Kidney Failure, Chronic
Conditions
Keywords
end stage renal disease, end stage kidney disease, ESRD, Uremia, Renal Dialysis
Brief summary
The purpose of this trial is to explore the effect of LY2127399 on those antibodies that are a barrier to kidney transplant. Transplantation is currently the definitive treatment for End-Stage Renal Disease (ESRD), providing prolonged survival and improved quality of life.
Detailed description
In this study, LY2127399 will be tested as a potential treatment to reduce the blood proteins in some participants with ESRD. These proteins are called alloantibodies and are made by the body to react with other proteins on cells of transplanted organs called human leukocyte antigen (HLA) proteins. When a participant has these antibodies, they are referred to as HLA-presensitized. Often the presence of these antibodies, categorized by a method called the panel reactive antibody (PRA), can make a person ineligible to receive a transplant or experience very long wait times on the kidney transplant waiting list. Therefore the need to reduce the antibodies is significant for the successful treatment of ESRD. This study will treat ESRD participants for 6 months with LY2127399 and measure PRA levels for a total of 18 months.
Interventions
DRUGLY2127399
120 milligrams (mg) administered subcutaneously every 4 weeks for 20 weeks. A loading dose of 240 mg will be given as the first dose of the study medication
Sponsors
Eli Lilly and Company
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Have ESRD and are awaiting kidney transplant * Have a stable PRA score \>50%
Exclusion criteria
* Have had a tonsillectomy * Have a semi-permanent/tunneled catheter * Have had intravenous immunoglobulin (IVIg) in the past 6 months * Have had plasmapheresis in the past 6 months * Uncontrolled hypertension * Presence of clinically significant cardiac disease in the past 6 months * Malignancy in the past 5 years, with the exception of cervical, basal cell and squamous epithelial cell cancers * Have active or recent infection including herpes zoster or herpes simplex in the last 30 days * Have evidence or suspicion of active Tuberculosis (TB) * Have had major surgery in the past 2 months * Have had a serious infection with recovery in the past 3 months * Have Hepatitis B or C or have Human Immunodeficiency Virus (HIV)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in PRA | Baseline, Weeks 8, 16, 24, 36, 52, 64 and 76 | The PRA value is calculated and expressed as a percentage, which can range from 0 % to 100%. The value represents a summation of the total HLA antibody burden that the participant has and how frequently those HLA antigens appear in organ donor population. A calculated PRA of 20% means the participant has antibodies that represent an antigen frequency that exists in approximately 20% of the population. |
| Change From Baseline in Arcsine Transformed PRA Scores | Baseline, Weeks 8, 16, 24, 36, 52, 64 and 76 | The PRA value is calculated and expressed as a percentage, which can range from 0% to 100%. The value represents a summation of the total HLA antibody burden that the participant has and how frequently those HLA antigens appear in organ donor population. A calculated PRA of 20% means the participant has antibodies that represent an antigen frequency that exists in approximately 20% of the population. PRA scores were transformed using the arcsine function, which enables a skewed distribution of data typically expressed as proportions to achieve properties closer to a normal distribution. The range of possible arcsine transformed PRA scores is 0 (when PRA = 0) to approximately 1.57 (when PRA =100). Higher scores indicate the participant has antibodies against HLA antigens that appear frequently in the organ donor population. |
| Number of Participants With a Change From Baseline Positive to Post-Baseline Negative in the Summation of Top 10 Highest Antibody Levels (Class I and Class II Single Antigen Reactivity Reported Separately) During Treatment and Follow-Up | Baseline through Weeks 24, 52 and 76 | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline in Absolute Counts of B Cell Populations in Peripheral Blood | Baseline, Weeks1, 4, 8, 16, 24, 36 and 52 | B cell population counts are: Total B cells (CD19+), mature naïve B cells (CD19+CD27-IgD+CD10-), switched memory B cells (CD19+CD27+IgD-), unswitched memory B cells (CD19+CD27+IgD+), Tr B cells (CD19+CD38++/+++CD24+++/+CD10+) and Tr B cells (CD19+CD27-IgD+CD10+). |
| Change From Baseline in Serum Immunoglobulin Levels | Baseline, Weeks 8, 16, 24, 36 and 52 | Immunoglobulins (Ig), or antibodies, are large molecular weight proteins used by the immune system to identify and neutralize foreign particles such as bacteria and viruses. Their normal blood levels indicate proper immune status. Change from baseline in serum immunoglobulin A (IgA), immunoglobulin G (IgG), IgG1-4, and immunoglobulin M (IgM) levels are reported. A negative change indicates a decrease in Ig levels. |
| Population Pharmacokinetics (PK): Constant Clearance | Baseline through Week 24 | Population estimate of constant clearance as determined by population PK analysis. A 2-compartment model was used in PK modeling. Constant clearance is the PK parameter which describes the linear elimination of LY2127399 from serum. |
| Percent Change From Baseline at Week 1 and Week 24 in Relative Percent of Lymphocytes for B Cell Populations in the Tonsil | Baseline, Weeks 1 and 24 | B cell population counts are: Total B cells \[cluster designation (CD)19+\], mature naïve B cells \[CD19+CD27-immunoglobulin D (IgD)+CD10-\], switched memory B cells (CD19+CD27+IgD-), unswitched memory B cells (CD19+CD27+IgD+), germinal center B cells Bm2&apos (CD19+CD38+IgD+), germinal center B cells Bm3, Bm4 (CD19+CD38+IgD-), germinal center B cells (CD19+CD38+CD10+CD71+), transitional (Tr) B cells (CD19+CD38++/+++CD24+++/+CD10+) and Tr B cells (CD19+CD27-IgD+CD10+). |
| Percent Change From Baseline in Relative Percent of Lymphocytes for B Cell Populations in Peripheral Blood | Baseline, Weeks1, 4, 8, 16, 24, 36, 52, 64 and 76 | B cell population counts are: Total B cells (CD19+), mature naïve B cells (CD19+CD27-IgD+CD10-), switched memory B cells (CD19+CD27+IgD-), unswitched memory B cells (CD19+CD27+IgD+), Tr B cells (CD19+CD38++/+++CD24+++/+CD10+) and Tr B cells (CD19+CD27-IgD+CD10+). |
Countries
United States
Participant flow
Pre-assignment details
This study consisted of a 24-week treatment period (Weeks 0-24) and a follow-up period (up to Week 76). Participants who discontinued study drug administration were placed into the post-treatment follow-up period.
