Trial Outcomes & Findings for An Observational Study of the Impact of RoActemra/Actemra on Fatigue in Patients With Rheumatoid Arthritis (PEPS) (NCT NCT01185522)

Last Updated: 2016-06-23

Results Overview

Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue score assesses self-reported fatigue and its impact upon daily activities and function. It is calculated with 13-item questionnaire on 5-point scale: 0 (not at all) to 4 (very much). The larger the participant's response to the questions (exception of 2 negatively stated), the greater the participants fatigue. For all questions (except for 2 negatively stated), the code is reversed and a new score is calculated as 4 minus the participant's response. The sum of all responses resulted a total possible score of 0 (worse score) to 52 (better score). A higher score reflects an improvement in the participant's health status. Clinically relevant improvement is defined as a \>= 4-point change from Baseline. This was performed using the last observation carried forward (LOCF) method and for participants who completed a FACIT-Fatigue score at Month 4 (completers).

Recruitment status

COMPLETED

Target enrollment

719 participants

Primary outcome timeframe

At Month 4

Results posted on

2016-06-23

Participant Flow

A total of 719 participants were enrolled in this study conducted from Jan 2010 to May 2011 at 20 centers in France

Of 719 participants, 25 did not respect inclusion criteria (age less than 18 years or missing age, no or missing attestation of information about the study) and one did not receive any tocilizumab (RoActemra®) infusion.

Participant milestones

Participant milestones
Measure	Tocilizumab Eligible participants who were receiving tocilizumab according to summary of product characteristics in a real life setting were observed for 4 months.
Overall Study STARTED	693
Overall Study COMPLETED	585
Overall Study NOT COMPLETED	108

Reasons for withdrawal

Reasons for withdrawal
Measure	Tocilizumab Eligible participants who were receiving tocilizumab according to summary of product characteristics in a real life setting were observed for 4 months.
Overall Study Lack of Efficacy	28
Overall Study Lost to Follow-up	19
Overall Study Withdrawal by Subject	10
Overall Study Poor tolerance	39
Overall Study Other reasons	12

Baseline Characteristics

An Observational Study of the Impact of RoActemra/Actemra on Fatigue in Patients With Rheumatoid Arthritis (PEPS)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tocilizumab n=693 Participants Participants who received tocilizumab according to summary of product characteristics in a real life setting were observed for 4 months.
Age, Continuous	55.65 Year STANDARD_DEVIATION 13.09 • n=5 Participants
Sex/Gender, Customized Female	561 participants n=5 Participants
Sex/Gender, Customized Male	125 participants n=5 Participants
Sex/Gender, Customized Missing	7 participants n=5 Participants

PRIMARY outcome

Timeframe: At Month 4

Population: Patient analysis population consisted of all participants included in the study, who respected inclusion criteria, received at least one tocilizumab infusion, had an evaluable FACIT-Fatigue score at inclusion, and at least one evaluable FACIT fatigue score during treatment.

Outcome measures

Outcome measures
Measure	Tocilizumab n=610 Participants Eligible participants who were receiving tocilizumab according to summary of product characteristics in a real life setting were observed for 4 months.
Percentage of Participants With a Clinically Significant Improvement in Fatigue After 4 Months of Tocilizumab Treatment	63.3 Percentage of participants Interval 58.7 to 67.9

PRIMARY outcome

Timeframe: At Month 4

Population: Patient analysis population was considered. Participants whom baseline characteristics were available at inclusion and who completed a FACIT-Fatigue score at Month 4 and had clinically significant improvement in fatigue with respect to predictive factors were analyzed for this outcome measure.

Predictive factors of fatigue were taken into account included gender, age, time since initial diagnosis, Erosive RA, disease activity score (DAS, ranging from 0 \[no disease activity\] to 10 \[worsening in disease activity\]), erythrocyte sedimentation rate (ESR), anemia, treatment with corticosteroids, doses of corticosteroids, health assessment questionnaire (HAQ, ranging from 0 \[without any difficulty\] to 60 \[worsening or unable to do physical activities\]), FACIT-Fatigue score (ranging from 0 \[worse score\] to 52 \[better score\]), visual analogue score (VAS) for fatigue, pain, quality of sleep, and global assessment (ranging from 0 \[symptom-free and no arthritis symptoms\] to 100 \[worsening of symptoms and arthritis disease activity\]), Short Form 36 (SF36) vitality score (ranging from 0 \[worst\] to 100 \[best\]), Hospital Anxiety and Depression Scale (HADS; represented as score \</= 7 \[no case\], 7 to 10 \[doubtful case\], and \> 10 \[certain case of HAD\]).

