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

NCT03975790 | Completed Results

• 1 other identifier: A3921336
• Study Type: observational
• Target: 479
• Locations: 1 country
• Sites: 1

Brief 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)

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (68)

• Number of Participants as Per Type of Insurance Plan

  Number of participants covered by type of insurance is reported. There were two types of insurance: 1) a private insurance plan, that is, one purchased by the participants, commercially available; 2) employer-provided insurance plan, that is, the participant's employer provided the insurance.

  During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])

• Number of Participants in Each Geographic Region

  Number of participants enrolled in the study per geographic region of the United States (northeast; north central; south; west; unknown) is reported.

  During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])

• Number of Participants With Biologic Disease Modifying Antirheumatic Drug (bDMARD) Use During Pre-Index Period

  Number of Participants with use of at least one bDMARD during pre-index period is reported. The bDMARD could have been any tumor-necrosis factor-alpha inhibitors (TNFi), any non-TNFi, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, anakinra, abatacept, tocilizumab or rituximab.

  During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])

• Number of Participants With Biologic Disease Modifying Antirheumatic Drug (bDMARD) Use During Variable Length Pre-Index Period

  Number of Participants with use of at least one bDMARD during variable length pre-index period is reported. The bDMARD could have been any TNFi, any non-TNFi, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, anakinra, abatacept, tocilizumab or rituximab. Variable-length pre-index period defined as the period from the participant's first date of enrollment in the database to the day before the index date. The date of enrollment had to be at least 1 year prior to the index date and depending on the participant, could have been as much as maximum of 5.2 years. The index date was the date of the first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years.

  During variable length pre-index period (1 year before the index date up to 5.2 years)

• Mean Number of Biologic Disease Modifying Antirheumatic Drug (bDMARD) Received During Pre-Index Period

  Mean number of bDMARD received during pre-index period is reported. The bDMARD could have been any TNFi, any non-TNFi, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, anakinra, abatacept, tocilizumab or rituximab.

  During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])

• Mean Number of Biologic Disease Modifying Antirheumatic Drug (bDMARD) Received During Variable Length Pre-Index Period

  Mean number of bDMARD received during variable length pre-index period is reported. The bDMARD could have been any TNFi, any non-TNFi, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, anakinra, abatacept, tocilizumab or rituximab. Variable-length pre-index period defined as the period from the participant's first date of enrollment in the database to the day before the index date. The date of enrollment had to be at least 1 year prior to the index date and depending on the participant could have been as much as maximum of 5.2 years. The index date was the date of the first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years.

  During variable length pre-index period (1 year before the index date up to 5.2 years)

• Number of Participants With Non-biologic Disease Modifying Antirheumatic Drug (NB-DMARD) Use During Pre-Index Period

  Number of Participants with NB-DMARD use during pre-index period is reported. The NB-DMARD could have been hydroxychloroquine, MTX oral, leflunomide, sulfasalazine, chloroquine, cyclosporine, thalidomide, azathioprine, cyclophosphamide, auranofin, aurothioglucose, gold sodium thiomalate, penicillamine, tacrolimus or minocycline.

  During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])

• Number of Participants With Non-Biologic Disease Modifying Antirheumatic Drug (NB-DMARD) Use During Variable Length Pre-Index Period

  Number of Participants with NB-MARD use during variable length pre-index period is reported. The NB-DMARD could have been hydroxychloroquine, MTX oral, leflunomide, sulfasalazine, chloroquine, cyclosporine, thalidomide, azathioprine, cyclophosphamide, auranofin, aurothioglucose, gold sodium thiomalate, penicillamine, tacrolimus or minocycline. Variable-length pre-index period defined as the period from the participant's first date of enrollment in the database to the day before the index date. The date of enrollment had to be at least 1 year prior to the index date and depending on the participant could have been as much as maximum of 5.2 years. The index date was the date of the first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years.