Participants by arm
| Arm | Count |
|---|---|
| LY2127399 LY2127399 was administered as a loading dose of 240-mg SC injection at Week 0 followed by maintenance doses of 120-mg SC injections every 4 weeks at Weeks 4, 8, 12, 16 and 20. | 18 |
| Total | 18 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Post-Treatment Follow-Up Period | Death | 2 |
| Treatment Period | Adverse Event | 1 |
Baseline characteristics
| Characteristic | LY2127399 |
|---|---|
| Age, Continuous | 44.2 years STANDARD_DEVIATION 12.09 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 18 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Panel Reactive Antibodies (PRA) | 93.111 percentage of population STANDARD_DEVIATION 10.593 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 11 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 6 Participants |
| Region of Enrollment United States | 18 Participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 18 / 18 |
| serious Total, serious adverse events | 9 / 18 |
Outcome results
Primary
Change From Baseline in Arcsine Transformed PRA Scores
The PRA value is calculated and expressed as a percentage, which can range from 0% to 100%. The value represents a summation of the total HLA antibody burden that the participant has and how frequently those HLA antigens appear in organ donor population. A calculated PRA of 20% means the participant has antibodies that represent an antigen frequency that exists in approximately 20% of the population. PRA scores were transformed using the arcsine function, which enables a skewed distribution of data typically expressed as proportions to achieve properties closer to a normal distribution. The range of possible arcsine transformed PRA scores is 0 (when PRA = 0) to approximately 1.57 (when PRA =100). Higher scores indicate the participant has antibodies against HLA antigens that appear frequently in the organ donor population.
Time frame: Baseline, Weeks 8, 16, 24, 36, 52, 64 and 76
Population: All enrolled participants who received at least 1 dose of study drug, had a non-missing baseline PRA score and at least 1 non-missing post-baseline PRA score.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LY2127399 | Change From Baseline in Arcsine Transformed PRA Scores | Week 8 | -0.022 units on a scale | Standard Deviation 0.086 |
| LY2127399 | Change From Baseline in Arcsine Transformed PRA Scores | Week 16 | -0.059 units on a scale | Standard Deviation 0.101 |
| LY2127399 | Change From Baseline in Arcsine Transformed PRA Scores | Week 24 | -0.060 units on a scale | Standard Deviation 0.104 |
| LY2127399 | Change From Baseline in Arcsine Transformed PRA Scores | Week 36 | -0.078 units on a scale | Standard Deviation 0.099 |
| LY2127399 | Change From Baseline in Arcsine Transformed PRA Scores | Week 52 | -0.014 units on a scale | Standard Deviation 0.133 |
| LY2127399 | Change From Baseline in Arcsine Transformed PRA Scores | Week 64 | -0.053 units on a scale | Standard Deviation 0.124 |
| LY2127399 | Change From Baseline in Arcsine Transformed PRA Scores | Week 76 | -0.071 units on a scale | Standard Deviation 0.158 |
p-value: 0.335Mixed Effect Model Repeat Measurement
p-value: 0.043Mixed Effect Model Repeat Measurement
p-value: 0.073Mixed Effect Model Repeat Measurement
p-value: 0.004Mixed Effect Model Repeat Measurement
p-value: 0.699Mixed Effect Model Repeat Measurement
p-value: 0.095Mixed Effect Model Repeat Measurement
p-value: 0.082Mixed Effect Model Repeat Measurement
Primary
Change From Baseline in PRA
The PRA value is calculated and expressed as a percentage, which can range from 0 % to 100%. The value represents a summation of the total HLA antibody burden that the participant has and how frequently those HLA antigens appear in organ donor population. A calculated PRA of 20% means the participant has antibodies that represent an antigen frequency that exists in approximately 20% of the population.
Time frame: Baseline, Weeks 8, 16, 24, 36, 52, 64 and 76
Population: All enrolled participants who received at least 1 dose of study drug, had a non-missing baseline PRA score and at least 1 non-missing post-baseline PRA score.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LY2127399 | Change From Baseline in PRA | Week 64 | -1.706 percentage of population | Standard Deviation 4.497 |
| LY2127399 | Change From Baseline in PRA | Week 76 | -2.800 percentage of population | Standard Deviation 7.674 |
| LY2127399 | Change From Baseline in PRA | Week 8 | -0.706 percentage of population | Standard Deviation 2.664 |
| LY2127399 | Change From Baseline in PRA | Week 16 | -2.176 percentage of population | Standard Deviation 3.575 |
| LY2127399 | Change From Baseline in PRA | Week 24 | -1.688 percentage of population | Standard Deviation 3.24 |
| LY2127399 | Change From Baseline in PRA | Week 36 | -2.353 percentage of population | Standard Deviation 3.499 |
| LY2127399 | Change From Baseline in PRA | Week 52 | -0.529 percentage of population | Standard Deviation 3.573 |
p-value: 0.324Mixed Effect Model Repeat Measurement
p-value: 0.031Mixed Effect Model Repeat Measurement
p-value: 0.076Mixed Effect Model Repeat Measurement
p-value: 0.013Mixed Effect Model Repeat Measurement
p-value: 0.553Mixed Effect Model Repeat Measurement
p-value: 0.132Mixed Effect Model Repeat Measurement
p-value: 0.23Mixed Effect Model Repeat Measurement
Primary
Number of Participants With a Change From Baseline Positive to Post-Baseline Negative in the Summation of Top 10 Highest Antibody Levels (Class I and Class II Single Antigen Reactivity Reported Separately) During Treatment and Follow-Up
Time frame: Baseline through Weeks 24, 52 and 76
Population: All enrolled participants who received at least 1 dose of study drug and had single antigen reactivity assessed at baseline, during treatment and during follow-up.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| LY2127399 | Number of Participants With a Change From Baseline Positive to Post-Baseline Negative in the Summation of Top 10 Highest Antibody Levels (Class I and Class II Single Antigen Reactivity Reported Separately) During Treatment and Follow-Up | Class I - Week 24 | 0 Participants |
| LY2127399 | Number of Participants With a Change From Baseline Positive to Post-Baseline Negative in the Summation of Top 10 Highest Antibody Levels (Class I and Class II Single Antigen Reactivity Reported Separately) During Treatment and Follow-Up | Class I - Week 52 | 0 Participants |
| LY2127399 | Number of Participants With a Change From Baseline Positive to Post-Baseline Negative in the Summation of Top 10 Highest Antibody Levels (Class I and Class II Single Antigen Reactivity Reported Separately) During Treatment and Follow-Up | Class I - Week 76 | 0 Participants |
| LY2127399 | Number of Participants With a Change From Baseline Positive to Post-Baseline Negative in the Summation of Top 10 Highest Antibody Levels (Class I and Class II Single Antigen Reactivity Reported Separately) During Treatment and Follow-Up | Class II - Week 24 | 0 Participants |
| LY2127399 | Number of Participants With a Change From Baseline Positive to Post-Baseline Negative in the Summation of Top 10 Highest Antibody Levels (Class I and Class II Single Antigen Reactivity Reported Separately) During Treatment and Follow-Up | Class II - Week 52 | 0 Participants |
| LY2127399 | Number of Participants With a Change From Baseline Positive to Post-Baseline Negative in the Summation of Top 10 Highest Antibody Levels (Class I and Class II Single Antigen Reactivity Reported Separately) During Treatment and Follow-Up | Class II - Week 76 | 0 Participants |
Secondary
Change From Baseline in Serum Immunoglobulin Levels
Immunoglobulins (Ig), or antibodies, are large molecular weight proteins used by the immune system to identify and neutralize foreign particles such as bacteria and viruses. Their normal blood levels indicate proper immune status. Change from baseline in serum immunoglobulin A (IgA), immunoglobulin G (IgG), IgG1-4, and immunoglobulin M (IgM) levels are reported. A negative change indicates a decrease in Ig levels.
