N/A Completed N=479

Comparative Analysis of Outcomes Among Patients Initiating Xeljanz in Combination With Oral MTX Who Withdraw MTX Versus Continue MTX

Rheumatoid Arthritis

Source: ClinicalTrials.gov NCT03975790 ↗

Enrolled (actual)

479

Serious AEs

—

Results posted

Oct 2019

Primary outcomePrimary: Number of Participants as Per Type of Insurance Plan — 36; 13; 9; 301 Participants

Summary

To address the objectives, a retrospective cohort design will be employed to evaluate patient characteristics, treatment patterns, medication effectiveness, and health care cost and utilization in RA patients newly initiating tofacitinib in combination with oral methotrexate (MTX)

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants as Per Type of Insurance Plan	36; 13; 9; 301; 81; 39	—
PRIMARY Number of Participants in Each Geographic Region	81; 25; 10; 76; 17; 14	—
PRIMARY Number of Participants With Biologic Disease Modifying Antirheumatic Drug (bDMARD) Use During Pre-Index Period	225; 59; 31	0.4695
PRIMARY Number of Participants With Biologic Disease Modifying Antirheumatic Drug (bDMARD) Use During Variable Length Pre-Index Period	247; 69; 36	0.9829
PRIMARY Mean Number of Biologic Disease Modifying Antirheumatic Drug (bDMARD) Received During Pre-Index Period	1.38; 1.31; 1.23	0.2864
PRIMARY Mean Number of Biologic Disease Modifying Antirheumatic Drug (bDMARD) Received During Variable Length Pre-Index Period	1.81; 1.55; 1.50	0.0280 sig
PRIMARY Number of Participants With Non-biologic Disease Modifying Antirheumatic Drug (NB-DMARD) Use During Pre-Index Period	333; 93; 47	0.9215
PRIMARY Number of Participants With Non-Biologic Disease Modifying Antirheumatic Drug (NB-DMARD) Use During Variable Length Pre-Index Period	334; 94; 48	0.3586
PRIMARY Mean Number of Non-Biologic Disease Modifying Antirheumatic Drug (NB-DMARD) Received During Pre-Index Period	1.46; 1.41; 1.40	0.5372
PRIMARY Mean Number of Non-Biologic Disease Modifying Antirheumatic Drug (NB-DMARD) Received During Variable Length Pre-Index Period	1.62; 1.52; 1.63	0.2514
PRIMARY Mean Quan-Charlson Comorbidity Score of Participants	1.69; 1.76; 1.90	0.6033
PRIMARY Number of Participants With Top 25 Comorbid Conditions as Per Agency for Healthcare Research and Quality (AHRQ) During Pre-Index Period	337; 94; 48; 277; 68; 36	0.0345 sig
PRIMARY Number of Participants With Top 25 Comorbid Conditions as Per Agency for Healthcare Research and Quality (AHRQ) During Post-Index Period	336; 92; 48; 290; 69; 39	0.0590
PRIMARY Mean Claims Based Index of RA Severity (CIRAS) Score During Pre-Index Period	4.57; 4.76; 4.31	0.2336
PRIMARY Number of Participants With 25 Most Common Medications Use During Pre-Index Period	330; 92; 47; 243; 65; 34	0.9758
PRIMARY Number of Participants With 26 Most Common Medications Use During Post-Index Period	332; 94; 48; 254; 68; 35	0.2349
PRIMARY Number of Participants Who Used Opioids During Pre-Index Period	173; 55; 27	0.2178
PRIMARY Number of Participants Who Used Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) During Pre-Index Period	160; 44; 21	0.9085
PRIMARY Number of Participants Who Used Opioids During Post-Index Period	170; 47; 28	0.9392
PRIMARY Number of Participants Who Used NSAIDs During Post-Index Period	152; 41; 24	0.7977
PRIMARY Mean Number of Pharmacy Claims for Opioids During Pre-Index Period	5.21; 6.83; 9.00	0.1461
