Rheumatoid Arthritis
Conditions
Brief summary
A Randomized, Double Blind, Placebo Controlled Phase 2 Study To assess the Immune Response Following Administration of Influenza and Pneumococcal Vaccines to Subjects with Rheumatoid Arthritis receiving CP-690,550 with and Without background Methotrexate
Interventions
DRUGCP-690,550
Treatment Group 1: 10 mg BID CP-690,550 (100 subjects). Strata 1: 10 mg BID CP-690,550 on background methotrexate (50 subjects); Strata 2: 10 mg BID CP-690,550 monotherapy (50 subjects).
DRUGplacebo
Placebo CP-690,550 (100 subjects). Strata 1: Placebo CP-690,550 on background methotrexate (50 subjects); Strata 2: Placebo CP-690,550 monotherapy (50 subjects). Influenza and pneumococcal vaccines will be administered to all subjects
Sponsors
Pfizer
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
* The subject must meet the American College of Rheumatology (ACR) classification criteria for the diagnosis of RA by satisfying at least four of the seven criteria. * The subject must have active disease at both screening and baseline
Exclusion criteria
* History of any documented influenza or pneumococcal infection within the last 3 months. * Receipt of any vaccine within 1 month prior to the initial study drug administration (CP-690,550 or placebo CP-690,550). * If a subject has received an influenza vaccine within 6 months or a pneumococcal vaccine within 5 years of initial study drug administration.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Satisfactory Humoral Response to the Pneumococcal Vaccine at Visit 3 (Day 64) | Day 64 (End of Study [EOS]) | Satisfactory humoral response to the pneumococcal vaccine was defined as greater than or equal to (\>=) 2 fold increase in antibody concentrations from vaccination baseline (Day 29) in at least 6 of 12 pneumococcal antigens (1, 3, 4, 5, 6B, 7F, 9V, 14, 19A, 19F, 23F, 18C). Data was stratified by the background methotrexate use. |
| Percentage of Participants With Satisfactory Humoral Response to the Seasonal Influenza Vaccine at Visit 3 (Day 64) | Day 64 (EOS) | Satisfactory humoral response to the influenza vaccine was defined as \>= 4 fold increase in antibody titers from vaccination baseline (Day 29) in at least 2 of 3 influenza antigens (B, H1N1, H3N2). Data was stratified by the background methotrexate use. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Protective Antibody Titers to the Seasonal Influenza Vaccine | Day 64 (EOS) | Seroprotection was defined as achieving protective antibody titers to the influenza vaccine as measured by a hemagglutination inhibition (HAI) assay titer of \>= 1:40 in at least 2 of 3 influenza antigens (B, H1N1, H3N2). Data was stratified by the background methotrexate use. |
| Geometric Mean Fold Rise (GMFR) of Anti-Pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens Above Vaccination Baseline Values (Day 29) | Day 64 (EOS) | Geometric mean fold rises (GMFRs) for the 12 pneumococcal antigens (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) from pre-vaccination (Day 29) to Day 64 (Day 35 post-vaccination) were computed using the logarithmically transformed assay results. Confidence intervals (CIs) for GMFR are back transformations of a CI based on the Student t-distribution for the mean logarithm of the titers. Data was stratified by the background methotrexate use. |
| Percentage of Participants Who Responded to Each of the 12 Pneumococcal Antigens | Day 64 (EOS) | Response to the pneumococcal vaccine (seroconversion) was defined as \>= 2 fold increase in antibody concentrations from vaccination baseline (Day 29) in each of the 12 pneumococcal antigens (1, 3, 4, 5, 6B, 7F, 9V, 14, 19A, 19F, 23F, 18C). Data was stratified by the background methotrexate use. |
| Geometric Mean Concentrations (GMC) of Anti-Pneumococcal Antibody | Day 64 (EOS) | Antibody geometric mean concentration (GMC) for 12 pneumococcal antigens (1, 3, 4, 5, 6B, 7F, 9V, 14, 19A, 19F, 23F, 18C) as measured by geometric mean of three independent determinations of the antibody response of that antigen. GMC and corresponding 2-sided 95% confidence intervals (CI) were evaluated. |
| Geometric Mean Titer (GMT) of Anti-Influenza Antibody | Day 64 (EOS) | Antibody geometric mean titer (GMT) for 3 influenza antigens antigens (B, H1N1, H3N2) as measured by geometric mean of three independent determinations of the antibody response of that antigen. GMT and corresponding 2-sided 95% confidence intervals (CI) were evaluated. |
| Geometric Mean Fold Rise (GMFR) of Anti-Influenza Antibody Levels to Each of the Influenza Antigens Above Vaccination Baseline Values (Day 29) | Day 64 (EOS) | GMFRs for the 3 influenza antigens (B, H1N1, H3N2) from pre-vaccination (Day 29) to Day 64 (Day 35 post-vaccination) were computed using the logarithmically transformed assay results. CIs for GMFR are back transformations of a CI based on the Student t-distribution for the mean logarithm of the titers. Data was stratified by the background methotrexate use. |
| Percentage of Participants Who Responded to Each of the 3 Influenza Antigens | Day 64 (EOS) | Response to the influenza vaccine (seroconversion) was defined as \>= 4 fold increase in antibody titers from vaccination baseline (Day 29) in each of 3 influenza antigens (B, H1N1, H3N2). Data was stratified by the background methotrexate use. |
Countries
Poland, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CP-690,550 + Influenza and Pneumococcal Vaccine CP-690,550 10 milligram (mg) tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice. | 112 |
| Placebo + Influenza and Pneumococcal Vaccine Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice. | 111 |
| Total | 223 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 4 | 3 |
| Overall Study | Lack of Efficacy | 1 | 1 |
| Overall Study | Other | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Placebo + Influenza and Pneumococcal Vaccine | Total | CP-690,550 + Influenza and Pneumococcal Vaccine |
|---|---|---|---|
| Age Continuous | 52.2 years STANDARD_DEVIATION 11.1 | 52.4 years STANDARD_DEVIATION 10.8 | 52.7 years STANDARD_DEVIATION 10.4 |
| Number of Participants With Background (BG) Methotrexate (MTX) use With Background MTX use | 62 participants | 124 participants | 62 participants |
| Number of Participants With Background (BG) Methotrexate (MTX) use Without Background MTX use | 49 participants | 99 participants | 50 participants |
| Sex: Female, Male Female | 90 Participants | 171 Participants | 81 Participants |
| Sex: Female, Male Male | 21 Participants | 52 Participants | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 17 / 112 | 17 / 111 |
| serious Total, serious adverse events | 4 / 112 | 1 / 111 |
Outcome results
Primary
Percentage of Participants With Satisfactory Humoral Response to the Pneumococcal Vaccine at Visit 3 (Day 64)
Satisfactory humoral response to the pneumococcal vaccine was defined as greater than or equal to (\>=) 2 fold increase in antibody concentrations from vaccination baseline (Day 29) in at least 6 of 12 pneumococcal antigens (1, 3, 4, 5, 6B, 7F, 9V, 14, 19A, 19F, 23F, 18C). Data was stratified by the background methotrexate use.
Time frame: Day 64 (End of Study [EOS])
Population: Evaluable immunogenicity population:eligible,randomized participants;who met rheumatoid arthritis disease activity criteria;received vaccination as scheduled and \>=80% study drug;had pre and post-vaccination blood draw;complete set of assay results;had no major protocol violations.n=participants evaluable at specified categories for each arm group.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CP-690,550 + Influenza and Pneumococcal Vaccine | Percentage of Participants With Satisfactory Humoral Response to the Pneumococcal Vaccine at Visit 3 (Day 64) | Regardless MTX use (n=102,98) | 45.1 percentage of participants |
| CP-690,550 + Influenza and Pneumococcal Vaccine | Percentage of Participants With Satisfactory Humoral Response to the Pneumococcal Vaccine at Visit 3 (Day 64) | With BG MTX use (n=57,55) | 31.6 percentage of participants |
| CP-690,550 + Influenza and Pneumococcal Vaccine | Percentage of Participants With Satisfactory Humoral Response to the Pneumococcal Vaccine at Visit 3 (Day 64) | Without BG MTX use (n=45,43) | 62.2 percentage of participants |
| Placebo + Influenza and Pneumococcal Vaccine | Percentage of Participants With Satisfactory Humoral Response to the Pneumococcal Vaccine at Visit 3 (Day 64) | Regardless MTX use (n=102,98) | 68.4 percentage of participants |
| Placebo + Influenza and Pneumococcal Vaccine | Percentage of Participants With Satisfactory Humoral Response to the Pneumococcal Vaccine at Visit 3 (Day 64) | With BG MTX use (n=57,55) | 61.8 percentage of participants |
| Placebo + Influenza and Pneumococcal Vaccine | Percentage of Participants With Satisfactory Humoral Response to the Pneumococcal Vaccine at Visit 3 (Day 64) | Without BG MTX use (n=45,43) | 76.7 percentage of participants |
Primary
Percentage of Participants With Satisfactory Humoral Response to the Seasonal Influenza Vaccine at Visit 3 (Day 64)
Satisfactory humoral response to the influenza vaccine was defined as \>= 4 fold increase in antibody titers from vaccination baseline (Day 29) in at least 2 of 3 influenza antigens (B, H1N1, H3N2). Data was stratified by the background methotrexate use.