Time frame: Baseline, Weeks 8, 16, 24, 36 and 52
Population: All enrolled participants who received at least 1 dose of study drug, had a non-missing baseline Ig value and at least 1 non-missing post-baseline Ig value.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LY2127399 | Change From Baseline in Serum Immunoglobulin Levels | IgA at Week 52 | -0.098 grams/liter (g/L) | Standard Deviation 0.509 |
| LY2127399 | Change From Baseline in Serum Immunoglobulin Levels | IgG at Week 8 | -1.625 grams/liter (g/L) | Standard Deviation 1.85 |
| LY2127399 | Change From Baseline in Serum Immunoglobulin Levels | IgG at Week 16 | -1.856 grams/liter (g/L) | Standard Deviation 1.5373 |
| LY2127399 | Change From Baseline in Serum Immunoglobulin Levels | IgG at Week 24 | -2.048 grams/liter (g/L) | Standard Deviation 1.8486 |
| LY2127399 | Change From Baseline in Serum Immunoglobulin Levels | IgG at Week 36 | -2.245 grams/liter (g/L) | Standard Deviation 2.1388 |
| LY2127399 | Change From Baseline in Serum Immunoglobulin Levels | IgG at Week 52 | -0.625 grams/liter (g/L) | Standard Deviation 3.0933 |
| LY2127399 | Change From Baseline in Serum Immunoglobulin Levels | IgG1 at Week 8 | -1.018 grams/liter (g/L) | Standard Deviation 1.4024 |
| LY2127399 | Change From Baseline in Serum Immunoglobulin Levels | IgG1 at Week 16 | -1.459 grams/liter (g/L) | Standard Deviation 1.5242 |
| LY2127399 | Change From Baseline in Serum Immunoglobulin Levels | IgG3 at Week 8 | -0.046 grams/liter (g/L) | Standard Deviation 0.0847 |
| LY2127399 | Change From Baseline in Serum Immunoglobulin Levels | IgG3 at Week 16 | -0.072 grams/liter (g/L) | Standard Deviation 0.0601 |
| LY2127399 | Change From Baseline in Serum Immunoglobulin Levels | IgG3 at Week 24 | -0.076 grams/liter (g/L) | Standard Deviation 0.0899 |
| LY2127399 | Change From Baseline in Serum Immunoglobulin Levels | IgG3 at Week 36 | -0.061 grams/liter (g/L) | Standard Deviation 0.1074 |
| LY2127399 | Change From Baseline in Serum Immunoglobulin Levels | IgG3 at Week 52 | -0.022 grams/liter (g/L) | Standard Deviation 0.0761 |
| LY2127399 | Change From Baseline in Serum Immunoglobulin Levels | IgG4 at Week 8 | 0.013 grams/liter (g/L) | Standard Deviation 0.0511 |
| LY2127399 | Change From Baseline in Serum Immunoglobulin Levels | IgG4 at Week 16 | -0.009 grams/liter (g/L) | Standard Deviation 0.0512 |
| LY2127399 | Change From Baseline in Serum Immunoglobulin Levels | IgG4 at Week 24 | -0.010 grams/liter (g/L) | Standard Deviation 0.05 |
| LY2127399 | Change From Baseline in Serum Immunoglobulin Levels | IgG4 at Week 36 | -0.032 grams/liter (g/L) | Standard Deviation 0.0558 |
| LY2127399 | Change From Baseline in Serum Immunoglobulin Levels | IgG4 at Week 52 | 0.019 grams/liter (g/L) | Standard Deviation 0.0899 |
| LY2127399 | Change From Baseline in Serum Immunoglobulin Levels | IgM at Week 8 | -0.208 grams/liter (g/L) | Standard Deviation 0.265 |
| LY2127399 | Change From Baseline in Serum Immunoglobulin Levels | IgM at Week 52 | -0.197 grams/liter (g/L) | Standard Deviation 0.3032 |
| LY2127399 | Change From Baseline in Serum Immunoglobulin Levels | IgA at Week 8 | -0.305 grams/liter (g/L) | Standard Deviation 0.4552 |
| LY2127399 | Change From Baseline in Serum Immunoglobulin Levels | IgA at Week 16 | -0.261 grams/liter (g/L) | Standard Deviation 0.3983 |
| LY2127399 | Change From Baseline in Serum Immunoglobulin Levels | IgA at Week 24 | -0.409 grams/liter (g/L) | Standard Deviation 0.5467 |
| LY2127399 | Change From Baseline in Serum Immunoglobulin Levels | IgA at Week 36 | -0.325 grams/liter (g/L) | Standard Deviation 0.5715 |
| LY2127399 | Change From Baseline in Serum Immunoglobulin Levels | IgG1 at Week 24 | -1.682 grams/liter (g/L) | Standard Deviation 1.819 |
| LY2127399 | Change From Baseline in Serum Immunoglobulin Levels | IgG1 at Week 36 | -1.969 grams/liter (g/L) | Standard Deviation 1.6652 |
| LY2127399 | Change From Baseline in Serum Immunoglobulin Levels | IgG1 at Week 52 | -0.668 grams/liter (g/L) | Standard Deviation 2.9531 |
| LY2127399 | Change From Baseline in Serum Immunoglobulin Levels | IgG2 at Week 8 | -0.125 grams/liter (g/L) | Standard Deviation 0.3016 |
| LY2127399 | Change From Baseline in Serum Immunoglobulin Levels | IgG2 at Week 16 | -0.261 grams/liter (g/L) | Standard Deviation 0.3044 |
| LY2127399 | Change From Baseline in Serum Immunoglobulin Levels | IgG2 at Week 24 | -0.274 grams/liter (g/L) | Standard Deviation 0.2693 |
| LY2127399 | Change From Baseline in Serum Immunoglobulin Levels | IgG2 at Week 36 | -0.226 grams/liter (g/L) | Standard Deviation 0.3951 |
| LY2127399 | Change From Baseline in Serum Immunoglobulin Levels | IgG2 at Week 52 | 0.046 grams/liter (g/L) | Standard Deviation 0.5918 |
| LY2127399 | Change From Baseline in Serum Immunoglobulin Levels | IgM at Week 16 | -0.295 grams/liter (g/L) | Standard Deviation 0.2895 |
| LY2127399 | Change From Baseline in Serum Immunoglobulin Levels | IgM at Week 24 | -0.266 grams/liter (g/L) | Standard Deviation 0.2781 |
| LY2127399 | Change From Baseline in Serum Immunoglobulin Levels | IgM at Week 36 | -0.302 grams/liter (g/L) | Standard Deviation 0.2449 |
Secondary
Percent Change From Baseline at Week 1 and Week 24 in Relative Percent of Lymphocytes for B Cell Populations in the Tonsil
