N/A
Completed N=1,349
A Study to Evaluate Patient Characteristics and Treatment Patterns Among Rheumatoid Arthritis Patients
Source: ClinicalTrials.gov NCT04047121 ↗Enrolled (actual)
1,349
Serious AEs
—
Results posted
Oct 2020
Primary outcomePrimary: Percentage of Participants Who Were Persistent With Index Medication During 12 Months Post-index Date — 47.42; 42.81; 36.71; 50.52 Percentage of participants — p=0.2531
Summary
This is a retrospective cohort study to evaluate patient characteristics, treatment patterns including a 6-factor effectiveness proxy measure, health care resource use and associated costs among Rheumatoid Arthritis patients initiating treatment comparator groups of interest between January 2014 and September 2016 across three United States insurance claims databases.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Were Persistent With Index Medication During 12 Months Post-index Date |
47.42; 42.81; 36.71; 50.52; 38.39; 45.80 | 0.2531 |
| PRIMARY Percentage of Participants Who Immediately Switched Index Medication During 12 Months Post-index Date |
10.32; 10.70; 22.78; 15.33; 25.89; 22.90 | 0.8786 |
| PRIMARY Percentage of Participants Who Discontinued Then Switched Index Medication During 12 Months Post-index Date |
3.87; 4.68; 8.86; 6.62; 7.14; 5.34 | 0.6205 |
| PRIMARY Percentage of Participants Who Discontinued Then Restarted Index Medication During 12 Months Post-index Date |
13.23; 15.72; 11.39; 10.10; 11.61; 10.69 | 0.3817 |
| PRIMARY Percentage of Participants Who Discontinued Without Switching or Restarting Index Medication During 12 Months Post-index Date |
25.16; 26.09; 20.25; 17.42; 16.96; 15.27 | 0.7936 |
| SECONDARY Percentage of Participants Who Switched Index Medication Any Time During 12 Months Post-index Date |
14.19; 16.05; 34.18; 23.00; 35.71; 29.77 | 0.5217 |
| SECONDARY Mean of Number of Days to Immediate Switch From Index Medication During 12 Months Post-index Date |
155.00; 149.56; 144.00; 125.84; 148.69; 145.37 | 0.8122 |
| SECONDARY Mean of Number of Days to Immediate or Delayed Switch Index Medication During 12 Months Post-index Date |
168.11; 175.98; 182.70; 158.71; 170.73; 169.36 | 0.6006 |
| SECONDARY Mean of Number of Days to Discontinue Index Medication During 12 Months Post-index Date |
119.62; 106.17; 111.74; 109.42; 130.18; 118.91 | 0.9084 |
| SECONDARY Duration of Index Medication Persistent Therapy During 12 Months Post-index Date |
235.60; 273.50; 203.65; 239.02; 219.75; 234.34 | 0.1736 |
| SECONDARY Percentage of Participants Who Were Persistent With Main Non-Biologic Disease Modifying Antirheumatic Drugs (NB-DMARD) During 12 Months Post-index Date: Combination Therapy |
36.31; 35.86; 36.36; 43.71; 38.60; 42.86 | 0.9361 |
| SECONDARY Percentage of Participants Who Immediately Switched From Main NB-DMARDs During 12 Months Post-index Date: Combination Therapy |
30.57; 26.21; 22.73; 22.52; 31.58; 23.81 | 0.4009 |
| SECONDARY Percentage of Participants Who Discontinued Then Switched From Main NB-DMARDs During 12 Months Post-index Date: Combination Therapy |
2.55; 0.69; 6.82; 2.65; 0.00; 0.00 | 0.2061 |
| SECONDARY Percentage of Participants Who Discontinued Then Restarted Main NB-DMARDs During 12 Months Post-index Date: Combination Therapy |
13.38; 12.41; 13.64; 11.26; 21.05; 18.10 | 0.8033 |
| SECONDARY Percentage of Participants Who Discontinued Without Switching or Restarting Main NB-DMARDs During 12 Months Post-index Date: Combination Therapy |
17.20; 24.83; 20.45; 19.87; 8.77; 15.24 | 0.1030 |
| SECONDARY Percentage of Participants Who Initiated Index Medication as Monotherapy and Eventually Added NB-DMARDs During 12 Months Post-index Date |
29.41; 28.57; 48.57; 25.74; 34.55; 26.75 | — |
| SECONDARY Percentage of Participants Who Met Adherence Effectiveness Criteria During 12 Months Post-index Date |
38.71; 36.12; 30.38; 44.95; 33.04; 38.93 | 0.5092 |
| SECONDARY Percentage of Participants Who Met Dose Escalation Effectiveness Criteria During 12 Months Post-index Date |
96.13; 94.31; 97.47; 94.77; 81.25; 95.80 | 0.2931 |
| SECONDARY Percentage of Participants Who Met Switched Effectiveness Criteria During 12 Months Post-index Date |
