Trial Outcomes & Findings for Observational Study of Tocilizumab in Participants With Rheumatoid Arthritis in Australia (NCT NCT01683604)

Results Overview

Percentage of participants on tocilizumab treatment at Month 6 was calculated as: \[(participants on tocilizumab treatment at Month 6) divided by (participants evaluable for primary objective)\] multiplied by 100.

Recruitment status

COMPLETED

Target enrollment

37 participants

Primary outcome timeframe

Month 6

Results posted on

2016-07-21

Participant Flow

Participant milestones

Participant milestones
Measure	Rheumatoid Arthritis (RA) Participants (All Groups) Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
Overall Study STARTED	37
Overall Study COMPLETED	32
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Rheumatoid Arthritis (RA) Participants (All Groups) Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
Overall Study Adverse Event	2
Overall Study Lack of Efficacy	1
Overall Study Other	2

Baseline Characteristics

Observational Study of Tocilizumab in Participants With Rheumatoid Arthritis in Australia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	RA Participants (All Groups) n=37 Participants Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
Age, Continuous	59.3 years STANDARD_DEVIATION 10.62 • n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants

PRIMARY outcome

Timeframe: Month 6

Population: FAS population

Percentage of participants on tocilizumab treatment at Month 6 was calculated as: \[(participants on tocilizumab treatment at Month 6) divided by (participants evaluable for primary objective)\] multiplied by 100.

Outcome measures

Outcome measures
Measure	RA Participants (Biologic Naïve Group) n=29 Participants Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.	RA Participants (Biologic Exposed Group) n=8 Participants Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.	RA Participants (Monotherapy Group) n=5 Participants Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.	RA Participants (Combination Therapy Group) n=32 Participants Participants with severe RA, were prescribed with disease-modifying anti-rheumatic drug (DMARD) at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.	RA Participants (All Groups) n=37 Participants Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
Percentage of Participants on Tocilizumab Treatment at Month 6 After Treatment Initiation	79.3 percentage of participants	100 percentage of participants	80 percentage of participants	84.4 percentage of participants	83.8 percentage of participants

PRIMARY outcome

Timeframe: Baseline

Population: FAS population. Here, Number of participants analyzed = participants evaluable for the outcome measure.

Participants measured the pain intensity due to RA on a 100 millimeter (mm) VAS, where the responses were on a continuous range from 0 = no pain to 100 = unbearable pain.

Outcome measures

Outcome measures
Measure	RA Participants (Biologic Naïve Group) n=25 Participants Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.	RA Participants (Biologic Exposed Group) n=6 Participants Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.	RA Participants (Monotherapy Group) n=3 Participants Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.	RA Participants (Combination Therapy Group) n=28 Participants Participants with severe RA, were prescribed with disease-modifying anti-rheumatic drug (DMARD) at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.	RA Participants (All Groups) n=31 Participants Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
Patient Assessment of Pain Using Visual Analog Scale (VAS) at Baseline	60.1 millimeters (mm) Standard Deviation 31.08	47.2 millimeters (mm) Standard Deviation 31.93	79.3 millimeters (mm) Standard Deviation 19.55	55.3 millimeters (mm) Standard Deviation 31.49	57.6 millimeters (mm) Standard Deviation 31.14

PRIMARY outcome

Timeframe: Baseline

Population: FAS population. Here, Number of participants analyzed = participants evaluable for the outcome measure.

The patient's global assessment of disease activity was measured using a 100 mm VAS, where the responses were on a continuous range from 0 = managing very well to 100 = managing very poorly.

Outcome measures

Outcome measures
Measure	RA Participants (Biologic Naïve Group) n=24 Participants Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.	RA Participants (Biologic Exposed Group) n=6 Participants Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.	RA Participants (Monotherapy Group) n=3 Participants Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.	RA Participants (Combination Therapy Group) n=27 Participants Participants with severe RA, were prescribed with disease-modifying anti-rheumatic drug (DMARD) at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.	RA Participants (All Groups) n=30 Participants Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
Patient Global Assessment of Disease Activity Using VAS at Baseline	69.6 mm Standard Deviation 29.71	59.0 mm Standard Deviation 33.03	85.0 mm Standard Deviation 11.36	65.5 mm Standard Deviation 31.02	67.5 mm Standard Deviation 30.11

PRIMARY outcome

Timeframe: Baseline

Population: FAS population. Here, Number of participants analyzed = participants evaluable for the outcome measure.

Physician global assessment of disease activity was assessed on a 100 mm VAS, where 0 = no arthritis activity to 100 = extremely active arthritis.

Outcome measures

Outcome measures
Measure	RA Participants (Biologic Naïve Group) n=25 Participants Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.	RA Participants (Biologic Exposed Group) n=6 Participants Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.	RA Participants (Monotherapy Group) n=3 Participants Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.	RA Participants (Combination Therapy Group) n=28 Participants Participants with severe RA, were prescribed with disease-modifying anti-rheumatic drug (DMARD) at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.	RA Participants (All Groups) n=31 Participants Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
Physician Global Assessment of Disease Activity Using VAS at Baseline	65.2 mm Standard Deviation 24.53	63.3 mm Standard Deviation 9.61	69.0 mm Standard Deviation 9.00	64.4 mm Standard Deviation 23.33	64.9 mm Standard Deviation 22.30

PRIMARY outcome

Timeframe: Baseline

Population: FAS population. Here, Number of participants analyzed = participants evaluable for the outcome measure.

The HAQ-DI is a questionnaire that measures functional status (disability) and health-related quality of life. It measures the participant's ability to perform everyday tasks. The index consists of 20 questions regarding the function of the upper and lower extremities. These questions are summarized in 8 categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and common activities over past week. Each question is evaluated according to the degree of severity on a 4-point scale. Total score for HAQ-DI is the average of all questions and ranges from 0 = without any difficulty to 3 = unable to do.

Outcome measures

Outcome measures
Measure	RA Participants (Biologic Naïve Group) n=24 Participants Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.	RA Participants (Biologic Exposed Group) n=6 Participants Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.	RA Participants (Monotherapy Group) n=3 Participants Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.	RA Participants (Combination Therapy Group) n=27 Participants Participants with severe RA, were prescribed with disease-modifying anti-rheumatic drug (DMARD) at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.	RA Participants (All Groups) n=30 Participants Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
Health Assessment Questionnaire Disability Index (HAQ-DI) Scores at Baseline	1.7 units on a scale Standard Deviation 0.86	1.7 units on a scale Standard Deviation 0.98	1.7 units on a scale Standard Deviation 0.59	1.7 units on a scale Standard Deviation 0.90	1.7 units on a scale Standard Deviation 0.87

PRIMARY outcome

Timeframe: Baseline

Population: FAS population. Here, Number of participants analyzed = participants evaluable for the outcome measure and n= participants with available data for the specified category.

TJC was determined by examining 28 and 68 joints and identifying the joints that were painful under pressure or to passive motion. Tenderness was recorded on the joint assessment form at baseline, no tenderness = 0, tenderness = 1. SJC was determined by examining 28 and 66 joints and identifying when swelling was present. Swelling was recorded on the joint assessment form at baseline, no swelling = 0, swelling =1.