B cell population counts are: Total B cells \[cluster designation (CD)19+\], mature naïve B cells \[CD19+CD27-immunoglobulin D (IgD)+CD10-\], switched memory B cells (CD19+CD27+IgD-), unswitched memory B cells (CD19+CD27+IgD+), germinal center B cells Bm2&apos (CD19+CD38+IgD+), germinal center B cells Bm3, Bm4 (CD19+CD38+IgD-), germinal center B cells (CD19+CD38+CD10+CD71+), transitional (Tr) B cells (CD19+CD38++/+++CD24+++/+CD10+) and Tr B cells (CD19+CD27-IgD+CD10+).
Time frame: Baseline, Weeks 1 and 24
Population: All enrolled participants who received at least 1 dose of study drug, had a non-missing baseline tonsil B cell populations value and at least 1 non-missing post-baseline B cell populations value.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LY2127399 | Percent Change From Baseline at Week 1 and Week 24 in Relative Percent of Lymphocytes for B Cell Populations in the Tonsil | Tr(CD19+CD38++/+++CD24+++/+CD10+) at Week 24 | 26.999 relative percent of Lymphocytes | Standard Deviation 79.5306 |
| LY2127399 | Percent Change From Baseline at Week 1 and Week 24 in Relative Percent of Lymphocytes for B Cell Populations in the Tonsil | Tr (CD19+CD27-IgD+CD10+) at Week 1 | -8.977 relative percent of Lymphocytes | Standard Deviation 53.7335 |
| LY2127399 | Percent Change From Baseline at Week 1 and Week 24 in Relative Percent of Lymphocytes for B Cell Populations in the Tonsil | Total B cells at Week 1 | 12.732 relative percent of Lymphocytes | Standard Deviation 61.2266 |
| LY2127399 | Percent Change From Baseline at Week 1 and Week 24 in Relative Percent of Lymphocytes for B Cell Populations in the Tonsil | Total B cells at Week 24 | -25.371 relative percent of Lymphocytes | Standard Deviation 40.1642 |
| LY2127399 | Percent Change From Baseline at Week 1 and Week 24 in Relative Percent of Lymphocytes for B Cell Populations in the Tonsil | Mature naïve at Week 1 | -1.559 relative percent of Lymphocytes | Standard Deviation 4.9348 |
| LY2127399 | Percent Change From Baseline at Week 1 and Week 24 in Relative Percent of Lymphocytes for B Cell Populations in the Tonsil | Mature naïve at Week 24 | -21.611 relative percent of Lymphocytes | Standard Deviation 12.6669 |
| LY2127399 | Percent Change From Baseline at Week 1 and Week 24 in Relative Percent of Lymphocytes for B Cell Populations in the Tonsil | Switched memory at Week 1 | 11.850 relative percent of Lymphocytes | Standard Deviation 27.6106 |
| LY2127399 | Percent Change From Baseline at Week 1 and Week 24 in Relative Percent of Lymphocytes for B Cell Populations in the Tonsil | Switched memory at Week 24 | 92.905 relative percent of Lymphocytes | Standard Deviation 74.1293 |
| LY2127399 | Percent Change From Baseline at Week 1 and Week 24 in Relative Percent of Lymphocytes for B Cell Populations in the Tonsil | Germinal center Bm2' at Week 1 | -8.818 relative percent of Lymphocytes | Standard Deviation 21.98 |
| LY2127399 | Percent Change From Baseline at Week 1 and Week 24 in Relative Percent of Lymphocytes for B Cell Populations in the Tonsil | Germinal center Bm2' at Week 24 | -61.051 relative percent of Lymphocytes | Standard Deviation 20.9845 |
| LY2127399 | Percent Change From Baseline at Week 1 and Week 24 in Relative Percent of Lymphocytes for B Cell Populations in the Tonsil | Germinal center at Week 1 | 7.280 relative percent of Lymphocytes | Standard Deviation 58.0681 |
| LY2127399 | Percent Change From Baseline at Week 1 and Week 24 in Relative Percent of Lymphocytes for B Cell Populations in the Tonsil | Tr(CD19+CD38++/+++CD24+++/+CD10+) at Week 1 | 46.508 relative percent of Lymphocytes | Standard Deviation 96.0036 |
| LY2127399 | Percent Change From Baseline at Week 1 and Week 24 in Relative Percent of Lymphocytes for B Cell Populations in the Tonsil | Unswitched memory at Week 1 | 40.343 relative percent of Lymphocytes | Standard Deviation 82.3486 |
| LY2127399 | Percent Change From Baseline at Week 1 and Week 24 in Relative Percent of Lymphocytes for B Cell Populations in the Tonsil | Unswitched memory at Week 24 | 224.298 relative percent of Lymphocytes | Standard Deviation 331.6551 |
| LY2127399 | Percent Change From Baseline at Week 1 and Week 24 in Relative Percent of Lymphocytes for B Cell Populations in the Tonsil | Germinal center Bm3, Bm4 at Week 1 | 26.705 relative percent of Lymphocytes | Standard Deviation 51.6762 |
| LY2127399 | Percent Change From Baseline at Week 1 and Week 24 in Relative Percent of Lymphocytes for B Cell Populations in the Tonsil | Germinal center Bm3, Bm4 at Week 24 | 104.890 relative percent of Lymphocytes | Standard Deviation 230.9829 |
| LY2127399 | Percent Change From Baseline at Week 1 and Week 24 in Relative Percent of Lymphocytes for B Cell Populations in the Tonsil | Germinal center at Week 24 | 19.279 relative percent of Lymphocytes | Standard Deviation 102.9617 |
| LY2127399 | Percent Change From Baseline at Week 1 and Week 24 in Relative Percent of Lymphocytes for B Cell Populations in the Tonsil | Tr (CD19+CD27-IgD+CD10+) at Week24 | -59.131 relative percent of Lymphocytes | Standard Deviation 27.212 |
Secondary
Percent Change From Baseline in Absolute Counts of B Cell Populations in Peripheral Blood
B cell population counts are: Total B cells (CD19+), mature naïve B cells (CD19+CD27-IgD+CD10-), switched memory B cells (CD19+CD27+IgD-), unswitched memory B cells (CD19+CD27+IgD+), Tr B cells (CD19+CD38++/+++CD24+++/+CD10+) and Tr B cells (CD19+CD27-IgD+CD10+).
