This non-interventional study aims to identify key factors that are driving treatment decisions by rheumatologists in the treatment of rheumatoid arthritis (RA) patients starting treatment with Tofacitinib in a real world setting.
Study Type
OBSERVATIONAL
Enrollment
1,459
Patients who are started on Tofacitinib treatment according to the drug label
Number of Participants With Treatment Escalations
Treatment escalations was defined as participants who switched to another disease modifying antirheumatic drug (DMARD) or combination of DMARDs when compared to the last visit. The following three types of escalations were reported: treatment termination, treatment step-up/switch and treatment step-down. Treatment termination was defined as the termination of a DMARD (or multiple when on combination therapy) without starting a new DMARD therapy. Treatment step-up/switch was defined as an increase from the current treatment regime towards e.g.a combination of DMARDs and treatment step-down, was defined as de-escalation from the current treatment regime, example (e.g.) from combination therapy to monotherapy. One participant can fall into more than 1 type of escalation.
Time frame: From date of first prescription of tofacitinib up to 24 Months
Time to Treatment Escalation
Time to treatment escalation was defined as time in days from escalation visit date to next escalation visit date. The following three types of escalations were reported: treatment termination, treatment step-up/switch and treatment step-down. Treatment termination was defined as the termination of a DMARD (or multiple when on combination therapy) without starting a new DMARD therapy. Treatment step-up/switch was defined as an increase from the current treatment regime (monotherapy) towards a combination of DMARDs and treatment step-down, was defined as de-escalation from the current treatment regime, e.g. from combination therapy to monotherapy. Number of participants with total number of each type of treatment escalations during the study (step-up/switch, step-down, treatment termination along with all escalations) are reported in this outcome measure.
Time frame: From date of first prescription of tofacitinib up to 24 Months
Time to First Step Up Treatment Escalation
Time to first step-up treatment escalation was defined for participants who experienced a treatment step-up and was measured as date of first treatment step up escalation minus (-) date of first prescription of tofacitinib. Treatment step-up was defined as an increase from the current treatment regime (monotherapy) towards a combination of DMARDs.
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Private Praxis
Düsseldorf, North Rhine-Westphalia, Germany
Private Practice
Zschopau, Saxony, Germany
Private Practice Kupka
Altenburg, Germany
Private Practise Boehm
Altenholz, Germany
Private Practice Marycz
Amberg, Germany
Private Practice Fuchs
Augsburg, Germany
private practise Gause
Bad Bramstedt, Germany
ACURA Kliniken Rheinland-Pfalz AG
Bad Kreuznach, Germany
MFZ Medizinisches Forschungszentrum Weserbergland
Bad Pyrmont, Germany
Private Practice Manger
Bamberg, Germany
...and 81 more locations
Time frame: From date of first tofacitinib prescription up to date of first step-up treatment escalation (maximum up to 24 months)
Number of Participants Achieving Low Disease Activity (LDA) as Assessed by Simplified Disease Activity Index (SDAI) at Months 3, 6, 9, 12, 15, 18, 21 and 24
SDAI was calculated using the following formula: SDAI = Tender Joint Count (TJC) (using 28 joints) + Swollen Joint Count (SJC) (using 28 joints) + Patient Global Assessment of Arthritis (PtGA) (0-10 centimetre \[cm\] scale) + Physician's Global Assessment of Arthritis (PhGA) (0-10 cm scale) + C-reactive protein (CRP) (milligram per decilitre \[mg/dL\]). TJC28 joints included shoulders, elbows, wrists, metacarpophalangeal (MCP) and proximal interphalangeal (PIP) joints, and knees whereas SJC28 included shoulders, elbows, wrists, MCP, PIP and knees (excluding artificial joints). PtGA and PhGA both were assessed on 0-10 cm visual analogue scale (VAS) scale (0 cm \[very well\] to 10 cm \[worst\], where higher scores indicated greater affliction due to disease activity). SDAI total score ranged from 0 to 86, where higher scores indicated higher disease activity. SDAI score of less than or equal to (\<=11) indicates LDA.