Outcome measures

Outcome measures
Measure	RA Participants (Biologic Naïve Group) n=27 Participants Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.	RA Participants (Biologic Exposed Group) n=6 Participants Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.	RA Participants (Monotherapy Group) n=4 Participants Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.	RA Participants (Combination Therapy Group) n=29 Participants Participants with severe RA, were prescribed with disease-modifying anti-rheumatic drug (DMARD) at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.	RA Participants (All Groups) n=33 Participants Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
Tender Joint Count (TJC) and Swollen Joint Count (SJC) at Baseline TJC28 (n= 27, 6, 4, 29, 33)	15.6 joint counts Standard Deviation 7.68	14.7 joint counts Standard Deviation 8.48	13.0 joint counts Standard Deviation 8.41	15.8 joint counts Standard Deviation 7.69	15.4 joint counts Standard Deviation 7.70
Tender Joint Count (TJC) and Swollen Joint Count (SJC) at Baseline TJC68 (n= 18, 5, 2, 21, 23)	34.4 joint counts Standard Deviation 16.97	24.2 joint counts Standard Deviation 18.43	26.0 joint counts Standard Deviation 7.07	32.8 joint counts Standard Deviation 18.07	32.2 joint counts Standard Deviation 17.40
Tender Joint Count (TJC) and Swollen Joint Count (SJC) at Baseline SJC28 (n= 27, 6, 4, 29, 33)	14.0 joint counts Standard Deviation 6.66	14.0 joint counts Standard Deviation 7.51	12.5 joint counts Standard Deviation 3.79	14.2 joint counts Standard Deviation 7.03	14.0 joint counts Standard Deviation 6.70
Tender Joint Count (TJC) and Swollen Joint Count (SJC) at Baseline SJC66 (n= 18, 5, 2, 21, 23)	27.7 joint counts Standard Deviation 13.73	21.0 joint counts Standard Deviation 13.62	26.5 joint counts Standard Deviation 7.78	26.2 joint counts Standard Deviation 14.25	26.3 joint counts Standard Deviation 13.69

PRIMARY outcome

Timeframe: Baseline

Population: FAS population. Here, Number of participants analyzed = participants evaluable for the outcome measure.

ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 millimeters per hour (mm/hr). A decrease in the level indicates reduction in inflammation and therefore improvement.

Outcome measures

Outcome measures
Measure	RA Participants (Biologic Naïve Group) n=29 Participants Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.	RA Participants (Biologic Exposed Group) n=6 Participants Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.	RA Participants (Monotherapy Group) n=5 Participants Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.	RA Participants (Combination Therapy Group) n=30 Participants Participants with severe RA, were prescribed with disease-modifying anti-rheumatic drug (DMARD) at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.	RA Participants (All Groups) n=35 Participants Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
Erythrocyte Sedimentation Rate (ESR) at Baseline	27.0 mm/hr Standard Deviation 24.79	35.2 mm/hr Standard Deviation 36.78	34.8 mm/hr Standard Deviation 26.79	27.3 mm/hr Standard Deviation 27.04	28.4 mm/hr Standard Deviation 26.74

PRIMARY outcome

Timeframe: Baseline

Population: FAS population.

The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.

Outcome measures

Outcome measures
Measure	RA Participants (Biologic Naïve Group) n=29 Participants Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.	RA Participants (Biologic Exposed Group) n=8 Participants Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.	RA Participants (Monotherapy Group) n=5 Participants Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.	RA Participants (Combination Therapy Group) n=32 Participants Participants with severe RA, were prescribed with disease-modifying anti-rheumatic drug (DMARD) at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.	RA Participants (All Groups) n=37 Participants Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
C-Reactive Protein (CRP) at Baseline	15.3 milligrams per liter (mg/L) Standard Deviation 17.36	22.6 milligrams per liter (mg/L) Standard Deviation 42.91	22.5 milligrams per liter (mg/L) Standard Deviation 24.30	16.0 milligrams per liter (mg/L) Standard Deviation 24.84	16.9 milligrams per liter (mg/L) Standard Deviation 24.53

SECONDARY outcome

Timeframe: Baseline

Population: FAS population.

Outcome measures

Outcome measures
Measure	RA Participants (Biologic Naïve Group) n=29 Participants Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.	RA Participants (Biologic Exposed Group) n=8 Participants Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.	RA Participants (Monotherapy Group) n=5 Participants Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.	RA Participants (Combination Therapy Group) n=32 Participants Participants with severe RA, were prescribed with disease-modifying anti-rheumatic drug (DMARD) at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.	RA Participants (All Groups) n=37 Participants Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
Percentage of Participants Starting Tocilizumab After Stopping a Biologic Treatment or After Failing DMARDs Previous biologic therapy	0 percentage of participants	100 percentage of participants	40 percentage of participants	18.8 percentage of participants	21.6 percentage of participants
Percentage of Participants Starting Tocilizumab After Stopping a Biologic Treatment or After Failing DMARDs Previous DMARD therapy	31.0 percentage of participants	7.5 percentage of participants	100 percentage of participants	34.4 percentage of participants	43.2 percentage of participants

SECONDARY outcome

Timeframe: Month 6

Population: FAS population. Here Number of participants analyzed = participants evaluable for the outcome measure.

Outcome measures

Outcome measures
Measure	RA Participants (Biologic Naïve Group) n=23 Participants Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.	RA Participants (Biologic Exposed Group) n=8 Participants Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.	RA Participants (Monotherapy Group) n=4 Participants Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.	RA Participants (Combination Therapy Group) n=27 Participants Participants with severe RA, were prescribed with disease-modifying anti-rheumatic drug (DMARD) at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.	RA Participants (All Groups) n=31 Participants Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
Median Dose at Month 6	8 milligram per kilogram (mg/kg) Interval 7.0 to 8.0	8 milligram per kilogram (mg/kg) Interval 8.0 to 8.0	8 milligram per kilogram (mg/kg) Interval 8.0 to 8.0	8 milligram per kilogram (mg/kg) Interval 7.0 to 8.0	8 milligram per kilogram (mg/kg) Interval 7.0 to 8.0

SECONDARY outcome

Timeframe: Baseline up to Month 6

Population: FAS population.

Percentage of participants with increase or decrease in tocilizumab administration according to the reason for dose modification was reported.

Outcome measures

Outcome measures
Measure	RA Participants (Biologic Naïve Group) n=29 Participants Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.	RA Participants (Biologic Exposed Group) n=8 Participants Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.	RA Participants (Monotherapy Group) n=5 Participants Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.	RA Participants (Combination Therapy Group) n=32 Participants Participants with severe RA, were prescribed with disease-modifying anti-rheumatic drug (DMARD) at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.	RA Participants (All Groups) n=37 Participants Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
Percentage of Participants With Tocilizumab Dose Changed According to the Reason for Change Increase in dose	0 percentage of participants	12.5 percentage of participants	0 percentage of participants	3.1 percentage of participants	2.7 percentage of participants
Percentage of Participants With Tocilizumab Dose Changed According to the Reason for Change Decrease in dose	3.4 percentage of participants	0 percentage of participants	0 percentage of participants	3.1 percentage of participants	2.7 percentage of participants
Percentage of Participants With Tocilizumab Dose Changed According to the Reason for Change Reason:Unspecified	3.4 percentage of participants	12.5 percentage of participants	0 percentage of participants	6.3 percentage of participants	5.4 percentage of participants

SECONDARY outcome

Timeframe: Month 6

Population: FAS population. Here, Number of participants analyzed = participants evaluable for the outcome measure.

The time interval between two successive doses in days was reported.

Outcome measures

Outcome measures
Measure	RA Participants (Biologic Naïve Group) n=28 Participants Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.	RA Participants (Biologic Exposed Group) n=8 Participants Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.	RA Participants (Monotherapy Group) n=5 Participants Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.	RA Participants (Combination Therapy Group) n=31 Participants Participants with severe RA, were prescribed with disease-modifying anti-rheumatic drug (DMARD) at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.	RA Participants (All Groups) n=36 Participants Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
Mean Dosing Interval at Month 6	30.97 days Standard Deviation 3.803	32.10 days Standard Deviation 3.783	29.63 days Standard Deviation 1.505	31.48 days Standard Deviation 3.978	31.22 days Standard Deviation 3.775

SECONDARY outcome

Timeframe: Baseline up to Month 6

Population: FAS population. Here, Number of Participants Analyzed (N) signifies participants who discontinued tocilizumab treatment.