Time frame: Baseline, Weeks1, 4, 8, 16, 24, 36 and 52
Population: All enrolled participants who received at least 1 dose of study drug, had a non-missing baseline peripheral blood B cell populations value and at least 1 non-missing post-baseline B cell populations value.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LY2127399 | Percent Change From Baseline in Absolute Counts of B Cell Populations in Peripheral Blood | Total B cells at Week 1 | 37.305 percent change in absolute counts | Standard Deviation 48.241 |
| LY2127399 | Percent Change From Baseline in Absolute Counts of B Cell Populations in Peripheral Blood | Total B cells at Week 4 | -12.050 percent change in absolute counts | Standard Deviation 48.5995 |
| LY2127399 | Percent Change From Baseline in Absolute Counts of B Cell Populations in Peripheral Blood | Total B cells at Week 8 | -27.875 percent change in absolute counts | Standard Deviation 51.5586 |
| LY2127399 | Percent Change From Baseline in Absolute Counts of B Cell Populations in Peripheral Blood | Total B cells at Week 16 | -46.861 percent change in absolute counts | Standard Deviation 33.8978 |
| LY2127399 | Percent Change From Baseline in Absolute Counts of B Cell Populations in Peripheral Blood | Total B cells at Week 24 | -55.759 percent change in absolute counts | Standard Deviation 33.609 |
| LY2127399 | Percent Change From Baseline in Absolute Counts of B Cell Populations in Peripheral Blood | Total B cells at Week 36 | -68.301 percent change in absolute counts | Standard Deviation 23.1588 |
| LY2127399 | Percent Change From Baseline in Absolute Counts of B Cell Populations in Peripheral Blood | Total B cells at Week 52 | -65.676 percent change in absolute counts | Standard Deviation 17.3689 |
| LY2127399 | Percent Change From Baseline in Absolute Counts of B Cell Populations in Peripheral Blood | Mature naïve at Week 1 | 37.533 percent change in absolute counts | Standard Deviation 60.6785 |
| LY2127399 | Percent Change From Baseline in Absolute Counts of B Cell Populations in Peripheral Blood | Mature naïve at Week 4 | -23.351 percent change in absolute counts | Standard Deviation 47.2486 |
| LY2127399 | Percent Change From Baseline in Absolute Counts of B Cell Populations in Peripheral Blood | Mature naïve at Week 8 | -52.128 percent change in absolute counts | Standard Deviation 39.7386 |
| LY2127399 | Percent Change From Baseline in Absolute Counts of B Cell Populations in Peripheral Blood | Mature naïve at Week 16 | -72.891 percent change in absolute counts | Standard Deviation 19.8886 |
| LY2127399 | Percent Change From Baseline in Absolute Counts of B Cell Populations in Peripheral Blood | Mature naïve at Week 24 | -81.367 percent change in absolute counts | Standard Deviation 16.4389 |
| LY2127399 | Percent Change From Baseline in Absolute Counts of B Cell Populations in Peripheral Blood | Mature naïve at Week 36 | -85.213 percent change in absolute counts | Standard Deviation 12.9636 |
| LY2127399 | Percent Change From Baseline in Absolute Counts of B Cell Populations in Peripheral Blood | Mature naïve at Week 52 | -70.114 percent change in absolute counts | Standard Deviation 21.6407 |
| LY2127399 | Percent Change From Baseline in Absolute Counts of B Cell Populations in Peripheral Blood | Switched memory at Week 1 | 64.309 percent change in absolute counts | Standard Deviation 68.7102 |
| LY2127399 | Percent Change From Baseline in Absolute Counts of B Cell Populations in Peripheral Blood | Switched memory at Week 4 | 66.849 percent change in absolute counts | Standard Deviation 62.1042 |
| LY2127399 | Percent Change From Baseline in Absolute Counts of B Cell Populations in Peripheral Blood | Switched memory at Week 8 | 83.774 percent change in absolute counts | Standard Deviation 76.5159 |
| LY2127399 | Percent Change From Baseline in Absolute Counts of B Cell Populations in Peripheral Blood | Switched memory at Week 16 | 74.667 percent change in absolute counts | Standard Deviation 72.0109 |
| LY2127399 | Percent Change From Baseline in Absolute Counts of B Cell Populations in Peripheral Blood | Switched memory at Week 24 | 56.192 percent change in absolute counts | Standard Deviation 117.0402 |
| LY2127399 | Percent Change From Baseline in Absolute Counts of B Cell Populations in Peripheral Blood | Switched memory at Week 36 | 1.221 percent change in absolute counts | Standard Deviation 53.8382 |
| LY2127399 | Percent Change From Baseline in Absolute Counts of B Cell Populations in Peripheral Blood | Switched memory at Week 52 | -48.620 percent change in absolute counts | Standard Deviation 17.2563 |
| LY2127399 | Percent Change From Baseline in Absolute Counts of B Cell Populations in Peripheral Blood | Unswitched memory at Week 1 | 51.590 percent change in absolute counts | Standard Deviation 98.1357 |
