A Study To Describe The Use Of Tofacitinib After Use Of Rituximab In Patients With Rheumatoid Arthritis In A Real-World Setting

Completed

Conditions: Arthritis, Rheumatoid

Registration Number: NCT05487703

Lead Sponsor: Pfizer

Brief Summary: This study is to characterize the use of tofacitinib after use of rituximab in patients with Rheumatoid Arthritis in a real-world setting.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 318

Inclusion Criteria

Enrolled in the CorEvitas RA Registry and initiated tofacitinib on or after November 2012.
Initiate tofacitinib (defined as first ever use of tofacitinib) at Registry enrollment visit or at a Registry follow-up visit after November 2012
Have prior use of rituximab
Have CDAI measured at baseline and appropriate follow-up visit.

Exclusion Criteria

There are no exclusion criteria for this study

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Participants According to Smoking Status	At index date, index date could be anytime during observation period from 06-Nov-2012 to 31-Oct-2022, approximately 9 years (data was observed retrospectively in this study from 14-Nov-2022 to 23-Dec-2022, for approximately 1 month)	Number of participants according to smoking status was reported in this outcome measure. Index date was defined as the date of tofacitinib initiation at or after enrollment in the registry; initiation was defined as first ever use of tofacitinib.
Number of Participants According to Work Status	At index date, index date could be anytime during observation period from 06-Nov-2012 to 31-Oct-2022, approximately 9 years (data was observed retrospectively in this study from 14-Nov-2022 to 23-Dec-2022, for approximately 1 month)	Number of participants according to work status was reported in this outcome measure. Index date was defined as the date of tofacitinib initiation at or after enrollment in the registry; initiation was defined as first ever use of tofacitinib.
Number of Participants According to Alcohol Use	At index date, index date could be anytime during observation period from 06-Nov-2012 to 31-Oct-2022, approximately 9 years (data was observed retrospectively in this study from 14-Nov-2022 to 23-Dec-2022, for approximately 1 month)	Number of participants according to alcohol use were reported in this outcome measure. Index date was defined as the date of tofacitinib initiation at or after enrollment in the registry; initiation was defined as first ever use of tofacitinib.
Number of Participants According to History of Comorbidities	At index date, index date could be anytime during observation period from 06-Nov-2012 to 31-Oct-2022, approximately 9 years (data was observed retrospectively in this study from 14-Nov-2022 to 23-Dec-2022, for approximately 1 month)	Number of participants according to history of comorbidities were reported in this outcome measure. Index date was defined as the date of tofacitinib initiation at or after enrollment in the registry; initiation was defined as first ever use of tofacitinib. One participant might have more than one history of comorbidities.
Duration of Rheumatoid Arthritis at Index Date	At index date, index date could be anytime during observation period from 06-Nov-2012 to 31-Oct-2022, approximately 9 years (data was observed retrospectively in this study from 14-Nov-2022 to 23-Dec-2022, for approximately 1 month)	Duration of rheumatoid arthritis in participants at the time of index date was reported in this outcome measure. Index date was defined as the date of tofacitinib initiation at or after enrollment in the registry; initiation was defined as first ever use of tofacitinib.
Age at Onset of Rheumatoid Arthritis at Index Date	At index date, index date could be anytime during observation period from 06-Nov-2012 to 31-Oct-2022, approximately 9 years (data was observed retrospectively in this study from 14-Nov-2022 to 23-Dec-2022, for approximately 1 month)	Participants age at onset of rheumatoid arthritis at the time of index date was reported in this outcome measure. Index date was defined as the date of tofacitinib initiation at or after enrollment in the registry; initiation was defined as first ever use of tofacitinib.
