 45, 41) | 1 Participants |
| All Treated Participants | Short-term Period: Number of Participants With Marked Abnormalities in Serum Chemistry | GGT (n = 43, 40, 45, 41) | 1 Participants |
| Abatacept 10/10 | Short-term Period: Number of Participants With Marked Abnormalities in Serum Chemistry | BUN (n = 43, 40, 45, 41) | 0 Participants |
| Abatacept 10/10 | Short-term Period: Number of Participants With Marked Abnormalities in Serum Chemistry | GGT (n = 43, 40, 45, 41) | 0 Participants |
| Abatacept 10/10 | Short-term Period: Number of Participants With Marked Abnormalities in Serum Chemistry | ALT (n = 43, 40, 45, 41) | 0 Participants |
| Abatacept 10/10 | Short-term Period: Number of Participants With Marked Abnormalities in Serum Chemistry | Bilirubin (total) (n = 43, 40, 45, 41) | 0 Participants |
| Abatacept 10/10 | Short-term Period: Number of Participants With Marked Abnormalities in Serum Chemistry | Creatinine (n = 43, 40, 45, 41) | 0 Participants |
| Abatacept 10/10 | Short-term Period: Number of Participants With Marked Abnormalities in Serum Chemistry | AST (n = 43, 40, 45, 41) | 0 Participants |
| Abatacept 10/10 | Short-term Period: Number of Participants With Marked Abnormalities in Serum Chemistry | ALP (n = 43, 40, 45, 41) | 0 Participants |
| Abatacept 3/3 | Short-term Period: Number of Participants With Marked Abnormalities in Serum Chemistry | GGT (n = 43, 40, 45, 41) | 0 Participants |
| Abatacept 3/3 | Short-term Period: Number of Participants With Marked Abnormalities in Serum Chemistry | ALP (n = 43, 40, 45, 41) | 0 Participants |
| Abatacept 3/3 | Short-term Period: Number of Participants With Marked Abnormalities in Serum Chemistry | AST (n = 43, 40, 45, 41) | 0 Participants |
| Abatacept 3/3 | Short-term Period: Number of Participants With Marked Abnormalities in Serum Chemistry | ALT (n = 43, 40, 45, 41) | 0 Participants |
| Abatacept 3/3 | Short-term Period: Number of Participants With Marked Abnormalities in Serum Chemistry | Bilirubin (total) (n = 43, 40, 45, 41) | 0 Participants |
| Abatacept 3/3 | Short-term Period: Number of Participants With Marked Abnormalities in Serum Chemistry | BUN (n = 43, 40, 45, 41) | 0 Participants |
| Abatacept 3/3 | Short-term Period: Number of Participants With Marked Abnormalities in Serum Chemistry | Creatinine (n = 43, 40, 45, 41) | 0 Participants |
| Placebo | Short-term Period: Number of Participants With Marked Abnormalities in Serum Chemistry | ALT (n = 43, 40, 45, 41) | 0 Participants |
| Placebo | Short-term Period: Number of Participants With Marked Abnormalities in Serum Chemistry | Creatinine (n = 43, 40, 45, 41) | 0 Participants |
| Placebo | Short-term Period: Number of Participants With Marked Abnormalities in Serum Chemistry | BUN (n = 43, 40, 45, 41) | 0 Participants |
| Placebo | Short-term Period: Number of Participants With Marked Abnormalities in Serum Chemistry | AST (n = 43, 40, 45, 41) | 0 Participants |
| Placebo | Short-term Period: Number of Participants With Marked Abnormalities in Serum Chemistry | ALP (n = 43, 40, 45, 41) | 0 Participants |
| Placebo | Short-term Period: Number of Participants With Marked Abnormalities in Serum Chemistry | Bilirubin (total) (n = 43, 40, 45, 41) | 0 Participants |
| Placebo | Short-term Period: Number of Participants With Marked Abnormalities in Serum Chemistry | GGT (n = 43, 40, 45, 41) | 0 Participants |
Secondary
Short-term Period: Number of Participants With Marked Abnormalities in Serum Chemistry (Continued)
LLN=lower limit of normal; ULN=upper limit of normal; pre-Rx=pretreatment. Marked abnormality criteria: Sodium \<0.95\*LLN or \>1.05\*ULN (if pre-Rx\<LLN, \<0.95\*pre-Rx or \>ULN. If pre-Rx \>ULN,\>1.05\* pre-Rx or \<LLN); potassium, chloride \<0.9\*LLN or \>1.1\*ULN (if pre-Rx \<LLN, \<0.9\*pre-Rx or \>ULN. If pre-Rx \>ULN, \>1.1\*pre-Rx or \<LLN); calcium \<0.8\*LLN or \>1.2\*ULN (if pre-Rx \<LLN,\<0.75\* pre-Rx or \>ULN. If pre-Rx \>ULN, \>1.25\* pre-Rx or \<LLN); phosphorous \<0.75\*LLN or \>1.25\*ULN (if pre-Rx \<LLN, \<0.67\*pre-Rx or \>ULN. If pre-Rx \>ULN, \>1.33\*pre-Rx or \<LLN.