| LY2127399 | Percent Change From Baseline in Absolute Counts of B Cell Populations in Peripheral Blood | Unswitched memory at Week 4 | 17.522 percent change in absolute counts | Standard Deviation 62.0773 |
| LY2127399 | Percent Change From Baseline in Absolute Counts of B Cell Populations in Peripheral Blood | Unswitched memory at Week 8 | 35.339 percent change in absolute counts | Standard Deviation 84.768 |
| LY2127399 | Percent Change From Baseline in Absolute Counts of B Cell Populations in Peripheral Blood | Unswitched memory at Week 16 | 11.962 percent change in absolute counts | Standard Deviation 74.5105 |
| LY2127399 | Percent Change From Baseline in Absolute Counts of B Cell Populations in Peripheral Blood | Unswitched memory at Week 24 | -8.604 percent change in absolute counts | Standard Deviation 59.8587 |
| LY2127399 | Percent Change From Baseline in Absolute Counts of B Cell Populations in Peripheral Blood | Unswitched memory at Week 36 | -33.746 percent change in absolute counts | Standard Deviation 38.8791 |
| LY2127399 | Percent Change From Baseline in Absolute Counts of B Cell Populations in Peripheral Blood | Unswitched memory at Week 52 | -48.381 percent change in absolute counts | Standard Deviation 26.9717 |
| LY2127399 | Percent Change From Baseline in Absolute Counts of B Cell Populations in Peripheral Blood | Tr(CD19+CD38++/+++CD24+++/+CD10+) at Week 1 | 22.103 percent change in absolute counts | Standard Deviation 72.4137 |
| LY2127399 | Percent Change From Baseline in Absolute Counts of B Cell Populations in Peripheral Blood | Tr(CD19+CD38++/+++CD24+++/+CD10+) at Week 4 | -57.052 percent change in absolute counts | Standard Deviation 30.706 |
| LY2127399 | Percent Change From Baseline in Absolute Counts of B Cell Populations in Peripheral Blood | Tr(CD19+CD38++/+++CD24+++/+CD10+) at Week 8 | -64.282 percent change in absolute counts | Standard Deviation 25.8516 |
| LY2127399 | Percent Change From Baseline in Absolute Counts of B Cell Populations in Peripheral Blood | Tr(CD19+CD38++/+++CD24+++/+CD10+) at Week 16 | -71.138 percent change in absolute counts | Standard Deviation 26.0579 |
| LY2127399 | Percent Change From Baseline in Absolute Counts of B Cell Populations in Peripheral Blood | Tr(CD19+CD38++/+++CD24+++/+CD10+) at Week 24 | -80.746 percent change in absolute counts | Standard Deviation 12.1379 |
| LY2127399 | Percent Change From Baseline in Absolute Counts of B Cell Populations in Peripheral Blood | Tr(CD19+CD38++/+++CD24+++/+CD10+) at Week 36 | -75.133 percent change in absolute counts | Standard Deviation 20.0926 |
| LY2127399 | Percent Change From Baseline in Absolute Counts of B Cell Populations in Peripheral Blood | Tr(CD19+CD38++/+++CD24+++/+CD10+) at Week 52 | -59.288 percent change in absolute counts | Standard Deviation 31.9767 |
| LY2127399 | Percent Change From Baseline in Absolute Counts of B Cell Populations in Peripheral Blood | Tr(CD19+CD27-IgD+CD10+) at Week 1 | 25.018 percent change in absolute counts | Standard Deviation 44.8425 |
| LY2127399 | Percent Change From Baseline in Absolute Counts of B Cell Populations in Peripheral Blood | Tr(CD19+CD27-IgD+CD10+) at Week 4 | -47.991 percent change in absolute counts | Standard Deviation 42.3991 |
| LY2127399 | Percent Change From Baseline in Absolute Counts of B Cell Populations in Peripheral Blood | Tr(CD19+CD27-IgD+CD10+) at Week 8 | -70.447 percent change in absolute counts | Standard Deviation 20.195 |
| LY2127399 | Percent Change From Baseline in Absolute Counts of B Cell Populations in Peripheral Blood | Tr(CD19+CD27-IgD+CD10+) at Week 16 | -76.085 percent change in absolute counts | Standard Deviation 24.0089 |
| LY2127399 | Percent Change From Baseline in Absolute Counts of B Cell Populations in Peripheral Blood | Tr(CD19+CD27-IgD+CD10+) at Week 24 | -87.204 percent change in absolute counts | Standard Deviation 11.6008 |
| LY2127399 | Percent Change From Baseline in Absolute Counts of B Cell Populations in Peripheral Blood | Tr(CD19+CD27-IgD+CD10+) at Week 36 | -84.531 percent change in absolute counts | Standard Deviation 14.5977 |
| LY2127399 | Percent Change From Baseline in Absolute Counts of B Cell Populations in Peripheral Blood | Tr(CD19+CD27-IgD+CD10+) at Week 52 | -69.306 percent change in absolute counts | Standard Deviation 29.8739 |
Secondary
Percent Change From Baseline in Relative Percent of Lymphocytes for B Cell Populations in Peripheral Blood
B cell population counts are: Total B cells (CD19+), mature naïve B cells (CD19+CD27-IgD+CD10-), switched memory B cells (CD19+CD27+IgD-), unswitched memory B cells (CD19+CD27+IgD+), Tr B cells (CD19+CD38++/+++CD24+++/+CD10+) and Tr B cells (CD19+CD27-IgD+CD10+).
