An Observational Study to Assess the Real-World Effectiveness of Upadacitinib in Adult Participants With Rheumatoid Arthritis

The DAS28 CRP is a composite measure of a patient's level of disease activity at a given time. The score ranges from 0-9.4 with a higher score correlating to higher disease activity. A moderate EULAR response is defined as a DAS28 CRP >5.1 with a DAS28 CRP decrease >1.2 or DAS 28 CRP score >3.2 and ≤5.1 with DAS28 CRP decrease >0.6.

The DAS28 CRP is a composite measure of a patient's level of disease activity at a given time. The score ranges from 0-9.4 with a higher score correlating to higher disease activity. Clinical remission is defined as a DAS28 CRP <2.6.

The DAS28 CRP is a composite measure of a patient's level of disease activity at a given time. The score ranges from 0-9.4 with a higher score correlating to higher disease activity. Low disease activity is defined as DAS28 CRP <=3.2.

The DAS28 CRP is a composite measure of a patient's level of disease activity at a given time. The score ranges from 0-9.4 with a higher score correlating to higher disease activity. Low disease activity is defined as DAS28 CRP <=3.2.

The CDAI is a validated measure of RA disease activity. Scores on the CDAI range from 0 (lowest disease activity) to 76 (highest disease activity). Clinical remission is defined as CDAI <=2.8.

The CDAI is a validated measure of RA disease activity. Scores on the CDAI range from 0 (lowest disease activity) to 76 (highest disease activity). Low disease activity is defined as CDAI <=10.

The CDAI is a validated measure of RA disease activity. Scores on the CDAI range from 0 (lowest disease activity) to 76 (highest disease activity). Clinical remission is defined as CDAI <=2.8.

The CDAI is a validated measure of RA disease activity. Scores on the CDAI range from 0 (lowest disease activity) to 76 (highest disease activity). Low disease activity is defined as CDAI <=10.

Boolean remission is achieved when all of the following conditions are satisfied: tender joint count <=1, swollen joint count <=1, CRP <=1 mg/dL, and patient global assessment <=1 (on a 0-10 scale).

Boolean remission is achieved when all of the following conditions are satisfied: tender joint count <=1, swollen joint count <=1, CRP <=1 mg/dL, and patient global assessment <=1 (on a 0-10 scale).

Percentage of participants initiating upadacitinib without conventional synthetic disease-modifying antirheumatic drugs (csDMARDs).

Percentage of participants initiating upadacitinib in combination therapy with csDMARDs.

Time from initiation to discontinuation of upadacitinib.

Percentage of participants remaining on upadacitinib 6 months post initiation.

Other (not RA-related) concomitant medications include statins and other non-RA-related concomitant medications.

RA-related concomitant medications include csDMARDS, corticosteroids, non-steroidal anti-inflammatory drugs (NSAIDs), other painkillers, and other RA-related concomitant medications.

Percentage of participants who have received any COVID-19 or Herpes Zoster vaccination and a summary of vaccination details.

The patient's level of pain in the last 24 hours will be measured using a pain VAS. VAS scores range from 0 to 100 points with a higher score indicating more pain.

A fatigue VAS will be used to assess the patient's level of fatigue on a weekly basis. VAS scores range from 0 to 100 points with a higher score indicating more fatigue.

The FACIT-Fatigue Scale measures an individual's level of fatigue during their usual daily activities over the past week. on a four-point Likert scale (4 = not at all fatigued to 0 = very much fatigued). The score range for FACIT-Fatigue is between 0 and 52. A score of less than 30 indicates severe fatigue. The higher the score, the better the quality of life.

The PHQ-2 screens for the presence of possible depression. The PHQ-2 inquires about the frequency of depressed mood and anhedonia over the past 2 weeks, scoring each component from 0 ("not at all") to 3 ("nearly every day").

The HAQ-DI assesses physical function in RA. The HAQ-DI score is the average of the highest score in each of eight categories. The total score is between 0-3.0, in 0.125 increments. Increasing scores indicate worse functioning with 0 indicating no functional impairment and 3 indicating complete impairment

The EQ-5D-5L comprises of five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. In addition, a vertical VAS is used to assess patient's self-rated health status. The endpoints for the VAS are labelled 'the best health you can imagine' and 'the worst health you can imagine'. The recall period is one day.

The WPAI-GH measures the impact of health problems on absenteeism, presenteeism, overall work performance and non-work activities using a 0 to 10 VAS.

The patient's level of pain in the last 24 hours will be measured using a pain VAS. VAS scores range from 0 to 100 points with a higher score indicating more pain. MCID is defined as at least a 10 point difference from baseline.

A fatigue VAS will be used to assess the patient's level of fatigue on a weekly basis. VAS scores range from 0 to 100 points with a higher score indicating more fatigue. MCID is defined as a decrease of -1.12.

The FACIT-Fatigue Scale measures an individual's level of fatigue during their usual daily activities over the past week. on a four-point Likert scale (4 = not at all fatigued to 0 = very much fatigued). The score range for FACIT-Fatigue is between 0 and 52. A score of less than 30 indicates severe fatigue. The higher the score, the better the quality of life. MCID is defined as a 4-point increase.

The PHQ-2 screens for the presence of possible depression. The PHQ-2 inquires about the frequency of depressed mood and anhedonia over the past 2 weeks, scoring each component from 0 ("not at all") to 3 ("nearly every day"). MCID is defined as achievement of a PHQ-2 score <=2 and absence of low mood.

The HAQ-DI assesses physical function in RA. The HAQ-DI score is the average of the highest score in each of eight categories. The total score is between 0-3.0, in 0.125 increments. Increasing scores indicate worse functioning with 0 indicating no functional impairment and 3 indicating complete impairment. MCID is defined as decrease of -0.22.

The FACIT-Fatigue Scale measures an individual's level of fatigue during their usual daily activities over the past week. on a four-point Likert scale (4 = not at all fatigued to 0 = very much fatigued). The score range for FACIT-Fatigue is between 0 and 52. A score of less than 30 indicates severe fatigue. The higher the score, the better the quality of life. MCID is defined as a 4-point increase.

The patient's level of pain in the last 24 hours will be measured using a pain VAS. VAS scores range from 0 to 100 points with a higher score indicating more pain. MCID is defined as at least a 10 point difference from baseline.

A fatigue VAS will be used to assess the patient's level of fatigue on a weekly basis. VAS scores range from 0 to 100 points with a higher score indicating more fatigue. MCID is defined as a decrease of -1.12.

The PHQ-2 screens for the presence of possible depression. The PHQ-2 inquires about the frequency of depressed mood and anhedonia over the past 2 weeks, scoring each component from 0 ("not at all") to 3 ("nearly every day"). MCID is defined as achievement of a PHQ-2 score <=2 and absence of low mood.

The HAQ-DI assesses physical function in RA. The HAQ-DI score is the average of the highest score in each of eight categories. The total score is between 0-3.0, in 0.125 increments. Increasing scores indicate worse functioning with 0 indicating no functional impairment and 3 indicating complete impairment. MCID is defined as decrease of -0.22.