Time frame: Baseline to Day 169
Population: All participants who received at least 1 infusion of study medication during the double-blind period. n=number of participants with evaluable results (each arm respectively).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Treated Participants | Short-term Period: Number of Participants With Marked Abnormalities in Serum Chemistry (Continued) | Phosphorous , inorganic (n = 43, 40, 45, 41) | 0 Participants |
| All Treated Participants | Short-term Period: Number of Participants With Marked Abnormalities in Serum Chemistry (Continued) | Chloride (n = 43, 40, 45, 41) | 0 Participants |
| All Treated Participants | Short-term Period: Number of Participants With Marked Abnormalities in Serum Chemistry (Continued) | Sodium (n = 43, 40, 45, 41) | 0 Participants |
| All Treated Participants | Short-term Period: Number of Participants With Marked Abnormalities in Serum Chemistry (Continued) | Calcium (total) (n = 43, 40, 45, 41) | 0 Participants |
| All Treated Participants | Short-term Period: Number of Participants With Marked Abnormalities in Serum Chemistry (Continued) | Potassium (n = 43, 40, 45, 41) | 0 Participants |
| Abatacept 10/10 | Short-term Period: Number of Participants With Marked Abnormalities in Serum Chemistry (Continued) | Calcium (total) (n = 43, 40, 45, 41) | 0 Participants |
| Abatacept 10/10 | Short-term Period: Number of Participants With Marked Abnormalities in Serum Chemistry (Continued) | Phosphorous , inorganic (n = 43, 40, 45, 41) | 0 Participants |
| Abatacept 10/10 | Short-term Period: Number of Participants With Marked Abnormalities in Serum Chemistry (Continued) | Sodium (n = 43, 40, 45, 41) | 0 Participants |
| Abatacept 10/10 | Short-term Period: Number of Participants With Marked Abnormalities in Serum Chemistry (Continued) | Chloride (n = 43, 40, 45, 41) | 0 Participants |
| Abatacept 10/10 | Short-term Period: Number of Participants With Marked Abnormalities in Serum Chemistry (Continued) | Potassium (n = 43, 40, 45, 41) | 0 Participants |
| Abatacept 3/3 | Short-term Period: Number of Participants With Marked Abnormalities in Serum Chemistry (Continued) | Calcium (total) (n = 43, 40, 45, 41) | 0 Participants |
| Abatacept 3/3 | Short-term Period: Number of Participants With Marked Abnormalities in Serum Chemistry (Continued) | Potassium (n = 43, 40, 45, 41) | 0 Participants |
| Abatacept 3/3 | Short-term Period: Number of Participants With Marked Abnormalities in Serum Chemistry (Continued) | Chloride (n = 43, 40, 45, 41) | 0 Participants |
| Abatacept 3/3 | Short-term Period: Number of Participants With Marked Abnormalities in Serum Chemistry (Continued) | Phosphorous , inorganic (n = 43, 40, 45, 41) | 1 Participants |
| Abatacept 3/3 | Short-term Period: Number of Participants With Marked Abnormalities in Serum Chemistry (Continued) | Sodium (n = 43, 40, 45, 41) | 0 Participants |
| Placebo | Short-term Period: Number of Participants With Marked Abnormalities in Serum Chemistry (Continued) | Phosphorous , inorganic (n = 43, 40, 45, 41) | 1 Participants |
| Placebo | Short-term Period: Number of Participants With Marked Abnormalities in Serum Chemistry (Continued) | Chloride (n = 43, 40, 45, 41) | 0 Participants |
| Placebo | Short-term Period: Number of Participants With Marked Abnormalities in Serum Chemistry (Continued) | Potassium (n = 43, 40, 45, 41) | 1 Participants |
| Placebo | Short-term Period: Number of Participants With Marked Abnormalities in Serum Chemistry (Continued) | Calcium (total) (n = 43, 40, 45, 41) | 0 Participants |
