A Non-Interventional Study of RAYOS in Adult Patients With Rheumatoid Arthritis

Mean change in severity of morning stiffness was assessed using a 0 to 100 millimeter (mm) Visual Analogue Scale (VAS) where 0 corresponded to Not Severe at All and 100 to Extremely Severe. This measure was collected at baseline and at the last follow-up visit. As this study was a non-interventional research initiative and no assessments or visits were mandated, the mean change was only calculated for participants that had measurements at both baseline and final follow-up.

Time frame: Baseline to Last Follow up visit (up to 18.7 weeks)

Population: 56 participants were in the per protocol follow-up analysis set. Mean change in severity of morning stiffness was calculated for participants who had both baseline and follow-up severity of morning stiffness data. For severity of morning stiffness, the mean change from baseline is based on 38 participants.

ACR-N is the index of improvement in rheumatoid arthritis, and is defined as the lowest of 3 values: percent change in the number of swollen joints (scored 0-28 with higher scores indicating higher disease activity), percent change in the number of tender joints (scored 0-28 with higher scores indicating higher disease activity), and the median of the other 5 measures in the American College of Rheumatology core data set-Patient's global assessment (PGA, scored on a 1-10 scale with higher scores indicating higher disease activity), physician's global assessment (PhGA, scored on a 1-10 scale with higher scores indicating higher disease activity), pain scale (scored on a 1-10scale with higher scores indicating higher pain), functional questionnaire (scored on a 1-10 scale with higher scores indicating less function), and acute phase reactant (Erythrocyte Sedimentation Rate or C-reactive Protein). Positive percent change indicates improvement. Negative percent change indicates worsening.

Time frame: Baseline to Last Follow up visit (up to 18.7 weeks)

Population: 56 participants were in the per protocol follow-up analysis set. There were 27 participants with insufficient information to calculate ACR-N scores and 5 participants have only baseline data. ACR-N calculations were performed on data from 24 participants.

Please refer to the safety section for further details.

Time frame: Baseline to Last Follow up visit (up to 18.7 weeks)

Please refer to the safety section for further details.

Time frame: Baseline to Last Follow up visit (up to 18.7 weeks)

Clinical Disease Activity Index (CDAI) is the sum of 4 parameters: Swollen Joint Count 28 (SJC28, scored 0-28 with higher scores indicating higher disease activity) + Tender Joint Count 28 (TJC28, scored 0-28 with higher scores indicating higher disease activity) + Patient Global Assessment (PGA, scored on a visual analogue scale from 1-10 cm with higher scores indicating higher disease activity) + Physician Global Assessment (PhGA, scored on a visual analogue scale from 1-10 cm with higher scores indicating higher disease activity). CDAI scores range from 0 to 76 and indicate whether a participant is in remission or low, moderate or high activity; higher scores indicate higher disease activity. A negative change from baseline indicates improvement in condition. As this study was a non-interventional research initiative and no assessments/visits were mandated, the change in CDAI was only calculated for participants that had both baseline and final follow-up measurements.

Time frame: Baseline to Last Follow up visit (up to 18.7 weeks)

Population: 56 participants were in the per protocol follow-up analysis set. Change in Clinical Disease Activity Index (CDAI) was calculated for participants who had both baseline and follow-up data required to calculate CDAI. For this measure, the mean change from baseline is based on 33 participants.

The DAS28 is an index for measuring disease activity in rheumatoid arthritis (RA). The index includes swollen joint counts (SJC) and tender joint counts (TJC), both scored 0-28 (higher scores indicate higher disease activity), as well as acute phase response determined by erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP), and patient global assessment (PGA) on a visual analogue scale (higher scores indicate higher disease activity). DAS28-CRP was calculated according to the following formula: DAS28-CRP equals (=) \[0.56 multiplied by (\*) the square root (√) of TJC\] plus (+) \[0.28 \* √ of SJC\] + \[0.36 \* the natural logarithm (ln) of (CRP + 1)\] + \[0.014 \* PGA in mm\] + 0.96. A negative change from baseline indicated improvement. As this study was a non-interventional research initiative and no assessments or visits were mandated, the change in DAS28-CRP was only calculated for participants that had measurements at both baseline and final follow-up.