Outcome measures

Outcome measures
Measure	RA Participants (Biologic Naïve Group) n=5 Participants Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.	RA Participants (Biologic Exposed Group) Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.	RA Participants (Monotherapy Group) n=1 Participants Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.	RA Participants (Combination Therapy Group) n=4 Participants Participants with severe RA, were prescribed with disease-modifying anti-rheumatic drug (DMARD) at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.	RA Participants (All Groups) n=5 Participants Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
Percentage of Participants With Reasons Who Discontinued Tocilizumab Lack of efficacy	20.0 percentage of participants	—	0 percentage of participants	25.0 percentage of participants	20.0 percentage of participants
Percentage of Participants With Reasons Who Discontinued Tocilizumab Adverse event	40.0 percentage of participants	—	0 percentage of participants	50.0 percentage of participants	40.0 percentage of participants
Percentage of Participants With Reasons Who Discontinued Tocilizumab Unspecified	40.0 percentage of participants	—	100.0 percentage of participants	25.0 percentage of participants	40.0 percentage of participants

SECONDARY outcome

Timeframe: Baseline up to Month 6

Population: Analysis was not performed due to inadequate data available for this outcome measure.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline up to Month 6

Population: Analysis was not performed as the data was not collected on case report form.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Month 6

Population: FAS population. n= participants with available data at the specified visit.

Outcome measures

Outcome measures
Measure	RA Participants (Biologic Naïve Group) n=29 Participants Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.	RA Participants (Biologic Exposed Group) n=8 Participants Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.	RA Participants (Monotherapy Group) n=5 Participants Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.	RA Participants (Combination Therapy Group) n=32 Participants Participants with severe RA, were prescribed with disease-modifying anti-rheumatic drug (DMARD) at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.	RA Participants (All Groups) n=37 Participants Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
Percentage of Participants on Tocilizumab Monotherapy (8 mg/Kg) at Baseline and at Month 6 Baseline (n=29,8,5,32,37)	93.1 percentage of participants	100 percentage of participants	100.0 percentage of participants	93.8 percentage of participants	94.6 percentage of participants
Percentage of Participants on Tocilizumab Monotherapy (8 mg/Kg) at Baseline and at Month 6 Month 6 (n=20,8,4,24,28)	87.0 percentage of participants	100 percentage of participants	100.0 percentage of participants	88.9 percentage of participants	90.3 percentage of participants

SECONDARY outcome

Timeframe: Baseline up to Month 6

Population: FAS population.

Outcome measures

Outcome measures
Measure	RA Participants (Biologic Naïve Group) n=29 Participants Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.	RA Participants (Biologic Exposed Group) n=8 Participants Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.	RA Participants (Monotherapy Group) n=5 Participants Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.	RA Participants (Combination Therapy Group) n=32 Participants Participants with severe RA, were prescribed with disease-modifying anti-rheumatic drug (DMARD) at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.	RA Participants (All Groups) n=37 Participants Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
Duration of Tocilizumab Treatment	181.1 days Standard Deviation 56.31	211.3 days Standard Deviation 28.17	174.8 days Standard Deviation 48.43	189.7 days Standard Deviation 53.79	187.6 days Standard Deviation 52.71

SECONDARY outcome

Timeframe: Baseline, Month 3, Month 6

Population: FAS population. Here, n= participants with available data at specified visit.

Duration of morning stiffness was defined as the time elapsed between the time of usual awakening (even if not in the morning) and the time the participant was able to resume normal activities without stiffness. The participant assessment of morning stiffness was measured using a ruler on a 100 mm VAS by 1 of the six categories: less than (\<) 30 minutes, between 30 and 240 minutes, greater than (\>) 240 minutes and whole day.

Outcome measures

Outcome measures
Measure	RA Participants (Biologic Naïve Group) n=29 Participants Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.	RA Participants (Biologic Exposed Group) n=8 Participants Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.	RA Participants (Monotherapy Group) n=5 Participants Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.	RA Participants (Combination Therapy Group) n=32 Participants Participants with severe RA, were prescribed with disease-modifying anti-rheumatic drug (DMARD) at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.	RA Participants (All Groups) n=37 Participants Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
Percentage of Participants by Duration of Morning Stiffness Month 6 (whole day) (n= 12, 3, 3, 12, 15)	8.3 percentage of participants	0 percentage of participants	0 percentage of participants	8.3 percentage of participants	6.7 percentage of participants
Percentage of Participants by Duration of Morning Stiffness Baseline ( < 30 minutes) (n= 22, 6, 2, 26, 28)	4.5 percentage of participants	16.7 percentage of participants	0 percentage of participants	7.7 percentage of participants	7.1 percentage of participants
Percentage of Participants by Duration of Morning Stiffness Month 3 (< 30 minutes) (n=13, 4, 3, 14, 17)	30.8 percentage of participants	75.0 percentage of participants	33.3 percentage of participants	42.9 percentage of participants	41.2 percentage of participants
Percentage of Participants by Duration of Morning Stiffness Month 6 (< 30 minutes) (n= 12, 3, 3, 12, 15)	33.3 percentage of participants	0 percentage of participants	0 percentage of participants	33.3 percentage of participants	26.7 percentage of participants
Percentage of Participants by Duration of Morning Stiffness Baseline (30-60 minutes) (n= 22, 6, 2, 26, 28)	13.6 percentage of participants	16.7 percentage of participants	0 percentage of participants	15.4 percentage of participants	14.3 percentage of participants
Percentage of Participants by Duration of Morning Stiffness Month 3 (30-60 minutes) (n= 13, 4, 3, 14, 17)	53.8 percentage of participants	0 percentage of participants	33.3 percentage of participants	42.9 percentage of participants	41.2 percentage of participants
Percentage of Participants by Duration of Morning Stiffness Month 6 (30-60 minutes) (n= 12, 3, 3, 12, 15)	16.7 percentage of participants	66.7 percentage of participants	66.7 percentage of participants	16.7 percentage of participants	26.7 percentage of participants
Percentage of Participants by Duration of Morning Stiffness Baseline (60-120 minutes) (n= 22, 6, 2, 26, 28)	18.2 percentage of participants	16.7 percentage of participants	50.0 percentage of participants	15.4 percentage of participants	17.9 percentage of participants
Percentage of Participants by Duration of Morning Stiffness Month 3 (60-120 minutes) (n= 13, 4, 3, 14, 17)	7.7 percentage of participants	25.0 percentage of participants	33.3 percentage of participants	7.1 percentage of participants	11.8 percentage of participants
Percentage of Participants by Duration of Morning Stiffness Month 6 (60-120 minutes) (n= 12, 3, 3, 12, 15)	8.3 percentage of participants	0 percentage of participants	0 percentage of participants	8.3 percentage of participants	6.7 percentage of participants
Percentage of Participants by Duration of Morning Stiffness Baseline (120-240 minutes) (n= 22, 6, 2, 26, 28)	31.8 percentage of participants	33.3 percentage of participants	0 percentage of participants	34.6 percentage of participants	32.1 percentage of participants
Percentage of Participants by Duration of Morning Stiffness Month 3 (120-240 minutes) (n= 13, 4, 3, 14, 17)	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants by Duration of Morning Stiffness Month 6 (120-240 minutes) (n=12, 3, 3, 12, 15)	25.0 percentage of participants	0 percentage of participants	0 percentage of participants	25.0 percentage of participants	20.0 percentage of participants
Percentage of Participants by Duration of Morning Stiffness Baseline (> 240 minutes) (n= 22, 6, 2, 26, 28)	22.7 percentage of participants	16.7 percentage of participants	50.0 percentage of participants	19.2 percentage of participants	21.4 percentage of participants
Percentage of Participants by Duration of Morning Stiffness Month 3 (> 240 minutes) (n= 13, 4, 3, 14, 17)	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants by Duration of Morning Stiffness Month 6 (> 240 minutes) (n= 12, 3, 3, 12, 15)	8.3 percentage of participants	33.3 percentage of participants	33.3 percentage of participants	8.3 percentage of participants	13.3 percentage of participants
Percentage of Participants by Duration of Morning Stiffness Baseline (whole day) (n= 22, 6, 2, 26, 28)	9.1 percentage of participants	0 percentage of participants	0 percentage of participants	7.7 percentage of participants	7.1 percentage of participants
Percentage of Participants by Duration of Morning Stiffness Month 3 (whole day) (n= 13, 4, 3, 14, 17)	7.7 percentage of participants	0 percentage of participants	0 percentage of participants	7.1 percentage of participants	5.9 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Month 3, Month 6

Population: FAS population. Here, Number of participants analyzed = participants evaluable for the outcome measure and n= participants with available data at the specified visit.

