Arthritis, Psoriatic, Arthritis, Rheumatoid, Crohn's Disease, Psoriasis, Spondylitis, Ankylosing
Conditions
Brief summary
This study will be performed to evaluate and document the safety and efficacy of infliximab (Remicade®) in the treatment of chronic inflammatory diseases in big cohorts in the daily routine practice of rheumatologists, gastroenterologists, and dermatologists.
Detailed description
The study population was chosen from a non-probability sample. The safety population consisted of all participants with at least one documented infusion of infliximab. The evaluable population consisted of all participants that were \>=18 years of age with a recorded indication for infliximab use, that had available baseline data, and with at least 3 infusions of infliximab within the first 16 weeks of the study. Baseline characteristics are provided for this population.
Interventions
BIOLOGICALInfliximab
Infliximab administered at a dose of 3-10 mg/kg at Week 0, Week 2, and Week 6, and every 4-8 weeks thereafter for 24 months for the treatment of chronic inflammatory disease.
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
* Participants treated with infliximab by rheumatologists, gastroenterologists, and dermatologists for chronic inflammatory diseases, such as rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, psoriasis, or Crohn's disease.
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Experiencing at Least One Adverse Event | Baseline to Month 24 | An adverse event was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the treatment, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the treatment, was also an adverse event. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinicians' Impression of Disease Severity From Baseline to Week 102 | Baseline, Week 6, Week 14, Week 22, Week 54, Week 102 | Participant severity of disease was assessed at baseline, Week 6, Week 14, Week 22, Week 54, and Week 102 on the basis of the treating clinician's opinion of the participant being normal, not at all ill, borderline ill, mildly ill, moderately ill, markedly ill, severely ill, or extreme severe illness. Each time point was compared to the previous visit. |
| Clinicians' Impression of Therapeutic Efficacy | Week 6, Week 14, Week 22, Week 54, Week 102 | Therapeutic efficacy was rated by the treating physician at each time point as moderate-to-clear improvement, no change, not assessable, mild-to-slight improvement, very good-to-full improvement, or worsened. Each time point was compared to the previous visit. |
Participant flow
Pre-assignment details
Of 4485 total enrolled participants, 4465 received at least one infusion of infliximab and are included in the safety evaluation. 3228 of these participants were evaluable for all other study analyses.
Participants by arm
| Arm | Count |
|---|---|
| Infliximab Infliximab administered at a dose of 3-10 mg/kg administered at Week 0, Week 2, and Week 6, and every 4-8 weeks thereafter for 24 months for the treatment of chronic inflammatory disease. | 3,228 |
| Total | 3,228 |
Baseline characteristics
| Characteristic | Infliximab |
|---|---|
| Age, Continuous | 46.3 years STANDARD_DEVIATION 13.9 |
| Sex/Gender, Customized Female | 1591 participants |
| Sex/Gender, Customized Male | 1554 participants |
| Sex/Gender, Customized Not Specified | 83 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 4,465 |
| serious Total, serious adverse events | 296 / 4,465 |
Outcome results
Primary
Number of Participants Experiencing at Least One Adverse Event
An adverse event was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the treatment, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the treatment, was also an adverse event.
Time frame: Baseline to Month 24
Population: The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Infliximab 3-10 mg/kg | Number of Participants Experiencing at Least One Adverse Event | 609 Participants |
Secondary
Clinicians' Impression of Disease Severity From Baseline to Week 102
Participant severity of disease was assessed at baseline, Week 6, Week 14, Week 22, Week 54, and Week 102 on the basis of the treating clinician's opinion of the participant being normal, not at all ill, borderline ill, mildly ill, moderately ill, markedly ill, severely ill, or extreme severe illness. Each time point was compared to the previous visit.