  During variable length pre-index period (1 year before the index date up to 5.2 years)

• Mean Number of Non-Biologic Disease Modifying Antirheumatic Drug (NB-DMARD) Received During Pre-Index Period

  Mean number of NB-DMARD received during pre-index period is reported. The NB-DMARD could have been hydroxychloroquine, MTX oral, leflunomide, sulfasalazine, chloroquine, cyclosporine, thalidomide, azathioprine, cyclophosphamide, auranofin, aurothioglucose, gold sodium thiomalate, penicillamine, tacrolimus or minocycline.

  During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])

• Mean Number of Non-Biologic Disease Modifying Antirheumatic Drug (NB-DMARD) Received During Variable Length Pre-Index Period

  Mean number of NB-DMARD received during variable length pre-index period is reported. The NB-DMARD could have been hydroxychloroquine, MTX oral, leflunomide, sulfasalazine, chloroquine, cyclosporine, thalidomide, azathioprine, cyclophosphamide, auranofin, aurothioglucose, gold sodium thiomalate, penicillamine, tacrolimus or minocycline. Variable-length pre-index period defined as the period from the participant's first date of enrollment in the database to the day before the index date. The date of enrollment had to be at least 1 year prior to the index date and depending on the participant could have been as much as maximum of 5.2 years. The index date was the date of the first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years.

  During variable length pre-index period (1 year before the index date up to 5.2 years)

• Mean Quan-Charlson Comorbidity Score of Participants

  The mean Quan-Charlson Comorbidity Score during the Pre-Index Period is reported. Quan-Charlson Comorbidity Score predicts the probability of death within one year in participants and was based on the presence of any diagnosis codes on medical claims at any time during the 12-month pre-index period, based on the International Classification of Diseases (ICD) diagnosis codes. Total score ranges from 0 to 9.0. A score of zero indicates that no comorbidities were found. The higher the score, the more likely the predicted outcome could result in mortality or higher healthcare resource utilization.

  During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])

• Number of Participants With Top 25 Comorbid Conditions as Per Agency for Healthcare Research and Quality (AHRQ) During Pre-Index Period

  Top 25 comorbid conditions: 1) rheumatoid arthritis/related disease, 2)other aftercare, 3)other connective tissue disease, 4)other non-traumatic joint disorders, 5)medical examination/evaluation, 6) other suspected conditions(other miscellaneous conditions other than mental disorders/infectious disease), 7)immunizations/screening for infectious disease, 8)osteoarthritis, 9)essential hypertension, 10) residual codes: unclassified, 11)disorders of lipid metabolism, 12)back problems, 13)other upper respiratory infections, 14)other lower respiratory disease, 15)other nervous system disorders, 16)other skin disorders, 17)thyroid disorders, 18)other bone disease/musculoskeletal deformities, 19) malaise/fatigue, 20)esophageal disorders, 21)nutritional deficiencies, 22)other nutritional: endocrine, metabolic disorders, 23)diabetes mellitus without complication, 24)other/unspecified benign neoplasm, 25)genitourinary symptoms/ill-defined conditions. A participant could have had \>=1 comorbidity.

  During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])

• Number of Participants With Top 25 Comorbid Conditions as Per Agency for Healthcare Research and Quality (AHRQ) During Post-Index Period

  Top 25 comorbid conditions: 1) rheumatoid arthritis/related disease, 2)other aftercare, 3)other connective tissue disease, 4)other non-traumatic joint disorders, 5)medical examination/evaluation, 6) other suspected conditions(other miscellaneous conditions other than mental disorders/infectious disease), 7)immunizations/screening for infectious disease, 8)osteoarthritis, 9)essential hypertension, 10) residual codes: unclassified, 11)disorders of lipid metabolism, 12)back problems, 13)other upper respiratory infections, 14)other lower respiratory disease, 15)other nervous system disorders, 16)other skin disorders, 17)thyroid disorders, 18)other bone disease/musculoskeletal deformities, 19) malaise/fatigue, 20)esophageal disorders, 21)nutritional deficiencies, 22)other nutritional: endocrine, metabolic disorders, 23)diabetes mellitus without complication, 24)other/unspecified benign neoplasm, 25)Other upper respiratory disease. A participant could have had \>=1 comorbidity.