Time frame: Baseline, Weeks1, 4, 8, 16, 24, 36, 52, 64 and 76
Population: All enrolled participants who received at least 1 dose of study drug, had a non-missing baseline peripheral blood B cell populations value and at least 1 non-missing post-baseline B cell populations value.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LY2127399 | Percent Change From Baseline in Relative Percent of Lymphocytes for B Cell Populations in Peripheral Blood | Total B cells at Week 1 | 35.303 relative percent of Lymphocytes | Standard Deviation 34.2864 |
| LY2127399 | Percent Change From Baseline in Relative Percent of Lymphocytes for B Cell Populations in Peripheral Blood | Total B cells at Week 4 | -10.883 relative percent of Lymphocytes | Standard Deviation 24.1837 |
| LY2127399 | Percent Change From Baseline in Relative Percent of Lymphocytes for B Cell Populations in Peripheral Blood | Total B cells at Week 8 | -28.765 relative percent of Lymphocytes | Standard Deviation 25.2472 |
| LY2127399 | Percent Change From Baseline in Relative Percent of Lymphocytes for B Cell Populations in Peripheral Blood | Total B cells at Week 16 | -45.027 relative percent of Lymphocytes | Standard Deviation 23.1939 |
| LY2127399 | Percent Change From Baseline in Relative Percent of Lymphocytes for B Cell Populations in Peripheral Blood | Total B cells at Week 24 | -52.115 relative percent of Lymphocytes | Standard Deviation 22.5144 |
| LY2127399 | Percent Change From Baseline in Relative Percent of Lymphocytes for B Cell Populations in Peripheral Blood | Total B cells at Week 36 | -63.677 relative percent of Lymphocytes | Standard Deviation 17.2158 |
| LY2127399 | Percent Change From Baseline in Relative Percent of Lymphocytes for B Cell Populations in Peripheral Blood | Total B cells at Week 76 | -32.467 relative percent of Lymphocytes | Standard Deviation 32.7608 |
| LY2127399 | Percent Change From Baseline in Relative Percent of Lymphocytes for B Cell Populations in Peripheral Blood | Mature naïve at Week 1 | -1.172 relative percent of Lymphocytes | Standard Deviation 11.6626 |
| LY2127399 | Percent Change From Baseline in Relative Percent of Lymphocytes for B Cell Populations in Peripheral Blood | Mature naïve at Week 4 | -14.222 relative percent of Lymphocytes | Standard Deviation 13.8931 |
| LY2127399 | Percent Change From Baseline in Relative Percent of Lymphocytes for B Cell Populations in Peripheral Blood | Mature naïve at Week 8 | -34.496 relative percent of Lymphocytes | Standard Deviation 15.9776 |
| LY2127399 | Percent Change From Baseline in Relative Percent of Lymphocytes for B Cell Populations in Peripheral Blood | Mature naïve at Week 16 | -47.957 relative percent of Lymphocytes | Standard Deviation 19.008 |
| LY2127399 | Percent Change From Baseline in Relative Percent of Lymphocytes for B Cell Populations in Peripheral Blood | Mature naïve at Week 24 | -54.859 relative percent of Lymphocytes | Standard Deviation 23.8066 |
| LY2127399 | Percent Change From Baseline in Relative Percent of Lymphocytes for B Cell Populations in Peripheral Blood | Mature naïve at Week 36 | -54.030 relative percent of Lymphocytes | Standard Deviation 20.4375 |
| LY2127399 | Percent Change From Baseline in Relative Percent of Lymphocytes for B Cell Populations in Peripheral Blood | Mature naïve at Week 52 | -20.440 relative percent of Lymphocytes | Standard Deviation 29.5837 |
| LY2127399 | Percent Change From Baseline in Relative Percent of Lymphocytes for B Cell Populations in Peripheral Blood | Mature naïve at Week 64 | -1.237 relative percent of Lymphocytes | Standard Deviation 22.1831 |
| LY2127399 | Percent Change From Baseline in Relative Percent of Lymphocytes for B Cell Populations in Peripheral Blood | Switched memory at Week 4 | 111.611 relative percent of Lymphocytes | Standard Deviation 73.4853 |
| LY2127399 | Percent Change From Baseline in Relative Percent of Lymphocytes for B Cell Populations in Peripheral Blood | Switched memory at Week 8 | 204.443 relative percent of Lymphocytes | Standard Deviation 118.2768 |
| LY2127399 | Percent Change From Baseline in Relative Percent of Lymphocytes for B Cell Populations in Peripheral Blood | Switched memory at Week 16 | 305.653 relative percent of Lymphocytes | Standard Deviation 198.0679 |
| LY2127399 | Percent Change From Baseline in Relative Percent of Lymphocytes for B Cell Populations in Peripheral Blood | Switched memory at Week 24 | 305.930 relative percent of Lymphocytes | Standard Deviation 197.4446 |
| LY2127399 | Percent Change From Baseline in Relative Percent of Lymphocytes for B Cell Populations in Peripheral Blood | Switched memory at Week 36 | 285.668 relative percent of Lymphocytes | Standard Deviation 238.3301 |
| LY2127399 | Percent Change From Baseline in Relative Percent of Lymphocytes for B Cell Populations in Peripheral Blood | Switched memory at Week 52 | 75.155 relative percent of Lymphocytes | Standard Deviation 85.9638 |
| LY2127399 | Percent Change From Baseline in Relative Percent of Lymphocytes for B Cell Populations in Peripheral Blood | Switched memory at Week 64 | 20.179 relative percent of Lymphocytes | Standard Deviation 42.5419 |
| LY2127399 | Percent Change From Baseline in Relative Percent of Lymphocytes for B Cell Populations in Peripheral Blood | Switched memory at Week 76 | 11.947 relative percent of Lymphocytes | Standard Deviation 37.6837 |
| LY2127399 | Percent Change From Baseline in Relative Percent of Lymphocytes for B Cell Populations in Peripheral Blood | Unswitched memory at Week 4 | 45.073 relative percent of Lymphocytes | Standard Deviation 61.3175 |
| LY2127399 | Percent Change From Baseline in Relative Percent of Lymphocytes for B Cell Populations in Peripheral Blood | Unswitched memory at Week 8 | 110.285 relative percent of Lymphocytes | Standard Deviation 87.0203 |
| LY2127399 | Percent Change From Baseline in Relative Percent of Lymphocytes for B Cell Populations in Peripheral Blood | Unswitched memory at Week 16 | 143.020 relative percent of Lymphocytes | Standard Deviation 113.1325 |
| LY2127399 | Percent Change From Baseline in Relative Percent of Lymphocytes for B Cell Populations in Peripheral Blood | Unswitched memory at Week 24 | 138.646 relative percent of Lymphocytes | Standard Deviation 121.7276 |
| LY2127399 | Percent Change From Baseline in Relative Percent of Lymphocytes for B Cell Populations in Peripheral Blood | Unswitched memory at Week 36 | 140.917 relative percent of Lymphocytes | Standard Deviation 123.0888 |