Outcome measures

Outcome measures
Measure	Tocilizumab n=264 Participants Eligible participants who were receiving tocilizumab according to summary of product characteristics in a real life setting were observed for 4 months.
Number of Participants With Clinically Significant Improvement in Fatigue at Month 4 With Respect to Predictive Factors Erosive RA	187 Number of participants
Number of Participants With Clinically Significant Improvement in Fatigue at Month 4 With Respect to Predictive Factors DAS-28 (<= 5.1)	87 Number of participants
Number of Participants With Clinically Significant Improvement in Fatigue at Month 4 With Respect to Predictive Factors DAS-28 (> 5.1)	158 Number of participants
Number of Participants With Clinically Significant Improvement in Fatigue at Month 4 With Respect to Predictive Factors ESR (<= 28 mm/h)	134 Number of participants
Number of Participants With Clinically Significant Improvement in Fatigue at Month 4 With Respect to Predictive Factors ESR (> 28 mm/h)	118 Number of participants
Number of Participants With Clinically Significant Improvement in Fatigue at Month 4 With Respect to Predictive Factors Anemia	69 Number of participants
Number of Participants With Clinically Significant Improvement in Fatigue at Month 4 With Respect to Predictive Factors Corticosteroids treatment	178 Number of participants
Number of Participants With Clinically Significant Improvement in Fatigue at Month 4 With Respect to Predictive Factors HAQ score (<= 1.5)	118 Number of participants
Number of Participants With Clinically Significant Improvement in Fatigue at Month 4 With Respect to Predictive Factors HAQ score (> 1.5)	146 Number of participants
Number of Participants With Clinically Significant Improvement in Fatigue at Month 4 With Respect to Predictive Factors VAS patient: fatigue (<= 66)	115 Number of participants
Number of Participants With Clinically Significant Improvement in Fatigue at Month 4 With Respect to Predictive Factors VAS patient: fatigue (> 66)	146 Number of participants
Number of Participants With Clinically Significant Improvement in Fatigue at Month 4 With Respect to Predictive Factors VAS patient: pain (<= 66)	109 Number of participants
Number of Participants With Clinically Significant Improvement in Fatigue at Month 4 With Respect to Predictive Factors VAS patient: pain (> 66)	150 Number of participants
Number of Participants With Clinically Significant Improvement in Fatigue at Month 4 With Respect to Predictive Factors VAS patient: quality of sleep (<= 30)	62 Number of participants
Number of Participants With Clinically Significant Improvement in Fatigue at Month 4 With Respect to Predictive Factors VAS patient: quality of sleep (30 to 59)	60 Number of participants
Number of Participants With Clinically Significant Improvement in Fatigue at Month 4 With Respect to Predictive Factors VAS patient: quality of sleep (59 to 77) (n=264)	60 Number of participants
Number of Participants With Clinically Significant Improvement in Fatigue at Month 4 With Respect to Predictive Factors VAS patient: quality of sleep (> 77) (n=264)	76 Number of participants
Number of Participants With Clinically Significant Improvement in Fatigue at Month 4 With Respect to Predictive Factors VAS patient: global assessment (<= 67)	112 Number of participants
Number of Participants With Clinically Significant Improvement in Fatigue at Month 4 With Respect to Predictive Factors VAS patient: global assessment (> 67)	146 Number of participants
Number of Participants With Clinically Significant Improvement in Fatigue at Month 4 With Respect to Predictive Factors SF36 vitality score (> 33)	107 Number of participants
Number of Participants With Clinically Significant Improvement in Fatigue at Month 4 With Respect to Predictive Factors SF36 vitality score (<= 33)	145 Number of participants
Number of Participants With Clinically Significant Improvement in Fatigue at Month 4 With Respect to Predictive Factors HADS score: Anxiety (No case)	80 Number of participants
Number of Participants With Clinically Significant Improvement in Fatigue at Month 4 With Respect to Predictive Factors HADS score: Anxiety (Doubtful case)	61 Number of participants
Number of Participants With Clinically Significant Improvement in Fatigue at Month 4 With Respect to Predictive Factors HADS score: Anxiety (Certain case)	103 Number of participants
Number of Participants With Clinically Significant Improvement in Fatigue at Month 4 With Respect to Predictive Factors HADS score: Depression (No case)	114 Number of participants
Number of Participants With Clinically Significant Improvement in Fatigue at Month 4 With Respect to Predictive Factors HADS score: Depression (Doubtful case)	69 Number of participants
Number of Participants With Clinically Significant Improvement in Fatigue at Month 4 With Respect to Predictive Factors HADS score: Depression (Certain case)	69 Number of participants
Number of Participants With Clinically Significant Improvement in Fatigue at Month 4 With Respect to Predictive Factors Gender- female	214 Number of participants
Number of Participants With Clinically Significant Improvement in Fatigue at Month 4 With Respect to Predictive Factors Gender- male	46 Number of participants
Number of Participants With Clinically Significant Improvement in Fatigue at Month 4 With Respect to Predictive Factors Gender - missing	4 Number of participants
Number of Participants With Clinically Significant Improvement in Fatigue at Month 4 With Respect to Predictive Factors Age (<= 55 years)	139 Number of participants
Number of Participants With Clinically Significant Improvement in Fatigue at Month 4 With Respect to Predictive Factors Age (> 55 years)	125 Number of participants
Number of Participants With Clinically Significant Improvement in Fatigue at Month 4 With Respect to Predictive Factors Time since initial diagnosis (>= 10 years)	108 Number of participants
Number of Participants With Clinically Significant Improvement in Fatigue at Month 4 With Respect to Predictive Factors Time since initial diagnosis (< 10 years)	155 Number of participants