Time frame: Baseline, Week 6, Week 14, Week 22, Week 54, Week 102
Population: The efficacy evaluable population consisted of all participants with baseline data available that received at least 3 infusions of study drug within 14+2 weeks.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Infliximab 3-10 mg/kg | Clinicians' Impression of Disease Severity From Baseline to Week 102 | Baseline - Not at all ill | 0.7 Percentage of Participants |
| Infliximab 3-10 mg/kg | Clinicians' Impression of Disease Severity From Baseline to Week 102 | Baseline - Borderline ill | 1.3 Percentage of Participants |
| Infliximab 3-10 mg/kg | Clinicians' Impression of Disease Severity From Baseline to Week 102 | Baseline - Mildly ill | 4.9 Percentage of Participants |
| Infliximab 3-10 mg/kg | Clinicians' Impression of Disease Severity From Baseline to Week 102 | Baseline - Moderately ill | 17.6 Percentage of Participants |
| Infliximab 3-10 mg/kg | Clinicians' Impression of Disease Severity From Baseline to Week 102 | Baseline - Markedly ill | 51.2 Percentage of Participants |
| Infliximab 3-10 mg/kg | Clinicians' Impression of Disease Severity From Baseline to Week 102 | Baseline - Severely ill | 21.0 Percentage of Participants |
| Infliximab 3-10 mg/kg | Clinicians' Impression of Disease Severity From Baseline to Week 102 | Baseline - Extreme severe illness | 2.8 Percentage of Participants |
| Infliximab 3-10 mg/kg | Clinicians' Impression of Disease Severity From Baseline to Week 102 | Week 6 - Not at all ill | 5.1 Percentage of Participants |
| Infliximab 3-10 mg/kg | Clinicians' Impression of Disease Severity From Baseline to Week 102 | Week 6 - Borderline ill | 10.5 Percentage of Participants |
| Infliximab 3-10 mg/kg | Clinicians' Impression of Disease Severity From Baseline to Week 102 | Week 6 - Mildly ill | 23.6 Percentage of Participants |
| Infliximab 3-10 mg/kg | Clinicians' Impression of Disease Severity From Baseline to Week 102 | Week 6 - Moderately ill | 27.7 Percentage of Participants |
| Infliximab 3-10 mg/kg | Clinicians' Impression of Disease Severity From Baseline to Week 102 | Week 6 - Markedly ill | 24.3 Percentage of Participants |
| Infliximab 3-10 mg/kg | Clinicians' Impression of Disease Severity From Baseline to Week 102 | Week 6 - Severely ill | 7.5 Percentage of Participants |
| Infliximab 3-10 mg/kg | Clinicians' Impression of Disease Severity From Baseline to Week 102 | Week 6 - Extreme severe illness | 1.1 Percentage of Participants |
| Infliximab 3-10 mg/kg | Clinicians' Impression of Disease Severity From Baseline to Week 102 | Week 14 - Not at all ill | 8.3 Percentage of Participants |
| Infliximab 3-10 mg/kg | Clinicians' Impression of Disease Severity From Baseline to Week 102 | Week 14 - Borderline ill | 14.2 Percentage of Participants |
| Infliximab 3-10 mg/kg | Clinicians' Impression of Disease Severity From Baseline to Week 102 | Week 14 - Mildly ill | 23.3 Percentage of Participants |
| Infliximab 3-10 mg/kg | Clinicians' Impression of Disease Severity From Baseline to Week 102 | Week 14 - Moderately ill | 26.1 Percentage of Participants |
| Infliximab 3-10 mg/kg | Clinicians' Impression of Disease Severity From Baseline to Week 102 | Week 14 - Markedly ill | 21.2 Percentage of Participants |
| Infliximab 3-10 mg/kg | Clinicians' Impression of Disease Severity From Baseline to Week 102 | Week 14 - Severely ill | 5.9 Percentage of Participants |
| Infliximab 3-10 mg/kg | Clinicians' Impression of Disease Severity From Baseline to Week 102 | Week 14 - Extreme severe illness | 0.8 Percentage of Participants |