Time frame: Baseline to Last Follow up visit (up to 18.7 weeks)

Population: 56 participants were in the per protocol follow-up analysis set. Change in Disease Activity Score in 28 Joints calculated with C-reactive protein (DAS28-CRP) was calculated for participants who had both baseline and follow-up data required to calculate DAS28-CRP. For this measure, the mean change from baseline is based on 25 participants.

The DAS28 is an index for measuring disease activity in rheumatoid arthritis (RA). The index includes swollen joint counts (SJC) and tender joint counts (TJC), both scored 0-28 (higher scores indicate higher disease activity), as well as acute phase response determined by erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP), and patient global assessment (PGA) on a visual analogue scale (higher scores indicate higher disease activity). DAS28-ESR was calculated according to the following formula: DAS28-ESR equals (=) \[0.56 multiplied by (\*) the square root (√) of TJC\] plus (+) \[0.28 \* √ of SJC\] + \[0.70 \* the natural logarithm (ln) ESR in millimeters per hour (mm/h)\] + \[0.014 \* PGA in mm\]. A negative change from baseline indicates improvement. As this study was a non-interventional research initiative and no assessments or visits were mandated, the change in DAS28-ESR was only calculated for participants that had measurements at both baseline and final follow-up.

Time frame: Baseline to Last Follow up visit (up to 18.7 weeks)

Population: 56 participants were in the per protocol follow-up analysis set. Change in DAS28-ESR was calculated for participants who had both baseline and follow-up data required to calculate DAS28-ESR. For this measure, the mean change from baseline is based on 15 participants.

The duration of morning stiffness was the amount of time participants experienced stiffness after getting up in the morning. This measure was collected at baseline and at the last follow-up visit. As this study was a non-interventional research initiative and no assessments or visits were mandated, the change in duration of morning stiffness was only calculated for participants that had measurements at both baseline and final follow-up.

Time frame: Baseline to Last Follow up visit (up to 18.7 weeks)

Population: 56 participants were in the per protocol follow-up analysis set. The change in duration of morning stiffness (minutes) was calculated for participants who had both baseline and follow-up morning stiffness data. For duration of morning stiffness, the mean change from baseline is based on 41 participants.

The exercise aerobically for at least one-half hour (30 minutes) measure of the multidimensional health assessment questionnaire (MDHAQ) was scored as follows: 3 or more times a week (3), 1-2 times per week (2), 1-2 times per month (1), Do not exercise regularly (0), Cannot exercise due to disability/handicap (-1). As this study was a non-interventional research initiative and no assessments or visits were mandated, the change in MDHAQ exercise measure was only calculated for participants that had measurements at both baseline and final follow-up.

Time frame: Baseline to Last Follow up visit (up to 18.7 weeks)

Population: 56 participants were in the per protocol follow-up analysis set. Change in Multidimensional Health Assessment Questionnaire (MDHAQ) - exercise (EX) was calculated for participants who had both baseline and follow-up EX data. For this measure, the mean change from baseline is based on 33 participants.

Multidimensional Health Assessment Questionnaire (MDHAQ) - fatigue (FAT) scoring was gathered using a 0-10 scale where 0 corresponded to Fatigue is no problem and 10 to Fatigue is a major problem over the past week. A negative change from baseline indicates improvement. As this study was a non-interventional research initiative and no assessments or visits were mandated, the change in fatigue was only calculated for participants that had measurements at both baseline and final follow-up.

Time frame: Baseline to Last Follow up visit (up to 18.7 weeks)

Population: 56 participants were in the per protocol follow-up analysis set. Change in Multidimensional Health Assessment Questionnaire (MDHAQ) - fatigue (FAT) was calculated for participants who had both baseline and follow-up FAT data. For this measure, the mean change from baseline is based on 33 participants.