Morning stiffness was defined by the time elapsed between the time of usual awakening (even if not in the morning) and the time the participant was able to resume normal activities without stiffness. The participant assessed morning stiffness based on the following criteria: 1. Presence of participant's joints stiff when woke up that day, measured as yes or no 2. Duration of morning stiffness, measured using a ruler on a 100 mm VAS by 1 of the six categories: \< 30 minutes, between 30 and 240 minutes, \> 240 minutes, and the whole day. 3. Severity of morning stiffness measured using a ruler on a 100 mm VAS where the responses were on a continuous range from 0 = no stiffness to 100 = maximum stiffness.

Outcome measures

Outcome measures
Measure	RA Participants (Biologic Naïve Group) n=24 Participants Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.	RA Participants (Biologic Exposed Group) n=6 Participants Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.	RA Participants (Monotherapy Group) n=4 Participants Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.	RA Participants (Combination Therapy Group) n=27 Participants Participants with severe RA, were prescribed with disease-modifying anti-rheumatic drug (DMARD) at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.	RA Participants (All Groups) n=30 Participants Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
Percentage of Participants With and Without Morning Stiffness Baseline(with morning stiffness)(n=24,6,3,27,30)	95.8 percentage of participants	100 percentage of participants	100 percentage of participants	96.3 percentage of participants	96.7 percentage of participants
Percentage of Participants With and Without Morning Stiffness Baseline(without morningstiffness)(n=24,6,3,27,30)	4.2 percentage of participants	0 percentage of participants	0 percentage of participants	3.7 percentage of participants	3.3 percentage of participants
Percentage of Participants With and Without Morning Stiffness Month 3(with morning stiffness)(n=14,5,4,15,19)	92.9 percentage of participants	100 percentage of participants	100 percentage of participants	93.3 percentage of participants	94.7 percentage of participants
Percentage of Participants With and Without Morning Stiffness Month 3(without morning stiffness)(n=14,5,4,15,19)	7.1 percentage of participants	0 percentage of participants	0 percentage of participants	6.7 percentage of participants	5.3 percentage of participants
Percentage of Participants With and Without Morning Stiffness Month 6(with morning stiffness)(n=14,3,4,13,17)	92.9 percentage of participants	100 percentage of participants	100 percentage of participants	92.3 percentage of participants	94.1 percentage of participants
Percentage of Participants With and Without Morning Stiffness Month 6(without morning stiffness)(n=14,3,4,13,17)	17.1 percentage of participants	0 percentage of participants	0 percentage of participants	7.7 percentage of participants	5.9 percentage of participants

SECONDARY outcome

Timeframe: Baseline up to Month 6

Population: FAS population. Number of participants analyzed = participants with available data for this outcome measure.

Percentage of participants who adhered to local label/protocol for the management of adverse events is reported.

Outcome measures

Outcome measures
Measure	RA Participants (Biologic Naïve Group) n=4 Participants Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.	RA Participants (Biologic Exposed Group) n=1 Participants Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.	RA Participants (Monotherapy Group) n=1 Participants Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.	RA Participants (Combination Therapy Group) n=4 Participants Participants with severe RA, were prescribed with disease-modifying anti-rheumatic drug (DMARD) at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.	RA Participants (All Groups) n=5 Participants Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
Percentage of Participants Adhering to Local Label for Adverse Events	100 percentage of participants	100 percentage of participants	100 percentage of participants	75 percentage of participants	80 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Month 3, Month 6

Population: FAS population. Here, Number of participants analyzed = Participants evaluable for the outcome measure and n= participants with DAS28 score available at the specified visit.

The DAS28 score is a measurement of RA activity on a 0 to 10 scale, with higher scores representing higher disease activity, and calculated as DAS28 = 0.56 x √TJC28 + 0.28 x √SJC28 + 0.70 x natural logarithm (ln) (CRP + 1) + 0.014 x PGH + 0.96, where TJC28 = tender joint count on 28 units, SJC28 = swollen joint count on 28 units, CRP = serum concentration of c-reactive protein (after converting units to mg/dL), PGH = patient global assessment of disease activity, which was measured on a 100 mm VAS, where 0 = managing very well and 100 = managing very poorly. A score of less than 2.6 represents clinical remission, a score of greater than or equal to 2.6 and less than or equal to 3.2 represents low disease activity, a score of greater than 3.2 and less than or equal to 5.1 represents moderate disease activity, and a score of greater than 5.1 represents high (or severe) disease.

Outcome measures

Outcome measures
Measure	RA Participants (Biologic Naïve Group) n=22 Participants Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.	RA Participants (Biologic Exposed Group) n=6 Participants Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.	RA Participants (Monotherapy Group) n=3 Participants Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.	RA Participants (Combination Therapy Group) n=25 Participants Participants with severe RA, were prescribed with disease-modifying anti-rheumatic drug (DMARD) at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.	RA Participants (All Groups) n=28 Participants Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
Disease Activity Score Based on 28 Joint Count (DAS28) Score by Visit Month 3 (n=13, 4, 2, 15, 17)	2.69 units on a scale Standard Deviation 1.274	2.98 units on a scale Standard Deviation 1.250	3.61 units on a scale Standard Deviation 0.151	2.64 units on a scale Standard Deviation 1.275	2.76 units on a scale Standard Deviation 1.236
Disease Activity Score Based on 28 Joint Count (DAS28) Score by Visit Baseline (n=22, 6, 3, 25, 28)	6.34 units on a scale Standard Deviation 1.611	6.04 units on a scale Standard Deviation 1.272	6.73 units on a scale Standard Deviation 0.868	6.22 units on a scale Standard Deviation 1.592	6.28 units on a scale Standard Deviation 1.528
Disease Activity Score Based on 28 Joint Count (DAS28) Score by Visit Month 6 (n=12, 2, 2, 12, 14)	3.02 units on a scale Standard Deviation 1.459	2.75 units on a scale Standard Deviation 1.420	3.49 units on a scale Standard Deviation 0.380	2.89 units on a scale Standard Deviation 1.502	2.98 units on a scale Standard Deviation 1.402

SECONDARY outcome

Timeframe: Month 3 and Month 6

Population: FAS population. Here, Number of participants analyzed = participants evaluable for the outcome measure and n= participants with EULAR response available at specified visit.

Clinical response was assessed according to EULAR criteria that classified the participant according to individual changes in DAS28 score as good, moderate, or no response. The DAS28 score is a measurement of RA activity on a 0 to 10 scale, with higher scores represent higher disease activity, and calculated as DAS28 = 0.56 x √TJC28 + 0.28 x √SJC28 + 0.36 x ln(CRP + 1) + 0.014 x PGH + 0.96, where TJC28 = tender joint count on 28 units, SJC28 = swollen joint count on 28 units, CRP = serum concentration of c-reactive protein (after converting units to mg/dL), PGH = patient's global assessment of disease activity, which was measured on a 100 mm VAS, where 0 = managing very well and 100 = managing very poorly. Good responders experienced a change from baseline of greater than 1.2 with a DAS28 score less than or equal to 3.2.