Time frame: Day 64 (EOS)
Population: Evaluable immunogenicity population:eligible,randomized participants;who met rheumatoid arthritis disease activity criteria;received vaccination as scheduled and \>=80% study drug;had pre and post-vaccination blood draw;complete set of assay results;had no major protocol violations.n=participants evaluable at specified categories for each arm group.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CP-690,550 + Influenza and Pneumococcal Vaccine | Percentage of Participants With Satisfactory Humoral Response to the Seasonal Influenza Vaccine at Visit 3 (Day 64) | Regardless MTX use (n=102,98) | 56.9 percentage of participants |
| CP-690,550 + Influenza and Pneumococcal Vaccine | Percentage of Participants With Satisfactory Humoral Response to the Seasonal Influenza Vaccine at Visit 3 (Day 64) | With BG MTX use (n=57,55) | 50.9 percentage of participants |
| CP-690,550 + Influenza and Pneumococcal Vaccine | Percentage of Participants With Satisfactory Humoral Response to the Seasonal Influenza Vaccine at Visit 3 (Day 64) | Without BG MTX use (n=45,43) | 64.4 percentage of participants |
| Placebo + Influenza and Pneumococcal Vaccine | Percentage of Participants With Satisfactory Humoral Response to the Seasonal Influenza Vaccine at Visit 3 (Day 64) | Regardless MTX use (n=102,98) | 62.2 percentage of participants |
| Placebo + Influenza and Pneumococcal Vaccine | Percentage of Participants With Satisfactory Humoral Response to the Seasonal Influenza Vaccine at Visit 3 (Day 64) | With BG MTX use (n=57,55) | 58.2 percentage of participants |
| Placebo + Influenza and Pneumococcal Vaccine | Percentage of Participants With Satisfactory Humoral Response to the Seasonal Influenza Vaccine at Visit 3 (Day 64) | Without BG MTX use (n=45,43) | 67.4 percentage of participants |
Secondary
Geometric Mean Concentrations (GMC) of Anti-Pneumococcal Antibody
Antibody geometric mean concentration (GMC) for 12 pneumococcal antigens (1, 3, 4, 5, 6B, 7F, 9V, 14, 19A, 19F, 23F, 18C) as measured by geometric mean of three independent determinations of the antibody response of that antigen. GMC and corresponding 2-sided 95% confidence intervals (CI) were evaluated.
Time frame: Day 64 (EOS)
Population: Evaluable immunogenicity population:eligible,randomized participants;who met rheumatoid arthritis disease activity criteria;received vaccination as scheduled and \>=80% study drug;had pre and post-vaccination blood draw;complete set of assay results;had no major protocol violations.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| CP-690,550 + Influenza and Pneumococcal Vaccine | Geometric Mean Concentrations (GMC) of Anti-Pneumococcal Antibody | 1 | 1.81 microgram/milliliter (mcg/mL) |
| CP-690,550 + Influenza and Pneumococcal Vaccine | Geometric Mean Concentrations (GMC) of Anti-Pneumococcal Antibody | 14 | 5.24 microgram/milliliter (mcg/mL) |
| CP-690,550 + Influenza and Pneumococcal Vaccine | Geometric Mean Concentrations (GMC) of Anti-Pneumococcal Antibody | 18C | 2.53 microgram/milliliter (mcg/mL) |
| CP-690,550 + Influenza and Pneumococcal Vaccine | Geometric Mean Concentrations (GMC) of Anti-Pneumococcal Antibody | 19A | 5.21 microgram/milliliter (mcg/mL) |
| CP-690,550 + Influenza and Pneumococcal Vaccine | Geometric Mean Concentrations (GMC) of Anti-Pneumococcal Antibody | 19F | 2.59 microgram/milliliter (mcg/mL) |
| CP-690,550 + Influenza and Pneumococcal Vaccine | Geometric Mean Concentrations (GMC) of Anti-Pneumococcal Antibody | 23F | 2.41 microgram/milliliter (mcg/mL) |
| CP-690,550 + Influenza and Pneumococcal Vaccine | Geometric Mean Concentrations (GMC) of Anti-Pneumococcal Antibody | 3 | 0.66 microgram/milliliter (mcg/mL) |
| CP-690,550 + Influenza and Pneumococcal Vaccine | Geometric Mean Concentrations (GMC) of Anti-Pneumococcal Antibody | 4 | 0.72 microgram/milliliter (mcg/mL) |
| CP-690,550 + Influenza and Pneumococcal Vaccine | Geometric Mean Concentrations (GMC) of Anti-Pneumococcal Antibody | 5 | 4.05 microgram/milliliter (mcg/mL) |
| CP-690,550 + Influenza and Pneumococcal Vaccine | Geometric Mean Concentrations (GMC) of Anti-Pneumococcal Antibody | 6B | 2.99 microgram/milliliter (mcg/mL) |
| CP-690,550 + Influenza and Pneumococcal Vaccine | Geometric Mean Concentrations (GMC) of Anti-Pneumococcal Antibody | 7F | 3.28 microgram/milliliter (mcg/mL) |
| CP-690,550 + Influenza and Pneumococcal Vaccine | Geometric Mean Concentrations (GMC) of Anti-Pneumococcal Antibody | 9V | 2.61 microgram/milliliter (mcg/mL) |
| Placebo + Influenza and Pneumococcal Vaccine | Geometric Mean Concentrations (GMC) of Anti-Pneumococcal Antibody | 7F | 4.37 microgram/milliliter (mcg/mL) |
| Placebo + Influenza and Pneumococcal Vaccine | Geometric Mean Concentrations (GMC) of Anti-Pneumococcal Antibody | 1 | 3.27 microgram/milliliter (mcg/mL) |
| Placebo + Influenza and Pneumococcal Vaccine | Geometric Mean Concentrations (GMC) of Anti-Pneumococcal Antibody | 3 | 1.11 microgram/milliliter (mcg/mL) |
| Placebo + Influenza and Pneumococcal Vaccine | Geometric Mean Concentrations (GMC) of Anti-Pneumococcal Antibody | 14 | 6.40 microgram/milliliter (mcg/mL) |
| Placebo + Influenza and Pneumococcal Vaccine | Geometric Mean Concentrations (GMC) of Anti-Pneumococcal Antibody | 6B | 4.75 microgram/milliliter (mcg/mL) |
| Placebo + Influenza and Pneumococcal Vaccine | Geometric Mean Concentrations (GMC) of Anti-Pneumococcal Antibody | 18C | 4.60 microgram/milliliter (mcg/mL) |
| Placebo + Influenza and Pneumococcal Vaccine | Geometric Mean Concentrations (GMC) of Anti-Pneumococcal Antibody | 4 | 1.07 microgram/milliliter (mcg/mL) |
| Placebo + Influenza and Pneumococcal Vaccine | Geometric Mean Concentrations (GMC) of Anti-Pneumococcal Antibody | 19A | 8.57 microgram/milliliter (mcg/mL) |
| Placebo + Influenza and Pneumococcal Vaccine | Geometric Mean Concentrations (GMC) of Anti-Pneumococcal Antibody | 9V | 4.06 microgram/milliliter (mcg/mL) |
| Placebo + Influenza and Pneumococcal Vaccine | Geometric Mean Concentrations (GMC) of Anti-Pneumococcal Antibody | 19F | 3.09 microgram/milliliter (mcg/mL) |
| Placebo + Influenza and Pneumococcal Vaccine | Geometric Mean Concentrations (GMC) of Anti-Pneumococcal Antibody | 5 | 5.79 microgram/milliliter (mcg/mL) |
| Placebo + Influenza and Pneumococcal Vaccine | Geometric Mean Concentrations (GMC) of Anti-Pneumococcal Antibody | 23F | 3.55 microgram/milliliter (mcg/mL) |
Secondary
Geometric Mean Fold Rise (GMFR) of Anti-Influenza Antibody Levels to Each of the Influenza Antigens Above Vaccination Baseline Values (Day 29)
GMFRs for the 3 influenza antigens (B, H1N1, H3N2) from pre-vaccination (Day 29) to Day 64 (Day 35 post-vaccination) were computed using the logarithmically transformed assay results. CIs for GMFR are back transformations of a CI based on the Student t-distribution for the mean logarithm of the titers. Data was stratified by the background methotrexate use.