Clinical Disease Activity Index (CDAI)	At index date, index date could be anytime during observation period from 06-Nov-2012 to 31-Oct-2022, approximately 9 years (data was observed retrospectively in this study from 14-Nov-2022 to 23-Dec-2022, for approximately 1 month)	CDAI was a simplified index for assessing the disease activity comprising of the swollen joint counts (SJC), tender/painful joint counts (TJC), participant's global assessment of disease activity (PtGA) and physician's global assessment of disease activity (PGA). CDAI is the numerical sum of 4 outcome parameters: SJC and TJC (based on 28-joint assessment range from 0 to 28, higher scores indicated worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 centimeter (cm) visual analog scale (VAS); higher scores indicated greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. Index date was defined as the date of tofacitinib initiation at or after enrollment in the registry; initiation was defined as first ever use of tofacitinib.
Number of Participants According to Type of Health Insurance Plan	At index date, index date could be anytime during observation period from 06-Nov-2012 to 31-Oct-2022, approximately 9 years (data was observed retrospectively in this study from 14-Nov-2022 to 23-Dec-2022, for approximately 1 month)	Number of participants according to type of health insurance plan was reported in this outcome measure. The health insurance plan included private, Medicare, Medicaid and no insurance. Index date was defined as the date of tofacitinib initiation at or after enrollment in the registry; initiation was defined as first ever use of tofacitinib. One participant might have more than one type of insurance.
Number of Participants With College Graduation or Higher Education	At index date, index date could be anytime during observation period from 06-Nov-2012 to 31-Oct-2022, approximately 9 years (data was observed retrospectively in this study from 14-Nov-2022 to 23-Dec-2022, for approximately 1 month)	Number of participants who were college graduate or had higher education were reported in this outcome measure. Index date was defined as the date of tofacitinib initiation at or after enrollment in the registry; initiation was defined as first ever use of tofacitinib.
Number of Participants According to CDAI Categories	At index date, index date could be anytime during observation period from 06-Nov-2012 to 31-Oct-2022, approximately 9 years (data was observed retrospectively in this study from 14-Nov-2022 to 23-Dec-2022, for approximately 1 month)	Number of participants according to CDAI category were reported in this outcome measures. CDAI was simplified index for assessing disease activity comprising of SJC, TJC, PtGA and PGA. CDAI is numerical sum of 4 outcome parameters: SJC and TJC (based on 28-joint assessment range from 0 to 28, higher score indicated worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 cm VAS; higher score indicated greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher score indicated worse condition. Score range-Remission: CDAI less than or equal to (\<=) 2.8. Low Disease Activity: CDAI greater than (\>) 2.8 and \<= 10. Moderate Disease Activity: CDAI \> 10 and \<= 22. High Disease Activity: CDAI \> 22. Index date was defined as the date of tofacitinib initiation at or after enrollment in the registry; initiation was defined as first ever use of tofacitinib.
Tender Joint Count	At index date, index date could be anytime during observation period from 06-Nov-2012 to 31-Oct-2022, approximately 9 years (data was observed retrospectively in this study from 14-Nov-2022 to 23-Dec-2022, for approximately 1 month)	Tender joint count was used to measure the pain and inflammation in the joints, based on 28-joint assessment range from 0 to 28, where higher scores indicated worse condition. Index date was defined as the date of tofacitinib initiation at or after enrollment in the registry; initiation was defined as first ever use of tofacitinib.
Swollen Joint Count	At index date, index date could be anytime during observation period from 06-Nov-2012 to 31-Oct-2022, approximately 9 years (data was observed retrospectively in this study from 14-Nov-2022 to 23-Dec-2022, for approximately 1 month)	Swollen joint count was used to measure the pain and inflammation in the joints. Based on 28-joint assessment range from 0 to 28, where higher scores indicated worse condition. Index date was defined as the date of tofacitinib initiation at or after enrollment in the registry; initiation was defined as first ever use of tofacitinib.
Patient Global Assessment (PGA) VAS	At index date, index date could be anytime during observation period from 06-Nov-2012 to 31-Oct-2022, approximately 9 years (data was observed retrospectively in this study from 14-Nov-2022 to 23-Dec-2022, for approximately 1 month)	PGA-VAS was used to assess disease activity; assessed on 0-100 millimeter (mm) VAS; higher scores indicated greater affection due to disease activity. Index date was defined as the date of tofacitinib initiation at or after enrollment in the registry; initiation was defined as first ever use of tofacitinib.