PRIMARY Mean Number of Pharmacy Claims for Non-Steroidal Anti Inflammatory Drugs (NSAIDs) During Pre-Index Period	3.81; 4.29; 3.48	0.3955
PRIMARY Mean Number of Pharmacy Claims for Opioids During Post-Index Period	5.35; 6.51; 7.29	0.3292
PRIMARY Mean Number of Pharmacy Claims for Non-Steroidal Anti Inflammatory Drugs (NSAIDs) During Post-Index Period	4.40; 4.57; 3.00	0.8138
PRIMARY Mean Number of Days From The Index Date to The First Opioid Claim During Post Index Period	106.71; 109.93; 92.85	0.8453
PRIMARY Mean Number of Days From The Index Date to The First NSAIDs Claim During Post Index Period	100.25; 117.00; 124.08	0.3076
PRIMARY Number of Participants Who Used Opioids During Tofacitinib Persistency and Post-Persistency	159; 40; 25; 49; 20; 11	0.4261
PRIMARY Number of Participants Who Used NSAIDs During Tofacitinib Persistency and Post-Persistency	138; 37; 21; 51; 17; 8	0.7816
PRIMARY Number of Participants Who Used Oral Corticosteroids During Pre-Index Period	243; 75; 43	0.1344
PRIMARY Number of Participants Who Used Oral Corticosteroids During Post-Index Period	213; 59; 34	0.9379
PRIMARY Mean Total Dose of Oral Corticosteroids During Pre-Index Period	1617.82; 1572.15; 1209.77	0.8205
PRIMARY Mean Total Dose of Oral Corticosteroid During Post-Index Period	1792.20; 1871.85; 1593.97	0.8899
PRIMARY Mean Number of Visits to Rheumatologist During Pre-Index Period	5.43; 5.14; 4.74	0.5027
PRIMARY Mean Number of Visits to Rheumatologist During Variable-Length Pre-Index Period	12.20; 11.72; 10.16	0.6908
PRIMARY Mean Disease Duration	852.13; 786.30; 862.75	0.1906
PRIMARY Mean Out of Pocket Health Care Costs for Healthcare Services During Pre-Index Period	2471.36; 3296.62; 2233.31; 1261.49; 1484.58; 1002.81	0.0056 sig
PRIMARY Mean Out of Pocket Health Care Costs for Healthcare Services During Variable Length Pre-Index Period	7031.96; 7779.41; 6451.08; 3023.26; 3049.87; 2684.47	0.2930
PRIMARY Number of Participants With Comorbidities of Interest During Pre-Index Period	90; 25; 12; 20; 7; 4	0.9829
PRIMARY Number of Participants With Non-persistence to Index Medication (Tofacitinib)	110; 37; 27	0.2242
PRIMARY Number of Participants With Post-Persistence Treatment Patterns	58; 14; 8; 6; 3; 3	0.5944
PRIMARY Number of Participants Who Switched From Index Medication (Tofacitinib) at Any Time During Post-Index Period	64; 17; 12	0.8424
PRIMARY Number of Participants Who Re-started Index Medication (Tofacitinib) at Any Time During Post-Index Period	17; 8; 5	0.2036
PRIMARY Mean Medication Possession Ratio (MPR) for Methotrexate (MTX)	0.93	—
PRIMARY Mean Adherence To Methotrexate (MTX)	0.89; 0.43; 0.58	<0.0001 sig
PRIMARY Number of Participants Who Used Additional NB-DMARD During Post Index Period	7; 6; 1; 3; 4; 1	0.0309 sig
PRIMARY Number of Participants Who Met Medication Effectiveness Criteria: Adherence to Index Medication (Tofacitinib)	212; 50; 14	0.0880
PRIMARY Number of Participants Who Met Medication Effectiveness Criteria: No Dose Escalation for Index Medication (Tofacitinib)	321; 91; 48	0.5157
PRIMARY Number of Participants Who Met Medication Effectiveness Criteria: No Switch From Index Medication (Tofacitinib)	273; 77; 36	0.8424
PRIMARY Number of Participants Who Met Medication Effectiveness Criteria: No Addition of NB-DMARD	319; 84; 46	0.0654
PRIMARY Number of Participants Who Met Medication Effectiveness Criteria: Criteria for Oral Glucocorticoids	281; 81; 39	0.5146