  During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])

• Mean Claims Based Index of RA Severity (CIRAS) Score During Pre-Index Period

  The mean of the CIRAS score during pre-index period is reported. The CIRAS is based on claims at any time during the 12-month pre-index period, used to measure RA disease severity using 9 measures (age at index, gender, inflammatory marker test ordered, rehabilitation visit, rheumatoid factor test, Felty's syndrome, number of platelet counts ordered, number of chemistry panels ordered, rheumatologist visit). Value of all 9 measure was used to derive the overall CIRAS score which ranges from 0-7.9 with higher value indicating greater severity of RA.

  During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])

• Number of Participants With 25 Most Common Medications Use During Pre-Index Period

  Number of participants with 25 most common medications use during the pre-index period are reported. The 25 most medications: 1) MTX sodium, 2) folic acid, 3) prednisone, 4) acetaminophen/hydrocodone bitartrate, 5) azithromycin, 6) adalimumab, 7) hydroxychloroquine sulfate, 8) etanercept, 9) levothyroxine sodium, 10) methylprednisolone, 11) omeprazole, 12) tramadol hydrochloride, 13) meloxicam, 14) amoxicillin, 15) albuterol sulfate, 16) gabapentin, 17) acetaminophen/oxycodone hydrochloride, 18) amoxicillin/clavulanate potassium, 19) cyclobenzaprine hydrochloride, 20) fluticasone propionate, 21) ciprofloxacin hydrochloride, 22) duloxetine hydrochloride, 23) atorvastatin calcium, 24) diclofenac sodium, 25) levofloxacin. A participant could have received \>=1 most common medication.

  During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])

• Number of Participants With 26 Most Common Medications Use During Post-Index Period

  Number of participants with 26 most common medications use during the post-index period are reported. The 26 most common medications: 1) MTX sodium, 2) folic acid, 3) prednisone, 4) acetaminophen/hydrocodone bitartrate, 5) azithromycin, 6) adalimumab, 7) hydroxychloroquine sulfate, 8) etanercept, 9) levothyroxine sodium, 10) methylprednisolone, 11) omeprazole, 12) tramadol hydrochloride, 13) meloxicam, 14) amoxicillin, 15) albuterol sulfate, 16) gabapentin, 17) acetaminophen/oxycodone hydrochloride, 18) amoxicillin/clavulanate potassium, 19) cyclobenzaprine hydrochloride, 20) fluticasone propionate, 21) ciprofloxacin hydrochloride, 22) duloxetine hydrochloride, 23) diclofenac Sodium, 24) levofloxacin, 25) cephalexin, 26) ibuprofen. A participant could have received \>=1 most common medication.

  During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])

• Number of Participants Who Used Opioids During Pre-Index Period

  Number of participants who used at least one opioid during pre-index period are reported.

  During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])

• Number of Participants Who Used Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) During Pre-Index Period

  Number of participants who used at least one NSAID during pre-index period are reported.

  During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])

• Number of Participants Who Used Opioids During Post-Index Period

  Number of participants who used at least one opioid during the post-index period are reported.

  During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])

• Number of Participants Who Used NSAIDs During Post-Index Period

  Number of participants who used at least one NSAID during the post-index period are reported.

  During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])

• Mean Number of Pharmacy Claims for Opioids During Pre-Index Period

  The mean number of pharmacy claims for opioids during the pre-index period are reported. A pharmacy claim is defined as a claim made by participants to their insurance provider in purchasing opioids from their pharmacy.

  During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])

• Mean Number of Pharmacy Claims for Non-Steroidal Anti Inflammatory Drugs (NSAIDs) During Pre-Index Period

  The mean number of pharmacy claims for NSAIDs during the pre-index period are reported. A pharmacy claim is defined as a claim made by participants to their insurance provider in purchasing NSAIDs from their pharmacy.