PRIMARY outcome

Timeframe: At Month 4

Population: Patient analysis population was considered. Participants who completed a FACIT-Fatigue score at Month 4 and had clinically significant improvement in fatigue with respect to predictive factors were analyzed for this outcome measure.

Predictive factors were characteristics of participants that indicated greater or lesser likelihood of responding to a specific treatment regimen. C-reactive protein (CRP) is one of the biomarkers for the diagnosis and assessment of disease activity in RA.

Outcome measures

Outcome measures
Measure	Tocilizumab n=264 Participants Eligible participants who were receiving tocilizumab according to summary of product characteristics in a real life setting were observed for 4 months.
Median Clinically Significant Improvement in C-Reactive Protein as a Predictive Factors After 4 Months of Tocilizumab Treatment	13.0 milligram per liter Interval 5.0 to 32.3

PRIMARY outcome

Timeframe: At Month 4

Predictive factors were characteristics of participants that indicated greater or lesser likelihood of responding to a specific treatment regimen. For tender joint count (TJC), a total of 68 joints were assessed. The presence of a tender joint was scored as 1 and absence as 0. Total score is calculated by adding the scores, which is ranging from 0 (best possible score or no tender joint) to 68 (worse possible score or all tender joints). Lower scores indicate no tender joint and higher scores indicate worsening tender joints. For swollen joint count (SJC), a total of 66 joints were assessed. The presence of a tender joint was scored as 1 and absence as 0. Total score is calculated by adding the scores, which is ranging from 0 (best possible score or no swollen joint) to 66 (worse possible score or all swollen joints). Lower scores indicate no swollen joint and higher scores indicate worsening swollen joints.

Outcome measures

Outcome measures
Measure	Tocilizumab n=264 Participants Eligible participants who were receiving tocilizumab according to summary of product characteristics in a real life setting were observed for 4 months.
Mean Clinically Significant Improvement in Tender Joints and Swollen Joints as Predictive Factors After 4 Months of Tocilizumab Treatment Number of tender joints	10.02 Number of joints Standard Deviation 6.72
Mean Clinically Significant Improvement in Tender Joints and Swollen Joints as Predictive Factors After 4 Months of Tocilizumab Treatment Number of swollen joints	7.28 Number of joints Standard Deviation 5.36

SECONDARY outcome

Timeframe: Baseline (Day [D] 0)

Population: Patient analysis population was considered. Participants for whom data of disease duration was available at baseline were analyzed for this outcome measure.

Mean disease (rheumatoid arthritis) duration at inclusion was recorded for all participants as baseline disease characteristics.

Outcome measures

Outcome measures
Measure	Tocilizumab n=609 Participants Eligible participants who were receiving tocilizumab according to summary of product characteristics in a real life setting were observed for 4 months.
Baseline Disease Characteristics: Mean Disease Duration	11.7 years Standard Deviation 9.5

SECONDARY outcome

Timeframe: Baseline (D0)

Population: Patient analysis population was considered. Participants with positive RF and/or anti-CCP antibodies at baseline were analyzed for this outcome measure.

Blood was collected for Rheumatoid Factor (RF) at Baseline and was analyzed. RF level was reported in international units/milliliter (IU/mL). All participants were assessed for anti-cyclic citrullinated protein (anti-CCP) antibodies at baseline. Number of participants with a positive RF and/or anti-CCP antibodies were reported as baseline disease characteristics.

Outcome measures

Outcome measures
Measure	Tocilizumab n=572 Participants Eligible participants who were receiving tocilizumab according to summary of product characteristics in a real life setting were observed for 4 months.
Baseline Disease Characteristics: Number of Participants With Positive Rheumatoid Factor and/or Anti-cyclic Citrullinated Protein Antibodies	463 Number of Participants

SECONDARY outcome

Timeframe: Baseline (D0)

Population: Patient analysis population was considered. n = number of participants available for particular parameters.

For tender joint count, a total of 68 joints were assessed. The presence of a tender joint was scored as 1 and absence as 0. Total score is calculated by adding the scores, which is ranging from 0 (best possible score or no tender joint) to 68 (worse possible score or all tender joints). Lower scores indicate no tender joint and higher scores indicate worsening tender joints. For swollen joint count, a total of 66 joints were assessed. The presence of a tender joint was scored as 1 and absence as 0. Total score is calculated by adding the scores, which is ranging from 0 (best possible score or no swollen joint) to 66 (worse possible score or all swollen joints). Lower scores indicate no swollen joint and higher scores indicate worsening swollen joints. Tender joint count and swollen joint count were assessed at baseline and were used as baseline disease characteristics for assessment of rheumatoid arthritis.