Modified Health Assessment Questionnaire (mHAQ)	At index date, index date could be anytime during observation period from 06-Nov-2012 to 31-Oct-2022, approximately 9 years (data was observed retrospectively in this study from 14-Nov-2022 to 23-Dec-2022, for approximately 1 month)	mHAQ is the modified version of HAQ which simplifies it from 20 questions to 8 questions, which assessed the ability to perform tasks due to rheumatoid arthritis. It comprised of 8 questions on 8 categories of daily living activities: dress/groom; arise; eat; grip; walk; hygiene; reach; and common activities over past week before specified time point. Eight items were rated on a 4-point Likert scale from 0 to 3, where 0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total score ranged from 0 to 3, where 0 = least difficulty and 3 = extreme difficulty, higher scores indicated worse functioning. Index date was defined as the date of tofacitinib initiation at or after enrollment in the registry; initiation was defined as first ever use of tofacitinib.
Pain VAS	At index date, index date could be anytime during observation period from 06-Nov-2012 to 31-Oct-2022, approximately 9 years (data was observed retrospectively in this study from 14-Nov-2022 to 23-Dec-2022, for approximately 1 month)	Pain VAS was assessed using 100 millimeter (mm) horizontal line to rate pain. Score ranged from 0 mm to 100 mm; where, 0 = no pain and 100 = worst possible pain. Index date was defined as the date of tofacitinib initiation at or after enrollment in the registry; initiation was defined as first ever use of tofacitinib.
Fatigue VAS	At index date, index date could be anytime during observation period from 06-Nov-2012 to 31-Oct-2022, approximately 9 years (data was observed retrospectively in this study from 14-Nov-2022 to 23-Dec-2022, for approximately 1 month)	Participants assessed their fatigue using a 0 to 100 mm VAS scale, where 0 mm = no fatigue and 100 mm = worst possible fatigue. Index date was defined as the date of tofacitinib initiation at or after enrollment in the registry; initiation was defined as first ever use of tofacitinib.
Number of Participants With European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Domain Scores of 2 or Higher	At index date, index date could be anytime during observation period from 06-Nov-2012 to 31-Oct-2022, approximately 9 years (data was observed retrospectively in this study from 14-Nov-2022 to 23-Dec-2022, for approximately 1 month)	EQ-5D-3L is a health profile questionnaire used to assess quality of life along 5 dimensions. Participants rated 5 aspects of health (walking, self-care, usual activities, pain/discomfort, and anxiety/depression) by choosing from 3 answering options (1=no problems; 2=some problems; 3=extreme problems). The mean of the summed score ranged from 1 to 3 with "1" corresponding to no problems and "3" corresponding to severe problems in the 5 dimensions, where higher score indicated more severe problems. In this outcome measure number of participants with a domain score of 2 or higher in each individual domain are reported. Index date was defined as the date of tofacitinib initiation at or after enrollment in the registry; initiation was defined as first ever use of tofacitinib.
Number of Participants According to Previous Drug Therapies With Conventional Disease-Modifying Antirheumatic Drug (csDMARD)	At index date, index date could be anytime during observation period from 06-Nov-2012 to 31-Oct-2022, approximately 9 years (data was observed retrospectively in this study from 14-Nov-2022 to 23-Dec-2022, for approximately 1 month)	Number of participants according to previous drug therapies with csDMARD were reported in this outcome measure. Index date was defined as the date of tofacitinib initiation at or after enrollment in the registry; initiation was defined as first ever use of tofacitinib.
Number of Participants According to Line of Therapy at Tofacitinib Initiation	At index date, index date could be anytime during observation period from 06-Nov-2012 to 31-Oct-2022, approximately 9 years (data was observed retrospectively in this study from 14-Nov-2022 to 23-Dec-2022, for approximately 1 month)	Number of participants were classified according to line of therapy in which Tofacitinib was initiated and were reported in this outcome measure. Index date was defined as the date of tofacitinib initiation at or after enrollment in the registry; initiation was defined as first ever use of tofacitinib.