Time frame: Months 3, 6, 9, 12, 15, 18, 21 and 24
Number of Participants Achieving LDA as Assessed by Clinical Disease Activity Index (CDAI) at Months 3, 6, 9, 12, 15, 18, 21 and 24
CDAI was calculated using the following formula: CDAI = (28TJC) + (28SJC) + (PhyGA in cm) + (PtGA in cm). TJC28 joints included shoulders, elbows, wrists, MCP and proximal PIP joints, and knees whereas SJC28 included shoulders, elbows, wrists, MCP, PIP and knees (excluding artificial joints). PtGA and PhGA both were assessed on 0-10 cm VAS scale (0 cm \[very well\] to 10 cm \[worst\], where higher scores indicated greater affliction due to disease activity). CDAI total score ranged from 0 to 76, where higher scores indicated higher disease activity. CDAI score of \<= 10 indicates LDA.
Time frame: Months 3, 6, 9, 12, 15, 18, 21 and 24
Number of Participants Achieving LDA Based on Disease Activity Score (DAS28-4) Erythrocyte Sedimentation Rate (ESR) at Months 3, 6, 9, 12, 15, 18, 21 and 24
DAS28 is a measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (ESR) was calculated using the following formula: 0.56\* square root of (TJC28) + 0.28\* square root of (SJC28) + 0.70\* natural log (ln) (ESR in \[millimeter per hour \[mm/ hour\]) + 0.014\*(PtGA in cm). PtGA was assessed on 0-10 cm VAS scale (scores ranging from 0 cm \[very well\] to 10 cm \[worst\]), where higher scores indicated greater affliction due to disease activity). Total DAS28-4 (ESR) score range: 0 (none) to 9.4 (extreme disease activity), higher score indicated more disease activity. DAS28-4 ESR \<= 3.2 indicates LDA.
Time frame: Months 3, 6, 9, 12, 15, 18, 21 and 24
Number of Participants Achieving LDA as Based on DAS28-4 C-Reactive Protein (CRP) at Months 3, 6, 9, 12, 15, 18, 21 and 24
DAS28 is a measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (CRP) was calculated using the following formula: 0.56\* square root of (TJC28) + 0.28\* square root of (SJC28) + 0.36\*ln (CRP in mg/l +1) + 0.014\*(PtGA in mm)+ 0.96. PtGA was assessed on 0-10 cm VAS scale (scores ranging from 0 cm \[very well\] to 10 cm \[worst\]), where higher scores indicated greater affliction due to disease activity). Total DAS28-4 (CRP) score range: 0 (none) to 9.4 (extreme disease activity), higher score indicated more disease activity. DAS28-4 CRP \<= 3.2 indicates LDA.
Time frame: Months 3, 6, 9, 12, 15, 18, 21 and 24
Number of Participants Achieving Remission as Assessed by American College of Rheumatology (ACR)-EULAR Boolean Remission Criteria at Months 3, 6, 9, 12, 15, 18, 21 and 24
ACR-EULAR Boolean remission criteria was defined as when participant had ACR remission =1 if; TJC28 \<=1, SJC28 \<=1, CRP \<=1mg/dL and PtGA \<= 2 cm on a 0 to 10 cm scale, where higher values indicate greater affection due to disease activity.
Time frame: Months 3, 6, 9, 12, 15, 18, 21 and 24
Number of Participants Achieving Remission as Assessed by SDAI at Months 3, 6, 9, 12, 15, 18, 21 and 24
SDAI was calculated using the following formula: SDAI = (TJC28) + (SJC28) + (PtGA in cm) + (PhGA in cm) + (CRP in mg/dL). TJC28 joints included shoulders, elbows, wrists, MCP and PIP joints, and knees whereas SJC28 included shoulders, elbows, wrists, MCP, PIP and knees (excluding artificial joints). PtGA and PhGA both were assessed on 0-10 cm VAS scale (0 cm \[very well\] to 10 cm \[worst\], where higher scores indicated greater affliction due to disease activity). SDAI total score ranged from 0 to 86, where higher scores indicated higher disease activity. SDAI score of \<=3.3 indicates remission.
