Psoriasis
Conditions
Brief summary
Prospective, open-label-, 1-arm, multicenter observational study to determine the dose and interval of Infliximab infusions for subjects with plaque psoriasis.
Detailed description
This study population was chosen from a non-probability sample.
Interventions
BIOLOGICALInfliximab
Infliximab initial induction therapy consisting of 3 Infliximab infusions at weeks 0, 2, and 6 given in specialized centers. A maximum of 6 maintenance infusions will be given in doses and intervals 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
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* According to the European Summary of Product Characteristics (SPC): Adult subjects with moderate-to-severe plaque psoriasis who failed to respond to, or who have a contraindication to, or are intolerant to other systematic therapy including cyclosporine, methotrexate, or Psoralen-ultraviolet-A light (PUVA).
Exclusion criteria
* According to the European SPC: * Subjects with tuberculosis or other severe infections such as sepsis, abscesses, and opportunistic infections. * Subjects with moderate-to-severe heart failure (New York Heart Association (NYHA) class III/IV). * Subjects with a history of hypersensitivity to Infliximab or to other murine proteins or to any of the excipients. * Subjects with elevated liver enzymes (\>5 upper limit of normal (ULN)).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Therapies That Were Applied as Induction, Maintenance, or Episodic Therapies After One Infusion of Infliximab | Maximum 2 years | The types of therapies were assessed according to the following criteria: Induction therapy: first infusion given at Week 0 (Baseline). Second infusion given at Week 2 (+/- 7 days). Third infusion given at Week 6 (+/- 7 days). Maintenance therapy: given in approximately 8-week (56-day) intervals (time window +4 weeks to -2 weeks). One infusion given out of the time window was accepted to be classified as maintenance therapy, if the remaining infusions were given within the time window (8 weeks, +4 to -2 weeks). Episodic Therapy: given out of time frame (\> 12 weeks). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Time Interval Between Infliximab Infusions During Maintenance Treatment Following Induction Therapy | Maximum 2 years | — |
| Median Time Interval Between Infliximab Infusions During Maintenance Treatment Following Induction Therapy | Maximum 2 years | — |
| Mean Dose of Infliximab | Maximum 2 years | — |
| Median Dose of Infliximab | Maximum 2 years | — |
| Mean Percent Change From Baseline in Body Surface Area (BSA) Involved With Psoriasis After Treatment With Infliximab | Baseline and Infusion 9 | BSA estimation was determined using the participant's handprint (palmar surface of palms plus five digits). The number of handprints that covered the affected skin area was counted. One handprint was approximately equivalent to 1 percent of the BSA; therefore, BSA was calculated in percentages. The change from Baseline in BSA was calculated by subtracting Baseline from infusion 9. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Infliximab Infliximab induction therapy consisted of 3 infusions (5 mg/kg) in weeks 0, 2, and 6 given in specialized centers. Maintenance therapy consisted of a maximum of 6 infusions (5 mg/kg) given in doses and intervals at the discretion of the physician. | 26 |
| Total | 26 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 3 |
| Overall Study | Lack of Efficacy | 2 |
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Physician Decision | 1 |
| Overall Study | Reason not specified | 1 |
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | Infliximab |
|---|---|
| Age, Continuous | 46.23 years STANDARD_DEVIATION 10.17 |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 4 / 26 |
| serious Total, serious adverse events | 2 / 26 |
Outcome results
Primary
Number of Therapies That Were Applied as Induction, Maintenance, or Episodic Therapies After One Infusion of Infliximab
The types of therapies were assessed according to the following criteria: Induction therapy: first infusion given at Week 0 (Baseline). Second infusion given at Week 2 (+/- 7 days). Third infusion given at Week 6 (+/- 7 days). Maintenance therapy: given in approximately 8-week (56-day) intervals (time window +4 weeks to -2 weeks). One infusion given out of the time window was accepted to be classified as maintenance therapy, if the remaining infusions were given within the time window (8 weeks, +4 to -2 weeks). Episodic Therapy: given out of time frame (\> 12 weeks).