Outcome measures

Outcome measures
Measure	RA Participants (Biologic Naïve Group) n=11 Participants Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.	RA Participants (Biologic Exposed Group) n=3 Participants Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.	RA Participants (Monotherapy Group) n=1 Participants Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.	RA Participants (Combination Therapy Group) n=13 Participants Participants with severe RA, were prescribed with disease-modifying anti-rheumatic drug (DMARD) at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.	RA Participants (All Groups) n=14 Participants Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
Percentage of Participants Achieving Good European League Against Rheumatism (EULAR) Response at Month 3 and Month 6 Month 3 (n= 11, 3, 1, 13, 14)	63.6 percentage of participants	66.7 percentage of participants	0 percentage of participants	69.2 percentage of participants	64.3 percentage of participants
Percentage of Participants Achieving Good European League Against Rheumatism (EULAR) Response at Month 3 and Month 6 Month 6 (n= 10, 1,1, 10, 11)	50.0 percentage of participants	100 percentage of participants	0 percentage of participants	60.0 percentage of participants	54.5 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Month 3, Month 6

Population: FAS population. Here, Number of participants analyzed = participants evaluable for the outcome measure and n= participants with CDAI score available at specified visit.

The CDAI is a combined index for measuring disease activity in RA and calculated as CDAI = TJC28 + SJC28 + PGH (in centimeters) + PhGH (in centimeters), where TJC28 = tender joint count on 28 units, SJC28 = swollen joint count on 28 units, PGH = patient's global assessment of disease activity, assessed on a 100 mm VAS, where 0 = managing very well and 100 = managing very poorly, and PhGH = physician global assessment of disease activity, assessed on a 100 mm VAS, where 0 = no arthritis activity and 100 = extremely active arthritis; with a total score ranged from 0-76. Higher scores indicate greater disease activity. CDAI score of less than or equal to 2.8 represents clinical remission, score of less than or equal to 10.0 represents low disease activity, score of less than or equal to 22.0 represents moderate disease activity, and score of greater than 22.0 represents high (or severe) disease.

Outcome measures

Outcome measures
Measure	RA Participants (Biologic Naïve Group) n=22 Participants Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.	RA Participants (Biologic Exposed Group) n=6 Participants Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.	RA Participants (Monotherapy Group) n=4 Participants Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.	RA Participants (Combination Therapy Group) n=25 Participants Participants with severe RA, were prescribed with disease-modifying anti-rheumatic drug (DMARD) at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.	RA Participants (All Groups) n=28 Participants Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
Clinical Disease Activity Index (CDAI) Score by Visit Baseline (n= 22, 6, 3, 25, 28)	46.41 units on a scale Standard Deviation 16.482	40.90 units on a scale Standard Deviation 18.277	45.40 units on a scale Standard Deviation 4.900	45.21 units on a scale Standard Deviation 17.643	45.23 units on a scale Standard Deviation 16.687
Clinical Disease Activity Index (CDAI) Score by Visit Month 3 (n= 13, 5, 4, 14, 18)	12.37 units on a scale Standard Deviation 10.970	16.00 units on a scale Standard Deviation 5.632	13.05 units on a scale Standard Deviation 7.468	13.47 units on a scale Standard Deviation 10.564	13.38 units on a scale Standard Deviation 9.758
Clinical Disease Activity Index (CDAI) Score by Visit Month 6 (n= 13, 3, 4, 12, 16)	13.20 units on a scale Standard Deviation 15.017	14.93 units on a scale Standard Deviation 4.140	11.30 units on a scale Standard Deviation 7.338	14.27 units on a scale Standard Deviation 15.254	13.53 units on a scale Standard Deviation 13.534

SECONDARY outcome

Timeframe: Baseline, Month 3, Month 6

Population: FAS population. Here, Number of participants analyzed = participants evaluable for the outcome measure and n= participants with available data at the specified visit.

TJC was determined by examining 28 and 68 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at baseline, no tenderness = 0, tenderness = 1. SJC was determined by examination of 28 and 66 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at baseline, no swelling = 0, swelling =1.

Outcome measures

Outcome measures
Measure	RA Participants (Biologic Naïve Group) n=27 Participants Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.	RA Participants (Biologic Exposed Group) n=6 Participants Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.	RA Participants (Monotherapy Group) n=4 Participants Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.	RA Participants (Combination Therapy Group) n=29 Participants Participants with severe RA, were prescribed with disease-modifying anti-rheumatic drug (DMARD) at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.	RA Participants (All Groups) n=33 Participants Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
Change From Baseline in TJC and SJC at Month 3 and Month 6 TJC28: Change at Month 3 (n= 14, 4, 3, 15, 18)	-13.9 joint counts Standard Deviation 5.17	-11.0 joint counts Standard Deviation 6.78	-7.0 joint counts Standard Deviation 5.57	-14.5 joint counts Standard Deviation 4.70	-13.2 joint counts Standard Deviation 5.48
Change From Baseline in TJC and SJC at Month 3 and Month 6 SJC66: Change at Month 3 (n= 11, 3, 2, 12, 14)	-27.2 joint counts Standard Deviation 9.58	-12.7 joint counts Standard Deviation 5.51	-18.5 joint counts Standard Deviation 13.44	-25.0 joint counts Standard Deviation 10.54	-24.1 joint counts Standard Deviation 10.65
Change From Baseline in TJC and SJC at Month 3 and Month 6 SJC28: Baseline (n= 27, 6, 4, 29, 33)	14.0 joint counts Standard Deviation 6.66	14.0 joint counts Standard Deviation 7.51	12.5 joint counts Standard Deviation 3.79	14.2 joint counts Standard Deviation 7.03	14.0 joint counts Standard Deviation 6.70
Change From Baseline in TJC and SJC at Month 3 and Month 6 SJC28: Change at Month 3 (n= 14, 4, 3, 15, 18)	-13.8 joint counts Standard Deviation 4.54	-10.5 joint counts Standard Deviation 6.81	-9.3 joint counts Standard Deviation 5.51	-13.8 joint counts Standard Deviation 4.86	-13.1 joint counts Standard Deviation 5.09
Change From Baseline in TJC and SJC at Month 3 and Month 6 SJC28: Change at Month 6 (n= 14, 2, 3, 13, 16)	-10.8 joint counts Standard Deviation 6.34	-13.5 joint counts Standard Deviation 4.95	-11.7 joint counts Standard Deviation 2.89	-11.0 joint counts Standard Deviation 6.72	-11.1 joint counts Standard Deviation 6.11
Change From Baseline in TJC and SJC at Month 3 and Month 6 SJC66: Baseline (n= 18, 5, 2, 21, 23)	27.7 joint counts Standard Deviation 13.73	21.0 joint counts Standard Deviation 13.62	26.5 joint counts Standard Deviation 7.78	26.2 joint counts Standard Deviation 14.25	26.3 joint counts Standard Deviation 13.69
Change From Baseline in TJC and SJC at Month 3 and Month 6 SJC66: Change at Month 6 (n= 11, 1, 2, 10, 12)	-26.0 joint counts Standard Deviation 13.80	-17.0 joint counts Standard Deviation NA SD not calculable because only 1 participant was evaluated.	-21.5 joint counts Standard Deviation 6.36	-26.0 joint counts Standard Deviation 14.54	-25.3 joint counts Standard Deviation 13.41
Change From Baseline in TJC and SJC at Month 3 and Month 6 TJC28: Baseline (n= 27, 6, 4, 29, 33)	15.6 joint counts Standard Deviation 7.68	14.7 joint counts Standard Deviation 8.48	13.0 joint counts Standard Deviation 8.41	15.8 joint counts Standard Deviation 7.69	15.4 joint counts Standard Deviation 7.70
Change From Baseline in TJC and SJC at Month 3 and Month 6 TJC28: Change at Month 6 (n= 14, 2, 3, 13, 16)	-11.1 joint counts Standard Deviation 8.56	-15.0 joint counts Standard Deviation 7.07	-8.3 joint counts Standard Deviation 6.66	-12.3 joint counts Standard Deviation 8.67	-11.6 joint counts Standard Deviation 8.29
Change From Baseline in TJC and SJC at Month 3 and Month 6 TJC68: Baseline (n= 18, 5, 2, 21, 23 )	34.4 joint counts Standard Deviation 16.97	24.2 joint counts Standard Deviation 18.43	26.0 joint counts Standard Deviation 7.07	32.8 joint counts Standard Deviation 18.07	32.2 joint counts Standard Deviation 17.40
Change From Baseline in TJC and SJC at Month 3 and Month 6 TJC68: Change at Month 3 (n= 11, 3, 2, 12, 14)	-30.5 joint counts Standard Deviation 8.13	-12.3 joint counts Standard Deviation 6.66	-18.0 joint counts Standard Deviation 12.73	-28.1 joint counts Standard Deviation 10.42	-26.6 joint counts Standard Deviation 10.85
Change From Baseline in TJC and SJC at Month 3 and Month 6 TJC68: Change at Month 6 (n= 11, 1, 2, 10, 12 )	-27.5 joint counts Standard Deviation 17.41	-17.0 joint counts Standard Deviation NA SD not calculable because only 1 participant was evaluated.	-21.5 joint counts Standard Deviation 6.36	-27.7 joint counts Standard Deviation 18.34	-26.7 joint counts Standard Deviation 16.88