| Placebo | Short-term Period: Number of Participants With Marked Abnormalities in Serum Chemistry (Continued) | Sodium (n = 43, 40, 45, 41) | 0 Participants |
Secondary
Short-term Period: Number of Participants With Marked Abnormalities in Serum Chemistry (Continued)
LLN=lower limit of normal; ULN=upper limit of normal; pre-Rx=pretreatment. Marked abnormality criteria: Glucose \<65 or \>220 mg/dL; glucose (fasting)\<0.8\*LLN or \>1.5\*ULN (if pre-Rx \<LLN, \<0.8\*pre-Rx or \>ULN. If pre-Rx \>ULN, t\>2.0\*pre-Rx or \<LLN). Protein (total) \<0.9\*LLN or \>1.1\*ULN (if pre-Rx \<LLN, \<0.9\*pre-Rx or \>ULN. If pre-Rx \>ULN, \>1.1\*pre-Rx or \<LLN). Albumin \<0.9\*LLN (if pre-Rx \<LLN, \<0.75\* pre-Rx). Uric acid \>1.5\*ULN; if pre-Rx \>ULN or \>2\*pre-Rx value.
Time frame: From Baseline to Day 169
Population: All participants who received at least 1 infusion of study medication during the double-blind period. n=number of participants with evaluable results.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Treated Participants | Short-term Period: Number of Participants With Marked Abnormalities in Serum Chemistry (Continued) | Albumin (n = 43, 40, 45, 41) | 0 Participants |
| All Treated Participants | Short-term Period: Number of Participants With Marked Abnormalities in Serum Chemistry (Continued) | Glucose, fasting (n = 16, 12, 12, 15) | 0 Participants |
| All Treated Participants | Short-term Period: Number of Participants With Marked Abnormalities in Serum Chemistry (Continued) | Uric acid (n = 43, 40, 45, 41) | 0 Participants |
| All Treated Participants | Short-term Period: Number of Participants With Marked Abnormalities in Serum Chemistry (Continued) | Protein (total) (n = 43, 40, 45, 41) | 0 Participants |
| All Treated Participants | Short-term Period: Number of Participants With Marked Abnormalities in Serum Chemistry (Continued) | Glucose (n = 43, 40, 45, 41) | 1 Participants |
| Abatacept 10/10 | Short-term Period: Number of Participants With Marked Abnormalities in Serum Chemistry (Continued) | Protein (total) (n = 43, 40, 45, 41) | 0 Participants |
| Abatacept 10/10 | Short-term Period: Number of Participants With Marked Abnormalities in Serum Chemistry (Continued) | Albumin (n = 43, 40, 45, 41) | 0 Participants |
| Abatacept 10/10 | Short-term Period: Number of Participants With Marked Abnormalities in Serum Chemistry (Continued) | Uric acid (n = 43, 40, 45, 41) | 0 Participants |
| Abatacept 10/10 | Short-term Period: Number of Participants With Marked Abnormalities in Serum Chemistry (Continued) | Glucose, fasting (n = 16, 12, 12, 15) | 0 Participants |
| Abatacept 10/10 | Short-term Period: Number of Participants With Marked Abnormalities in Serum Chemistry (Continued) | Glucose (n = 43, 40, 45, 41) | 4 Participants |
| Abatacept 3/3 | Short-term Period: Number of Participants With Marked Abnormalities in Serum Chemistry (Continued) | Protein (total) (n = 43, 40, 45, 41) | 0 Participants |
| Abatacept 3/3 | Short-term Period: Number of Participants With Marked Abnormalities in Serum Chemistry (Continued) | Glucose (n = 43, 40, 45, 41) | 8 Participants |
| Abatacept 3/3 | Short-term Period: Number of Participants With Marked Abnormalities in Serum Chemistry (Continued) | Glucose, fasting (n = 16, 12, 12, 15) | 0 Participants |
| Abatacept 3/3 | Short-term Period: Number of Participants With Marked Abnormalities in Serum Chemistry (Continued) | Albumin (n = 43, 40, 45, 41) | 0 Participants |