Time frame: Day 64 (EOS)
Population: Evaluable immunogenicity population:eligible,randomized participants;who met rheumatoid arthritis disease activity criteria;received vaccination as scheduled and \>=80% study drug;had pre and post-vaccination blood draw;complete set of assay results;had no major protocol violations.n=participants evaluable at specified categories for each arm group.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| CP-690,550 + Influenza and Pneumococcal Vaccine | Geometric Mean Fold Rise (GMFR) of Anti-Influenza Antibody Levels to Each of the Influenza Antigens Above Vaccination Baseline Values (Day 29) | Regardless MTX use, H1N1 (n=102,98) | 6.04 fold rise |
| CP-690,550 + Influenza and Pneumococcal Vaccine | Geometric Mean Fold Rise (GMFR) of Anti-Influenza Antibody Levels to Each of the Influenza Antigens Above Vaccination Baseline Values (Day 29) | With BG MTX use, H1N1 (n=57,55) | 4.90 fold rise |
| CP-690,550 + Influenza and Pneumococcal Vaccine | Geometric Mean Fold Rise (GMFR) of Anti-Influenza Antibody Levels to Each of the Influenza Antigens Above Vaccination Baseline Values (Day 29) | Regardless MTX use, B (n=102,98) | 2.95 fold rise |
| CP-690,550 + Influenza and Pneumococcal Vaccine | Geometric Mean Fold Rise (GMFR) of Anti-Influenza Antibody Levels to Each of the Influenza Antigens Above Vaccination Baseline Values (Day 29) | With BG MTX use, H3N2 (n=57,55) | 5.69 fold rise |
| CP-690,550 + Influenza and Pneumococcal Vaccine | Geometric Mean Fold Rise (GMFR) of Anti-Influenza Antibody Levels to Each of the Influenza Antigens Above Vaccination Baseline Values (Day 29) | Regardless MTX use, H3N2 (n=102,98) | 7.11 fold rise |
| CP-690,550 + Influenza and Pneumococcal Vaccine | Geometric Mean Fold Rise (GMFR) of Anti-Influenza Antibody Levels to Each of the Influenza Antigens Above Vaccination Baseline Values (Day 29) | Without BG MTX use, H1N1 (n=45,43) | 7.88 fold rise |
| CP-690,550 + Influenza and Pneumococcal Vaccine | Geometric Mean Fold Rise (GMFR) of Anti-Influenza Antibody Levels to Each of the Influenza Antigens Above Vaccination Baseline Values (Day 29) | Without BG MTX use, B (n=45,43) | 3.11 fold rise |
| CP-690,550 + Influenza and Pneumococcal Vaccine | Geometric Mean Fold Rise (GMFR) of Anti-Influenza Antibody Levels to Each of the Influenza Antigens Above Vaccination Baseline Values (Day 29) | Without BG MTX use, H3N2 (n=45,43) | 9.43 fold rise |
| CP-690,550 + Influenza and Pneumococcal Vaccine | Geometric Mean Fold Rise (GMFR) of Anti-Influenza Antibody Levels to Each of the Influenza Antigens Above Vaccination Baseline Values (Day 29) | With BG MTX use, B (n=57,55) | 2.84 fold rise |
| Placebo + Influenza and Pneumococcal Vaccine | Geometric Mean Fold Rise (GMFR) of Anti-Influenza Antibody Levels to Each of the Influenza Antigens Above Vaccination Baseline Values (Day 29) | Without BG MTX use, H3N2 (n=45,43) | 15.25 fold rise |
| Placebo + Influenza and Pneumococcal Vaccine | Geometric Mean Fold Rise (GMFR) of Anti-Influenza Antibody Levels to Each of the Influenza Antigens Above Vaccination Baseline Values (Day 29) | Regardless MTX use, B (n=102,98) | 3.90 fold rise |
| Placebo + Influenza and Pneumococcal Vaccine | Geometric Mean Fold Rise (GMFR) of Anti-Influenza Antibody Levels to Each of the Influenza Antigens Above Vaccination Baseline Values (Day 29) | Regardless MTX use, H1N1 (n=102,98) | 9.50 fold rise |
| Placebo + Influenza and Pneumococcal Vaccine | Geometric Mean Fold Rise (GMFR) of Anti-Influenza Antibody Levels to Each of the Influenza Antigens Above Vaccination Baseline Values (Day 29) | Regardless MTX use, H3N2 (n=102,98) | 9.06 fold rise |
| Placebo + Influenza and Pneumococcal Vaccine | Geometric Mean Fold Rise (GMFR) of Anti-Influenza Antibody Levels to Each of the Influenza Antigens Above Vaccination Baseline Values (Day 29) | With BG MTX use, B (n=57,55) | 3.11 fold rise |
| Placebo + Influenza and Pneumococcal Vaccine | Geometric Mean Fold Rise (GMFR) of Anti-Influenza Antibody Levels to Each of the Influenza Antigens Above Vaccination Baseline Values (Day 29) | With BG MTX use, H1N1 (n=57,55) | 7.54 fold rise |
| Placebo + Influenza and Pneumococcal Vaccine | Geometric Mean Fold Rise (GMFR) of Anti-Influenza Antibody Levels to Each of the Influenza Antigens Above Vaccination Baseline Values (Day 29) | Without BG MTX use, B (n=45,43) | 5.20 fold rise |
| Placebo + Influenza and Pneumococcal Vaccine | Geometric Mean Fold Rise (GMFR) of Anti-Influenza Antibody Levels to Each of the Influenza Antigens Above Vaccination Baseline Values (Day 29) | Without BG MTX use, H1N1 (n=45,43) | 12.76 fold rise |
| Placebo + Influenza and Pneumococcal Vaccine | Geometric Mean Fold Rise (GMFR) of Anti-Influenza Antibody Levels to Each of the Influenza Antigens Above Vaccination Baseline Values (Day 29) | With BG MTX use, H3N2 (n=57,55) | 6.04 fold rise |
Secondary
Geometric Mean Fold Rise (GMFR) of Anti-Pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens Above Vaccination Baseline Values (Day 29)
Geometric mean fold rises (GMFRs) for the 12 pneumococcal antigens (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) from pre-vaccination (Day 29) to Day 64 (Day 35 post-vaccination) were computed using the logarithmically transformed assay results. Confidence intervals (CIs) for GMFR are back transformations of a CI based on the Student t-distribution for the mean logarithm of the titers. Data was stratified by the background methotrexate use.
