N/A Completed N=7,308

Comparative Analysis of Outcomes Among Patients Treated With Xeljanz vs Biologics

Arthritis, Rheumatoid

Source: ClinicalTrials.gov NCT03964649 ↗

Enrolled (actual)

7,308

Serious AEs

—

Results posted

Apr 2021

Primary outcomePrimary: Number of Participants Who Were on Combination Therapy and Monotherapy During 90 Days After Index Date — 183; 168; 2001; 119 Participants

Summary

To compare rheumatoid arthritis (RA) patient characteristics, adherence, and costs between patients treated with tofacitinib (IR, XR and combined groups) to patients treated with each of the bDMARDs.

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants Who Were on Combination Therapy and Monotherapy During 90 Days After Index Date	183; 168; 2001; 119; 1373; 266	—
PRIMARY Number of Participants for Each of the Most Commonly Used Medications During the 12 Months Post-index Date	163; 136; 1,789; 120; 1,193; 245	—
PRIMARY Number of Participants Who Used Opioids and Non-steroidal Anti-inflammatory Drug (NSAIDs) During 12 Months Post Index Period	210; 205; 1,623; 104; 1,236; 233	—
PRIMARY Mean Number of Pharmacy Claims for Opioids and NSAIDS During 12 Months Post Index Period	3.68; 4.99; 3.78; 3.80; 4.13; 4.30	—
PRIMARY Mean Number of Days From The Index Date to the First Opioid and NSAIDs Claim During 12 Months Post Index Period	85.35; 83.31; 95.67; 99.05; 94.05; 101.04	—
PRIMARY Number of Participants Who Used Opioids and NSAIDs While Persistent and After Persistent With Index Medication During 12 Months Post Index Period	138; 128; 1,035; 61; 774; 168	—
PRIMARY Number of Participants Who Used Oral Corticosteroids During 12 Months Post-Index Period	198; 216; 1,713; 126; 1,225; 241	—
PRIMARY Number of Participants Who Were Non-persistent to Index Medication	166; 189; 1381; 117; 1036; 139	—
PRIMARY Number of Participants Who Switched Immediately From Index Medication	41; 70; 575; 33; 451; 49	—
PRIMARY Number of Participants Who Discontinued Then Restarted Index Medication	43; 33; 201; 15; 152; 21	—
PRIMARY Number of Participants Who Discontinued Then Switched From Index Medication	12; 24; 127; 15; 130; 7	—
PRIMARY Number of Participants Who Discontinued Without Switching or Restarting Index Medication	70; 62; 478; 54; 303; 62	—
PRIMARY Number of Participants Who Switched Any Time From Index Medication	55; 96; 727; 48; 599; 56	—
PRIMARY Number of Participants Who Re-started Index Medication at Any Time	25; 25; 132; 6; 78; 13	—
PRIMARY Mean Medication Possession Ratio (MPR) for Methotrexate	0.89; 0.87; 0.91; 0.92; 0.91; 0.98	—
PRIMARY Proportion of Days Covered (PDC)	0.65; 0.55; 0.66; 0.56; 0.63; 0.77	—
PRIMARY Addition of Conventional Synthetic Disease-modifying Antirheumatic Drug (Cs-DMARDs) in Participants With Monotherapy	48; 37; 247; 29; 193; 28	—
PRIMARY Adherence to Cs-DMARDs in Participants With Combination Therapy	0.72; 0.79; 0.77; 0.74; 0.78; 0.79	—
PRIMARY Number of Participants Who Met Different Medication Effectiveness Criteria	168; 98; 1249; 64; 843; 222	—
PRIMARY All Cause Inpatient Visits Costs, Outpatient Visits Costs and Emergency Room (ER) Visits Costs During 12 Months Post Index Period	5,301.85; 4,326.53; 3,863.95; 4,691.74; 3,856.57; 5,260.88	—
PRIMARY Rheumatoid Arthritis (RA) Related Inpatient Visits Costs, Outpatient Visits Costs and Emergency Room (ER) Visits Costs During 12 Months Post Index Period	2,465.50; 2,470.87; 2,215.74; 1,794.11; 2,054.38; 3,561.22	—
PRIMARY All Cause Total Health Care Costs, Medical Costs, Pharmacy Costs During 12 Months Post-Index Period	61,431.53; 53,150.92; 66,645.17; 62,064.23; 64,120.91; 55,737.03	—
PRIMARY RA Related Total Health Care Costs, Medical Costs, Pharmacy Costs During 12 Months Post-Index Period	44,134.19; 38,462.40; 54,892.62; 41,845.23; 50,531.75; 42,227.78	—
PRIMARY Total All Cause Monthly Health Care Cost at Month 1 Post Index Date	7,985.18; 6,989.92; 9,290.98; 10,394.75; 8,777.27; 8,794.60	—
PRIMARY Total All Cause Monthly Health Care Cost at Month 2 Post Index Date	4,805.26; 3,207.83; 4,661.95; 4,734.42; 4,735.15; 4,915.29	—