| LY2127399 | Percent Change From Baseline in Relative Percent of Lymphocytes for B Cell Populations in Peripheral Blood | Unswitched memory at Week 52 | 65.607 relative percent of Lymphocytes | Standard Deviation 109.5101 |
| LY2127399 | Percent Change From Baseline in Relative Percent of Lymphocytes for B Cell Populations in Peripheral Blood | Unswitched memory at Week 76 | 26.283 relative percent of Lymphocytes | Standard Deviation 52.1802 |
| LY2127399 | Percent Change From Baseline in Relative Percent of Lymphocytes for B Cell Populations in Peripheral Blood | Tr(CD19+CD38++/+++CD24+++/+CD10+) at Week 1 | -13.511 relative percent of Lymphocytes | Standard Deviation 29.4311 |
| LY2127399 | Percent Change From Baseline in Relative Percent of Lymphocytes for B Cell Populations in Peripheral Blood | Tr(CD19+CD38++/+++CD24+++/+CD10+) at Week 4 | -49.869 relative percent of Lymphocytes | Standard Deviation 23.7764 |
| LY2127399 | Percent Change From Baseline in Relative Percent of Lymphocytes for B Cell Populations in Peripheral Blood | Tr(CD19+CD38++/+++CD24+++/+CD10+) at Week 8 | -49.292 relative percent of Lymphocytes | Standard Deviation 18.56 |
| LY2127399 | Percent Change From Baseline in Relative Percent of Lymphocytes for B Cell Populations in Peripheral Blood | Tr(CD19+CD38++/+++CD24+++/+CD10+) at Week 16 | -40.847 relative percent of Lymphocytes | Standard Deviation 36.94 |
| LY2127399 | Percent Change From Baseline in Relative Percent of Lymphocytes for B Cell Populations in Peripheral Blood | Tr(CD19+CD38++/+++CD24+++/+CD10+) at Week 24 | -44.355 relative percent of Lymphocytes | Standard Deviation 32.0001 |
| LY2127399 | Percent Change From Baseline in Relative Percent of Lymphocytes for B Cell Populations in Peripheral Blood | Tr(CD19+CD38++/+++CD24+++/+CD10+) at Week 36 | 10.080 relative percent of Lymphocytes | Standard Deviation 118.1582 |
| LY2127399 | Percent Change From Baseline in Relative Percent of Lymphocytes for B Cell Populations in Peripheral Blood | Tr(CD19+CD38++/+++CD24+++/+CD10+) at Week 52 | 36.776 relative percent of Lymphocytes | Standard Deviation 136.3827 |
| LY2127399 | Percent Change From Baseline in Relative Percent of Lymphocytes for B Cell Populations in Peripheral Blood | Tr(CD19+CD38++/+++CD24+++/+CD10+) at Week 64 | 9.357 relative percent of Lymphocytes | Standard Deviation 210.4455 |
| LY2127399 | Percent Change From Baseline in Relative Percent of Lymphocytes for B Cell Populations in Peripheral Blood | Tr(CD19+CD38++/+++CD24+++/+CD10+) at Week 76 | -7.396 relative percent of Lymphocytes | Standard Deviation 181.0879 |
| LY2127399 | Percent Change From Baseline in Relative Percent of Lymphocytes for B Cell Populations in Peripheral Blood | Tr (CD19+CD27-IgD+CD10+) at Week1 | -6.512 relative percent of Lymphocytes | Standard Deviation 23.602 |
| LY2127399 | Percent Change From Baseline in Relative Percent of Lymphocytes for B Cell Populations in Peripheral Blood | Tr (CD19+CD27-IgD+CD10+) at Week8 | -56.047 relative percent of Lymphocytes | Standard Deviation 13.9734 |
| LY2127399 | Percent Change From Baseline in Relative Percent of Lymphocytes for B Cell Populations in Peripheral Blood | Tr (CD19+CD27-IgD+CD10+) at Week 16 | -56.886 relative percent of Lymphocytes | Standard Deviation 32.9379 |
| LY2127399 | Percent Change From Baseline in Relative Percent of Lymphocytes for B Cell Populations in Peripheral Blood | Tr (CD19+CD27-IgD+CD10+) at Week 24 | -64.706 relative percent of Lymphocytes | Standard Deviation 24.3874 |
| LY2127399 | Percent Change From Baseline in Relative Percent of Lymphocytes for B Cell Populations in Peripheral Blood | Tr (CD19+CD27-IgD+CD10+) at Week 36 | -41.231 relative percent of Lymphocytes | Standard Deviation 48.6871 |
| LY2127399 | Percent Change From Baseline in Relative Percent of Lymphocytes for B Cell Populations in Peripheral Blood | Tr (CD19+CD27-IgD+CD10+) at Week 52 | 6.504 relative percent of Lymphocytes | Standard Deviation 118.6276 |
| LY2127399 | Percent Change From Baseline in Relative Percent of Lymphocytes for B Cell Populations in Peripheral Blood | Tr (CD19+CD27-IgD+CD10+) at Week 64 | 2.059 relative percent of Lymphocytes | Standard Deviation 177.4749 |
| LY2127399 | Percent Change From Baseline in Relative Percent of Lymphocytes for B Cell Populations in Peripheral Blood | Tr (CD19+CD27-IgD+CD10+) at Week 76 | -45.425 relative percent of Lymphocytes | Standard Deviation 90.9992 |
| LY2127399 | Percent Change From Baseline in Relative Percent of Lymphocytes for B Cell Populations in Peripheral Blood | Total B cells at Week 52 | -60.808 relative percent of Lymphocytes | Standard Deviation 17.8105 |
| LY2127399 | Percent Change From Baseline in Relative Percent of Lymphocytes for B Cell Populations in Peripheral Blood | Total B cells at Week 64 | -25.982 relative percent of Lymphocytes | Standard Deviation 49.3294 |
| LY2127399 | Percent Change From Baseline in Relative Percent of Lymphocytes for B Cell Populations in Peripheral Blood | Mature naïve at Week 76 | 9.210 relative percent of Lymphocytes | Standard Deviation 21.7629 |
| LY2127399 | Percent Change From Baseline in Relative Percent of Lymphocytes for B Cell Populations in Peripheral Blood | Switched memory at Week 1 | 20.241 relative percent of Lymphocytes | Standard Deviation 41.7855 |
| LY2127399 | Percent Change From Baseline in Relative Percent of Lymphocytes for B Cell Populations in Peripheral Blood | Unswitched memory at Week 1 | 5.563 relative percent of Lymphocytes | Standard Deviation 41.2351 |
| LY2127399 | Percent Change From Baseline in Relative Percent of Lymphocytes for B Cell Populations in Peripheral Blood | Unswitched memory at Week 64 | 17.782 relative percent of Lymphocytes | Standard Deviation 41.126 |
| LY2127399 | Percent Change From Baseline in Relative Percent of Lymphocytes for B Cell Populations in Peripheral Blood | Tr (CD19+CD27-IgD+CD10+) at Week4 | -42.852 relative percent of Lymphocytes | Standard Deviation 25.4319 |
Secondary
Population Pharmacokinetics (PK): Constant Clearance
Population estimate of constant clearance as determined by population PK analysis. A 2-compartment model was used in PK modeling. Constant clearance is the PK parameter which describes the linear elimination of LY2127399 from serum.
Time frame: Baseline through Week 24
Population: All randomized participants who received at least 1 dose of LY2127399 with evaluable LY2127399 PK data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LY2127399 | Population Pharmacokinetics (PK): Constant Clearance | 5.65 milliliters/hour (mL/h) | Standard Error 9.72 |