Time frame: Day 64 (EOS)
Population: Evaluable immunogenicity population:eligible,randomized participants;who met rheumatoid arthritis disease activity criteria;received vaccination as scheduled and \>=80% study drug;had pre and post-vaccination blood draw;complete set of assay results;had no major protocol violations.n=participants evaluable at specified categories for each arm group.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| CP-690,550 + Influenza and Pneumococcal Vaccine | Geometric Mean Fold Rise (GMFR) of Anti-Pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens Above Vaccination Baseline Values (Day 29) | Without BG MTX use, 18C (n=44,43) | 3.80 fold rise |
| CP-690,550 + Influenza and Pneumococcal Vaccine | Geometric Mean Fold Rise (GMFR) of Anti-Pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens Above Vaccination Baseline Values (Day 29) | Regardless MTX use, 19A (n=102,98) | 1.80 fold rise |
| CP-690,550 + Influenza and Pneumococcal Vaccine | Geometric Mean Fold Rise (GMFR) of Anti-Pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens Above Vaccination Baseline Values (Day 29) | Regardless MTX use, 4 (n=96,89) | 3.10 fold rise |
| CP-690,550 + Influenza and Pneumococcal Vaccine | Geometric Mean Fold Rise (GMFR) of Anti-Pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens Above Vaccination Baseline Values (Day 29) | Regardless MTX use, 1 (n=89,92) | 4.75 fold rise |
| CP-690,550 + Influenza and Pneumococcal Vaccine | Geometric Mean Fold Rise (GMFR) of Anti-Pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens Above Vaccination Baseline Values (Day 29) | Regardless MTX use, 18C (n=101,98) | 3.10 fold rise |
| CP-690,550 + Influenza and Pneumococcal Vaccine | Geometric Mean Fold Rise (GMFR) of Anti-Pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens Above Vaccination Baseline Values (Day 29) | Regardless MTX use, 19F (n=102,95) | 2.04 fold rise |
| CP-690,550 + Influenza and Pneumococcal Vaccine | Geometric Mean Fold Rise (GMFR) of Anti-Pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens Above Vaccination Baseline Values (Day 29) | Regardless MTX use, 23F (n=102,98) | 2.00 fold rise |
| CP-690,550 + Influenza and Pneumococcal Vaccine | Geometric Mean Fold Rise (GMFR) of Anti-Pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens Above Vaccination Baseline Values (Day 29) | Regardless MTX use, 3 (n=101,94) | 2.11 fold rise |
| CP-690,550 + Influenza and Pneumococcal Vaccine | Geometric Mean Fold Rise (GMFR) of Anti-Pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens Above Vaccination Baseline Values (Day 29) | Regardless MTX use, 5 (n=101,98) | 1.72 fold rise |
| CP-690,550 + Influenza and Pneumococcal Vaccine | Geometric Mean Fold Rise (GMFR) of Anti-Pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens Above Vaccination Baseline Values (Day 29) | Regardless MTX use, 6B (n=102,98) | 1.90 fold rise |
| CP-690,550 + Influenza and Pneumococcal Vaccine | Geometric Mean Fold Rise (GMFR) of Anti-Pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens Above Vaccination Baseline Values (Day 29) | Regardless MTX use, 7F (n=102,97) | 3.19 fold rise |
| CP-690,550 + Influenza and Pneumococcal Vaccine | Geometric Mean Fold Rise (GMFR) of Anti-Pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens Above Vaccination Baseline Values (Day 29) | Regardless MTX use, 9V (n=102,98) | 2.27 fold rise |
| CP-690,550 + Influenza and Pneumococcal Vaccine | Geometric Mean Fold Rise (GMFR) of Anti-Pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens Above Vaccination Baseline Values (Day 29) | With BG MTX use, 1 (n=49,53) | 3.92 fold rise |
| CP-690,550 + Influenza and Pneumococcal Vaccine | Geometric Mean Fold Rise (GMFR) of Anti-Pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens Above Vaccination Baseline Values (Day 29) | With BG MTX use, 14 (n=56,54) | 2.37 fold rise |
| CP-690,550 + Influenza and Pneumococcal Vaccine | Geometric Mean Fold Rise (GMFR) of Anti-Pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens Above Vaccination Baseline Values (Day 29) | With BG MTX use, 18C (n=57,55) | 2.64 fold rise |
| CP-690,550 + Influenza and Pneumococcal Vaccine | Geometric Mean Fold Rise (GMFR) of Anti-Pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens Above Vaccination Baseline Values (Day 29) | With BG MTX use, 19A (n=57,55) | 1.51 fold rise |
| CP-690,550 + Influenza and Pneumococcal Vaccine | Geometric Mean Fold Rise (GMFR) of Anti-Pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens Above Vaccination Baseline Values (Day 29) | With BG MTX use, 19F (n=57,53) | 1.92 fold rise |
| CP-690,550 + Influenza and Pneumococcal Vaccine | Geometric Mean Fold Rise (GMFR) of Anti-Pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens Above Vaccination Baseline Values (Day 29) | With BG MTX use, 23F (n=57,55) | 1.66 fold rise |
| CP-690,550 + Influenza and Pneumococcal Vaccine | Geometric Mean Fold Rise (GMFR) of Anti-Pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens Above Vaccination Baseline Values (Day 29) | With BG MTX use, 3 (n=56,54) | 1.78 fold rise |
| CP-690,550 + Influenza and Pneumococcal Vaccine | Geometric Mean Fold Rise (GMFR) of Anti-Pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens Above Vaccination Baseline Values (Day 29) | With BG MTX use, 4 (n=53,50) | 2.92 fold rise |
| CP-690,550 + Influenza and Pneumococcal Vaccine | Geometric Mean Fold Rise (GMFR) of Anti-Pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens Above Vaccination Baseline Values (Day 29) | With BG MTX use, 5 (n=57,55) | 1.62 fold rise |
| CP-690,550 + Influenza and Pneumococcal Vaccine | Geometric Mean Fold Rise (GMFR) of Anti-Pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens Above Vaccination Baseline Values (Day 29) | With BG MTX use, 6B (n=57,55) | 1.60 fold rise |
| CP-690,550 + Influenza and Pneumococcal Vaccine | Geometric Mean Fold Rise (GMFR) of Anti-Pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens Above Vaccination Baseline Values (Day 29) | With BG MTX use, 7F (n=57,55) | 2.38 fold rise |
| CP-690,550 + Influenza and Pneumococcal Vaccine | Geometric Mean Fold Rise (GMFR) of Anti-Pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens Above Vaccination Baseline Values (Day 29) | With BG MTX use, 9V (n=57,55) | 1.87 fold rise |
| CP-690,550 + Influenza and Pneumococcal Vaccine | Geometric Mean Fold Rise (GMFR) of Anti-Pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens Above Vaccination Baseline Values (Day 29) | Without BG MTX use, 1 (n=40,39) | 6.01 fold rise |
| CP-690,550 + Influenza and Pneumococcal Vaccine | Geometric Mean Fold Rise (GMFR) of Anti-Pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens Above Vaccination Baseline Values (Day 29) | Without BG MTX use, 14 (n=45,42) | 3.14 fold rise |
| CP-690,550 + Influenza and Pneumococcal Vaccine | Geometric Mean Fold Rise (GMFR) of Anti-Pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens Above Vaccination Baseline Values (Day 29) | Regardless MTX use, 14 (n=101,96) | 2.68 fold rise |
| CP-690,550 + Influenza and Pneumococcal Vaccine | Geometric Mean Fold Rise (GMFR) of Anti-Pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens Above Vaccination Baseline Values (Day 29) | Without BG MTX use, 19A (n=45,43) | 2.27 fold rise |
| CP-690,550 + Influenza and Pneumococcal Vaccine | Geometric Mean Fold Rise (GMFR) of Anti-Pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens Above Vaccination Baseline Values (Day 29) | Without BG MTX use, 19F (n=45,42) | 2.19 fold rise |
| CP-690,550 + Influenza and Pneumococcal Vaccine | Geometric Mean Fold Rise (GMFR) of Anti-Pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens Above Vaccination Baseline Values (Day 29) | Without BG MTX use, 23F (n=45,43) | 2.54 fold rise |
| CP-690,550 + Influenza and Pneumococcal Vaccine | Geometric Mean Fold Rise (GMFR) of Anti-Pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens Above Vaccination Baseline Values (Day 29) | Without BG MTX use, 3 (n=45,40) | 2.61 fold rise |
| CP-690,550 + Influenza and Pneumococcal Vaccine | Geometric Mean Fold Rise (GMFR) of Anti-Pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens Above Vaccination Baseline Values (Day 29) | Without BG MTX use, 4 (n=43,39) | 3.32 fold rise |
| CP-690,550 + Influenza and Pneumococcal Vaccine | Geometric Mean Fold Rise (GMFR) of Anti-Pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens Above Vaccination Baseline Values (Day 29) | Without BG MTX use, 5 (n=44,43) | 1.86 fold rise |
| CP-690,550 + Influenza and Pneumococcal Vaccine | Geometric Mean Fold Rise (GMFR) of Anti-Pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens Above Vaccination Baseline Values (Day 29) | Without BG MTX use, 6B (n=45,43) | 2.36 fold rise |
| CP-690,550 + Influenza and Pneumococcal Vaccine | Geometric Mean Fold Rise (GMFR) of Anti-Pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens Above Vaccination Baseline Values (Day 29) | Without BG MTX use, 7F (n=45,42) | 4.62 fold rise |
| CP-690,550 + Influenza and Pneumococcal Vaccine | Geometric Mean Fold Rise (GMFR) of Anti-Pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens Above Vaccination Baseline Values (Day 29) | Without BG MTX use, 9V (n=45,43) | 2.63 fold rise |