Outcome measures

Outcome measures
Measure	Tocilizumab n=606 Participants Eligible participants who were receiving tocilizumab according to summary of product characteristics in a real life setting were observed for 4 months.
Baseline Disease Characteristics: Tender Joint Count and Swollen Joint Count TJC (n = 606)	9.9 Number of joints Standard Deviation 6.6
Baseline Disease Characteristics: Tender Joint Count and Swollen Joint Count SJC (n = 605)	6.6 Number of joints Standard Deviation 5.1

SECONDARY outcome

Timeframe: Baseline (D0)

DAS28 is a combined index for measuring disease activity in RA. The index includes swollen (range 0-28) and tender (range 0-28) joint counts, acute phase response (ESR in mm/h), and patient's global assessment of disease activity (measured on a 100-mm visual analog scale, where 0 is no disease activity and 100 is maximum disease activity). The DAS28 scale ranges from 0 to 10, where higher scores indicate worsening disease activity. VAS pain score calculated as 0 to 10 cm; where 0 = no pain, and 10 = worst possible pain. HAQ indicates how the disease affected participant's activities of daily life. It consisted of 20 questions in 8 domains (dressing/grooming, arising, eating, walking, hygiene, reach, grip; common daily activities) rated on a 4-point scale, 0=without any difficulty to 3=unable to do. Sum of scores was divided by number of domains with a score for a total possible score of 0 (best/no difficulties to perform activities) to 3 (worst/ unable to perform activities at all).

Outcome measures

Outcome measures
Measure	Tocilizumab n=608 Participants Eligible participants who were receiving tocilizumab according to summary of product characteristics in a real life setting were observed for 4 months.
Baseline Disease Characteristic: DAS28, Patient's Global Assessment, VAS Pain and HAQ Score as Rheumatoid Arthritis Assessment Parameters DAS28 (n = 563)	5.3 Scores on a scale Standard Deviation 1.1
Baseline Disease Characteristic: DAS28, Patient's Global Assessment, VAS Pain and HAQ Score as Rheumatoid Arthritis Assessment Parameters Patient's global assessment (VAS) (n = 594)	63.9 Scores on a scale Standard Deviation 22.0
Baseline Disease Characteristic: DAS28, Patient's Global Assessment, VAS Pain and HAQ Score as Rheumatoid Arthritis Assessment Parameters VAS Pain (n = 597)	62.7 Scores on a scale Standard Deviation 22.8
Baseline Disease Characteristic: DAS28, Patient's Global Assessment, VAS Pain and HAQ Score as Rheumatoid Arthritis Assessment Parameters HAQ score (n = 608)	1.6 Scores on a scale Standard Deviation 0.7

SECONDARY outcome

Timeframe: Baseline (D0)

High Erythrocyte Sedimentation Rate (ESR) was defined as (1) for participants aged up to 50 years: \> 15 mm/h for men and \> 20 mm/h for women, and (2) for participants aged over 50 years: \> 20 mm/h for men and \> 25 mm/h for women. Anemia was defined as plasma hemoglobin level \<12 gram per deciliter (g/dL) for women and \<13 g/dL for men. The CRP test is evaluated for an acute phase reactant of inflammation. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. Patient-Acceptable Symptom State (PASS) that is defined as the highest level of symptom beyond which participants consider themselves well. PASS is a 1-question assessment of how rheumatoid arthritis has affected participant in last 48 hours.

Outcome measures

Outcome measures
Measure	Tocilizumab n=595 Participants Eligible participants who were receiving tocilizumab according to summary of product characteristics in a real life setting were observed for 4 months.
Baseline Disease Characteristic: Number of Participants With High Erythrocyte Sedimentation Rate, CRP Level, Anemia, and Unacceptable Patient Acceptable Symptom State Fatigue High ESR (n = 577)	307 Number of participants
Baseline Disease Characteristic: Number of Participants With High Erythrocyte Sedimentation Rate, CRP Level, Anemia, and Unacceptable Patient Acceptable Symptom State Fatigue CRP > 10 mg/L (n = 595)	278 Number of participants
Baseline Disease Characteristic: Number of Participants With High Erythrocyte Sedimentation Rate, CRP Level, Anemia, and Unacceptable Patient Acceptable Symptom State Fatigue Anemia (n = 574)	148 Number of participants
Baseline Disease Characteristic: Number of Participants With High Erythrocyte Sedimentation Rate, CRP Level, Anemia, and Unacceptable Patient Acceptable Symptom State Fatigue Unacceptable PASS fatigue (n = 578)	423 Number of participants