| Infliximab 3-10 mg/kg | Clinicians' Impression of Disease Severity From Baseline to Week 102 | Week 22 - Not at all ill | 10.6 Percentage of Participants |
| Infliximab 3-10 mg/kg | Clinicians' Impression of Disease Severity From Baseline to Week 102 | Week 22 - Borderline ill | 14.8 Percentage of Participants |
| Infliximab 3-10 mg/kg | Clinicians' Impression of Disease Severity From Baseline to Week 102 | Week 22 - Mildly ill | 22.7 Percentage of Participants |
| Infliximab 3-10 mg/kg | Clinicians' Impression of Disease Severity From Baseline to Week 102 | Week 22 - Moderately ill | 25.5 Percentage of Participants |
| Infliximab 3-10 mg/kg | Clinicians' Impression of Disease Severity From Baseline to Week 102 | Week 22 - Markedly ill | 19.5 Percentage of Participants |
| Infliximab 3-10 mg/kg | Clinicians' Impression of Disease Severity From Baseline to Week 102 | Week 22 - Severely ill | 5.9 Percentage of Participants |
| Infliximab 3-10 mg/kg | Clinicians' Impression of Disease Severity From Baseline to Week 102 | Week 22 - Extreme severe illness | 0.8 Percentage of Participants |
| Infliximab 3-10 mg/kg | Clinicians' Impression of Disease Severity From Baseline to Week 102 | Week 54 - Not at all ill | 12.9 Percentage of Participants |
| Infliximab 3-10 mg/kg | Clinicians' Impression of Disease Severity From Baseline to Week 102 | Week 54 - Borderline ill | 16.3 Percentage of Participants |
| Infliximab 3-10 mg/kg | Clinicians' Impression of Disease Severity From Baseline to Week 102 | Week 54 - Mildly ill | 22.2 Percentage of Participants |
| Infliximab 3-10 mg/kg | Clinicians' Impression of Disease Severity From Baseline to Week 102 | Week 54 - Moderately ill | 23.3 Percentage of Participants |
| Infliximab 3-10 mg/kg | Clinicians' Impression of Disease Severity From Baseline to Week 102 | Week 54 - Markedly ill | 19.3 Percentage of Participants |
| Infliximab 3-10 mg/kg | Clinicians' Impression of Disease Severity From Baseline to Week 102 | Week 54 - Severely ill | 4.8 Percentage of Participants |
| Infliximab 3-10 mg/kg | Clinicians' Impression of Disease Severity From Baseline to Week 102 | Week 54 - Extreme severe illness | 1.0 Percentage of Participants |
| Infliximab 3-10 mg/kg | Clinicians' Impression of Disease Severity From Baseline to Week 102 | Week 102 - Not at all ill | 17.2 Percentage of Participants |
| Infliximab 3-10 mg/kg | Clinicians' Impression of Disease Severity From Baseline to Week 102 | Week 102 - Borderline ill | 16.5 Percentage of Participants |
| Infliximab 3-10 mg/kg | Clinicians' Impression of Disease Severity From Baseline to Week 102 | Week 102 - Mildly ill | 21.1 Percentage of Participants |
| Infliximab 3-10 mg/kg | Clinicians' Impression of Disease Severity From Baseline to Week 102 | Week 102 - Moderately ill | 22.2 Percentage of Participants |
| Infliximab 3-10 mg/kg | Clinicians' Impression of Disease Severity From Baseline to Week 102 | Week 102 - Markedly ill | 17.1 Percentage of Participants |
| Infliximab 3-10 mg/kg | Clinicians' Impression of Disease Severity From Baseline to Week 102 | Week 102 - Severely ill | 4.1 Percentage of Participants |
| Infliximab 3-10 mg/kg | Clinicians' Impression of Disease Severity From Baseline to Week 102 | Week 102 - Extreme severe illness | 1.3 Percentage of Participants |
Secondary
Clinicians' Impression of Therapeutic Efficacy
Therapeutic efficacy was rated by the treating physician at each time point as moderate-to-clear improvement, no change, not assessable, mild-to-slight improvement, very good-to-full improvement, or worsened. Each time point was compared to the previous visit.