Time frame: Maximum 2 years
Population: Infliximab-naive participants who received Infliximab during the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Infliximab | Number of Therapies That Were Applied as Induction, Maintenance, or Episodic Therapies After One Infusion of Infliximab | Induction therapy | 7 Therapies |
| Infliximab | Number of Therapies That Were Applied as Induction, Maintenance, or Episodic Therapies After One Infusion of Infliximab | Maintenance therapy | 2 Therapies |
| Infliximab | Number of Therapies That Were Applied as Induction, Maintenance, or Episodic Therapies After One Infusion of Infliximab | Episodic therapy | 1 Therapies |
| Infliximab | Number of Therapies That Were Applied as Induction, Maintenance, or Episodic Therapies After One Infusion of Infliximab | No treatment regimen applied | 2 Therapies |
Secondary
Mean Dose of Infliximab
Time frame: Maximum 2 years
Population: All participants who received at least 1 Infliximab infusion during the observational phase.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Infliximab | Mean Dose of Infliximab | Infusion 8 (n=16) | 4.16 milligrams/kilograms (mg/kg) | Standard Deviation 1.02 |
| Infliximab | Mean Dose of Infliximab | Infusion 1 (n=26) | 4.55 milligrams/kilograms (mg/kg) | Standard Deviation 0.85 |
| Infliximab | Mean Dose of Infliximab | Infusion 2 (n=23) | 4.66 milligrams/kilograms (mg/kg) | Standard Deviation 0.89 |
| Infliximab | Mean Dose of Infliximab | Infusion 3 (n=23) | 4.67 milligrams/kilograms (mg/kg) | Standard Deviation 0.93 |
| Infliximab | Mean Dose of Infliximab | Infusion 4 (n=21) | 4.58 milligrams/kilograms (mg/kg) | Standard Deviation 0.97 |
| Infliximab | Mean Dose of Infliximab | Infusion 5 (n=18) | 4.51 milligrams/kilograms (mg/kg) | Standard Deviation 0.89 |
| Infliximab | Mean Dose of Infliximab | Infusion 6 (n=16) | 4.41 milligrams/kilograms (mg/kg) | Standard Deviation 0.91 |
| Infliximab | Mean Dose of Infliximab | Infusion 7 (n=16) | 4.44 milligrams/kilograms (mg/kg) | Standard Deviation 0.91 |
| Infliximab | Mean Dose of Infliximab | Infusion 9 (n=14) | 4.30 milligrams/kilograms (mg/kg) | Standard Deviation 1.06 |
Secondary
Mean Percent Change From Baseline in Body Surface Area (BSA) Involved With Psoriasis After Treatment With Infliximab
BSA estimation was determined using the participant's handprint (palmar surface of palms plus five digits). The number of handprints that covered the affected skin area was counted. One handprint was approximately equivalent to 1 percent of the BSA; therefore, BSA was calculated in percentages. The change from Baseline in BSA was calculated by subtracting Baseline from infusion 9.