SECONDARY outcome

Timeframe: Baseline (D0)

FACIT-fatigue score and VAS fatigue score were fatigue assessment parameters. FACIT-Fatigue score assesses self-reported fatigue and its impact upon daily activities and function. It is calculated with 13-item questionnaire on 5-point scale, 0 (not at all) to 4 (very much). The larger the participant's response to the questions (exception of 2 negatively stated), the greater the participants fatigue. For all questions (except for 2 negatively stated), the code is reversed and a new score is calculated as 4 minus the participant's response. The sum of all responses results a total possible score of 0 (worse score) to 52 (better score). VAS fatigue score ranges from 0 (symptom-free and no arthritis symptoms) to 100 (worsening in symptoms and arthritis disease activity). Clinically relevant improvement is defined as \>/= 4-point change from Baseline.

Outcome measures

Outcome measures
Measure	Tocilizumab n=610 Participants Eligible participants who were receiving tocilizumab according to summary of product characteristics in a real life setting were observed for 4 months.
Baseline Disease Characteristic: Mean FACIT-Fatigue Score and VAS Fatigue Score FACIT-Fatigue score (n = 610 )	24.4 Scores on a scale Standard Deviation 10.5
Baseline Disease Characteristic: Mean FACIT-Fatigue Score and VAS Fatigue Score VAS Fatigue (n = 602)	61.3 Scores on a scale Standard Deviation 23.2

SECONDARY outcome

Timeframe: From Baseline (D0) to Month (M) 4

Population: Patient analysis population was considered. Participants with Changes in FACIT-Fatigue Score and VAS Fatigue at Month 4 were analyzed for this outcome measure.

Correlation between FACIT-Fatigue score and VAS fatigue was evaluated for all participants at inclusion and after 4 months of tocilizumab treatment (relative change from baseline) using a linear regression. FACIT-Fatigue score assesses self-reported fatigue and its impact upon daily activities and function. It is calculated with 13-item questionnaire on 5-point scale, 0 (not at all) to 4 (very much). The larger the participant's response to the questions (exception of 2 negatively stated), the greater the participants fatigue. For all questions (except for 2 negatively stated), the code is reversed and a new score is calculated as 4 minus the participant's response. The sum of all responses results a total possible score of 0 (worse score) to 52 (better score). VAS fatigue score ranging from 0 (symptom-free and no arthritis symptoms) to 100 (worsening in symptoms and arthritis disease activity)

Outcome measures

Outcome measures
Measure	Tocilizumab n=87 Participants Eligible participants who were receiving tocilizumab according to summary of product characteristics in a real life setting were observed for 4 months.
Correlation Between Relative Changes From Baseline of FACIT-Fatigue Score and VAS Fatigue to 4 Months of Tocilizumab Treatment	-0.1736 Correlation Coefficient

SECONDARY outcome

Timeframe: Up to Month 4

Population: Patient analysis population was considered. Participants with increase of at least 4 points of the FACIT-Fatigue score were analyzed for this outcome measure.

The time of onset of a clinically significant improvement of fatigue was defined as the time between the date of the first tocilizumab infusion and the date of the first increase of at least 4 points of the FACIT-Fatigue score (date of questionnaire completion) during 4 months of tocilizumab treatment. FACIT-Fatigue score assesses self-reported fatigue and its impact upon daily activities and function. It is calculated with 13-item questionnaire on 5-point scale, 0 (not at all) to 4 (very much). The larger the participant's response to the questions (exception of 2 negatively stated), the greater the participants fatigue. For all questions (except for 2 negatively stated), the code is reversed and a new score is calculated as 4 minus the participant's response. The sum of all responses results a total possible score of 0 (worse score) to 52 (better score).

Outcome measures

Outcome measures
Measure	Tocilizumab n=264 Participants Eligible participants who were receiving tocilizumab according to summary of product characteristics in a real life setting were observed for 4 months.
Median Time to Onset of an Improvement of the FACIT-Fatigue Score	1.0 Months Interval 1.0 to 1.3

SECONDARY outcome

Timeframe: From Baseline (D0) to M 1, M 2, M 3, and M 4

Population: Patient analysis population was considered. Participants with changes in DAS 28 up to Month 4 were analyzed for this outcome measure. n = number of participants available for particular parameters at specified time points.