Number of Participants According to Concomitant Therapies	At index date, index date could be anytime during observation period from 06-Nov-2012 to 31-Oct-2022, approximately 9 years (data was observed retrospectively in this study from 14-Nov-2022 to 23-Dec-2022, for approximately 1 month)	Number of participants classified according to concomitant therapies were reported in this outcome measure. One participant might have received more than one concomitant therapy. Index date was defined as the date of tofacitinib initiation at or after enrollment in the registry; initiation was defined as first ever use of tofacitinib.
Percentage of Participants Who Used Rituximab (RTX) Directly Before Tofacitinib	At index date, index date could be anytime during observation period from 06-Nov-2012 to 31-Oct-2022, approximately 9 years (data was observed retrospectively in this study from 14-Nov-2022 to 23-Dec-2022, for approximately 1 month)	Percentage of participants who used rituximab directly before tofacitinib were reported in this outcome measure. Index date was defined as the date of tofacitinib initiation at or after enrollment in the registry; initiation was defined as first ever use of tofacitinib.
Duration of Prior Rituximab (RTX) Use	At index date, index date could be anytime during observation period from 06-Nov-2012 to 31-Oct-2022, approximately 9 years (data was observed retrospectively in this study from 14-Nov-2022 to 23-Dec-2022, for approximately 1 month)	Duration of prior RTX use (in months) was reported in this outcome measure. Index date was defined as the date of tofacitinib initiation at or after enrollment in the registry; initiation was defined as first ever use of tofacitinib.
Number of Participants According to Line of Therapy at Rituximab Initiation	At index date, index date could be anytime during observation period from 06-Nov-2012 to 31-Oct-2022, approximately 9 years (data was observed retrospectively in this study from 14-Nov-2022 to 23-Dec-2022, for approximately 1 month)	Number of participants were classified according to line of therapy in which Rituximab was initiated were reported in this outcome measure. Index date was defined as the date of tofacitinib initiation at or after enrollment in the registry; initiation was defined as first ever use of tofacitinib.
Number of Participants According to Year of Rituximab Discontinuations	At index date, index date could be anytime during observation period from 06-Nov-2012 to 31-Oct-2022, approximately 9 years (data was observed retrospectively in this study from 14-Nov-2022 to 23-Dec-2022, for approximately 1 month)	Number of participants were classified according to year of rituximab discontinuations and were reported in this outcome measure. Index date was defined as the date of tofacitinib initiation at or after enrollment in the registry; initiation was defined as first ever use of tofacitinib.
Percentage of Participants Who Discontinued Rituximab	At index date, index date could be anytime during observation period from 06-Nov-2012 to 31-Oct-2022, approximately 9 years (data was observed retrospectively in this study from 14-Nov-2022 to 23-Dec-2022, for approximately 1 month)	Percentage of participants who discontinued rituximab were reported in this outcome measure. Index date was defined as the date of tofacitinib initiation at or after enrollment in the registry; initiation was defined as first ever use of tofacitinib.
Number of Participants According to Reason for Discontinuation of Rituximab	At index date, index date could be anytime during observation period from 06-Nov-2012 to 31-Oct-2022, approximately 9 years (data was observed retrospectively in this study from 14-Nov-2022 to 23-Dec-2022, for approximately 1 month)	Number of participants were classified according to reasons for discontinuation of rituximab and were reported in this outcome measure. Reasons for discontinuation of rituximab included safety, effectiveness, insurance, participant doing well and other reasons. Index date was defined as the date of tofacitinib initiation at or after enrollment in the registry; initiation was defined as first ever use of tofacitinib.
Number of Participants According to Tofacitinib Initiation Year	At index date, index date could be anytime during observation period from 06-Nov-2012 to 31-Oct-2022, approximately 9 years (data was observed retrospectively in this study from 14-Nov-2022 to 23-Dec-2022, for approximately 1 month)	Number of participants were classified according to year of tofacitinib initiation and were reported in this outcome measure. Index date was defined as the date of tofacitinib initiation at or after enrollment in the registry; initiation was defined as first ever use of tofacitinib.