  During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])

• Mean Number of Pharmacy Claims for Opioids During Post-Index Period

  The mean number of pharmacy claims for opioids during the post-index period are reported. A pharmacy claim is defined as a claim made by participants to their insurance provider in purchasing opioids from their pharmacy.

  During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])

• Mean Number of Pharmacy Claims for Non-Steroidal Anti Inflammatory Drugs (NSAIDs) During Post-Index Period

  The mean number of pharmacy claims for NSAIDs during the post-index period are reported. A pharmacy claim is defined as a claim made by participants to their insurance provider in purchasing NSAIDs from their pharmacy.

  During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])

• Mean Number of Days From The Index Date to The First Opioid Claim During Post Index Period

  Mean number of days from the index date to the first opioid claim during post index period are reported.

  During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])

• Mean Number of Days From The Index Date to The First NSAIDs Claim During Post Index Period

  Mean number of days from the index date to the first NSAIDs claim during post index period are reported.

  During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])

• Number of Participants Who Used Opioids During Tofacitinib Persistency and Post-Persistency

  Number of participants who used opioids during tofacitinib persistency and post-persistency are reported. Persistence for participants is defined as the period of treatment with tofacitinib. Post persistence refers to switching to another medication from tofacitinib; or discontinuing tofacitinib either permanently or for a gap in time \>60 days before restarting.

  During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])

• Number of Participants Who Used NSAIDs During Tofacitinib Persistency and Post-Persistency

  Number of participants who used NSAIDs during tofacitinib persistency and post-persistency are reported. Persistence for participants is defined as the period of treatment with tofacitinib. Post persistence refers to switching to another medication from tofacitinib; or discontinuing tofacitinib either permanently or for a gap in time \>60 days before restarting.

  During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])

• Number of Participants Who Used Oral Corticosteroids During Pre-Index Period

  The number of participants who used at least one oral corticosteroid during the pre-index period is reported.

  During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])

• Number of Participants Who Used Oral Corticosteroids During Post-Index Period

  The number of participants who used at least one oral corticosteroid during the post-index period is reported.

  During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])

• Mean Total Dose of Oral Corticosteroids During Pre-Index Period

  Mean total dose of oral corticosteroids during pre-index period is reported. The total dose is expressed as a prednisone-equivalent dose of the oral corticosteroids used.

  During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])

• Mean Total Dose of Oral Corticosteroid During Post-Index Period

  Mean total dose of oral corticosteroids during post-index period is reported. The total dose is expressed as a prednisone-equivalent dose of the oral corticosteroids used.

  During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])

• Mean Number of Visits to Rheumatologist During Pre-Index Period

  Mean number of visits to a rheumatologist during pre-index period is reported. A visit is referring to out-patient visit specifically to a rheumatologist.

  During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])

• Mean Number of Visits to Rheumatologist During Variable-Length Pre-Index Period

  Mean number of visits to rheumatologist during the variable-length pre-index period is reported. A visit is referring to out-patient visit specifically to a rheumatologist. Variable-length pre-index period defined as the period from the participant's first date of enrollment in the database to the day before the index date. The date of enrollment had to be at least 1 year prior to the index date and depending on the participant could have been as much as maximum of 5.2 years. The index date was the date of the first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years.

  During variable length pre-index period (1 year before the index date up to 5.2 years)

• Mean Disease Duration

  Mean Disease Duration of RA based upon the variable length pre-index period is reported. Disease duration (in days) defined as the number of days from the earliest claim with a diagnosis of RA in the variable length pre-index period until the index date. Variable-length pre-index period defined as the period from the participant's first date of enrollment in the database to the day before the index date. The date of enrollment had to be at least 1 year prior to the index date and depending on the participant could have been as much as maximum of 5.2 years. The index date was the date of the first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years.

  During variable length pre-index period (1 year before the index date up to 5.2 years)

• Mean Out of Pocket Health Care Costs for Healthcare Services During Pre-Index Period

  Mean out of pocket health care costs for healthcare services during pre-index period is reported. It is categorized as: All causes and RA related. All cause consisted of money spent by participants on all health care services (pharmacy, medical \[ambulatory, emergency department and inpatient admission\]). RA related signifies money spent by participants on health care services for RA.