SECONDARY outcome

Timeframe: Baseline, Month 3, Month 6

Population: FAS population. Here, Number of participants analyzed = participants evaluable for the outcome measure and n= participants with SDAI score available at the specified visit.

The SDAI is a combined index for measuring disease activity in RA and calculated as SDAI = TJC28 + SJC28 + PGH (in centimeters) + PhGH (in centimeters) + CRP (in mg/dL), where TJC28 = tender joint count on 28 units, SJC28 = swollen joint count on 28 units, PGH = patient's global assessment of disease activity, assessed on a 100 mm VAS, where 0 = managing very well and 100 = managing very poorly, PhGH = physician global assessment of disease activity, assessed on a 100 mm VAS, where 0 = no arthritis activity and 100 = extremely active arthritis, CRP = serum concentration of c-reactive protein; with a total SDAI score ranged from 0-86. Higher scores indicate greater disease activity. SDAI scores of less than or equal to 3.3 represents clinical remission, less than or equal to 11.0 represents low disease activity, less than or equal to 26.0 represents moderate disease activity, and greater than 26.0 represents high (or severe) disease.

Outcome measures

Outcome measures
Measure	RA Participants (Biologic Naïve Group) n=22 Participants Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.	RA Participants (Biologic Exposed Group) n=6 Participants Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.	RA Participants (Monotherapy Group) n=3 Participants Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.	RA Participants (Combination Therapy Group) n=25 Participants Participants with severe RA, were prescribed with disease-modifying anti-rheumatic drug (DMARD) at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.	RA Participants (All Groups) n=28 Participants Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
Simplified Disease Activity Index (SDAI) Score by Visit Month 6 (n= 12, 2, 2, 12, 14)	14.55 units on a scale Standard Deviation 15.357	14.65 units on a scale Standard Deviation 5.798	13.70 units on a scale Standard Deviation 7.142	14.70 units on a scale Standard Deviation 15.301	14.56 units on a scale Standard Deviation 14.218
Simplified Disease Activity Index (SDAI) Score by Visit Baseline (n= 22, 6, 3, 25, 28)	48.01 units on a scale Standard Deviation 16.853	43.57 units on a scale Standard Deviation 14.898	47.07 units on a scale Standard Deviation 6.689	47.06 units on a scale Standard Deviation 17.173	47.06 units on a scale Standard Deviation 16.293
Simplified Disease Activity Index (SDAI) Score by Visit Month 3 (n= 11, 4, 2, 13, 15)	13.29 units on a scale Standard Deviation 11.602	15.16 units on a scale Standard Deviation 6.066	14.95 units on a scale Standard Deviation 3.536	13.61 units on a scale Standard Deviation 10.997	13.79 units on a scale Standard Deviation 10.236

SECONDARY outcome

Timeframe: Month 3 and Month 6

Population: FAS population. Here, Number of participants analyzed = participants evaluable for the outcome measure and n= participants with available data for the specified visit.

ACR 20,50 or 70 response=an improvement of ≥ 20%, ≥ 50% or ≥ 70% respectively, as compared to baseline in TJC28 and SJC28, and 20%, 50% or 70% improvement in at least 3 of the 5 following measures: Patient's Assessment of Pain over the previous 24 hours, PGA, PhGA, HAQ, and acute phase reactant (either CRP or ESR). TJC and SJC, based on 28-joint assessments. Number of tender joints and swollen joints were recorded on the joint assessment form at baseline, no tenderness = 0 and tenderness = 1, no swelling = 0 and swelling =1, respectively. HAQ measures functional status (disability) and health-related quality of life with 20 questions, summarized in 8 categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip and common activities over past week, 0=without difficulty to 3=unable to do. Patient's assessment of pain assessed using a VAS; 0=no pain, 100=unbearable pain; PGA and PhGA, assessed using VAS ; 0= no disease activity, 100=maximum disease activity.

Outcome measures

Outcome measures
Measure	RA Participants (Biologic Naïve Group) n=11 Participants Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.	RA Participants (Biologic Exposed Group) n=3 Participants Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.	RA Participants (Monotherapy Group) n=2 Participants Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.	RA Participants (Combination Therapy Group) n=12 Participants Participants with severe RA, were prescribed with disease-modifying anti-rheumatic drug (DMARD) at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.	RA Participants (All Groups) n=14 Participants Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
Percentage of Participants With an American College of Rheumatology (ACR) 20%, 50%, or 70% (ACR20/50/70) Response at Month 3 and Month 6 From the Start of Tocilizumab Treatment Month 3: ACR50 responders (n= 11, 3, 2, 12, 14)	63.6 percentage of participants Interval 30.8 to 89.1	33.3 percentage of participants Interval 0.8 to 90.6	0.0 percentage of participants Interval 0.0 to 84.2	66.7 percentage of participants Interval 34.9 to 90.1	57.1 percentage of participants Interval 28.9 to 82.3
Percentage of Participants With an American College of Rheumatology (ACR) 20%, 50%, or 70% (ACR20/50/70) Response at Month 3 and Month 6 From the Start of Tocilizumab Treatment Month 3: ACR20 responders (n= 11, 3, 2, 12, 14)	90.9 percentage of participants Interval 58.7 to 99.8	100.0 percentage of participants Interval 29.2 to 100.0	100.0 percentage of participants Interval 15.8 to 100.0	91.7 percentage of participants Interval 61.5 to 99.8	92.9 percentage of participants Interval 66.1 to 99.8
Percentage of Participants With an American College of Rheumatology (ACR) 20%, 50%, or 70% (ACR20/50/70) Response at Month 3 and Month 6 From the Start of Tocilizumab Treatment Month 6: ACR20 responders (n= 10, 1, 2, 9, 11)	80.0 percentage of participants Interval 44.4 to 97.5	100.0 percentage of participants Interval 2.5 to 100.0	100.0 percentage of participants Interval 15.8 to 100.0	77.8 percentage of participants Interval 40.0 to 97.2	81.8 percentage of participants Interval 48.2 to 97.7
Percentage of Participants With an American College of Rheumatology (ACR) 20%, 50%, or 70% (ACR20/50/70) Response at Month 3 and Month 6 From the Start of Tocilizumab Treatment Month 6: ACR50 responders (n= 10, 1, 2, 9, 11)	70.0 percentage of participants Interval 34.8 to 93.3	0.0 percentage of participants Interval 0.0 to 97.5	50.0 percentage of participants Interval 1.3 to 98.7	66.7 percentage of participants Interval 29.9 to 92.5	63.6 percentage of participants Interval 30.8 to 89.1
Percentage of Participants With an American College of Rheumatology (ACR) 20%, 50%, or 70% (ACR20/50/70) Response at Month 3 and Month 6 From the Start of Tocilizumab Treatment Month 3: ACR70 responders (n= 11, 3, 2, 12, 14)	36.4 percentage of participants Interval 10.9 to 69.2	0.0 percentage of participants Interval 0.0 to 70.8	0.0 percentage of participants Interval 0.0 to 84.2	33.3 percentage of participants Interval 9.9 to 65.1	28.6 percentage of participants Interval 8.4 to 58.1
Percentage of Participants With an American College of Rheumatology (ACR) 20%, 50%, or 70% (ACR20/50/70) Response at Month 3 and Month 6 From the Start of Tocilizumab Treatment Month 6: ACR70 responders (n= 10, 1, 2, 9, 11)	50.0 percentage of participants Interval 18.7 to 81.3	0.0 percentage of participants Interval 0.0 to 97.5	0.0 percentage of participants Interval 0.0 to 84.2	55.6 percentage of participants Interval 21.2 to 86.3	45.5 percentage of participants Interval 16.7 to 76.6

SECONDARY outcome

Timeframe: Baseline, Month 3, Month 6

Population: FAS population. Here, Number of participants analyzed = participants evaluable for the outcome measure and n= participants with available data at the specified visit.