Time frame: Months 3, 6, 9, 12, 15, 18, 21 and 24
Number of Participants Achieving Remission as Assessed by CDAI at Months 3, 6, 9, 12, 15, 18, 21 and 24
CDAI was calculated using the following formula: CDAI = (28TJC) + (28SJC) + (PhyGA in cm) + (PtGA in cm). TJC28 joints included shoulders, elbows, wrists, MCP and proximal PIP joints, and knees whereas SJC28 included shoulders, elbows, wrists, MCP, PIP and knees (excluding artificial joints). PtGA and PhGA both were assessed on 0-10 cm VAS scale (0 cm \[very well\] to 10 cm \[worst\], where higher scores indicated greater affliction due to disease activity). CDAI total score ranged from 0 to 76, where higher scores indicated higher disease activity. CDAI score of \<=2.8 indicates remission.
Time frame: Months 3, 6, 9, 12, 15, 18, 21 and 24
Number of Participants Achieving Remission as Assessed by DAS-28 ESR at Months 3, 6, 9, 12, 15, 18, 21 and 24
DAS28 is a measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (ESR) was calculated using the following formula: 0.56\*square root of (TJC28) + 0.28\*square root of (SJC28) + 0.70\*In (ESR in mm/ hour) + 0.014\*PtGA in cm. PtGA was assessed on 0-10 cm VAS scale (scores ranging from 0 cm \[very well\] to 10 cm \[worst\]), where higher scores indicated greater affliction due to disease activity). Total DAS28-4 (ESR) score range: 0 (none) to 9.4 (extreme disease activity), higher score indicated more disease activity. DAS28-4 ESR score of \<2.6 indicates remission.
Time frame: Months 3, 6, 9, 12, 15, 18, 21 and 24
Number of Participants Achieving Remission as Assessed by DAS28-4 CRP at Months 3, 6, 9, 12, 15, 18, 21 and 24
DAS28 is a measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (CRP) was calculated using the following formula: 0.56\*square root of (TJC28) + 0.28\*square root of (SJC28) + 0.36\*ln (CRP in mg/l +1) + 0.014\*(PtGA in cm)+ 0.96. PtGA was assessed on 0-10 cm VAS scale (scores ranging from 0 cm \[very well\] to 10 cm \[worst\]), where higher scores indicated greater affliction due to disease activity). Total DAS28-4 (CRP) score range: 0 (none) to 9.4 (extreme disease activity), higher score indicated more disease activity. DAS28-4 CRP score of \<2.6 indicates remission.
Time frame: Months 3, 6, 9, 12, 15, 18, 21 and 24
Change From Baseline in DAS28-4 ESR at Months 3, 6, 9, 12, 15, 18, 21 and 24
DAS28 is a measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (ESR) was calculated using the following formula: 0.56\*square root of (TJC28) + 0.28\*square root of (SJC28) + 0.70\*In (ESR in mm/ hour) + 0.014\*PtGA in cm. PtGA was assessed on 0-10 cm VAS scale (scores ranging from 0 cm \[very well\] to 10 cm \[worst\]), where higher scores indicated greater affliction due to disease activity). Total DAS28-4 (ESR) score range: 0 (none) to 9.4 (extreme disease activity), higher score indicated more disease activity.
Time frame: Baseline, Months 3, 6, 9, 12, 15, 18, 21 and 24
Change From Baseline in DAS28-4 CRP at Months 3, 6, 9, 12, 15, 18, 21 and 24
DAS28 is a measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (CRP) was calculated using the following formula: 0.56\*square root of(TJC28) + 0.28\*square root of(SJC28) + 0.36\*ln (CRP in mg/l +1) + 0.014\*(PtGA in cm)+ 0.96. PtGA was assessed on 0-10 cm VAS scale (scores ranging from 0 cm \[very well\] to 10 cm \[worst\]), where higher scores indicated greater affliction due to disease activity). Total DAS28-4 (CRP) score range: 0 (none) to 9.4 (extreme disease activity), higher score indicated more disease activity.
Time frame: Baseline, Months 3, 6, 9, 12, 15, 18, 21 and 24
Change From Baseline in Duration of Morning Stiffness at Months 3, 6, 9, 12, 15, 18, 21 and 24
The duration of morning stiffness was determined by asking the following questions: "When you wake up in the morning, do you currently suffer from morning stiffness?" "How long does the morning stiffness last from the time you wake up?". The change from baseline in duration of morning stiffness was calculated as: morning stiffness at time point -morning stiffness at baseline.