Change From Baseline in CDAI at 6 Months Follow-up	Baseline, Month 6 follow up visit (anytime during observation period from 06-Nov-2012 to 31-Oct-2022, approximately 9 years [data was observed retrospectively in this study from 14-Nov-2022 to 23-Dec-2022, for approximately 1 month])	CDAI was a simplified index for assessing the disease activity comprising of the swollen joint counts (SJC), tender/painful joint counts (TJC), participant's global assessment of disease activity (PtGA) and physician's global assessment of disease activity (PGA). CDAI is the numerical sum of 4 outcome parameters: SJC and TJC (based on 28-joint assessment range from 0 to 28, higher scores indicated worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 centimeter (cm) visual analog scale; higher scores indicated greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. Index date was defined as the date of tofacitinib initiation at or after enrollment in the registry; initiation was defined as first ever use of tofacitinib.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants Who Achieved Minimum Clinically Important Difference (MCID) at 6 Month Follow Up	Baseline, Month 6 follow up visit (anytime during observation period from 06-Nov-2012 to 31-Oct-2022, approximately 9 years [data was observed retrospectively in this study from 14-Nov-2022 to 23-Dec-2022, for approximately 1 month])	MCID improvement was assessed based on health assessment questionnaire (HAQ). HAQ: self-reported, valid assessment of functional disability in RA. Assessed based on ability of participants to perform daily activities in 8 categories: dressing, arising, eating, walking, reaching, gripping, hygiene, and conducting daily activities. Eight items were rated on a 4-point Likert scale from 0 to 3, where 0= without any difficulty, 1= with some difficulty, 2= with much difficulty, and 3= unable to do. Overall score was computed as sum of domain scores and divided by number of domains answered. Total score ranged from 0 to 3, where 0= least difficulty and 3= extreme difficulty, higher scores indicating worse functioning. Achievement of MCID for HAQ was defined as decrease in minimum of 0.22 units from baseline. Index date was defined as the date of tofacitinib initiation at or after enrollment in the registry; initiation was defined as first ever use of tofacitinib.
Change From Baseline in Health Assessment Questionnaire (HAQ) at 6 Months Follow-up	Baseline, Month 6 follow up visit (anytime during observation period from 06-Nov-2012 to 31-Oct-2022, approximately 9 years [data was observed retrospectively in this study from 14-Nov-2022 to 23-Dec-2022, for approximately 1 month])	HAQ: self-reported, valid assessment of functional disability in RA. The 20-question instrument assessed ability of participants to perform daily activities in 8 functional areas: dressing, arising, eating, walking, hygiene, reaching, griping, and conducting daily activities. Eight items were rated on a 4-point Likert scale from 0 to 3, where 0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total score ranged from 0 to 3, where 0 = least difficulty and 3 = extreme difficulty, higher scores indicating worse functioning. Index date was defined as the date of tofacitinib initiation at or after enrollment in the registry; initiation was defined as first ever use of tofacitinib.
Change From Baseline in Pain VAS at 6 Months Follow-up	Baseline, Month 6 follow up visit (anytime during observation period from 06-Nov-2012 to 31-Oct-2022, approximately 9 years [data was observed retrospectively in this study from 14-Nov-2022 to 23-Dec-2022, for approximately 1 month])	Pain VAS was assessed using 100 mm horizontal line to rate pain. Score ranged from 0 mm to 100 mm; where, 0 = no pain and 100 = worst possible pain. Index date was defined as the date of tofacitinib initiation at or after enrollment in the registry; initiation was defined as first ever use of tofacitinib.
Change From Baseline in Fatigue VAS at 6 Months Follow-up	Baseline, Month 6 follow up visit (anytime during observation period from 06-Nov-2012 to 31-Oct-2022, approximately 9 years [data was observed retrospectively in this study from 14-Nov-2022 to 23-Dec-2022, for approximately 1 month])	Participants assessed their fatigue using a 0 to 100 mm VAS scale, where 0 mm = no fatigue and 100 mm = worst possible fatigue. Index date was defined as the date of tofacitinib initiation at or after enrollment in the registry; initiation was defined as first ever use of tofacitinib.