Relative change from Baseline (BL) in DAS 28 was evaluated for all participants at each evaluation time (on raw data at inclusion; at Month 1, Month 2, Month 3, and Month 4 using a linear regression. DAS-28 and VAS patient's global assessment (PGA) were described as continuous variables for all participants at each evaluation time points (Baseline to M4). DAS 28 ranging from 0 (no disease activity) to 10 (worsening in disease activity) and VAS PGA ranging from 0 (symptom-free and no arthritis symptoms) to 100 (worsening of symptoms and arthritis disease activity),

Outcome measures

Outcome measures
Measure	Tocilizumab n=519 Participants Eligible participants who were receiving tocilizumab according to summary of product characteristics in a real life setting were observed for 4 months.
Relative Median Change From Baseline in DAS 28 and VAS Patient's Global Assessment to Month 1, Month 2, Month 3, and Month 4 Change from BL in VAS PGA at M4 (n=405)	-42.9 Percent change Interval -100.0 to 376.2
Relative Median Change From Baseline in DAS 28 and VAS Patient's Global Assessment to Month 1, Month 2, Month 3, and Month 4 Change from BL in DAS28 to M1 (n=462)	-30.9 Percent change Interval -84.0 to 71.0
Relative Median Change From Baseline in DAS 28 and VAS Patient's Global Assessment to Month 1, Month 2, Month 3, and Month 4 Change from BL in DAS-28 at M2 (n=431)	-40.5 Percent change Interval -91.5 to 45.8
Relative Median Change From Baseline in DAS 28 and VAS Patient's Global Assessment to Month 1, Month 2, Month 3, and Month 4 Change from BL in DAS-28 at M3 (n=416)	-46.1 Percent change Interval -92.3 to 89.9
Relative Median Change From Baseline in DAS 28 and VAS Patient's Global Assessment to Month 1, Month 2, Month 3, and Month 4 Change from BL in DAS-28 at M4 (n=366)	-48.4 Percent change Interval -98.8 to 62.7
Relative Median Change From Baseline in DAS 28 and VAS Patient's Global Assessment to Month 1, Month 2, Month 3, and Month 4 Change from BL in VAS PGA at M1 (n=519)	-21.7 Percent change Interval -100.0 to 700.0
Relative Median Change From Baseline in DAS 28 and VAS Patient's Global Assessment to Month 1, Month 2, Month 3, and Month 4 Change from BL in VAS PGA at M2 (n=477)	-34.8 Percent change Interval -100.0 to 1040.0
Relative Median Change From Baseline in DAS 28 and VAS Patient's Global Assessment to Month 1, Month 2, Month 3, and Month 4 Change from BL in VAS PGA at M3 (n=460)	-40.0 Percent change Interval -100.0 to 1060.0

SECONDARY outcome

Timeframe: From Baseline (D0) to M 1, M 2, M 3, and M 4

Population: Patient analysis population was considered. Participants with changes in TJC and SJC up to Month 4 were analyzed for this outcome measure. n = number of participants available for particular parameters at specified time points.

Relative change (RC) from Baseline (BL) in disease activity included TJC and SJC was evaluated as continuous variables for all participants at each evaluation time points. For tender joint count, a total of 68 joints were assessed. The presence of a tender joint was scored as 1 and absence as 0. Total score is calculated by adding the scores, which is ranging from 0 (best possible score or no tender joint) to 68 (worse possible score or all tender joints). Lower scores indicate no tender joint and higher scores indicate worsening tender joints. For swollen joint count, a total of 66 joints were assessed. The presence of a tender joint was scored as 1 and absence as 0. Total score is calculated by adding the scores, which is ranging from 0 (best possible score or no swollen joint) to 66 (worse possible score or all swollen joints). Lower scores indicate no swollen joint and higher scores indicate worsening swollen joints.

Outcome measures

Outcome measures
Measure	Tocilizumab n=578 Participants Eligible participants who were receiving tocilizumab according to summary of product characteristics in a real life setting were observed for 4 months.
Relative Median Change From Baseline in Disease Activity (Tender Joint Count and Swollen Joint Count) to Month 1, Month 2, Month 3, and Month 4 RC from BL of TJC at M1 (n=578)	-34.3 Percent change Interval -100.0 to 1600.0
Relative Median Change From Baseline in Disease Activity (Tender Joint Count and Swollen Joint Count) to Month 1, Month 2, Month 3, and Month 4 RC from BL of TJC at M2 (n=558)	-55.3 Percent change Interval -100.0 to 950.0
Relative Median Change From Baseline in Disease Activity (Tender Joint Count and Swollen Joint Count) to Month 1, Month 2, Month 3, and Month 4 RC from BL of TJC at M3 (n=537)	-66.7 Percent change Interval -100.0 to 550.0
Relative Median Change From Baseline in Disease Activity (Tender Joint Count and Swollen Joint Count) to Month 1, Month 2, Month 3, and Month 4 RC from BL of TJC at M4 (n=498)	-67.3 Percent change Interval -100.0 to 1200.0
Relative Median Change From Baseline in Disease Activity (Tender Joint Count and Swollen Joint Count) to Month 1, Month 2, Month 3, and Month 4 RC from BL of SJC at M1 (n=546)	-42.9 Percent change Interval -100.0 to 1100.0
Relative Median Change From Baseline in Disease Activity (Tender Joint Count and Swollen Joint Count) to Month 1, Month 2, Month 3, and Month 4 RC from BL of SJC at M2 (n=530)	-60.0 Percent change Interval -100.0 to 1300.0
Relative Median Change From Baseline in Disease Activity (Tender Joint Count and Swollen Joint Count) to Month 1, Month 2, Month 3, and Month 4 RC from BL of SJC at M3 (n=507)	-69.2 Percent change Interval -100.0 to 700.0
Relative Median Change From Baseline in Disease Activity (Tender Joint Count and Swollen Joint Count) to Month 1, Month 2, Month 3, and Month 4 RC from BL of SJC at M4 (n=470)	-75.0 Percent change Interval -100.0 to 700.0

