Arthritis, Psoriatic
Conditions
Brief summary
This is a prospective, open-label, 1-arm, multicenter observational study to determine the dose and time interval of Remicade (Infliximab) infusions in psoriatic arthritis (PsA).
Detailed description
This study population was chosen from a non-probability sample.
Interventions
BIOLOGICALRemicade (Infliximab)
Induction infusions of Remicade will be administered at weeks 0, 2, and 6 given in a dosage due to the decision of the physicians. A maximum of 6 maintenance infusions will be administered with the dosage and interval due to the discretion of the physicians.
Sponsors
Centocor, Inc.
Merck Sharp & Dohme LLC
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Participants with active and progressive psoriatic arthritis who have responded inadequately to disease-modifying anti-rheumatic drugs.
Exclusion criteria
* All according to contraindications in the label especially: * Participants with tuberculosis or other severe infections such as sepsis, abscesses, and opportunistic infections. * Participants with moderate or severe heart failure (NYHA class III/IV). * Participants with a history of hypersensitivity to infliximab or to other murine proteins, or to any of the excipients.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Time Interval Between Infusions During Maintenance Therapy | Up to 24 months | The mean time interval measured in days between Infliximab infusions in participants during the maintenance therapy (between infusion 3/4, 4/5, 5/6, 6/7, 7/8, 8/9) following induction therapy. |
| Median Time Interval Between Infusions During Maintenance Therapy | Up to 24 months | The median time interval measured in days between Infliximab infusions in participants during the maintenance therapy (between infusion 3/4, 4/5, 5/6, 6/7, 7/8, 8/9) following induction therapy. |
| Average Dose During Induction Therapy and Subsequent Maintenance Therapy | Up to 24 Months | The average dose per infusion measured in milligrams/killogram (mg/kg) in participants receiving induction therapy and subsequent maintenance therapy (Infusions 1-3 were induction therapy and infusions 4-9 were maintenance therapy for a total of 9 consecutive infusions). |
| Median Dose During Induction Therapy and Subsequent Maintenance Therapy | Up to 24 Months | The median dose per infusion measured in mg/kg in participants receiving induction therapy and subsequent maintenance therapy (Infusions 1-3 were induction therapy and infusions 4-9 were maintenance therapy for a total of 9 consecutive infusions). |
| Average Overall Dose of All Infusions Per Participant | Up to 24 Months | The average overall dose of all infusions among all Infliximab-naive participants measured in mg/kg. |
| Median Dose of All Infusions Per Participant | Up to 24 Months | The median dose of all infusions among all Infliximab-naive participants measured in mg/kg. |
Participant flow
Pre-assignment details
A total of 178 participants were enrolled in this study. Of these, 159 participants were Infliximab-naive and 19 participants were already on Remicade (Infliximab). A total of 163 participants received at least one dose: 152 of the 159 naive participants and 11 of the 19 non-naive participants.
Participants by arm
| Arm | Count |
|---|---|
| Infliximab Participants with active and progressive PsA who have responded inadequately to disease-modifying anti-rheumatic drugs received induction intravenous (IV) infusions of Infliximab at weeks 0, 2, and 6 given in a dosage due to the decision of the physicians and in the usual manner in accordance to the term of the applicable marketing authorization. Then, a maximum of 6 maintenance infusions were administered with the dosage and interval due to the discretion of the physicians. According to the European Summary of Product Characteristics (SPC), Infliximab 5 mg/kg is given as an IV infusion over a 2-hour period followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter. | 163 |
| Total | 163 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 11 |
| Overall Study | Lack of Efficacy | 7 |
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Non-Compliance | 2 |
| Overall Study | Other | 38 |
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | Infliximab |
|---|---|
| Age, Continuous | 47.96 years STANDARD_DEVIATION 13.22 |
| Sex: Female, Male Female | 62 Participants |
| Sex: Female, Male Male | 101 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 163 |
| serious Total, serious adverse events | 6 / 163 |
Outcome results
Primary
Average Dose During Induction Therapy and Subsequent Maintenance Therapy
The average dose per infusion measured in milligrams/killogram (mg/kg) in participants receiving induction therapy and subsequent maintenance therapy (Infusions 1-3 were induction therapy and infusions 4-9 were maintenance therapy for a total of 9 consecutive infusions).