| Placebo + Influenza and Pneumococcal Vaccine | Geometric Mean Fold Rise (GMFR) of Anti-Pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens Above Vaccination Baseline Values (Day 29) | With BG MTX use, 23F (n=57,55) | 2.34 fold rise |
| Placebo + Influenza and Pneumococcal Vaccine | Geometric Mean Fold Rise (GMFR) of Anti-Pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens Above Vaccination Baseline Values (Day 29) | Without BG MTX use, 4 (n=43,39) | 9.15 fold rise |
| Placebo + Influenza and Pneumococcal Vaccine | Geometric Mean Fold Rise (GMFR) of Anti-Pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens Above Vaccination Baseline Values (Day 29) | With BG MTX use, 3 (n=56,54) | 2.43 fold rise |
| Placebo + Influenza and Pneumococcal Vaccine | Geometric Mean Fold Rise (GMFR) of Anti-Pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens Above Vaccination Baseline Values (Day 29) | Without BG MTX use, 18C (n=44,43) | 8.05 fold rise |
| Placebo + Influenza and Pneumococcal Vaccine | Geometric Mean Fold Rise (GMFR) of Anti-Pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens Above Vaccination Baseline Values (Day 29) | Without BG MTX use, 19A (n=45,43) | 2.72 fold rise |
| Placebo + Influenza and Pneumococcal Vaccine | Geometric Mean Fold Rise (GMFR) of Anti-Pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens Above Vaccination Baseline Values (Day 29) | Regardless MTX use, 1 (n=89,92) | 6.83 fold rise |
| Placebo + Influenza and Pneumococcal Vaccine | Geometric Mean Fold Rise (GMFR) of Anti-Pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens Above Vaccination Baseline Values (Day 29) | Regardless MTX use, 14 (n=101,96) | 3.90 fold rise |
| Placebo + Influenza and Pneumococcal Vaccine | Geometric Mean Fold Rise (GMFR) of Anti-Pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens Above Vaccination Baseline Values (Day 29) | With BG MTX use, 4 (n=53,50) | 3.27 fold rise |
| Placebo + Influenza and Pneumococcal Vaccine | Geometric Mean Fold Rise (GMFR) of Anti-Pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens Above Vaccination Baseline Values (Day 29) | Regardless MTX use, 18C (n=101,98) | 4.82 fold rise |
| Placebo + Influenza and Pneumococcal Vaccine | Geometric Mean Fold Rise (GMFR) of Anti-Pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens Above Vaccination Baseline Values (Day 29) | Regardless MTX use, 19A (n=102,98) | 2.34 fold rise |
| Placebo + Influenza and Pneumococcal Vaccine | Geometric Mean Fold Rise (GMFR) of Anti-Pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens Above Vaccination Baseline Values (Day 29) | Without BG MTX use, 9V (n=45,43) | 3.83 fold rise |
| Placebo + Influenza and Pneumococcal Vaccine | Geometric Mean Fold Rise (GMFR) of Anti-Pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens Above Vaccination Baseline Values (Day 29) | Regardless MTX use, 19F (n=102,95) | 2.89 fold rise |
| Placebo + Influenza and Pneumococcal Vaccine | Geometric Mean Fold Rise (GMFR) of Anti-Pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens Above Vaccination Baseline Values (Day 29) | With BG MTX use, 5 (n=57,55) | 1.99 fold rise |
| Placebo + Influenza and Pneumococcal Vaccine | Geometric Mean Fold Rise (GMFR) of Anti-Pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens Above Vaccination Baseline Values (Day 29) | Regardless MTX use, 23F (n=102,98) | 2.81 fold rise |
| Placebo + Influenza and Pneumococcal Vaccine | Geometric Mean Fold Rise (GMFR) of Anti-Pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens Above Vaccination Baseline Values (Day 29) | Without BG MTX use, 19F (n=45,42) | 3.88 fold rise |
| Placebo + Influenza and Pneumococcal Vaccine | Geometric Mean Fold Rise (GMFR) of Anti-Pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens Above Vaccination Baseline Values (Day 29) | Regardless MTX use, 3 (n=101,94) | 2.79 fold rise |
| Placebo + Influenza and Pneumococcal Vaccine | Geometric Mean Fold Rise (GMFR) of Anti-Pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens Above Vaccination Baseline Values (Day 29) | Regardless MTX use, 4 (n=96,89) | 5.13 fold rise |
| Placebo + Influenza and Pneumococcal Vaccine | Geometric Mean Fold Rise (GMFR) of Anti-Pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens Above Vaccination Baseline Values (Day 29) | With BG MTX use, 6B (n=57,55) | 2.24 fold rise |
| Placebo + Influenza and Pneumococcal Vaccine | Geometric Mean Fold Rise (GMFR) of Anti-Pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens Above Vaccination Baseline Values (Day 29) | Regardless MTX use, 5 (n=101,98) | 2.27 fold rise |
| Placebo + Influenza and Pneumococcal Vaccine | Geometric Mean Fold Rise (GMFR) of Anti-Pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens Above Vaccination Baseline Values (Day 29) | Without BG MTX use, 5 (n=44,43) | 2.68 fold rise |
| Placebo + Influenza and Pneumococcal Vaccine | Geometric Mean Fold Rise (GMFR) of Anti-Pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens Above Vaccination Baseline Values (Day 29) | Regardless MTX use, 6B (n=102,98) | 2.56 fold rise |
| Placebo + Influenza and Pneumococcal Vaccine | Geometric Mean Fold Rise (GMFR) of Anti-Pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens Above Vaccination Baseline Values (Day 29) | With BG MTX use, 7F (n=57,55) | 3.46 fold rise |
| Placebo + Influenza and Pneumococcal Vaccine | Geometric Mean Fold Rise (GMFR) of Anti-Pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens Above Vaccination Baseline Values (Day 29) | Regardless MTX use, 7F (n=102,97) | 4.06 fold rise |
| Placebo + Influenza and Pneumococcal Vaccine | Geometric Mean Fold Rise (GMFR) of Anti-Pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens Above Vaccination Baseline Values (Day 29) | Without BG MTX use, 23F (n=45,43) | 3.55 fold rise |
| Placebo + Influenza and Pneumococcal Vaccine | Geometric Mean Fold Rise (GMFR) of Anti-Pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens Above Vaccination Baseline Values (Day 29) | Regardless MTX use, 9V (n=102,98) | 3.16 fold rise |
| Placebo + Influenza and Pneumococcal Vaccine | Geometric Mean Fold Rise (GMFR) of Anti-Pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens Above Vaccination Baseline Values (Day 29) | With BG MTX use, 9V (n=57,55) | 2.72 fold rise |
| Placebo + Influenza and Pneumococcal Vaccine | Geometric Mean Fold Rise (GMFR) of Anti-Pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens Above Vaccination Baseline Values (Day 29) | With BG MTX use, 1 (n=49,53) | 4.51 fold rise |
| Placebo + Influenza and Pneumococcal Vaccine | Geometric Mean Fold Rise (GMFR) of Anti-Pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens Above Vaccination Baseline Values (Day 29) | Without BG MTX use, 7F (n=45,42) | 5.02 fold rise |
| Placebo + Influenza and Pneumococcal Vaccine | Geometric Mean Fold Rise (GMFR) of Anti-Pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens Above Vaccination Baseline Values (Day 29) | With BG MTX use, 14 (n=56,54) | 2.85 fold rise |
| Placebo + Influenza and Pneumococcal Vaccine | Geometric Mean Fold Rise (GMFR) of Anti-Pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens Above Vaccination Baseline Values (Day 29) | Without BG MTX use, 1 (n=40,39) | 12.04 fold rise |
| Placebo + Influenza and Pneumococcal Vaccine | Geometric Mean Fold Rise (GMFR) of Anti-Pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens Above Vaccination Baseline Values (Day 29) | With BG MTX use, 18C (n=57,55) | 3.23 fold rise |
| Placebo + Influenza and Pneumococcal Vaccine | Geometric Mean Fold Rise (GMFR) of Anti-Pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens Above Vaccination Baseline Values (Day 29) | Without BG MTX use, 3 (n=45,40) | 3.37 fold rise |
| Placebo + Influenza and Pneumococcal Vaccine | Geometric Mean Fold Rise (GMFR) of Anti-Pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens Above Vaccination Baseline Values (Day 29) | With BG MTX use, 19A (n=57,55) | 2.08 fold rise |
| Placebo + Influenza and Pneumococcal Vaccine | Geometric Mean Fold Rise (GMFR) of Anti-Pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens Above Vaccination Baseline Values (Day 29) | Without BG MTX use, 14 (n=45,42) | 5.85 fold rise |
| Placebo + Influenza and Pneumococcal Vaccine | Geometric Mean Fold Rise (GMFR) of Anti-Pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens Above Vaccination Baseline Values (Day 29) | With BG MTX use, 19F (n=57,53) | 2.29 fold rise |
| Placebo + Influenza and Pneumococcal Vaccine | Geometric Mean Fold Rise (GMFR) of Anti-Pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens Above Vaccination Baseline Values (Day 29) | Without BG MTX use, 6B (n=45,43) | 3.04 fold rise |
Secondary
Geometric Mean Titer (GMT) of Anti-Influenza Antibody
Antibody geometric mean titer (GMT) for 3 influenza antigens antigens (B, H1N1, H3N2) as measured by geometric mean of three independent determinations of the antibody response of that antigen. GMT and corresponding 2-sided 95% confidence intervals (CI) were evaluated.