The change in Multidimensional Health Assessment Questionnaire (MDHAQ) - function (FN) was assessed by asking participants to score the performance of multiple activities as without any difficulty (score of 0), with some difficulty (score of 1), with much difficulty (score of 2) or unable to do (score of 3). The results were summed and divided by 3 to give a score from 0 to10. A negative change from baseline indicates improvement. As this study was a non-interventional research initiative and no assessments or visits were mandated, the change in function was only calculated for participants that had measurements at both baseline and final follow-up.

Time frame: Baseline to Last Follow up visit (up to 18.7 weeks)

Population: 56 participants were in the per protocol follow-up analysis set. Change in Multidimensional Health Assessment Questionnaire (MDHAQ) - Function (FN) was calculated for participants who had both baseline and follow-up FN data. For this measure, the mean change from baseline is based on 33 participants.

The Multidimensional Health Assessment Questionnaire (MDHAQ) - how do you feel today compared to one week ago question was scored as follows: 1: Much Better, 2: Better, 3: The Same, 4: Worse, 5: Much Worse. A negative change from baseline indicates improvement. As this study was a non-interventional research initiative and no assessments or visits were mandated, the change in How do you feel measure was only calculated for participants that had measurements at both baseline and final follow-up.

Time frame: Baseline to Last Follow up visit (up to 18.7 weeks)

Population: 56 participants were in the per protocol follow-up analysis set. Change in Multidimensional Health Assessment Questionnaire - How do you feel today (compared to 1wk ago) from Baseline to Final Visit was calculated for participants who had both baseline and follow-up data. For this measure, the mean change from baseline is based on 33 participants.

The duration of morning stiffness was the amount of time participants experienced stiffness after waking up in the morning (over the last week). This measure was collected at baseline and at the last follow-up visit. A negative change from baseline indicates improvement. As this study was a non-interventional research initiative and no assessments or visits were mandated, the change in duration of morning stiffness was only calculated for participants that had measurements at both baseline and final follow-up.

Time frame: Baseline to Last Follow up visit (up to 18.7 weeks)

Population: 56 participants were in the per protocol follow-up analysis set. Change in Multidimensional Health Assessment Questionnaire (MDHAQ) - morning stiffness, minutes (past week) was calculated for participants who had both baseline and follow-up data. For this measure, the mean change from baseline is based on 30 participants.

For the Multidimensional Health Assessment Questionnaire (MDHAQ) - neck and back (NB), participants were asked to score the amount of pain they were experiencing in their neck and back as None (score of 0), Mild (score of 1), Moderate (score of 2) or Severe (score of 3). The raw 0-6 score was adjusted to 0-10. A negative change from baseline indicates improvement. As this study was a non-interventional research initiative and no assessments or visits were mandated, the change in NB measure was only calculated for participants that had measurements at both baseline and final follow-up.

Time frame: Baseline to Last Follow up visit (up to 18.7 weeks)

Population: 56 participants were in the per protocol follow-up analysis set. Change in Multidimensional Health Assessment Questionnaire (MDHAQ) - neck and back (NB) was calculated for participants who had both baseline and follow-up NB data. For this measure, the mean change from baseline is based on 33 participants.

Multidimensional Health Assessment Questionnaire (MDHAQ) - pain (PN) scoring was gathered using a 0-10 scale where 0 corresponded to No Pain and 10 to Pain as bad as it could be because of the condition (over the past week). A negative change from baseline indicates improvement. As this study was a non-interventional research initiative and no assessments or visits were mandated, the change in pain was only calculated for participants that had measurements at both baseline and final follow-up.

Time frame: Baseline to Last Follow up visit (up to 18.7 weeks)

Population: 56 participants were in the per protocol follow-up analysis set. Change in Multidimensional Health Assessment Questionnaire (MDHAQ) - Pain (PN) was calculated for participants who had both baseline and follow-up PN data. For this measure, the mean change from baseline is based on 33 participants.

