NCT04047121

A Study to Evaluate Patient Characteristics and Treatment Patterns Among Rheumatoid Arthritis Patients

Completed Results posted Last updated 9 June 2023

What this trial tests

trial in Rheumatoid Arthritis in 1,349 participants. Completed in 21 October 2019.

Timeline

20 May 2019

Primary endpoint
21 October 2019

21 October 2019

Quick facts

Lead sponsor	Pfizer
Status	Completed
Study type	OBSERVATIONAL
Enrollment	1,349
Start date	20 May 2019
Primary completion	21 October 2019
Estimated completion	21 October 2019
Sites	1 location across United States

Conditions studied

• Rheumatoid Arthritis — all drugs for Rheumatoid Arthritis →

Sponsor

Pfizer — full company profile →

Who can join

18 and older, any sex, with Rheumatoid Arthritis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Participants Who Were Persistent With Index Medication During 12 Months Post-index Date Primary · During 12 months post-index date

Persistent with the index medication was defined as not having a gap in the therapy of at least 60 days between prescription fill dates and their administration. Index medications were tofacitinib, adalimumab or etanercept.

Group	Value	95% CI
Tofacitinib Low OOP Cost	47.42
Tofacitinib High OOP Cost	42.81
Switch From Adalimumab to Etanercept	36.71
Switch From Adalimumab to Tofacitinib	50.52
Switch From Etanercept to Adalimumab	38.39
Switch From Etanercept to Tofacitinib	45.80

Percentage of Participants Who Immediately Switched Index Medication During 12 Months Post-index Date Primary · During 12 months post-index date

Participants who switched from index medication immediately were those who initiated a non-index advanced therapy before end of a 60-day gap in index medication. Index medications were tofacitinib, adalimumab or etanercept.

Group	Value	95% CI
Tofacitinib Low OOP Cost	10.32
Tofacitinib High OOP Cost	10.70
Switch From Adalimumab to Etanercept	22.78
Switch From Adalimumab to Tofacitinib	15.33
Switch From Etanercept to Adalimumab	25.89
Switch From Etanercept to Tofacitinib	22.90

Percentage of Participants Who Discontinued Then Switched Index Medication During 12 Months Post-index Date Primary · During 12 months post-index date

Participants who discontinued index medication then switched from index medication were those who had gap in the index medication therapy of at least 60 days and then after the gap they switched to an advanced therapy different from index medication. Index medications were tofacitinib, adalimumab or etanercept.

Group	Value	95% CI
Tofacitinib Low OOP Cost	3.87
Tofacitinib High OOP Cost	4.68
Switch From Adalimumab to Etanercept	8.86
Switch From Adalimumab to Tofacitinib	6.62
Switch From Etanercept to Adalimumab	7.14
Switch From Etanercept to Tofacitinib	5.34

Percentage of Participants Who Discontinued Then Restarted Index Medication During 12 Months Post-index Date Primary · During 12 months post index date

Participants who discontinued index medication and then restarted index medication were those who had a gap in the index medication therapy of at least 60 days and the first advanced therapy observed after the gap was the index medication. Index medications were tofacitinib, adalimumab or etanercept.

Group	Value	95% CI
Tofacitinib Low OOP Cost	13.23
Tofacitinib High OOP Cost	15.72
Switch From Adalimumab to Etanercept	11.39
Switch From Adalimumab to Tofacitinib	10.10
Switch From Etanercept to Adalimumab	11.61
Switch From Etanercept to Tofacitinib	10.69

Percentage of Participants Who Discontinued Without Switching or Restarting Index Medication During 12 Months Post-index Date Primary · During 12 months post index date

Participants who discontinued index medication without switching or restarting index medication were those who had a gap in index medication therapy of at least 60 days and there were no claims for either the index medication or a different advanced therapy for the remainder of the follow-up period. Index medications were tofacitinib, adalimumab or etanercept.

Group	Value	95% CI
Tofacitinib Low OOP Cost	25.16
Tofacitinib High OOP Cost	26.09
Switch From Adalimumab to Etanercept	20.25
Switch From Adalimumab to Tofacitinib	17.42
Switch From Etanercept to Adalimumab	16.96
Switch From Etanercept to Tofacitinib	15.27

Percentage of Participants Who Switched Index Medication Any Time During 12 Months Post-index Date Secondary · During 12 months post-index date

Participants who switched from index medication at any time during the 12-month follow-up post-index period were evaluated. Index medications were tofacitinib, adalimumab or etanercept.

Group	Value	95% CI
Tofacitinib Low OOP Cost	14.19
Tofacitinib High OOP Cost	16.05
Switch From Adalimumab to Etanercept	34.18
Switch From Adalimumab to Tofacitinib	23.00
Switch From Etanercept to Adalimumab	35.71
Switch From Etanercept to Tofacitinib	29.77

Mean of Number of Days to Immediate Switch From Index Medication During 12 Months Post-index Date Secondary · During 12 months post-index date

Participants who switched from index medication immediately were those who initiated a non-index advanced therapy before the end of a 60-day gap in index medication. Index medications were tofacitinib, adalimumab or etanercept. Number of days to immediately switch from index medication = immediate switch date - index date + 1.