SECONDARY outcome

Timeframe: From Baseline (D0) to M 1, M 2, M 3, and M 4

Population: Patient analysis population was considered. Participants with Changes in ESR values up to Month 4 were analyzed for this outcome measure. n = number of participants available at specified time points.

The correlation between fatigue and ESR value was evaluated for all participants at each evaluation time (on raw data at inclusion; on relative changes at M1 to M4) using a linear regression. ESR values were described as continuous variables for all participants at each evaluation time (Baseline to M4).

Outcome measures

Outcome measures
Measure	Tocilizumab n=537 Participants Eligible participants who were receiving tocilizumab according to summary of product characteristics in a real life setting were observed for 4 months.
Relative Median Change From Baseline in ESR to Month 1, Month 2, Month 3, and Month 4 M1 (n=537)	-70.0 Percent change Interval -97.9 to 860.0
Relative Median Change From Baseline in ESR to Month 1, Month 2, Month 3, and Month 4 M2 (n=530)	-75.0 Percent change Interval -98.8 to 600.0
Relative Median Change From Baseline in ESR to Month 1, Month 2, Month 3, and Month 4 M3 (n=514)	-78.1 Percent change Interval -98.9 to 385.7
Relative Median Change From Baseline in ESR to Month 1, Month 2, Month 3, and Month 4 M4 (n=476)	-78.6 Percent change Interval -100.0 to 1450.0

SECONDARY outcome

Timeframe: From Baseline (D0) to M 1, M 2, M 3, and M 4

Population: Patient analysis population was considered. Participants with Changes in CRP level up to Month 4 were analyzed for this outcome measure. n = number of participants available at specified time points.

The correlation between fatigue and CRP value was evaluated for all participants at each evaluation time (on raw data at inclusion; on relative changes at M1 to M4) using a linear regression. CRP values were described as continuous variables for all participants at each evaluation time (Baseline to M4).

Outcome measures

Outcome measures
Measure	Tocilizumab n=561 Participants Eligible participants who were receiving tocilizumab according to summary of product characteristics in a real life setting were observed for 4 months.
Relative Median Change From Baseline in C - Reacting Protein at Month 1, Month 2, Month 3, and Month 4 M1 (n=561)	-76.6 Percent change Interval -100.0 to 1600.0
Relative Median Change From Baseline in C - Reacting Protein at Month 1, Month 2, Month 3, and Month 4 M2 (n=549)	-80.0 Percent change Interval -100.0 to 1080.0
Relative Median Change From Baseline in C - Reacting Protein at Month 1, Month 2, Month 3, and Month 4 M3 (n=531)	-80.4 Percent change Interval -100.0 to 1005.3
Relative Median Change From Baseline in C - Reacting Protein at Month 1, Month 2, Month 3, and Month 4 M4 (n=493)	-81.3 Percent change Interval -100.0 to 2400.0

SECONDARY outcome

Timeframe: Baseline (D0) and Month 4

A PASS score at Day 0 and Month 4 calculated on participants with acceptable symptom state. PASS is defined as the highest level of symptom beyond which participants consider themselves well. PASS is a 1-question assessment of how rheumatoid arthritis has affected participant in last 48 hours.

Outcome measures

Outcome measures
Measure	Tocilizumab n=578 Participants Eligible participants who were receiving tocilizumab according to summary of product characteristics in a real life setting were observed for 4 months.
Number of Participants Achieving PASS Score at Baseline (Day 0) and Month 4 D0 (n=578)	155 Number of participants
Number of Participants Achieving PASS Score at Baseline (Day 0) and Month 4 M4 (n=403)	269 Number of participants

SECONDARY outcome

Timeframe: Baseline (D0) and Month 4

FACIT-Fatigue score (ranging from 0 \[worse score\] to 52 \[better score\]), VAS (ranging from 0 \[symptom-free and no arthritis symptoms\] to 100 \[worsening in arthritis disease activity\]) and SF36 vitality score (ranging from 0 \[worst\] to 100 \[best\]) were calculated at Baseline and Month 4.