  During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])

• Mean Out of Pocket Health Care Costs for Healthcare Services During Variable Length Pre-Index Period

  Mean out of pocket health care costs for healthcare services during variable length pre-index period is reported. It is categorized as: All causes and RA related. All cause consisted of money spent by participants on all health care services (pharmacy, medical \[ambulatory, emergency department and inpatient admission\]). RA related signifies one spent by participants on health care services for RA. Variable-length pre-index period defined as the period from the participant's first date of enrollment in the database to the day before the index date. The date of enrollment had to be at least 1 year prior to the index date and depending on the participant could have been as much as maximum of 5.2 years. The index date was the date of the first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years.

  During variable length pre-index period (1 year before the index date up to 5.2 years)

• Number of Participants With Comorbidities of Interest During Pre-Index Period

  Number of participants with at least one of comorbidity of interest during pre-index period is reported. The comorbidities of interest included cardiovascular diseases, chronic obstructive pulmonary disorder (COPD), asthma, kidney disease, diabetes, depression, anxiety, liver disease, sleep disorders. A participant could have \>1 comorbidity of interest.

  During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])

• Number of Participants With Non-persistence to Index Medication (Tofacitinib)

  Non-persistence was defined as the gap of at least 60 days in treatment with the index medication (tofacitinib) or switching to other biologic.

  During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])

• Number of Participants With Post-Persistence Treatment Patterns

  Number of participants with post-persistence treatment patterns is reported. Post-persistence was categorized as: 1) switch immediately (if participants initiated a non-index biologic before a 60-day gap in treatment is observed for the index medication); 2) discontinue then restart (if there was a gap in the index therapy of at least 60 days and the first medication observed after the gap is the index medication); 3) discontinue then switch ( if there was a gap in the index therapy of at least 60 days and the first medication observed after the gap is a biologic \[including Tofacitinib\] different from index medication), 4) discontinue without switch or restart (if participant's had a gap in therapy of at least 60 days and there are no claims for either the index medication or a different biologic for the remaining observation period).

  During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])

• Number of Participants Who Switched From Index Medication (Tofacitinib) at Any Time During Post-Index Period

  Number of participants who switched from index medication (tofacitinib) to a biologic at any time during post-index period is reported.

  During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])

• Number of Participants Who Re-started Index Medication (Tofacitinib) at Any Time During Post-Index Period

  Number of participants who re-started tofacitinib (after considered as non-persistence with the tofacitinib) after discontinuation at any time during post-index period is reported.

  During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])

• Mean Medication Possession Ratio (MPR) for Methotrexate (MTX)

  Mean MPR for Methotrexate is reported. MPR was calculated as the total days supply of MTX between the first and including the last prescription/administration divided by the time between the first through and including last biologic prescription/administration days supply.

  During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])

• Mean Adherence To Methotrexate (MTX)

  Mean adherence for methotrexate is reported. Adherence was calculated as the total number of days supplied for MTX during the post-index period divided by the number of days from the first claim during the post-index period to the end of the post-index period

  During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])

• Number of Participants Who Used Additional NB-DMARD During Post Index Period

  Number of participants who used additional NB-DMARD during post index period is reported. Additional NB-DMARD use could have been leflunomide, sulfasalazine and hydroxychloroquine.

  During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])

• Number of Participants Who Met Medication Effectiveness Criteria: Adherence to Index Medication (Tofacitinib)

  Medication effectiveness criteria categorized as: 1) adherence to index medication, 2) no dose escalation for index medication, 3) no switch from index medication, 4) no addition of NB-DMARD, 5) criteria for oral glucocorticoids, 6) use of Injectable glucocorticoids. Adherence to index medication was defined as at least 30 days continuous supply of tofacitinib during post-index period.