Time frame: Week 6, Week 14, Week 22, Week 54, Week 102
Population: The efficacy evaluable population consisted of all participants with baseline data available that received at least 3 infusions of study drug within 14+2 weeks.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Infliximab 3-10 mg/kg | Clinicians' Impression of Therapeutic Efficacy | Week 6: Moderate-to-Clear Improvement | 34.8 Percentage of Participants |
| Infliximab 3-10 mg/kg | Clinicians' Impression of Therapeutic Efficacy | Week 6: Unchanged | 8.9 Percentage of Participants |
| Infliximab 3-10 mg/kg | Clinicians' Impression of Therapeutic Efficacy | Week 6: Not Assessable | 1.4 Percentage of Participants |
| Infliximab 3-10 mg/kg | Clinicians' Impression of Therapeutic Efficacy | Week 6: Mild-to-Slight Improvement | 17.4 Percentage of Participants |
| Infliximab 3-10 mg/kg | Clinicians' Impression of Therapeutic Efficacy | Week 6: Very Good-to-Full Improvement | 37.3 Percentage of Participants |
| Infliximab 3-10 mg/kg | Clinicians' Impression of Therapeutic Efficacy | Week 6: Worsened | 0.2 Percentage of Participants |
| Infliximab 3-10 mg/kg | Clinicians' Impression of Therapeutic Efficacy | Week 14: Moderate-to-Clear Improvement | 30.1 Percentage of Participants |
| Infliximab 3-10 mg/kg | Clinicians' Impression of Therapeutic Efficacy | Week 14: Unchanged | 9.9 Percentage of Participants |
| Infliximab 3-10 mg/kg | Clinicians' Impression of Therapeutic Efficacy | Week 14: Not Assessable | 1.5 Percentage of Participants |
| Infliximab 3-10 mg/kg | Clinicians' Impression of Therapeutic Efficacy | Week 14: Mild-to-Slight Improvement | 15.1 Percentage of Participants |
| Infliximab 3-10 mg/kg | Clinicians' Impression of Therapeutic Efficacy | Week 14: Very Good-to Full Improvement | 43.1 Percentage of Participants |
| Infliximab 3-10 mg/kg | Clinicians' Impression of Therapeutic Efficacy | Week 14: Worsened | 0.3 Percentage of Participants |
| Infliximab 3-10 mg/kg | Clinicians' Impression of Therapeutic Efficacy | Week 22: Moderate-to-Clear Improvement | 29.5 Percentage of Participants |
| Infliximab 3-10 mg/kg | Clinicians' Impression of Therapeutic Efficacy | Week 22: Unchanged | 11.3 Percentage of Participants |
| Infliximab 3-10 mg/kg | Clinicians' Impression of Therapeutic Efficacy | Week 22: Not Assessable | 1.9 Percentage of Participants |
| Infliximab 3-10 mg/kg | Clinicians' Impression of Therapeutic Efficacy | Week 22: Mild-to-Slight Improvement | 13.0 Percentage of Participants |
| Infliximab 3-10 mg/kg | Clinicians' Impression of Therapeutic Efficacy | Week 22: Very Good-to-Full Improvement | 43.9 Percentage of Participants |
| Infliximab 3-10 mg/kg | Clinicians' Impression of Therapeutic Efficacy | Week 22: Worsened | 0.3 Percentage of Participants |
| Infliximab 3-10 mg/kg | Clinicians' Impression of Therapeutic Efficacy | Week 54: Moderate-to-Clear Improvement | 27.0 Percentage of Participants |
| Infliximab 3-10 mg/kg | Clinicians' Impression of Therapeutic Efficacy | Week 54: Unchanged | 15.1 Percentage of Participants |
| Infliximab 3-10 mg/kg | Clinicians' Impression of Therapeutic Efficacy | Week 54: Not Assessable | 1.6 Percentage of Participants |
| Infliximab 3-10 mg/kg | Clinicians' Impression of Therapeutic Efficacy | Week 54: Mild-to-Slight Improvement | 9.3 Percentage of Participants |
| Infliximab 3-10 mg/kg | Clinicians' Impression of Therapeutic Efficacy | Week 54: Very Good-to-Full Improvement | 46.4 Percentage of Participants |
| Infliximab 3-10 mg/kg | Clinicians' Impression of Therapeutic Efficacy | Week 54: Worsened | 0.5 Percentage of Participants |
| Infliximab 3-10 mg/kg | Clinicians' Impression of Therapeutic Efficacy | Week 102: Moderate-to-Clear Improvement | 25.7 Percentage of Participants |
| Infliximab 3-10 mg/kg | Clinicians' Impression of Therapeutic Efficacy | Week 102: Unchanged | 16.3 Percentage of Participants |
| Infliximab 3-10 mg/kg | Clinicians' Impression of Therapeutic Efficacy | Week 102: Not Assessable | 1.7 Percentage of Participants |
| Infliximab 3-10 mg/kg | Clinicians' Impression of Therapeutic Efficacy | Week 102: Mild-to-Slight Improvement | 5.6 Percentage of Participants |
| Infliximab 3-10 mg/kg | Clinicians' Impression of Therapeutic Efficacy | Week 102: Very Good-to-Full Improvement | 50.0 Percentage of Participants |
| Infliximab 3-10 mg/kg | Clinicians' Impression of Therapeutic Efficacy | Week 102: Worsened | 0.6 Percentage of Participants |