Time frame: Up to 24 Months
Population: N= number of Infliximab-naive participants that received induction \& maintenance therapy.~Out of 152 Infliximab-naive participants who were treated, 94 participants received induction therapy (Infliximab at weeks 0, 2, and 6), 83 participants received induction therapy and subsequent maintenance therapy (maximum of 6 maintenance infusions).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Infliximab | Average Dose During Induction Therapy and Subsequent Maintenance Therapy | Infusion 1 (n=83) | 3.92 mg/kg | Standard Deviation 0.8 |
| Infliximab | Average Dose During Induction Therapy and Subsequent Maintenance Therapy | Infusion 2 (n=83) | 3.92 mg/kg | Standard Deviation 0.81 |
| Infliximab | Average Dose During Induction Therapy and Subsequent Maintenance Therapy | Infusion 3 (n=83) | 3.98 mg/kg | Standard Deviation 0.86 |
| Infliximab | Average Dose During Induction Therapy and Subsequent Maintenance Therapy | Infusion 4 (n=83) | 3.96 mg/kg | Standard Deviation 0.87 |
| Infliximab | Average Dose During Induction Therapy and Subsequent Maintenance Therapy | Infusion 5 (n=83) | 3.94 mg/kg | Standard Deviation 0.85 |
| Infliximab | Average Dose During Induction Therapy and Subsequent Maintenance Therapy | Infusion 6 (n=79) | 3.94 mg/kg | Standard Deviation 0.85 |
| Infliximab | Average Dose During Induction Therapy and Subsequent Maintenance Therapy | Infusion 7 (n=77) | 3.97 mg/kg | Standard Deviation 0.84 |
| Infliximab | Average Dose During Induction Therapy and Subsequent Maintenance Therapy | Infusion 8 (n=73) | 3.97 mg/kg | Standard Deviation 0.87 |
| Infliximab | Average Dose During Induction Therapy and Subsequent Maintenance Therapy | Infusion 9 (n=70) | 3.97 mg/kg | Standard Deviation 0.89 |
Primary
Average Overall Dose of All Infusions Per Participant
The average overall dose of all infusions among all Infliximab-naive participants measured in mg/kg.
Time frame: Up to 24 Months
Population: 152 out of the 159 Infliximab-naive participants were treated in the active phase.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Infliximab | Average Overall Dose of All Infusions Per Participant | 4.07 mg/kg | Standard Deviation 0.84 |
Primary
Mean Time Interval Between Infusions During Maintenance Therapy
The mean time interval measured in days between Infliximab infusions in participants during the maintenance therapy (between infusion 3/4, 4/5, 5/6, 6/7, 7/8, 8/9) following induction therapy.
Time frame: Up to 24 months
Population: N= number of Infliximab-naive participants that received induction \& maintenance therapy.~Out of 152 Infliximab-naive participants who were treated, 94 participants received induction therapy (Infliximab at weeks 0, 2, and 6), 83 participants received induction therapy and subsequent maintenance therapy (maximum of 6 maintenance infusions).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Infliximab | Mean Time Interval Between Infusions During Maintenance Therapy | Interval between infusion 3/4 (n= 83) | 57.03 days | Standard Deviation 7.83 |
| Infliximab | Mean Time Interval Between Infusions During Maintenance Therapy | Interval between infusion 4/5 (n=83) | 57.90 days | Standard Deviation 7.97 |
| Infliximab | Mean Time Interval Between Infusions During Maintenance Therapy | Interval between infusion 5/6 (n=79) | 58.59 days | Standard Deviation 12.28 |
| Infliximab | Mean Time Interval Between Infusions During Maintenance Therapy | Interval between infusion 6/7 (n=77) | 56.02 days | Standard Deviation 10.59 |
| Infliximab | Mean Time Interval Between Infusions During Maintenance Therapy | Interval between infusion 7/8 (n=73) | 56.92 days | Standard Deviation 10.76 |
| Infliximab | Mean Time Interval Between Infusions During Maintenance Therapy | Interval between infusion 8/9 (n=70) | 59.32 days | Standard Deviation 18.39 |
Primary
Median Dose During Induction Therapy and Subsequent Maintenance Therapy
The median dose per infusion measured in mg/kg in participants receiving induction therapy and subsequent maintenance therapy (Infusions 1-3 were induction therapy and infusions 4-9 were maintenance therapy for a total of 9 consecutive infusions).