PRIMARY Number of Participants Who Met Medication Effectiveness Criteria: Use of Injectable Glucocorticoids	278; 77; 36	0.8966
PRIMARY Number of Participants With All Cause Ambulatory Visits During Pre-Index Period	337; 94; 48	—
PRIMARY Number of Participants With All Cause Emergency Department Visits During Pre-Index Period	88; 29; 15	0.3610
PRIMARY Number of Participants With All Cause Inpatient Admissions During Pre-Index Period	40; 12; 7	0.8135
PRIMARY Number of Participants With RA Related Ambulatory Visits During Pre-Index Period	336; 94; 48	0.5970
PRIMARY Number of Participants With RA Related Emergency Department Visits During Pre-Index Period	29; 10; 5	0.5435
PRIMARY Number of Participants With RA Related Inpatient Admissions During Pre-Index Period	24; 6; 5	0.8035
PRIMARY Number of Participants With All Cause Ambulatory Visits During Post-Index Period	337; 94; 48	—
PRIMARY Number of Participants With All Cause Emergency Department Visits During Post-Index Period	85; 25; 18	0.7871
PRIMARY Number of Participants With All Cause Inpatient Admissions During Post-Index Period	41; 7; 9	0.1984
PRIMARY Number of Participants With RA Related Ambulatory Visits During Post Index Period	335; 92; 48	0.1702
PRIMARY Number of Participants With RA Related Emergency Department Visits During Post Index Period	24; 7; 4	0.9141
PRIMARY Number of Participants With RA Related Inpatient Admissions During Post Index Period	31; 4; 9	0.1208
PRIMARY Mean Total Health Care Cost All Cause During Pre-Index Period	38294.06; 37703.67; 40845.52	0.8698
PRIMARY Mean Total Health Care Cost RA Related During Pre-Index Period	26310.56; 21927.28; 25941.25	0.0536
PRIMARY Mean Total Health Care Cost Due to All Cause During Post-Index Period	54792.79; 52877.64; 54617.88	0.6963
PRIMARY Mean Total Health Care Cost RA Related During Post-Index Period	42402.93; 35768.64; 41984.33	0.0003 sig
PRIMARY Mean Treatment Persistence Duration Measured for Index Medication (Tofacitinib)	297.61; 284.48; 246.94	0.2614
SECONDARY Mean Total All Cause Monthly Health Care Cost	1982.85; 1298.00; 1590.23; 2961.52; 2859.41; 2007.33	0.0051 sig
SECONDARY Mean Total RA Related Monthly Health Care Cost	1195.04; 671.18; 636.05; 1903.16; 1577.52; 1141.74	0.0063 sig

Eligibility Criteria

Inclusion Criteria

At least one claim for tofacitinib between 01 January 2014 and 31 January 2017 (the identification period).
Presence of The International Classification of Diseases, 9th Revision, Clinical Modification (ICD-9 CM) code for RA (in any position) during the one-year pre-index period or on the index date. ICD-9 = 714.0x-714.4x & 714.81 or ICD10 = M05.* & M06.0*-M06.3* or M06.8*-M06.9*.
At least 18 years old as of the index date.

Exclusion Criteria

Patients with claims for other conditions for which biologics 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 biologics approved for RA (Tumor-Necrosis Factor-alpha inhibitors (TNFi) [adalimumab (Humira), etanercept (Enbrel), certolizumab pegol (Cimzia), golimumab (Simponi), infliximab (Remicade)] and non-TNFi's with alternative mechanisms of action [abatacept (Orencia), and rituximab (Rituxan), anakinra (Kineret), tocilizumab (Actemra)]) during the one-year pre-index period.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03975790). 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.