Group	Value	95% CI
Tofacitinib Low OOP Cost	155.00	± 91.02
Tofacitinib High OOP Cost	149.56	± 88.40
Switch From Adalimumab to Etanercept	144.00	± 59.64
Switch From Adalimumab to Tofacitinib	125.84	± 84.73
Switch From Etanercept to Adalimumab	148.69	± 73.22
Switch From Etanercept to Tofacitinib	145.37	± 87.59

Mean of Number of Days to Immediate or Delayed Switch Index Medication During 12 Months Post-index Date Secondary · During 12 month post-index date

Number of days to immediate or delayed switch from index medication any time during the 12-month follow-up period = immediate or delayed switch date - index date + 1. Index medications were tofacitinib, adalimumab or etanercept.

Group	Value	95% CI
Tofacitinib Low OOP Cost	168.11	± 84.29
Tofacitinib High OOP Cost	175.98	± 90.52
Switch From Adalimumab to Etanercept	182.70	± 83.90
Switch From Adalimumab to Tofacitinib	158.71	± 90.81
Switch From Etanercept to Adalimumab	170.73	± 81.64
Switch From Etanercept to Tofacitinib	169.36	± 96.58

Mean of Number of Days to Discontinue Index Medication During 12 Months Post-index Date Secondary · During 12 months post-index date

Number of days to discontinue index medication = date of last persistent index medication prescription/administration + days supply- index date + 1. Index medications were tofacitinib, adalimumab or etanercept. Persistent with the index medication was defined as not having a gap in the therapy of at least 60 days between prescription fill dates and their administration.

Group	Value	95% CI
Tofacitinib Low OOP Cost	119.62	± 80.01
Tofacitinib High OOP Cost	106.17	± 76.50
Switch From Adalimumab to Etanercept	111.74	± 74.97
Switch From Adalimumab to Tofacitinib	109.42	± 74.16
Switch From Etanercept to Adalimumab	130.18	± 70.71
Switch From Etanercept to Tofacitinib	118.91	± 77.58

Duration of Index Medication Persistent Therapy During 12 Months Post-index Date Secondary · During 12 months post-index date

Index medication persistent therapy duration was defined as days to discontinue or immediate switch or end of 12 months post-index follow if participants remained persistent, whichever came first. Index medications were tofacitinib, adalimumab or etanercept. Persistent with the index medication: not having a gap in the therapy of at least 60 days between prescription fill dates and their administration. Discontinuation from index medication: gap in the index medication therapy of at least 60 days. Immediate switch from index medication: initiation of a non-index advanced therapy before end of

Group	Value	95% CI
Tofacitinib Low OOP Cost	235.60	± 133.02
Tofacitinib High OOP Cost	273.50	± 136.81
Switch From Adalimumab to Etanercept	203.65	± 133.21
Switch From Adalimumab to Tofacitinib	239.02	± 134.51
Switch From Etanercept to Adalimumab	219.75	± 126.09
Switch From Etanercept to Tofacitinib	234.34	± 131.10

Percentage of Participants Who Were Persistent With Main Non-Biologic Disease Modifying Antirheumatic Drugs (NB-DMARD) During 12 Months Post-index Date: Combination Therapy Secondary · During 12 months post-index date

Participants who initiated index medication in combination with main NB-DMARDSs were analyzed to evaluate percentage of participants who were persistent with main NB-DMARDs use. Main NB-DMARDs considered in the study were methotrexate, sulfasalazine, leflunomide, and hydroxychloroquine. Index medications were tofacitinib, adalimumab or etanercept. Persistence with main NB-DMARDs was defined as not having a gap of at least 60 days between prescription fill dates and their administration.

Group	Value	95% CI
Tofacitinib Low OOP Cost	36.31
Tofacitinib High OOP Cost	35.86
Switch From Adalimumab to Etanercept	36.36
Switch From Adalimumab to Tofacitinib	43.71
Switch From Etanercept to Adalimumab	38.60
Switch From Etanercept to Tofacitinib	42.86

Percentage of Participants Who Immediately Switched From Main NB-DMARDs During 12 Months Post-index Date: Combination Therapy Secondary · During 12 months post-index date

Participants who initiated index medication in combination with main NB-DMARDSs were analyzed to evaluate percentage of participants who immediately switched from main NB-DMARDs. Main NB-DMARDS considered in the study were methotrexate, sulfasalazine, leflunomide, and hydroxychloroquine. Index medications were tofacitinib, adalimumab or etanercept. Immediate switch from main NB-DMARDs was defined as initiation of other medication than main NB-DMARDs, before end of a 60-day gap.

Group	Value	95% CI
Tofacitinib Low OOP Cost	30.57
Tofacitinib High OOP Cost	26.21
Switch From Adalimumab to Etanercept	22.73
Switch From Adalimumab to Tofacitinib	22.52
Switch From Etanercept to Adalimumab	31.58
Switch From Etanercept to Tofacitinib	23.81

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.