Time frame: Baseline, Months 3, 6, 9, 12, 15, 18, 21 and 24
Change From Baseline in the Functional Ability Questionnaire Hannover (FFbH) at Months 3, 6, 9, 12, 15, 18, 21 and 24
The FFbH for RA is a German short questionnaire for the assessment of patientive functional capacity in the context of basic everyday activities (range: 0-100% functional capacity, where higher percentage indicates more capacity for everyday activities). The FFbH questionnaire consisted of 18 questions with 3 possible responses (Yes; Yes, but with effort; No or only with outside help). The total score was the sum of the scores of all 18 questions, where for each question (Yes = 2 points; Yes, but with effort = 1 point; No or only with outside help = 0 points).The functional capacity (%) is calculated by (total score\*100) divided by (2\*number of valid responses). The change from baseline was calculated at each time point as functional capacity at timepoint - functional capacity at baseline.
Time frame: Baseline, Months 3, 6, 9, 12, 15, 18, 21 and 24
Number of Participants Achieving Functional Remission in FFbH at Months 3, 6, 9, 12, 15, 18, 21 and 24
The FFbH for RA is a German short questionnaire for the assessment of patientive functional capacity in the context of basic everyday activities (range: 0-100% functional capacity, where higher percentage indicates more capacity for everyday activities). The FFbH questionnaire consisted of 18 questions with 3 possible responses (Yes; Yes, but with effort; No or only with outside help). The total score was the sum of the scores of all 18 questions, where for each question (Yes = 2 points; Yes, but with effort = 1 point; No or only with outside help = 0 points). The functional capacity \[%\] is calculated by (total score\*100)/ (2\*number of valid responses). Functional remission in FFbH was defined as functional capacity \> 83 %.
Time frame: Months 3, 6, 9, 12, 15, 18, 21 and 24
Change From Baseline in European Quality of Life (EuroQoL) Group EuroQoL- 5 Dimensions- 3 Levels (EQ-5D-3L) Total Scores at Months 3, 6, 9, 12, 15, 18, 21 and 24
The EQ-5D-3L is a standardised instrument used to measure quality of life. It is based on five dimensions: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression with each dimension having three levels of function: 1 indicates no problem; 2 indicates some problem; 3 indicates extreme problem. Scoring formula developed by EuroQol Group (German weights) assigns a utility value for each domain in the profile. Score was transformed and results in a total score range of 0.05 to 1.00; higher scores indicating a better health state.
Time frame: Baseline, Months 3, 6, 9, 12, 15, 18, 21 and 24
Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)- Fatigue Scale at Months 3, 6, 9, 12, 15, 18, 21 and 24
The FACIT-F Scale is a participant completed questionnaire consisting of 13 items that assess fatigue. Participants responded to each item on a 5-point scale based on their experience of fatigue during the past 7 days (0 = not at all; 1 = a little bit; 2 =somewhat; 3 = quite a bit; 4 = very much). Instrument scoring yielded a range from 0 to 52 (negatively worded items were reversed during analysis), with higher scores representing better participant status (less fatigue).
Time frame: Baseline, Months 3, 6, 9, 12, 15, 18, 21 and 24
Mean Number of Days of Drug Survival at Months 12 and 24
Drug survival was assessed using Kaplan-Meier methodology. For participants who terminated tofacitinib, the drug survival status was recorded as (status = 1 and time = termination date tofacitinib - date of initiation on tofacitinib) and for participants who do not terminate tofacitinib (status = 0 and time = date of final visit - date of initiation on tofacitinib.
Time frame: At 12 and 24 months
Number of Participants Per Categories of Satisfaction With Tofacitinib Treatment at Months 3, 6, 9, 12, 15, 18, 21 and 24
Satisfaction with treatment was assessed on a 5-point Likert scale (where 0 = extremely dissatisfied, 1= dissatisfied, 2 = neither satisfied nor dissatisfied, 3 = satisfied and 4 = extremely satisfied) in response to the question "How satisfied are you with the drugs that you have received for your arthritis since your last visit?".
Time frame: Months 3, 6, 9, 12, 15, 18, 21 and 24