  During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])

• Number of Participants Who Met Medication Effectiveness Criteria: No Dose Escalation for Index Medication (Tofacitinib)

  Medication effectiveness criteria categorized as: 1) adherence to index medication, 2) no dose escalation for index medication, 3) no switch from index medication, 4) no addition of NB-DMARD, 5) criteria for oral glucocorticoids, 6) use of Injectable glucocorticoids. No dose escalation for index medication was defined as no increase in dose for index medication compared to the starting dose during post-index period.

  During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])

• Number of Participants Who Met Medication Effectiveness Criteria: No Switch From Index Medication (Tofacitinib)

  Medication effectiveness criteria categorized as: 1) adherence to index medication, 2) no dose escalation for index medication, 3) no switch from index medication, 4) no addition of NB-DMARD, 5) criteria for oral glucocorticoids, 6) use of Injectable glucocorticoids. No switch from index medication was defined as no switching from the index medication to a (different) biologic agent during post-index period.

  During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])

• Number of Participants Who Met Medication Effectiveness Criteria: No Addition of NB-DMARD

  Medication effectiveness criteria categorized as: 1) adherence to index medication, 2) no dose escalation for index medication, 3) no switch from index medication, 4) no addition of NB-DMARD, 5) criteria for oral glucocorticoids, 6) use of Injectable glucocorticoids. No addition of NB-DMARD was defined as no addition of new NB-DMARD to index therapy during post-index period.

  During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])

• Number of Participants Who Met Medication Effectiveness Criteria: Criteria for Oral Glucocorticoids

  Medication effectiveness criteria categorized as: 1) adherence to index medication, 2) no dose escalation for index medication, 3) no switch from index medication, 4) no addition of NB-DMARD, 5) criteria for oral glucocorticoids, 6) use of Injectable glucocorticoids. Medication effectiveness criteria for oral glucocorticoids was defined as either of the following: 1) Participants cannot receive oral glucocorticoids for \> 30 days between (index date +91 days) to (index date + 359 days); 2) No increase in oral glucocorticoid dose during months 6-12 after index date.

  During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])

• Number of Participants Who Met Medication Effectiveness Criteria: Use of Injectable Glucocorticoids

  Medication effectiveness criteria categorized as: 1) adherence to index medication, 2) no dose escalation for index medication, 3) no switch from index medication, 4) no addition of NB-DMARD, 5) criteria for oral glucocorticoids, 6) use of Injectable glucocorticoids. Use of Injectable glucocorticoids was defined as maximum one parenteral or intra-articular glucocorticoid joint injection use after the participant had been on biologic treatment for \>3 months post index date (\[index date +91 days\] to \[index date +359 days\]).

  During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])

• Number of Participants With All Cause Ambulatory Visits During Pre-Index Period

  Number of participants with at least one ambulatory visit that was due to all cause during the pre-index period is reported. All cause refers to ambulatory visits due to all comorbidities, including RA.

  During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])

• Number of Participants With All Cause Emergency Department Visits During Pre-Index Period

  Number of participants with at least one emergency department visits that was due to all cause during the pre-index period is reported. All cause refers to emergency visits due to all comorbidities, including RA.

  During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])

• Number of Participants With All Cause Inpatient Admissions During Pre-Index Period

  Number of participants with at least one inpatient admissions that was due to all cause during the pre-index period is reported. All cause refers to inpatient admission due to all comorbidities, including RA.

  During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])

• Number of Participants With RA Related Ambulatory Visits During Pre-Index Period

  Number of participants with at least one ambulatory visit that was due to RA during the pre-index period is reported. RA related refers to ambulatory visits due to RA.

  During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])

• Number of Participants With RA Related Emergency Department Visits During Pre-Index Period

  Number of participants with at least one emergency department visits that was due to RA during the pre-index period is reported. RA related refers to emergency department visits due to RA.

  During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])

• Number of Participants With RA Related Inpatient Admissions During Pre-Index Period

  Number of participants with at least one inpatient admissions that was due to RA during the pre-index period is reported. RA related refers to inpatient admission due to RA.