Time frame: Day 64 (EOS)
Population: Evaluable immunogenicity population:eligible,randomized participants;who met rheumatoid arthritis disease activity criteria;received vaccination as scheduled and \>=80% study drug;had pre and post-vaccination blood draw;complete set of assay results;had no major protocol violations.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| CP-690,550 + Influenza and Pneumococcal Vaccine | Geometric Mean Titer (GMT) of Anti-Influenza Antibody | B | 33.39 titer |
| CP-690,550 + Influenza and Pneumococcal Vaccine | Geometric Mean Titer (GMT) of Anti-Influenza Antibody | H1N1 | 86.40 titer |
| CP-690,550 + Influenza and Pneumococcal Vaccine | Geometric Mean Titer (GMT) of Anti-Influenza Antibody | H3N2 | 132.3 titer |
| Placebo + Influenza and Pneumococcal Vaccine | Geometric Mean Titer (GMT) of Anti-Influenza Antibody | B | 50.74 titer |
| Placebo + Influenza and Pneumococcal Vaccine | Geometric Mean Titer (GMT) of Anti-Influenza Antibody | H1N1 | 221.5 titer |
| Placebo + Influenza and Pneumococcal Vaccine | Geometric Mean Titer (GMT) of Anti-Influenza Antibody | H3N2 | 244.0 titer |
Secondary
Percentage of Participants Who Responded to Each of the 12 Pneumococcal Antigens
Response to the pneumococcal vaccine (seroconversion) was defined as \>= 2 fold increase in antibody concentrations from vaccination baseline (Day 29) in each of the 12 pneumococcal antigens (1, 3, 4, 5, 6B, 7F, 9V, 14, 19A, 19F, 23F, 18C). Data was stratified by the background methotrexate use.
Time frame: Day 64 (EOS)
Population: Evaluable immunogenicity population:eligible,randomized participants;who met rheumatoid arthritis disease activity criteria;received vaccination as scheduled and \>=80% study drug;had pre and post-vaccination blood draw;complete set of assay results;had no major protocol violations.n=participants evaluable at specified categories for each arm group.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CP-690,550 + Influenza and Pneumococcal Vaccine | Percentage of Participants Who Responded to Each of the 12 Pneumococcal Antigens | With BG MTX use, 23F (n=57,55) | 24.6 percentage of participants |
| CP-690,550 + Influenza and Pneumococcal Vaccine | Percentage of Participants Who Responded to Each of the 12 Pneumococcal Antigens | Regardless MTX use, 5 (n=102,98) | 28.4 percentage of participants |
| CP-690,550 + Influenza and Pneumococcal Vaccine | Percentage of Participants Who Responded to Each of the 12 Pneumococcal Antigens | With BG MTX use, 3 (n=57,55) | 24.6 percentage of participants |
| CP-690,550 + Influenza and Pneumococcal Vaccine | Percentage of Participants Who Responded to Each of the 12 Pneumococcal Antigens | Regardless MTX use, 14 (n=102,98) | 52 percentage of participants |
| CP-690,550 + Influenza and Pneumococcal Vaccine | Percentage of Participants Who Responded to Each of the 12 Pneumococcal Antigens | With BG MTX use, 4 (n=57,55) | 52.6 percentage of participants |
| CP-690,550 + Influenza and Pneumococcal Vaccine | Percentage of Participants Who Responded to Each of the 12 Pneumococcal Antigens | Regardless MTX use, 6B (n=102,98) | 36.3 percentage of participants |
| CP-690,550 + Influenza and Pneumococcal Vaccine | Percentage of Participants Who Responded to Each of the 12 Pneumococcal Antigens | With BG MTX use, 5 (n=57,55) | 28.1 percentage of participants |
| CP-690,550 + Influenza and Pneumococcal Vaccine | Percentage of Participants Who Responded to Each of the 12 Pneumococcal Antigens | Regardless MTX use, 19F (n=102,98) | 35.3 percentage of participants |
| CP-690,550 + Influenza and Pneumococcal Vaccine | Percentage of Participants Who Responded to Each of the 12 Pneumococcal Antigens | With BG MTX use, 6B (n=57,55) | 29.8 percentage of participants |
| CP-690,550 + Influenza and Pneumococcal Vaccine | Percentage of Participants Who Responded to Each of the 12 Pneumococcal Antigens | Regardless MTX use, 7F (n=102,98) | 58.8 percentage of participants |
| CP-690,550 + Influenza and Pneumococcal Vaccine | Percentage of Participants Who Responded to Each of the 12 Pneumococcal Antigens | With BG MTX use, 7F (n=57,55) | 49.1 percentage of participants |
| CP-690,550 + Influenza and Pneumococcal Vaccine | Percentage of Participants Who Responded to Each of the 12 Pneumococcal Antigens | Regardless MTX use, 1 (n=102,98) | 59.8 percentage of participants |
| CP-690,550 + Influenza and Pneumococcal Vaccine | Percentage of Participants Who Responded to Each of the 12 Pneumococcal Antigens | With BG MTX use, 9V (n=57,55) | 33.3 percentage of participants |
| CP-690,550 + Influenza and Pneumococcal Vaccine | Percentage of Participants Who Responded to Each of the 12 Pneumococcal Antigens | Regardless MTX use, 9V (n=102,98) | 45.1 percentage of participants |
| CP-690,550 + Influenza and Pneumococcal Vaccine | Percentage of Participants Who Responded to Each of the 12 Pneumococcal Antigens | Without BG MTX use, 1 (n=45,43) | 62.2 percentage of participants |
| CP-690,550 + Influenza and Pneumococcal Vaccine | Percentage of Participants Who Responded to Each of the 12 Pneumococcal Antigens | Regardless MTX use, 23F (n=102,98) | 40.2 percentage of participants |
| CP-690,550 + Influenza and Pneumococcal Vaccine | Percentage of Participants Who Responded to Each of the 12 Pneumococcal Antigens | Without BG MTX use, 14 (n=45,43) | 57.8 percentage of participants |
| CP-690,550 + Influenza and Pneumococcal Vaccine | Percentage of Participants Who Responded to Each of the 12 Pneumococcal Antigens | With BG MTX use, 1 (n=57,55) | 57.9 percentage of participants |
| CP-690,550 + Influenza and Pneumococcal Vaccine | Percentage of Participants Who Responded to Each of the 12 Pneumococcal Antigens | Without BG MTX use, 18C (n=45,43) | 73.3 percentage of participants |
| CP-690,550 + Influenza and Pneumococcal Vaccine | Percentage of Participants Who Responded to Each of the 12 Pneumococcal Antigens | Regardless MTX use, 18C (n=102,98) | 59.8 percentage of participants |
| CP-690,550 + Influenza and Pneumococcal Vaccine | Percentage of Participants Who Responded to Each of the 12 Pneumococcal Antigens | Without BG MTX use, 19A (n=45,43) | 48.9 percentage of participants |
| CP-690,550 + Influenza and Pneumococcal Vaccine | Percentage of Participants Who Responded to Each of the 12 Pneumococcal Antigens | With BG MTX use, 14 (n=57,55) | 47.4 percentage of participants |
| CP-690,550 + Influenza and Pneumococcal Vaccine | Percentage of Participants Who Responded to Each of the 12 Pneumococcal Antigens | Without BG MTX use, 23F (n=45,43) | 60 percentage of participants |
| CP-690,550 + Influenza and Pneumococcal Vaccine | Percentage of Participants Who Responded to Each of the 12 Pneumococcal Antigens | Regardless MTX use, 3 (n=102,98) | 38.2 percentage of participants |
| CP-690,550 + Influenza and Pneumococcal Vaccine | Percentage of Participants Who Responded to Each of the 12 Pneumococcal Antigens | Without BG MTX use, 3 (n=45,43) | 55.6 percentage of participants |
| CP-690,550 + Influenza and Pneumococcal Vaccine | Percentage of Participants Who Responded to Each of the 12 Pneumococcal Antigens | With BG MTX use, 18C (n=57,55) | 49.1 percentage of participants |
| CP-690,550 + Influenza and Pneumococcal Vaccine | Percentage of Participants Who Responded to Each of the 12 Pneumococcal Antigens | Without BG MTX use, 4 (n=45,43) | 66.7 percentage of participants |
| CP-690,550 + Influenza and Pneumococcal Vaccine | Percentage of Participants Who Responded to Each of the 12 Pneumococcal Antigens | Without BG MTX use, 19F (n=45,43) | 44.4 percentage of participants |
| CP-690,550 + Influenza and Pneumococcal Vaccine | Percentage of Participants Who Responded to Each of the 12 Pneumococcal Antigens | Without BG MTX use, 5 (n=45,43) | 28.9 percentage of participants |
| CP-690,550 + Influenza and Pneumococcal Vaccine | Percentage of Participants Who Responded to Each of the 12 Pneumococcal Antigens | With BG MTX use, 19A (n=57,55) | 19.3 percentage of participants |
| CP-690,550 + Influenza and Pneumococcal Vaccine | Percentage of Participants Who Responded to Each of the 12 Pneumococcal Antigens | Without BG MTX use, 6B (n=45,43) | 44.4 percentage of participants |
| CP-690,550 + Influenza and Pneumococcal Vaccine | Percentage of Participants Who Responded to Each of the 12 Pneumococcal Antigens | Regardless MTX use, 4 (n=102,98) | 58.8 percentage of participants |