The physician global assessment of disease activity was evaluated using a 100 mm VAS where 0 = no arthritis activity and 100 = extremely active arthritis. Higher scores indicated increased level of disease.

Outcome measures

Outcome measures
Measure	RA Participants (Biologic Naïve Group) n=25 Participants Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.	RA Participants (Biologic Exposed Group) n=6 Participants Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.	RA Participants (Monotherapy Group) n=3 Participants Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.	RA Participants (Combination Therapy Group) n=28 Participants Participants with severe RA, were prescribed with disease-modifying anti-rheumatic drug (DMARD) at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.	RA Participants (All Groups) n=31 Participants Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
Change From Baseline in Physician Global Assessment of Disease Activity at Months 3 and 6 Baseline (n= 25, 6, 3, 28, 31)	65.2 mm Standard Deviation 24.53	63.3 mm Standard Deviation 9.61	69.0 mm Standard Deviation 9.00	64.4 mm Standard Deviation 23.33	64.9 mm Standard Deviation 22.30
Change From Baseline in Physician Global Assessment of Disease Activity at Months 3 and 6 Change at Month 3 (n= 13, 4, 2, 15, 17)	-40.8 mm Standard Deviation 24.07	-33.8 mm Standard Deviation 11.56	-43.5 mm Standard Deviation 4.95	-38.6 mm Standard Deviation 23.05	-39.2 mm Standard Deviation 21.66
Change From Baseline in Physician Global Assessment of Disease Activity at Months 3 and 6 Change at Month 6 (n= 13, 2, 2, 13, 15)	-35.2 mm Standard Deviation 28.12	-38.5 mm Standard Deviation 13.44	-45.5 mm Standard Deviation 23.33	-34.2 mm Standard Deviation 27.27	-35.7 mm Standard Deviation 26.31

SECONDARY outcome

Timeframe: Baseline, Month 3, Month 6

Population: FAS population. Here, Number of participants analyzed = participants evaluable for the outcome measure and n= participants with available data at the specified visit.

The patient's global assessment of disease activity was measured using a 100 mm VAS, where the responses were on a continuous range from 0= managing very well and 100 = managing very poorly.

Outcome measures

Outcome measures
Measure	RA Participants (Biologic Naïve Group) n=24 Participants Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.	RA Participants (Biologic Exposed Group) n=6 Participants Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.	RA Participants (Monotherapy Group) n=3 Participants Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.	RA Participants (Combination Therapy Group) n=27 Participants Participants with severe RA, were prescribed with disease-modifying anti-rheumatic drug (DMARD) at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.	RA Participants (All Groups) n=30 Participants Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
Change From Baseline in Patient Global Assessment of Disease Activity at Months 3 and 6 Baseline (n=24, 6, 3, 27, 30)	69.6 mm Standard Deviation 29.71	59.0 mm Standard Deviation 33.03	85.0 mm Standard Deviation 11.36	65.5 mm Standard Deviation 31.02	67.5 mm Standard Deviation 30.11
Change From Baseline in Patient Global Assessment of Disease Activity at Months 3 and 6 Change at Month 3 (n= 16, 4, 2, 18, 20 )	-43.2 mm Standard Deviation 35.87	-34.5 mm Standard Deviation 18.70	-50.0 mm Standard Deviation 16.97	-40.5 mm Standard Deviation 34.42	-41.5 mm Standard Deviation 32.92
Change From Baseline in Patient Global Assessment of Disease Activity at Months 3 and 6 Change at Month 6 (n= 13, 2, 2, 13, 15)	-26.4 mm Standard Deviation 31.28	-37.0 mm Standard Deviation 33.94	-32.0 mm Standard Deviation 26.87	-27.2 mm Standard Deviation 32.05	-27.8 mm Standard Deviation 30.57

SECONDARY outcome

Timeframe: Baseline, Month 3, Month 6

Population: FAS population. Here, Number of participants analyzed = participants evaluable for the outcome measure and n = participants with available HAQ-DI score at specified visit.

The HAQ-DI is a questionnaire that measures functional status (disability) and health-related quality of life. It measures the participant's ability to perform everyday tasks. The index consists of 20 questions regarding the function of the upper and lower extremities. These questions are summarized in 8 categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip and common activities over past week. Each question was evaluated according to the degree of severity on a 4-point scale ranging from 0 = without any difficulty to 3 = unable to do. Total score is the sum of each question, which ranges from 0 to 60, where higher scores represent higher disease activity. The change from baseline in HAQ-DI score at Month 3 and Month 6 was calculated as the difference between HAQ-D1 score reported at baseline and the HAQ-D1 score reported at Month 3 and Month 6.

Outcome measures

Outcome measures
Measure	RA Participants (Biologic Naïve Group) n=24 Participants Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.	RA Participants (Biologic Exposed Group) n=6 Participants Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.	RA Participants (Monotherapy Group) n=3 Participants Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.	RA Participants (Combination Therapy Group) n=27 Participants Participants with severe RA, were prescribed with disease-modifying anti-rheumatic drug (DMARD) at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.	RA Participants (All Groups) n=30 Participants Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
Change From Baseline in HAQ-DI Score at Months 3 and 6 Change at Month 3 (n= 16, 4, 2, 18, 20)	-0.5 units on a scale Standard Deviation 0.94	-0.4 units on a scale Standard Deviation 0.37	-0.3 units on a scale Standard Deviation 0.35	-0.5 units on a scale Standard Deviation 0.89	-0.5 units on a scale Standard Deviation 0.85
Change From Baseline in HAQ-DI Score at Months 3 and 6 Baseline (n= 24, 6, 3, 27, 30)	1.7 units on a scale Standard Deviation 0.86	1.7 units on a scale Standard Deviation 0.98	1.7 units on a scale Standard Deviation 0.59	1.7 units on a scale Standard Deviation 0.90	1.7 units on a scale Standard Deviation 0.87
Change From Baseline in HAQ-DI Score at Months 3 and 6 Change at Month 6 (n= 12, 2, 2, 12, 14)	-0.3 units on a scale Standard Deviation 0.48	-0.6 units on a scale Standard Deviation 0.35	-0.4 units on a scale Standard Deviation 0.09	-0.3 units on a scale Standard Deviation 0.51	-0.3 units on a scale Standard Deviation 0.46

SECONDARY outcome

Timeframe: Baseline, Month 3, Month 6

Population: FAS population. Here, Number of participants analyzed = participants evaluable for the outcome measure and n= participants with available data at the specified visit.

Participants measured the level of fatigue due to RA using a 100 mm VAS, where the responses were on a continuous range from 0 = no fatigue to 100 = extreme fatigue.