| Abatacept 3/3 | Short-term Period: Number of Participants With Marked Abnormalities in Serum Chemistry (Continued) | Uric acid (n = 43, 40, 45, 41) | 0 Participants |
| Placebo | Short-term Period: Number of Participants With Marked Abnormalities in Serum Chemistry (Continued) | Albumin (n = 43, 40, 45, 41) | 0 Participants |
| Placebo | Short-term Period: Number of Participants With Marked Abnormalities in Serum Chemistry (Continued) | Glucose, fasting (n = 16, 12, 12, 15) | 0 Participants |
| Placebo | Short-term Period: Number of Participants With Marked Abnormalities in Serum Chemistry (Continued) | Glucose (n = 43, 40, 45, 41) | 2 Participants |
| Placebo | Short-term Period: Number of Participants With Marked Abnormalities in Serum Chemistry (Continued) | Protein (total) (n = 43, 40, 45, 41) | 0 Participants |
| Placebo | Short-term Period: Number of Participants With Marked Abnormalities in Serum Chemistry (Continued) | Uric acid (n = 43, 40, 45, 41) | 0 Participants |
Secondary
Short-term Period: Number of Participants With Marked Abnormalities in Urinalysis
Pre-Rx=pretreatment. Criteria for marked abnormality: Protein, glucose, blood, leukocyte esterase, red blood cells (RBC), white blood cells (WBC) \>=2+ (or, if value \>=4, or if pre-Rx value=0 or 0.5, \>= 2\* or if pre-RX value =1, \>=3, or if pre-Rx =2 or 3, \>=4).
Time frame: From Baseline to Day 169
Population: All participants who received at least 1 infusion of study medication during the double-blind period. n = number of participants with evaluable results (each arm respectively).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Treated Participants | Short-term Period: Number of Participants With Marked Abnormalities in Urinalysis | Protein (n = 42, 37, 38, 40) | 0 Participants |
| All Treated Participants | Short-term Period: Number of Participants With Marked Abnormalities in Urinalysis | Glucose (n = 42, 37, 38, 40) | 0 Participants |
| All Treated Participants | Short-term Period: Number of Participants With Marked Abnormalities in Urinalysis | Leukocyte esterase (n = 3, 7, 4, 5) | 0 Participants |
| All Treated Participants | Short-term Period: Number of Participants With Marked Abnormalities in Urinalysis | WBC (n = 6, 8, 8, 6) | 1 Participants |
| All Treated Participants | Short-term Period: Number of Participants With Marked Abnormalities in Urinalysis | RBC (n = 6, 7, 5, 6) | 3 Participants |
| All Treated Participants | Short-term Period: Number of Participants With Marked Abnormalities in Urinalysis | Blood (n = 42, 37, 38, 40) | 2 Participants |
| Abatacept 10/10 | Short-term Period: Number of Participants With Marked Abnormalities in Urinalysis | Leukocyte esterase (n = 3, 7, 4, 5) | 0 Participants |
| Abatacept 10/10 | Short-term Period: Number of Participants With Marked Abnormalities in Urinalysis | Blood (n = 42, 37, 38, 40) | 2 Participants |
| Abatacept 10/10 | Short-term Period: Number of Participants With Marked Abnormalities in Urinalysis | WBC (n = 6, 8, 8, 6) | 1 Participants |
| Abatacept 10/10 | Short-term Period: Number of Participants With Marked Abnormalities in Urinalysis | Glucose (n = 42, 37, 38, 40) | 0 Participants |
| Abatacept 10/10 | Short-term Period: Number of Participants With Marked Abnormalities in Urinalysis | Protein (n = 42, 37, 38, 40) | 0 Participants |
| Abatacept 10/10 | Short-term Period: Number of Participants With Marked Abnormalities in Urinalysis | RBC (n = 6, 7, 5, 6) | 1 Participants |