  During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])

• Number of Participants With All Cause Ambulatory Visits During Post-Index Period

  Number of participants with at least one ambulatory visit that was due to all cause during the post-index period is reported. All cause refers to ambulatory visits due to all comorbidities, including RA.

  During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])

• Number of Participants With All Cause Emergency Department Visits During Post-Index Period

  Number of participants with at least one emergency department visits that was due to all cause during the post-index period is reported. All cause refers to emergency department visits due to all comorbidities, including RA.

  During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])

• Number of Participants With All Cause Inpatient Admissions During Post-Index Period

  Number of participants with at least one inpatient admissions that was due to all cause during the post-index period is reported. All cause refers to inpatient admissions due to all comorbidities, including RA.

  During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])

• Number of Participants With RA Related Ambulatory Visits During Post Index Period

  Number of participants with at least one of the RA-related ambulatory visits during the post-index period is reported. RA related refers to ambulatory visits due to RA.

  During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])

• Number of Participants With RA Related Emergency Department Visits During Post Index Period

  Number of participants with at least one of the RA-related emergency department visit during the post-index period is reported. RA related refers to emergency department visits due to RA.

  During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])

• Number of Participants With RA Related Inpatient Admissions During Post Index Period

  Number of participants with at least one of an RA-related inpatient admission during the post-index period is reported. RA related refers to inpatient admissions due to RA.

  During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])

• Mean Total Health Care Cost All Cause During Pre-Index Period

  Mean total health care cost all cause during pre-index period is reported. All cause refers to cost spent due to all comorbidities including RA and calculated as the total of pharmacy cost (home healthcare cost, urgent care cost and other medical services costs) and medical cost (ambulatory cost, emergency department visits cost, inpatient admission cost and other costs).

  During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])

• Mean Total Health Care Cost RA Related During Pre-Index Period

  RA related healthcare cost refers to cost spent due to RA alone and was calculated as the total of treatment cost (cost of tofacitinib, biologic DMARDs, NB-DMARDs and administration of intravenous (IV) biologics) and medical cost (cost of ambulatory cost, emergency department visits cost, inpatient admission cost, home health care cost, urgent care cost and other medical services cost).

  During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])

• Mean Total Health Care Cost Due to All Cause During Post-Index Period

  Mean total health care cost due to all cause during post-index period is reported. All cause refers to cost spent due to all comorbidities, including RA and calculated as the total of pharmacy cost (cost of home healthcare cost, urgent care cost and other medical services costs) and medical cost (cost of ambulatory cost, emergency department visits cost, inpatient admission cost and other costs).

  During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])

• Mean Total Health Care Cost RA Related During Post-Index Period

  RA related healthcare cost refers to cost spent due to RA alone and was calculated as the total of treatment cost (cost of tofacitinib, biologic DMARDs, NB-DMARDs and administration of IV biologics) and medical cost (ambulatory cost, emergency department visits cost, inpatient admission cost, home health care cost, urgent care cost and other medical services cost).

  During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])

• Mean Treatment Persistence Duration Measured for Index Medication (Tofacitinib)

  Treatment persistence with tofacitinib was defined as not having a gap in therapy of at least 60 days between prescription re-fills of tofacitinib.

  During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])

Secondary Outcomes (2)

• Mean Total All Cause Monthly Health Care Cost

  During pre-index period (at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 months before index date) and post index period (at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 month post index date)

• Mean Total RA Related Monthly Health Care Cost

  During pre-index period (at1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 months before index date) and post index period (at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 month after index date)

Study Arms (1)

Truven Health MarketScan Research Database

Compare treatment patterns including dosing, concomitant medication use, adherence, persistence, and switching among tofacitinb+MTX patients who withdraw MTX vs. persist with MTX or experience interrupted MTX

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals who are privately insured and with Medicare Supplemental insurance

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer

New York, New York, 10017, United States

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2019
• First Posted: June 5, 2019
• Study Start: May 29, 2018
• Primary Completion: October 2, 2018
• Study Completion: October 2, 2018
• Last Updated: June 9, 2023
• Results First Posted: October 22, 2019

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)