Multidimensional Health Assessment Questionnaire (MDHAQ) - patient global assessment (PTGL) was measured by asking the participant to rate on a 0 to 10 scale how they were doing considering all of the ways in which their illness and health conditions affected them: 0 - Very Well, 10 - Very Poor. A negative change from baseline indicates improvement. As this study was a non-interventional research initiative and no assessments or visits were mandated, the change in PTGL was only calculated for participants that had measurements at both baseline and final follow-up.

Time frame: Baseline to Last Follow up visit (up to 18.7 weeks)

Population: 56 participants were in the per protocol follow-up analysis set. Change in Multidimensional Health Assessment Questionnaire (MDHAQ) - patient global assessment (PTGL) was calculated for participants who had both baseline and follow-up PTGL data. For this measure, the mean change from baseline is based on 33 participants.

The change in Multidimensional Health Assessment Questionnaire (MDHAQ) - Psychological status (PS) was assessed by asking participants to score how they were sleeping, dealing with anxiety/nervousness, and dealing with depression as without any difficulty (score of 0), with some difficulty (score of 1.1), with much difficulty (score of 2.2) or unable to do (score of 3.3). The results were summed to give a score ranging from 0 to 9.9. A negative change from baseline indicates improvement. As this study was a non-interventional research initiative and no assessments or visits were mandated, the change in psychological status was only calculated for participants that had measurements at both baseline and final follow-up.

Time frame: Baseline to Last Follow up visit (up to 18.7 weeks)

Population: 56 participants were in the per protocol follow-up analysis set. Change in Multidimensional Health Assessment Questionnaire (MDHAQ) - Psychological status (PS) was calculated for participants who had both baseline and follow-up PS data. For this measure, the mean change from baseline is based on 33 participants.

Multidimensional Health Assessment Questionnaire (MDHAQ) - recent medical history was gathered using a medical history checklist and was calculated by summing the total number of items checked Yes (0 to 12 items could be checked). A negative change from baseline indicates fewer items were checked at the follow-up visit. As this study was a non-interventional research initiative and no assessments or visits were mandated, the change in MDHAQ recent medical history was only calculated for participants that had measurements at both baseline and final follow-up.

Time frame: Baseline to Last Follow up visit (up to 18.7 weeks)

Population: 56 participants were in the per protocol follow-up analysis set. Change in Multidimensional Health Assessment Questionnaire (MDHAQ) - recent medical history was calculated for participants who had both baseline and follow-up recent medical history data. For this measure, the mean change from baseline is based on 33 participants.

Multidimensional Health Assessment Questionnaire (MDHAQ) - review of symptoms (ROS) was gathered using a symptom checklist and was calculated by summing the total number of items checked (0 to 60 symptoms could be checked). A negative change from baseline indicates improvement. As this study was a non-interventional research initiative and no assessments or visits were mandated, the change in MDHAQ ROS was only calculated for participants that had measurements at both baseline and final follow-up.

Time frame: Baseline to Last Follow up visit (up to 18.7 weeks)

Population: 56 participants were in the per protocol follow-up analysis set. Change in Multidimensional Health Assessment Questionnaire (MDHAQ) - review of symptoms (ROS) was calculated for participants who had both baseline and follow-up ROS data. For this measure, the mean change from baseline is based on 33 participants.

For the Change in Multidimensional Health Assessment Questionnaire (MDHAQ) - the Rheumatoid Arthritis disease Activity Index (RADAI) patient self-report joint count (PTJT), participants were asked to score the amount of pain they were experiencing in each of 16 joints (left joint, left wrist, right shoulder etc.) as None (score of 0), Mild (score of 1), Moderate (score of 2) or Severe (score of 3). The raw 0-48 score is adjusted to 0-10 using a scoring template. A negative change from baseline indicates improvement. As this study was a non-interventional research initiative and no assessments or visits were mandated, the change in PTJT was only calculated for participants that had measurements at both baseline and final follow-up.