| Abatacept 3/3 | Short-term Period: Number of Participants With Marked Abnormalities in Urinalysis | RBC (n = 6, 7, 5, 6) | 1 Participants |
| Abatacept 3/3 | Short-term Period: Number of Participants With Marked Abnormalities in Urinalysis | Blood (n = 42, 37, 38, 40) | 3 Participants |
| Abatacept 3/3 | Short-term Period: Number of Participants With Marked Abnormalities in Urinalysis | Leukocyte esterase (n = 3, 7, 4, 5) | 1 Participants |
| Abatacept 3/3 | Short-term Period: Number of Participants With Marked Abnormalities in Urinalysis | Glucose (n = 42, 37, 38, 40) | 0 Participants |
| Abatacept 3/3 | Short-term Period: Number of Participants With Marked Abnormalities in Urinalysis | WBC (n = 6, 8, 8, 6) | 3 Participants |
| Abatacept 3/3 | Short-term Period: Number of Participants With Marked Abnormalities in Urinalysis | Protein (n = 42, 37, 38, 40) | 0 Participants |
| Placebo | Short-term Period: Number of Participants With Marked Abnormalities in Urinalysis | WBC (n = 6, 8, 8, 6) | 3 Participants |
| Placebo | Short-term Period: Number of Participants With Marked Abnormalities in Urinalysis | Blood (n = 42, 37, 38, 40) | 2 Participants |
| Placebo | Short-term Period: Number of Participants With Marked Abnormalities in Urinalysis | Glucose (n = 42, 37, 38, 40) | 1 Participants |
| Placebo | Short-term Period: Number of Participants With Marked Abnormalities in Urinalysis | Protein (n = 42, 37, 38, 40) | 1 Participants |
| Placebo | Short-term Period: Number of Participants With Marked Abnormalities in Urinalysis | Leukocyte esterase (n = 3, 7, 4, 5) | 1 Participants |
| Placebo | Short-term Period: Number of Participants With Marked Abnormalities in Urinalysis | RBC (n = 6, 7, 5, 6) | 2 Participants |
Secondary
Short-term Period: Number of Participants With Positive Responses for Serum Levels of Abatacept-specific Antibodies (Anti-Abatacept-C)
Meso Scale Discovery electrochemiluminescence, a validated, sensitive immunoassay technique (anti-abatacept assay C) was used to measure serum levels of abatacept-specific antibodies against the whole molecule (both the CTLA4 and possibly immunoglobulin G portion \[anti-abatacept antibody\].
Time frame: From Baseline to Day 169
Population: Participants who received abatacept and for whom baseline and at least 1 additional measurement were available during the double-blind (short-term) period.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Treated Participants | Short-term Period: Number of Participants With Positive Responses for Serum Levels of Abatacept-specific Antibodies (Anti-Abatacept-C) | 1 Participants |
| Abatacept 10/10 | Short-term Period: Number of Participants With Positive Responses for Serum Levels of Abatacept-specific Antibodies (Anti-Abatacept-C) | 0 Participants |
| Abatacept 3/3 | Short-term Period: Number of Participants With Positive Responses for Serum Levels of Abatacept-specific Antibodies (Anti-Abatacept-C) | 2 Participants |
Secondary
Short-term Period: Population Pharmacokinetic (POPPK) Analysis of the Pharmacokinetic (PK) Parameters
PK data: summaries of concentrations and concentration versus time plots were obtained. These data were to be used to develop a POPPK model using a nonlinear mixed-effects model. Prediction of PK data for each of the 3 abatacept treatment groups using POPPK methodology was not performed, because it would not provide any relevant information over the observed PK data.
Time frame: Days 1, 15, 29, 57, 85, 113, 141, and 169