PRIMARY Total All Cause Monthly Health Care Cost at Month 3 Post Index Date	5,093.95; 4,551.06; 5,975.14; 6,950.34; 5,674.03; 3,047.15	—
PRIMARY Total All Cause Monthly Health Care Cost at Month 4 Post Index Date	5,079.28; 3,969.48; 5,301.22; 5,014.75; 5,120.19; 5,346.93	—
PRIMARY Total All Cause Monthly Health Care Cost at Month 5 Post Index Date	4,122.15; 4,874.41; 4,828.27; 4,102.21; 4,915.71; 3,363.56	—
PRIMARY Total All Cause Monthly Health Care Cost at Month 6 Post Index Date	4,867.20; 3,826.79; 5,997.83; 4,830.11; 4,982.15; 4,626.76	—
PRIMARY Total All Cause Monthly Health Care Cost at Month 7 Post Index Date	4,950.36; 4,939.24; 5,004.78; 4,392.10; 4,817.34; 3,067.81	—
PRIMARY Total All Cause Monthly Health Care Cost at Month 8 Post Index Date	3,815.56; 4,139.87; 5,021.37; 5,095.74; 5,068.81; 4,943.14	—
PRIMARY Total All Cause Monthly Health Care Cost at Month 9 Post Index Date	4,300.84; 4,399.74; 5,335.04; 3,921.54; 5,210.21; 5,064.33	—
PRIMARY Total All Cause Monthly Health Care Cost at Month 10 Post Index Date	5,670.69; 3,939.86; 5,186.08; 3,998.95; 4,698.56; 4,147.01	—
PRIMARY Total All Cause Monthly Health Care Cost at Month 11 Post-index Date	4,244.03; 4,083.34; 5,032.88; 4,500.99; 5,202.71; 4,334.84	—
PRIMARY Total All Cause Monthly Health Care Cost at Month 12 Post Index Date	6,497.03; 4,229.36; 5,009.64; 4,128.34; 4,918.79; 4,085.60	—
PRIMARY Total RA Related Monthly Health Care Cost at Month 1 Post Index Date	6,743.68; 6,021.42; 8,562.89; 9,390.90; 7,943.89; 7,850.66	—
PRIMARY Total RA Related Monthly Health Care Cost at Month 2 Post Index Date	2,998.35; 2,450.14; 3,876.12; 2,761.42; 3,639.87; 3,941.04	—
PRIMARY Total RA Related Monthly Health Care Cost at Month 3 Post Index Date	3,747.82; 3,494.46; 5,049.33; 3,829.80; 4,522.20; 2,108.64	—
PRIMARY Total RA Related Monthly Health Care Cost at Month 4 Post Index Date	3,935.88; 2,932.92; 4,279.35; 3,333.94; 4,058.48; 4,336.50	—
PRIMARY Total RA Related Monthly Health Care Cost at Month 5 Post Index Date	2,872.41; 3,192.69; 3,951.04; 2,631.47; 3,715.18; 2,408.72	—
PRIMARY Total RA Related Monthly Health Care Cost at Month 6 Post Index Date	3,914.17; 2,567.31; 4,657.35; 3,208.61; 4,017.72; 3,257.63	—
PRIMARY Total RA Related Monthly Health Care Cost at Month 7 Post Index Date	3,493.19; 3,724.00; 3,937.19; 3,091.38; 3,745.42; 2,156.48	—
PRIMARY Total RA Related Monthly Health Care Cost at Month 8 Post Index Date	2,724.51; 2,945.03; 4,118.25; 2,660.95; 3,837.85; 3,849.37	—
PRIMARY Total RA Related Monthly Health Care Cost at Month 9 Post Index Date	3,304.66; 2,938.67; 4,368.93; 2,782.29; 3,934.80; 3,535.00	—
PRIMARY Total RA Related Monthly Health Care Cost at Month 10 Post Index Date	3,416.78; 2,848.24; 4,146.86; 2,519.73; 3,677.71; 2,989.40	—
PRIMARY Total RA Related Monthly Health Care Cost at Month 11 Post-index Date	3,010.75; 2,418.53; 3,926.41; 2,861.97; 3,793.28; 2,982.23	—
PRIMARY Total RA Related Monthly Health Care Cost at Month 12 Post Index Date	3,971.99; 2,929.00; 4,018.90; 2,772.76; 3,645.36; 2,812.13	—

Eligibility Criteria

Inclusion Criteria

At least one claim for methotrexate during the variable-length pre-index period.
At least one claim for tofacitinib or bDMARDs between 01 February 2016 and 31 July 2019 (the identification period).

Exclusion Criteria

Patients with claims for other conditions for which bDMARDs are used during the one-year pre-index period or on the index date: ankylosing spondylitis, Crohn's disease, psoriasis, psoriatic arthritis, or ulcerative colitis will be excluded from the study.
Patients with evidence of the index medication during the one-year pre-index period will be removed from the analysis. Patients will be allowed to have been treated with (other) bDMARDs during the one-year pre-index period.
Patients with more than 1 bDMARD or bDMARD with tofacitinib filled on the index date will be removed from the study.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03964649). 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.