Time frame: Baseline to Last Follow up visit (up to 18.7 weeks)

Population: 56 participants were in the per protocol follow-up analysis set. Change in Multidimensional Health Assessment Questionnaire (MDHAQ) - RADAI patient self-report joint count (PTJT) was calculated for participants who had both baseline and follow-up data. For this measure, the mean change from baseline is based on 33 participants.

Patient's Overall Assessment in Disease Activity was measured by asking the participant to rate on a 10-cm visual analogue scale (VAS) how well they were doing considering all of the ways their arthritis affected them: 0 - Very Well, 10 - Very Poor. As this study was a non-interventional research initiative and no assessments or visits were mandated, the change in Patient's Overall Assessment in Disease Activity was only calculated for participants that had measurements at both baseline and final follow-up.

Time frame: Baseline to Last Follow up visit (up to 18.7 weeks)

Population: 56 participants were in the per protocol follow-up analysis set. Change in Patient's Overall Assessment in Disease Activity was calculated for participants who had both baseline and follow-up Patient's Overall Assessment in Disease Activity data. For this measure, the mean change from baseline is based on 36 participants.

Physician's Overall Assessment in Disease Activity was measured with a 10-cm visual analogue scale (VAS) where 0 corresponded to Very Well' and 10 to Very Poor. As this study was a non-interventional research initiative and no assessments or visits were mandated, the change in Physician's Overall Assessment in Disease Activity was only calculated for participants that had measurements at both baseline and final follow-up.

Time frame: Baseline to Last Follow-up visit (up to 18.7 weeks)

Population: 56 participants were in the per protocol follow-up analysis set. Change in Physician's Overall Assessment in Disease Activity was calculated for participants who had both baseline and follow-up Physician's Overall Assessment in Disease Activity data. For this measure, the mean change from baseline is based on 37 participants.

Routine Assessment of Patient Index Data (RAPID3) was calculated by summing three measures: physical function (0 to 10 with higher scores indicating less function), pain (0 to 10 with higher scores indicating higher pain), and patient global assessment (0 to 10 with higher scores indicating the participant was doing very poorly considering the ways in which the illness was affecting them). As this study was a non-interventional research initiative and no assessments or visits were mandated, the change in RAPID3 was only calculated for participants that had measurements at both baseline and final follow-up. RAPID3 scores range from 0 to 30 with higher scores meaning worse condition. A negative change from baseline indicates improvement in condition.

Time frame: Baseline to Last Follow up visit (up to 18.7 weeks)

Population: 56 participants were in the per protocol follow-up analysis set. Change in Routine Assessment of Patient Index Data (RAPID3) was calculated for participants who had both baseline and follow-up data required to calculate RAPID3. For this measure, the mean change from baseline is based on 33 participants.

Simple Disease Activity Index (SDAI) is the sum of the following 5 components to assess rheumatoid arthritis severity: Swollen Joint Count 28 (SJC28, scored 0-28 with higher scores indicating higher disease activity) + Tender Joint Count 28 (TJC28, scored 0-28 with higher scores indicating higher disease activity) + Patient Global Assessment (PGA, scored on a visual analogue scale from 1-10 cm with higher scores indicating higher disease activity) + Physician Global Assessment (PhGA, scored on a visual analogue scale from 1-10 cm with higher scores indicating higher disease activity) + C-reactive Protein (CRP). SDAI scores indicate whether a participant is in remission or low, moderate or high activity. A negative change in SDAI indicates improvement.

Time frame: Baseline to Last Follow up visit (up to 18.7 weeks)

Population: 56 participants were in the per protocol follow-up analysis set. Change in Simple Disease Activity Index (SDAI) was calculated for participants who had both baseline and follow-up data required to calculate SDAI. For this measure, the mean change from baseline is based on 25 participants.

The change in total daily prednisone from baseline to follow-up (whether the patient was taking RAYOS or returned to conventional prednisone) was calculated for all participants.