| CP-690,550 + Influenza and Pneumococcal Vaccine | Percentage of Participants Who Responded to Each of the 12 Pneumococcal Antigens | Without BG MTX use, 7F (n=45,43) | 71.1 percentage of participants |
| CP-690,550 + Influenza and Pneumococcal Vaccine | Percentage of Participants Who Responded to Each of the 12 Pneumococcal Antigens | With BG MTX use, 19F (n=57,55) | 28.1 percentage of participants |
| CP-690,550 + Influenza and Pneumococcal Vaccine | Percentage of Participants Who Responded to Each of the 12 Pneumococcal Antigens | Without BG MTX use, 9V (n=45,43) | 60 percentage of participants |
| CP-690,550 + Influenza and Pneumococcal Vaccine | Percentage of Participants Who Responded to Each of the 12 Pneumococcal Antigens | Regardless MTX use, 19A (n=102,98) | 32.4 percentage of participants |
| Placebo + Influenza and Pneumococcal Vaccine | Percentage of Participants Who Responded to Each of the 12 Pneumococcal Antigens | Without BG MTX use, 9V (n=45,43) | 69.8 percentage of participants |
| Placebo + Influenza and Pneumococcal Vaccine | Percentage of Participants Who Responded to Each of the 12 Pneumococcal Antigens | Regardless MTX use, 1 (n=102,98) | 69.4 percentage of participants |
| Placebo + Influenza and Pneumococcal Vaccine | Percentage of Participants Who Responded to Each of the 12 Pneumococcal Antigens | Regardless MTX use, 14 (n=102,98) | 61.2 percentage of participants |
| Placebo + Influenza and Pneumococcal Vaccine | Percentage of Participants Who Responded to Each of the 12 Pneumococcal Antigens | Regardless MTX use, 18C (n=102,98) | 70.4 percentage of participants |
| Placebo + Influenza and Pneumococcal Vaccine | Percentage of Participants Who Responded to Each of the 12 Pneumococcal Antigens | Regardless MTX use, 19A (n=102,98) | 46.9 percentage of participants |
| Placebo + Influenza and Pneumococcal Vaccine | Percentage of Participants Who Responded to Each of the 12 Pneumococcal Antigens | Regardless MTX use, 19F (n=102,98) | 56.1 percentage of participants |
| Placebo + Influenza and Pneumococcal Vaccine | Percentage of Participants Who Responded to Each of the 12 Pneumococcal Antigens | Regardless MTX use, 23F (n=102,98) | 58.2 percentage of participants |
| Placebo + Influenza and Pneumococcal Vaccine | Percentage of Participants Who Responded to Each of the 12 Pneumococcal Antigens | Regardless MTX use, 3 (n=102,98) | 54.1 percentage of participants |
| Placebo + Influenza and Pneumococcal Vaccine | Percentage of Participants Who Responded to Each of the 12 Pneumococcal Antigens | Regardless MTX use, 4 (n=102,98) | 65.3 percentage of participants |
| Placebo + Influenza and Pneumococcal Vaccine | Percentage of Participants Who Responded to Each of the 12 Pneumococcal Antigens | Regardless MTX use, 5 (n=102,98) | 38.8 percentage of participants |
| Placebo + Influenza and Pneumococcal Vaccine | Percentage of Participants Who Responded to Each of the 12 Pneumococcal Antigens | Regardless MTX use, 6B (n=102,98) | 54.1 percentage of participants |
| Placebo + Influenza and Pneumococcal Vaccine | Percentage of Participants Who Responded to Each of the 12 Pneumococcal Antigens | Regardless MTX use, 7F (n=102,98) | 65.3 percentage of participants |
| Placebo + Influenza and Pneumococcal Vaccine | Percentage of Participants Who Responded to Each of the 12 Pneumococcal Antigens | Regardless MTX use, 9V (n=102,98) | 58.2 percentage of participants |
| Placebo + Influenza and Pneumococcal Vaccine | Percentage of Participants Who Responded to Each of the 12 Pneumococcal Antigens | With BG MTX use, 1 (n=57,55) | 61.8 percentage of participants |
| Placebo + Influenza and Pneumococcal Vaccine | Percentage of Participants Who Responded to Each of the 12 Pneumococcal Antigens | With BG MTX use, 14 (n=57,55) | 56.4 percentage of participants |
| Placebo + Influenza and Pneumococcal Vaccine | Percentage of Participants Who Responded to Each of the 12 Pneumococcal Antigens | With BG MTX use, 18C (n=57,55) | 58.2 percentage of participants |
| Placebo + Influenza and Pneumococcal Vaccine | Percentage of Participants Who Responded to Each of the 12 Pneumococcal Antigens | With BG MTX use, 19A (n=57,55) | 40 percentage of participants |
| Placebo + Influenza and Pneumococcal Vaccine | Percentage of Participants Who Responded to Each of the 12 Pneumococcal Antigens | With BG MTX use, 19F (n=57,55) | 49.1 percentage of participants |
| Placebo + Influenza and Pneumococcal Vaccine | Percentage of Participants Who Responded to Each of the 12 Pneumococcal Antigens | With BG MTX use, 23F (n=57,55) | 49.1 percentage of participants |
| Placebo + Influenza and Pneumococcal Vaccine | Percentage of Participants Who Responded to Each of the 12 Pneumococcal Antigens | With BG MTX use, 3 (n=57,55) | 49.1 percentage of participants |
| Placebo + Influenza and Pneumococcal Vaccine | Percentage of Participants Who Responded to Each of the 12 Pneumococcal Antigens | With BG MTX use, 4 (n=57,55) | 56.4 percentage of participants |
| Placebo + Influenza and Pneumococcal Vaccine | Percentage of Participants Who Responded to Each of the 12 Pneumococcal Antigens | With BG MTX use, 5 (n=57,55) | 29.1 percentage of participants |
| Placebo + Influenza and Pneumococcal Vaccine | Percentage of Participants Who Responded to Each of the 12 Pneumococcal Antigens | With BG MTX use, 6B (n=57,55) | 47.3 percentage of participants |
| Placebo + Influenza and Pneumococcal Vaccine | Percentage of Participants Who Responded to Each of the 12 Pneumococcal Antigens | With BG MTX use, 7F (n=57,55) | 56.4 percentage of participants |
| Placebo + Influenza and Pneumococcal Vaccine | Percentage of Participants Who Responded to Each of the 12 Pneumococcal Antigens | With BG MTX use, 9V (n=57,55) | 49.1 percentage of participants |
| Placebo + Influenza and Pneumococcal Vaccine | Percentage of Participants Who Responded to Each of the 12 Pneumococcal Antigens | Without BG MTX use, 1 (n=45,43) | 79.1 percentage of participants |
| Placebo + Influenza and Pneumococcal Vaccine | Percentage of Participants Who Responded to Each of the 12 Pneumococcal Antigens | Without BG MTX use, 14 (n=45,43) | 67.4 percentage of participants |
| Placebo + Influenza and Pneumococcal Vaccine | Percentage of Participants Who Responded to Each of the 12 Pneumococcal Antigens | Without BG MTX use, 18C (n=45,43) | 86 percentage of participants |
| Placebo + Influenza and Pneumococcal Vaccine | Percentage of Participants Who Responded to Each of the 12 Pneumococcal Antigens | Without BG MTX use, 19F (n=45,43) | 65.1 percentage of participants |
| Placebo + Influenza and Pneumococcal Vaccine | Percentage of Participants Who Responded to Each of the 12 Pneumococcal Antigens | Without BG MTX use, 23F (n=45,43) | 69.8 percentage of participants |
| Placebo + Influenza and Pneumococcal Vaccine | Percentage of Participants Who Responded to Each of the 12 Pneumococcal Antigens | Without BG MTX use, 3 (n=45,43) | 60.5 percentage of participants |
| Placebo + Influenza and Pneumococcal Vaccine | Percentage of Participants Who Responded to Each of the 12 Pneumococcal Antigens | Without BG MTX use, 4 (n=45,43) | 76.7 percentage of participants |
| Placebo + Influenza and Pneumococcal Vaccine | Percentage of Participants Who Responded to Each of the 12 Pneumococcal Antigens | Without BG MTX use, 5 (n=45,43) | 51.2 percentage of participants |
| Placebo + Influenza and Pneumococcal Vaccine | Percentage of Participants Who Responded to Each of the 12 Pneumococcal Antigens | Without BG MTX use, 6B (n=45,43) | 62.8 percentage of participants |
| Placebo + Influenza and Pneumococcal Vaccine | Percentage of Participants Who Responded to Each of the 12 Pneumococcal Antigens | Without BG MTX use, 7F (n=45,43) | 76.7 percentage of participants |
| Placebo + Influenza and Pneumococcal Vaccine | Percentage of Participants Who Responded to Each of the 12 Pneumococcal Antigens | Without BG MTX use, 19A (n=45,43) | 55.8 percentage of participants |
Secondary
Percentage of Participants Who Responded to Each of the 3 Influenza Antigens
Response to the influenza vaccine (seroconversion) was defined as \>= 4 fold increase in antibody titers from vaccination baseline (Day 29) in each of 3 influenza antigens (B, H1N1, H3N2). Data was stratified by the background methotrexate use.