Time frame: Baseline and Infusion 9
Population: Infliximab-naive participants who received Infliximab during the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Infliximab | Mean Percent Change From Baseline in Body Surface Area (BSA) Involved With Psoriasis After Treatment With Infliximab | Baseline | 38.63 Percent of BSA involved with psoriasis | Standard Deviation 25.63 |
| Infliximab | Mean Percent Change From Baseline in Body Surface Area (BSA) Involved With Psoriasis After Treatment With Infliximab | Change from Baseline after Infusion 9 | -11.17 Percent of BSA involved with psoriasis | Standard Deviation 21.22 |
Secondary
Mean Time Interval Between Infliximab Infusions During Maintenance Treatment Following Induction Therapy
Time frame: Maximum 2 years
Population: Infliximab-naive participants who received induction therapy and subsequent maintenance therapy with Infliximab.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Infliximab | Mean Time Interval Between Infliximab Infusions During Maintenance Treatment Following Induction Therapy | Between Infusion 3 and 4 (n=4) | 49.25 Days | Standard Deviation 13.5 |
| Infliximab | Mean Time Interval Between Infliximab Infusions During Maintenance Treatment Following Induction Therapy | Between Infusion 4 and 5 (n=4) | 57.25 Days | Standard Deviation 2.5 |
| Infliximab | Mean Time Interval Between Infliximab Infusions During Maintenance Treatment Following Induction Therapy | Between Infusion 5 and 6 (n=3) | 59.67 Days | Standard Deviation 8.14 |
| Infliximab | Mean Time Interval Between Infliximab Infusions During Maintenance Treatment Following Induction Therapy | Between Infusion 6 and 7 (n=3) | 55.00 Days | Standard Deviation 3.61 |
| Infliximab | Mean Time Interval Between Infliximab Infusions During Maintenance Treatment Following Induction Therapy | Between Infusion 7 and 8 (n=3) | 56.00 Days | Standard Deviation 0 |
| Infliximab | Mean Time Interval Between Infliximab Infusions During Maintenance Treatment Following Induction Therapy | Between Infusion 8 and 9 (n=2) | 55.50 Days | Standard Deviation 2.12 |
Secondary
Median Dose of Infliximab
Time frame: Maximum 2 years
Population: All participants who received at least 1 Infliximab infusion during the observational phase.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Infliximab | Median Dose of Infliximab | Infusion 1 (n=26) | 4.88 mg/kg |
| Infliximab | Median Dose of Infliximab | Infusion 2 (n=23) | 5.00 mg/kg |
| Infliximab | Median Dose of Infliximab | Infusion 3 (n=23) | 5.00 mg/kg |
| Infliximab | Median Dose of Infliximab | Infusion 4 (n=21) | 5.00 mg/kg |
| Infliximab | Median Dose of Infliximab | Infusion 5 (n=18) | 4.91 mg/kg |
| Infliximab | Median Dose of Infliximab | Infusion 6 (n=16) | 4.71 mg/kg |
| Infliximab | Median Dose of Infliximab | Infusion 7 (n=16) | 4.94 mg/kg |
| Infliximab | Median Dose of Infliximab | Infusion 8 (n=16) | 4.68 mg/kg |
| Infliximab | Median Dose of Infliximab | Infusion 9 (n=14) | 4.94 mg/kg |
Secondary
Median Time Interval Between Infliximab Infusions During Maintenance Treatment Following Induction Therapy
Time frame: Maximum 2 years
Population: Infliximab-naive participants who received induction therapy and subsequent maintenance therapy with Infliximab.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Infliximab | Median Time Interval Between Infliximab Infusions During Maintenance Treatment Following Induction Therapy | Between Infusion 3 and 4 (n=4) | 56.00 Days |
| Infliximab | Median Time Interval Between Infliximab Infusions During Maintenance Treatment Following Induction Therapy | Between Infusion 4 and 5 (n=4) | 56.00 Days |
| Infliximab | Median Time Interval Between Infliximab Infusions During Maintenance Treatment Following Induction Therapy | Between Infusion 5 and 6 (n=3) | 56.00 Days |
| Infliximab | Median Time Interval Between Infliximab Infusions During Maintenance Treatment Following Induction Therapy | Between Infusion 6 and 7 (n=3) | 56.00 Days |
| Infliximab | Median Time Interval Between Infliximab Infusions During Maintenance Treatment Following Induction Therapy | Between Infusion 7 and 8 (n=3) | 56.00 Days |
| Infliximab | Median Time Interval Between Infliximab Infusions During Maintenance Treatment Following Induction Therapy | Between Infusion 8 and 9 (n=2) | 55.50 Days |