Time frame: Baseline to Last Follow up visit (up to 18.7 weeks)

American College of Rheumatology (ACR) 20, a patient must demonstrate a \>= 20% improvement in tender and swollen joints (each scored 0-28 with higher scores indicating higher disease activity) as well as a 20% improvement in at least 3 of the following 5 parameters: patient global assessment (PGA, scored on a 1-10 scale with higher scores indicating higher disease activity), physician global assessment (PhGA, scored on a 1-10 scale with higher scores indicating higher disease activity), pain scale (scored on a 1-10 scale with higher scores indicating higher pain), functional questionnaire (scored on a 1-10 scale with higher scores indicating less function), and acute phase reactant (Erythrocyte Sedimentation Rate or C-reactive Protein).

Time frame: Baseline to Last Follow up visit (up to 18.7 weeks)

Population: 56 participants were in the per protocol follow-up analysis set. There were 27 participants with insufficient information to calculate ACR20 response and 5 participants have only baseline data. The percentages were calculated based on 56 participants.

American College of Rheumatology (ACR) 50, a patient must demonstrate a \>= 50% improvement in tender and swollen joints (each scored 0-28 with higher scores indicating higher disease activity) as well as a 50% improvement in at least 3 of the following 5 parameters: patient global assessment (PGA, scored on a 1-10 scale with higher scores indicating higher disease activity), physician global assessment (PhGA, scored on a 1-10 scale with higher scores indicating higher disease activity), pain scale (scored on a 1-10 scale with higher scores indicating higher pain), functional questionnaire (scored on a 1-10 scale with higher scores indicating less function), and acute phase reactant (Erythrocyte Sedimentation Rate or C-reactive Protein).

Time frame: Baseline to Last Follow up visit (up to 18.7 weeks)

Population: 56 participants were in the per protocol follow-up analysis set. There were 27 participants with insufficient information to calculate ACR20 response and 5 participants have only Baseline data. The percentages were calculated based on 56 participants.

American College of Rheumatology (ACR) 70 a patient must demonstrate a \>= 70% improvement in tender and swollen joints (each scored 0-28 with higher scores indicating higher disease activity) as well as a 70% improvement in at least 3 of the following 5 parameters: patient global assessment (PGA, scored on a 1-10 scale with higher scores indicating higher disease activity), physician global assessment (PhGA, scored on a 1-10 scale with higher scores indicating higher disease activity), pain scale (scored on a 1-10 scale with higher scores indicating higher pain), functional questionnaire (scored on a 1-10 scale with higher scores indicating less function), and acute phase reactant (Erythrocyte Sedimentation Rate or C-reactive Protein).

Time frame: Baseline to Last Follow up visit (up to 18.7 weeks)

Population: 56 participants were in the per protocol follow-up analysis set. There were 27 participants with insufficient information to calculate ACR70 response and 5 participants have only baseline data. The percentages were calculated based on 56 participants.

European League Against Rheumatism (EULAR) response is based on change (improvement) in Disease Activity Score in 28 Joints score from baseline to last follow-up visit. DAS28 scores were broken into 3 categories: ≤3.2 at last follow-up (low disease activity), \>3.2 and ≤ 5.1 at last follow-up (moderate or high disease activity), and DAS28 \>5.1 at last follow-up (high disease activity). Then based on the category and magnitude of the change in DAS28 from baseline, the EULAR response of Good, Moderate or No Response was determined. DAS28 is an index for measuring disease activity in rheumatoid arthritis (RA). The index includes swollen joint counts (SJC) and tender joint counts (TJC), both scored 0-28 (higher scores indicate higher disease activity), as well as acute phase response determined as erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP), and patient global assessment (PGA) on a visual analogue scale (higher scores indicate higher disease activity).

Time frame: Baseline to Last Follow up visit (up to 18.7 weeks)

Vectra DA and DAS28 data were collected, however not analyzed or correlated.

Time frame: Baseline to Last Follow up visit (up to 18.7 weeks)

Population: Analysis and correlations were not completed for this outcome measure.