Time frame: Day 64 (EOS)
Population: Evaluable immunogenicity population:eligible,randomized participants;who met rheumatoid arthritis disease activity criteria;received vaccination as scheduled and \>=80% study drug;had pre and post-vaccination blood draw;complete set of assay results;had no major protocol violations.n=participants evaluable at specified categories for each arm group.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CP-690,550 + Influenza and Pneumococcal Vaccine | Percentage of Participants Who Responded to Each of the 3 Influenza Antigens | Regardless MTX use, H1N1 (n=102,98) | 60.8 percentage of participants |
| CP-690,550 + Influenza and Pneumococcal Vaccine | Percentage of Participants Who Responded to Each of the 3 Influenza Antigens | With BG MTX use, H3N2 (n=57,55) | 57.9 percentage of participants |
| CP-690,550 + Influenza and Pneumococcal Vaccine | Percentage of Participants Who Responded to Each of the 3 Influenza Antigens | With BG MTX use, B (n=57,55) | 35.1 percentage of participants |
| CP-690,550 + Influenza and Pneumococcal Vaccine | Percentage of Participants Who Responded to Each of the 3 Influenza Antigens | Without BG MTX use, B (n=45,43) | 42.2 percentage of participants |
| CP-690,550 + Influenza and Pneumococcal Vaccine | Percentage of Participants Who Responded to Each of the 3 Influenza Antigens | Regardless MTX use, H3N2 (n=102,98) | 60.8 percentage of participants |
| CP-690,550 + Influenza and Pneumococcal Vaccine | Percentage of Participants Who Responded to Each of the 3 Influenza Antigens | Without BG MTX use, H1N1 (n=45,43) | 71.1 percentage of participants |
| CP-690,550 + Influenza and Pneumococcal Vaccine | Percentage of Participants Who Responded to Each of the 3 Influenza Antigens | With BG MTX use, H1N1 (n=57,55) | 52.6 percentage of participants |
| CP-690,550 + Influenza and Pneumococcal Vaccine | Percentage of Participants Who Responded to Each of the 3 Influenza Antigens | Without BG MTX use, H3N2 (n=45,43) | 64.4 percentage of participants |
| CP-690,550 + Influenza and Pneumococcal Vaccine | Percentage of Participants Who Responded to Each of the 3 Influenza Antigens | Regardless MTX use, B (n=102,98) | 38.2 percentage of participants |
| Placebo + Influenza and Pneumococcal Vaccine | Percentage of Participants Who Responded to Each of the 3 Influenza Antigens | Without BG MTX use, H3N2 (n=45,43) | 74.4 percentage of participants |
| Placebo + Influenza and Pneumococcal Vaccine | Percentage of Participants Who Responded to Each of the 3 Influenza Antigens | Regardless MTX use, B (n=102,98) | 52 percentage of participants |
| Placebo + Influenza and Pneumococcal Vaccine | Percentage of Participants Who Responded to Each of the 3 Influenza Antigens | Regardless MTX use, H1N1 (n=102,98) | 63.3 percentage of participants |
| Placebo + Influenza and Pneumococcal Vaccine | Percentage of Participants Who Responded to Each of the 3 Influenza Antigens | Regardless MTX use, H3N2 (n=102,98) | 69.4 percentage of participants |
| Placebo + Influenza and Pneumococcal Vaccine | Percentage of Participants Who Responded to Each of the 3 Influenza Antigens | With BG MTX use, B (n=57,55) | 41.8 percentage of participants |
| Placebo + Influenza and Pneumococcal Vaccine | Percentage of Participants Who Responded to Each of the 3 Influenza Antigens | With BG MTX use, H1N1 (n=57,55) | 58.2 percentage of participants |
| Placebo + Influenza and Pneumococcal Vaccine | Percentage of Participants Who Responded to Each of the 3 Influenza Antigens | With BG MTX use, H3N2 (n=57,55) | 65.5 percentage of participants |
| Placebo + Influenza and Pneumococcal Vaccine | Percentage of Participants Who Responded to Each of the 3 Influenza Antigens | Without BG MTX use, B (n=45,43) | 65.1 percentage of participants |
| Placebo + Influenza and Pneumococcal Vaccine | Percentage of Participants Who Responded to Each of the 3 Influenza Antigens | Without BG MTX use, H1N1 (n=45,43) | 69.8 percentage of participants |
Secondary
Percentage of Participants With Protective Antibody Titers to the Seasonal Influenza Vaccine
Seroprotection was defined as achieving protective antibody titers to the influenza vaccine as measured by a hemagglutination inhibition (HAI) assay titer of \>= 1:40 in at least 2 of 3 influenza antigens (B, H1N1, H3N2). Data was stratified by the background methotrexate use.
Time frame: Day 64 (EOS)
Population: Evaluable immunogenicity population:eligible,randomized participants;who met rheumatoid arthritis disease activity criteria;received vaccination as scheduled and \>=80% study drug;had pre and post-vaccination blood draw;complete set of assay results;had no major protocol violations.n=participants evaluable at specified categories for each arm group.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CP-690,550 + Influenza and Pneumococcal Vaccine | Percentage of Participants With Protective Antibody Titers to the Seasonal Influenza Vaccine | Without BG MTX use (n=45,43) | 91.1 percentage of participants |
| CP-690,550 + Influenza and Pneumococcal Vaccine | Percentage of Participants With Protective Antibody Titers to the Seasonal Influenza Vaccine | Regardless MTX use (n=102,98) | 76.5 percentage of participants |
| CP-690,550 + Influenza and Pneumococcal Vaccine | Percentage of Participants With Protective Antibody Titers to the Seasonal Influenza Vaccine | With BG MTX use (n=57,55) | 64.9 percentage of participants |
| Placebo + Influenza and Pneumococcal Vaccine | Percentage of Participants With Protective Antibody Titers to the Seasonal Influenza Vaccine | Without BG MTX use (n=45,43) | 90.7 percentage of participants |
| Placebo + Influenza and Pneumococcal Vaccine | Percentage of Participants With Protective Antibody Titers to the Seasonal Influenza Vaccine | Regardless MTX use (n=102,98) | 91.8 percentage of participants |
| Placebo + Influenza and Pneumococcal Vaccine | Percentage of Participants With Protective Antibody Titers to the Seasonal Influenza Vaccine | With BG MTX use (n=57,55) | 92.7 percentage of participants |