85.81; 83.95; 65.82; 77.00; 64.29; 70.23 | 0.5217 |
| SECONDARY Percentage of Participants Who Met NB-DMARD Effectiveness Criteria During 12 Months Post-index Date |
71.61; 74.58; 64.56; 77.00; 66.96; 79.39 | 0.4090 |
| SECONDARY Percentage of Participants Who Met Oral Glucocorticoid Effectiveness Criteria During 12 Months Post-index Date |
83.55; 86.96; 83.54; 85.02; 86.61; 81.30 | 0.2361 |
| SECONDARY Percentage of Participants Who Met Infusion Glucocorticoid Effectiveness Criteria During 12 Months Post-index Date |
83.87; 82.61; 74.68; 82.58; 83.04; 76.34 | 0.6767 |
| SECONDARY Mean of Rheumatoid Arthritis (RA) Related Inpatient Visits During 12 Months Pre-index Date |
0.08; 0.09; 0.05; 0.08; 0.04; 0.08 | 0.6318 |
| SECONDARY Mean of Rheumatoid Arthritis Related Emergency Department (ED) Visits During 12 Months Pre-Index Date |
0.16; 0.10; 0.13; 0.14; 0.14; 0.21 | 0.1473 |
| SECONDARY Mean of Rheumatoid Arthritis Related Outpatient Visits During 12 Months Pre-index Date |
7.83; 8.38; 7.90; 8.80; 7.19; 8.89 | 0.2246 |
| SECONDARY Mean of Rheumatoid Arthritis-Related Pharmacy Visits During 12 Months Pre-index Date |
13.25; 14.16; 17.23; 17.85; 16.60; 17.40 | 0.2667 |
| SECONDARY Mean of Rheumatoid Arthritis Related Inpatient Visits During 12 Months Post-index Date |
0.14; 0.10; 0.04; 0.08; 0.11; 0.08 | 0.3142 |
| SECONDARY Mean of Rheumatoid Arthritis Related Emergency Department (ED) Visits During 12 Months Post-index Date |
0.18; 0.12; 0.11; 0.08; 0.29; 0.23 | 0.0658 |
| SECONDARY Mean of Rheumatoid Arthritis Related Outpatient Visits During 12 Months Post-index Date |
8.60; 8.14; 7.51; 8.06; 8.52; 8.88 | 0.3832 |
| SECONDARY Mean of Rheumatoid Arthritis Related Pharmacy Visits During 12 Months Post-index Date |
18.76; 17.86; 19.80; 18.57; 20.13; 19.08 | 0.3107 |
| SECONDARY Mean of All Cause Inpatient Visits During 12 Months Pre-Index Date |
0.14; 0.17; 0.13; 0.15; 0.10; 0.16 | 0.4555 |
| SECONDARY Mean of All Cause Emergency Department (ED) Visits During 12 Months Pre-index Date |
0.55; 0.47; 0.52; 0.47; 0.63; 0.60 | 0.4133 |
| SECONDARY Mean of All Cause Outpatient Visits During 12 Months Pre-Index Date |
31.70; 27.26; 28.48; 29.92; 27.23; 31.45 | 0.0104 sig |
| SECONDARY Mean of All Cause Pharmacy Visits During 12 Months Pre-index Date |
41.69; 40.56; 42.47; 46.24; 41.83; 47.29 | 0.6344 |
| SECONDARY Mean of All Cause Inpatient Visits During 12 Months Post-index Date |
0.24; 0.16; 0.14; 0.14; 0.24; 0.25 | 0.0839 |
| SECONDARY Mean of All Cause Emergency Department (ED) Visits During 12 Months Post-index Date |
0.68; 0.41; 0.52; 0.44; 1.04; 0.81 | 0.0021 sig |
| SECONDARY Mean of All Cause Outpatient Visits During 12 Months Post-index Date |
33.30; 27.16; 27.00; 28.89; 28.39; 32.76 | 0.0035 sig |
| SECONDARY Mean of All Cause Pharmacy Visits During 12 Months Post-index Date |
49.32; 45.25; 46.33; 47.70; 45.70; 50.09 | 0.1125 |
| SECONDARY Mean of Rheumatoid Arthritis Related Total Health Care Cost During 12 Months Pre-index Date |
6316.86; 7414.19; 16343.48; 27375.50; 18432.35; 22777.88 | 0.3919 |
| SECONDARY Mean of Rheumatoid Arthritis Related Total Health Care Cost During 12 Months Post-index Date |
35601.32; 34503.47; 34010.25; 37431.71; 40027.03; 36963.17 | 0.6184 |
| SECONDARY All Cause Total Health Care Cost During 12 Months Pre-index Date |
22626.74; 19514.09; 25944.31; 38749.72; 29643.91; 36152.42 | 0.3087 |
| SECONDARY All Cause Total Health Care Cost During 12 Months Post-index Date |
56515.65; 46126.57; 50343.02; 49109.94; 56302.76; 56786.41 | 0.0421 sig |
Eligibility Criteria
Inclusion Criteria
- first pharmacy claim for Tofacitinib and then Etanercept or Adalimumab between Jan 2014 and Sep 2016 represents the index claim
- First, select patients receiving ≥1 Tofacitinib pharmacy claim (Jan 2014-Sep 2016) who did not have a Tofacitinib claim anytime prior to index
- Patients do have >1 advanced therapy filled on index date
- Physician diagnosis of Rheumatoid Arthritis (in any position) during the 1-year pre-index period, or on the index date
- Age 18+ years at index
Exclusion Criteria
-None
Data sourced from ClinicalTrials.gov (NCT04047121). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.