Time frame: Up to 24 Months
Population: N= number of Infliximab-naive participants that received induction \& maintenance therapy.~Out of 152 Infliximab-naive participants who were treated, 94 participants received induction therapy (Infliximab at weeks 0, 2, and 6), 83 participants received induction therapy and subsequent maintenance therapy (maximum of 6 maintenance infusions).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Infliximab | Median Dose During Induction Therapy and Subsequent Maintenance Therapy | Infusion 1 (n=83) | 3.75 mg/kg |
| Infliximab | Median Dose During Induction Therapy and Subsequent Maintenance Therapy | Infusion 2 (n=83) | 3.75 mg/kg |
| Infliximab | Median Dose During Induction Therapy and Subsequent Maintenance Therapy | Infusion 3 (n=83) | 3.75 mg/kg |
| Infliximab | Median Dose During Induction Therapy and Subsequent Maintenance Therapy | Infusion 4 (n=83) | 3.75 mg/kg |
| Infliximab | Median Dose During Induction Therapy and Subsequent Maintenance Therapy | Infusion 5 (n=83) | 3.75 mg/kg |
| Infliximab | Median Dose During Induction Therapy and Subsequent Maintenance Therapy | Infusion 6 (n=79) | 3.75 mg/kg |
| Infliximab | Median Dose During Induction Therapy and Subsequent Maintenance Therapy | Infusion 7 (n=77) | 3.75 mg/kg |
| Infliximab | Median Dose During Induction Therapy and Subsequent Maintenance Therapy | Infusion 8 (n=73) | 3.75 mg/kg |
| Infliximab | Median Dose During Induction Therapy and Subsequent Maintenance Therapy | Infusion 9 (n=70) | 3.75 mg/kg |
Primary
Median Dose of All Infusions Per Participant
The median dose of all infusions among all Infliximab-naive participants measured in mg/kg.
Time frame: Up to 24 Months
Population: 152 out of the 159 Infliximab-naive participants were treated in the active phase.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Infliximab | Median Dose of All Infusions Per Participant | 3.87 mg/kg |
Primary
Median Time Interval Between Infusions During Maintenance Therapy
The median time interval measured in days between Infliximab infusions in participants during the maintenance therapy (between infusion 3/4, 4/5, 5/6, 6/7, 7/8, 8/9) following induction therapy.
Time frame: Up to 24 months
Population: N= number of Infliximab-naive participants that received induction \& maintenance therapy.~Out of 152 Infliximab-naive participants who were treated, 94 participants received induction therapy (Infliximab at weeks 0, 2, and 6), 83 participants received induction therapy and subsequent maintenance therapy (maximum of 6 maintenance infusions).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Infliximab | Median Time Interval Between Infusions During Maintenance Therapy | Interval between infusion 3/4 (n= 83) | 56 days |
| Infliximab | Median Time Interval Between Infusions During Maintenance Therapy | Interval between infusion 4/5 (n=83) | 56 days |
| Infliximab | Median Time Interval Between Infusions During Maintenance Therapy | Interval between infusion 5/6 (n=79) | 56 days |
| Infliximab | Median Time Interval Between Infusions During Maintenance Therapy | Interval between infusion 6/7 (n=77) | 56 days |
| Infliximab | Median Time Interval Between Infusions During Maintenance Therapy | Interval between infusion 7/8 (n=73) | 56 days |
| Infliximab | Median Time Interval Between Infusions During Maintenance Therapy | Interval between infusion 8/9 (n=70) | 56 days |