Outcome measures

Outcome measures
Measure	RA Participants (Biologic Naïve Group) n=25 Participants Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.	RA Participants (Biologic Exposed Group) n=6 Participants Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.	RA Participants (Monotherapy Group) n=3 Participants Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.	RA Participants (Combination Therapy Group) n=28 Participants Participants with severe RA, were prescribed with disease-modifying anti-rheumatic drug (DMARD) at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.	RA Participants (All Groups) n=31 Participants Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
Change From Baseline in VAS-Fatigue at Months 3 and 6 Baseline (n= 25, 6, 3, 28, 31)	59.0 mm Standard Deviation 34.35	67.8 mm Standard Deviation 27.01	86.3 mm Standard Deviation 8.08	58.0 mm Standard Deviation 33.35	60.7 mm Standard Deviation 32.84
Change From Baseline in VAS-Fatigue at Months 3 and 6 Change at Month 3 (n= 16, 4, 2, 18, 20)	-23.2 mm Standard Deviation 29.90	-37.8 mm Standard Deviation 24.93	-38.5 mm Standard Deviation 13.44	-24.7 mm Standard Deviation 30.13	-26.1 mm Standard Deviation 28.98
Change From Baseline in VAS-Fatigue at Months 3 and 6 Change at Month 6 (n=12, 2, 2, 12, 14)	-19.8 mm Standard Deviation 29.81	-34.0 mm Standard Deviation 22.63	-51.5 mm Standard Deviation 2.12	-16.8 mm Standard Deviation 27.91	-21.8 mm Standard Deviation 28.60

SECONDARY outcome

Timeframe: Baseline, Month 3, Month 6

Population: FAS population. Here, Number of participants analyzed = participants evaluable for the outcome measure and n = participants with available data for the specified visit.

Participants measured the pain intensity due to RA using a 100 mm VAS, where the responses were on a continuous range from 0 = no pain to 100 = unbearable pain.

Outcome measures

Outcome measures
Measure	RA Participants (Biologic Naïve Group) n=25 Participants Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.	RA Participants (Biologic Exposed Group) n=6 Participants Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.	RA Participants (Monotherapy Group) n=3 Participants Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.	RA Participants (Combination Therapy Group) n=28 Participants Participants with severe RA, were prescribed with disease-modifying anti-rheumatic drug (DMARD) at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.	RA Participants (All Groups) n=31 Participants Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
Change From Baseline in Patient's Assessment of Pain at Months 3 and 6 Change at Month 3 (n= 16, 4, 2, 18, 20)	-35.6 mm Standard Deviation 39.39	-15.8 mm Standard Deviation 26.99	-39.5 mm Standard Deviation 14.85	-30.8 mm Standard Deviation 39.38	-31.17 mm Standard Deviation 37.50
Change From Baseline in Patient's Assessment of Pain at Months 3 and 6 Baseline (n= 25, 6, 3, 28, 31)	60.1 mm Standard Deviation 31.08	47.2 mm Standard Deviation 31.93	79.3 mm Standard Deviation 19.55	55.3 mm Standard Deviation 31.49	57.6 mm Standard Deviation 31.14
Change From Baseline in Patient's Assessment of Pain at Months 3 and 6 Change at Month 6 (n= 13, 2, 2, 13, 15)	-32.3 mm Standard Deviation 34.88	-47.0 mm Standard Deviation 14.14	-51.5 mm Standard Deviation 7.78	-31.6 mm Standard Deviation 34.68	-34.3 mm Standard Deviation 32.93

SECONDARY outcome

Timeframe: Baseline, Month 3, Month 6

Population: FAS population. Here, Number of participants analyzed = participants evaluable for the outcome measure and n= participants with available data at the specified visit.

The participant assessment of morning stiffness was measured using a ruler on a 100 mm VAS, where the responses were on a continuous range from 0 = no stiffness and 100 = maximum stiffness.

Outcome measures

Outcome measures
Measure	RA Participants (Biologic Naïve Group) n=25 Participants Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.	RA Participants (Biologic Exposed Group) n=6 Participants Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.	RA Participants (Monotherapy Group) n=3 Participants Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.	RA Participants (Combination Therapy Group) n=28 Participants Participants with severe RA, were prescribed with disease-modifying anti-rheumatic drug (DMARD) at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.	RA Participants (All Groups) n=31 Participants Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
Change From Baseline in Participant Assessment of Morning Stiffness Using VAS at Months 3 and 6 Baseline (n= 25, 6, 3, 28, 31)	65.6 mm Standard Deviation 31.29	57.3 mm Standard Deviation 29.92	77.3 mm Standard Deviation 22.03	62.5 mm Standard Deviation 31.46	64.0 mm Standard Deviation 30.71
Change From Baseline in Participant Assessment of Morning Stiffness Using VAS at Months 3 and 6 Change at Month 3 (n= 15, 4, 2, 17, 19)	-30.7 mm Standard Deviation 37.88	-34.0 mm Standard Deviation 17.80	-42.5 mm Standard Deviation 14.85	-30.1 mm Standard Deviation 35.86	-31.4 mm Standard Deviation 34.21
Change From Baseline in Participant Assessment of Morning Stiffness Using VAS at Months 3 and 6 Change at Month 6 (n= 12, 2, 2, 12, 14)	-30.2 mm Standard Deviation 35.88	-38.0 mm Standard Deviation 14.14	-31.5 mm Standard Deviation 4.95	-31.3 mm Standard Deviation 36.23	-31.3 mm Standard Deviation 33.35

Adverse Events

RA Participants (All Groups)

Serious events: 2 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	RA Participants (All Groups) n=37 participants at risk Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
Infections and infestations Mycoplasma infection	2.7% 1/37 • Adverse events (AEs) were recorded from enrollment up to 6 months (final visit).
Nervous system disorders Cerebrovascular accident	2.7% 1/37 • Adverse events (AEs) were recorded from enrollment up to 6 months (final visit).
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	2.7% 1/37 • Adverse events (AEs) were recorded from enrollment up to 6 months (final visit).

Other adverse events

Other adverse events
Measure	RA Participants (All Groups) n=37 participants at risk Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
Blood and lymphatic system disorders Neutropenia	8.1% 3/37 • Adverse events (AEs) were recorded from enrollment up to 6 months (final visit).
Gastrointestinal disorders Nausea	10.8% 4/37 • Adverse events (AEs) were recorded from enrollment up to 6 months (final visit).
Gastrointestinal disorders Vomiting	5.4% 2/37 • Adverse events (AEs) were recorded from enrollment up to 6 months (final visit).
Infections and infestations Upper respiratory tract infection	8.1% 3/37 • Adverse events (AEs) were recorded from enrollment up to 6 months (final visit).
Injury, poisoning and procedural complications Contusion	5.4% 2/37 • Adverse events (AEs) were recorded from enrollment up to 6 months (final visit).
Injury, poisoning and procedural complications Infusion related reaction	5.4% 2/37 • Adverse events (AEs) were recorded from enrollment up to 6 months (final visit).
Investigations Alanine aminotransferase increased	5.4% 2/37 • Adverse events (AEs) were recorded from enrollment up to 6 months (final visit).
Metabolism and nutrition disorders Hypercholesterolaemia	5.4% 2/37 • Adverse events (AEs) were recorded from enrollment up to 6 months (final visit).
Musculoskeletal and connective tissue disorders Arthralgia	5.4% 2/37 • Adverse events (AEs) were recorded from enrollment up to 6 months (final visit).
Musculoskeletal and connective tissue disorders Pain in extremity	5.4% 2/37 • Adverse events (AEs) were recorded from enrollment up to 6 months (final visit).
Nervous system disorders Paraesthesia	5.4% 2/37 • Adverse events (AEs) were recorded from enrollment up to 6 months (final visit).
Vascular disorders Hypertension	8.1% 3/37 • Adverse events (AEs) were recorded from enrollment up to 6 months (final visit).

Additional Information

Medical Communications

HoffmannLaRoche

Phone: 800-821-8590

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Publication restrictions are in place

Restriction type: OTHER