This is a retrospective observational study looking at the characteristics and outcomes of participants taking Inflectra using the CorEvitas Rheumatoid Arthritis Registry.
Study Type
OBSERVATIONAL
Enrollment
255
Pfizer
Collegeville, Pennsylvania, United States
Percentage of Participants Who Achieved Low Disease Activity (LDA) at 6 Months After Inflectra Initiation
Clinical disease activity index (CDAI) was the numerical sum of 4 outcome parameters: tender and swollen joint count based on a 28-joint assessment, participant global assessment and physician global assessment assessed on 0 to 10 millimeter (mm) visual analogue scale (VAS) where 0 mm = minimum possible pain (best) and 100 mm = maximum possible pain (worst). Total score for CDAI ranged from 0 to 76 with higher score indicating greater disease activity. Participants who achieved LDA had CDAI score less than or equal to (\<=)10. Participants with moderate or high disease activity (CDAI greater than \[\>\]10) at baseline were analyzed for this outcome measure.
Time frame: 6 Months (from the retrospective data collected from the CorEvitas RA registry)
Percentage of Participants Who Achieved Clinical Remission at 6 Months After Inflectra Initiation
CDAI was the numerical sum of 4 outcome parameters: tender and swollen joint count based on a 28-joint assessment, participant global assessment and physician global assessment assessed on 0 to 10 mm VAS where 0 mm = minimum possible pain (best) and 100 mm = maximum possible pain (worst). Total score for CDAI ranged from 0 to 76 with higher score indicating greater disease activity. Participants who achieved clinical remission had a CDAI score \<=2.8. Participants with low, moderate or high disease activity (CDAI\>2.8) at baseline were analyzed for this outcome measure.
Time frame: 6 Months (from the retrospective data collected from the CorEvitas RA registry)
Change From Baseline in CDAI at 6 Months After Inflectra Initiation
CDAI was the numerical sum of 4 outcome parameters: tender and swollen joint count based on a 28-joint assessment, participant global assessment and physician global assessment assessed on 0 to 10 mm VAS where 0 mm = minimum possible pain (best) and 100 mm = maximum possible pain (worst). CDAI total score = 0 to 76, higher scores=greater affection due to disease activity. CDAI \<2.8 indicated disease remission, 2.8 to \<10 indicated low disease activity, 10 to \<22 indicated moderate disease activity, and \>=22 indicated high disease activity.
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Time frame: Baseline, 6 Months (from the retrospective data collected from the CorEvitas RA registry)
Change From Baseline in Health Assessment Questionnaire (HAQ) at 6 Months After Inflectra Initiation
HAQ: participant-reported questionnaire for the assessment of rheumatoid arthritis. It comprised of 20 questions in 8 categories of activities: dress/groom; arise; eat; grip; walk; hygiene; reach; and activities over past week. Each activity was assessed on a 4-point Likert scale from 0 to 3, where 0 = without difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score ranged from 0 to 3, where 0 = least difficulty and 3 = extreme difficulty, higher scores indicating worse functioning.
Time frame: Baseline, 6 Months (from the retrospective data collected from the CorEvitas RA registry)
Change From Baseline in Participant Pain Assessment at 6 Months After Inflectra Initiation
Participant pain was measured on a VAS where 0 mm = minimum possible pain (best) and 100 mm = maximum possible pain (worst).
Time frame: Baseline, 6 Months (from the retrospective data collected from the CorEvitas RA registry)
Change From Baseline in Participant Fatigue Assessment at 6 Months After Inflectra Initiation
Participant fatigue was measured on a VAS, where 0 mm = no fatigue and 100 mm = worst possible fatigue.
Time frame: Baseline, 6 Months (from the retrospective data collected from the CorEvitas RA registry)
Percentage of Participants With a Modified American College of Rheumatology 20 Percent (%) (mACR20) Response at 6 Months After Inflectra Initiation
mACR20 response: \>= 20% improvement in tender and swollen joint count and 20% improvement in two of the following four criteria: 1) participant assessment of pain (scored from 0 mm to 100 mm, higher scores indicated worsening of pain); 2) participant global assessment of disease activity (scored from 0 to 100, higher scores indicated worsening of condition); 3) physician global assessment of disease activity (scored from 0 to 100, higher scores indicated worsening of condition); 4) self-assessed disability index of the mHAQ (scored from 0 to 3, higher scores indicated worsening of function).
Time frame: 6 Months (from the retrospective data collected from the CorEvitas RA registry)
Percentage of Participants With mACR50 at 6 Months After Inflectra Initiation
mACR50 response: \>= 50% improvement in tender and swollen joint count and 50% improvement in two of the following four criteria: 1) participant assessment of pain (scored from 0 mm to 100 mm, higher scores indicated worsening of pain); 2) participant global assessment of disease activity (scored from 0 to 100, higher scores indicated worsening of condition); 3) physician global assessment of disease activity (scored from 0 to 100, higher scores indicated worsening of condition); 4) self-assessed disability index of the mHAQ (scored from 0 to 3, higher scores indicated worsening of function).
Time frame: 6 Months (from the retrospective data collected from the CorEvitas RA registry)
Percentage of Participants With mACR70 at 6 Months After Inflectra Initiation
mACR70 response: \>= 70% improvement in tender and swollen joint count and 70% improvement in two of the following four criteria: 1) participant assessment of pain (scored from 0 mm to 100 mm, higher scores indicated worsening of pain); 2) participant global assessment of disease activity (scored from 0 to 100, higher scores indicated worsening of condition); 3) physician global assessment of disease activity (scored from 0 to 100, higher scores indicated worsening of condition); 4) self-assessed disability index of the mHAQ (scored from 0 to 3, higher scores indicated worsening of function).
Time frame: 6 Months (from the retrospective data collected from the CorEvitas RA registry)