Outcome measures

Outcome measures
Measure	Tocilizumab n=610 Participants Eligible participants who were receiving tocilizumab according to summary of product characteristics in a real life setting were observed for 4 months.
Percentage of Participants With FACIT-Fatigue Score, SF36 Vitality Score, and VAS Fatigue at Day 0 and Month 4 FACIT-Fatigue score at D0	39.0 Percentage of participants
Percentage of Participants With FACIT-Fatigue Score, SF36 Vitality Score, and VAS Fatigue at Day 0 and Month 4 FACIT-Fatigue score at M4	45.0 Percentage of participants
Percentage of Participants With FACIT-Fatigue Score, SF36 Vitality Score, and VAS Fatigue at Day 0 and Month 4 SF36 vitality score at D0	55.0 Percentage of participants
Percentage of Participants With FACIT-Fatigue Score, SF36 Vitality Score, and VAS Fatigue at Day 0 and Month 4 SF36 vitality score at M4	60.0 Percentage of participants
Percentage of Participants With FACIT-Fatigue Score, SF36 Vitality Score, and VAS Fatigue at Day 0 and Month 4 VAS fatigue at D0	61.0 Percentage of participants
Percentage of Participants With FACIT-Fatigue Score, SF36 Vitality Score, and VAS Fatigue at Day 0 and Month 4 VAS fatigue at M4	47.0 Percentage of participants

SECONDARY outcome

Timeframe: Day 0 and Month 4

Fatigue was assessed by FACIT-Fatigue scale (ranging from 0 \[worse score\] to 52 \[better score\]) and VAS fatigue (ranging from 0 \[symptom-free and no arthritis symptoms\] to 100 \[worsening of symptoms and arthritis disease activity\]). Other participant reported outcomes (PROs) were VAS for pain and quality of sleep (ranging from 0 \[symptom-free and no arthritis symptoms\] to 100 \[worsening in arthritis disease activity\]), SF36 vitality score (ranging from 0 \[worst\] to 100 \[best\]) and HAD score (calculated using the 14 items and each item was scored 0, 1, 2 or 3 where a score of 3 corresponds to the most anxious/depressed. 7-item depression and 7-item anxiety subscales were summed; each resulting in a total score of 0-21). Correlation between fatigue as assessed by FACIT-Fatigue score or VAS fatigue was evaluated for all participants using a linear regression and were reported for D0 and M4.

Outcome measures

Outcome measures
Measure	Tocilizumab n=610 Participants Eligible participants who were receiving tocilizumab according to summary of product characteristics in a real life setting were observed for 4 months.
Correlations Between Fatigue and Other Participant Reported Outcomes at Day 0 and Month 4 FACIT-Fatigue : VAS pain at D0	-0.4843 Coefficient of correlation
Correlations Between Fatigue and Other Participant Reported Outcomes at Day 0 and Month 4 FACIT-Fatigue : VAS pain at M4	-0.0656 Coefficient of correlation
Correlations Between Fatigue and Other Participant Reported Outcomes at Day 0 and Month 4 FACIT-Fatigue : VAS quality of sleep at D0	-0.4785 Coefficient of correlation
Correlations Between Fatigue and Other Participant Reported Outcomes at Day 0 and Month 4 FACIT-Fatigue : VAS quality of sleep at M4	-0.1339 Coefficient of correlation
Correlations Between Fatigue and Other Participant Reported Outcomes at Day 0 and Month 4 FACIT-Fatigue : SF36 vitality at D0	0.7536 Coefficient of correlation
Correlations Between Fatigue and Other Participant Reported Outcomes at Day 0 and Month 4 FACIT-Fatigue : SF36 vitality at M4	0.6720 Coefficient of correlation
Correlations Between Fatigue and Other Participant Reported Outcomes at Day 0 and Month 4 FACIT-Fatigue : HAQ score at D0	-0.5314 Coefficient of correlation
Correlations Between Fatigue and Other Participant Reported Outcomes at Day 0 and Month 4 FACIT-Fatigue : HAQ score at M4	-0.2248 Coefficient of correlation
Correlations Between Fatigue and Other Participant Reported Outcomes at Day 0 and Month 4 FACIT-Fatigue : HADS Anxiety score at D0	-0.4400 Coefficient of correlation
Correlations Between Fatigue and Other Participant Reported Outcomes at Day 0 and Month 4 FACIT-Fatigue : HADS Anxiety score at M4	-0.1584 Coefficient of correlation
Correlations Between Fatigue and Other Participant Reported Outcomes at Day 0 and Month 4 FACIT-Fatigue : HADS Depression score at D0	-0.5791 Coefficient of correlation
Correlations Between Fatigue and Other Participant Reported Outcomes at Day 0 and Month 4 FACIT-Fatigue : HADS Depression score at M4	-0.2817 Coefficient of correlation
Correlations Between Fatigue and Other Participant Reported Outcomes at Day 0 and Month 4 VAS fatigue : VAS pain at D0	0.6040 Coefficient of correlation
Correlations Between Fatigue and Other Participant Reported Outcomes at Day 0 and Month 4 VAS fatigue : VAS pain at M4	0.0273 Coefficient of correlation
Correlations Between Fatigue and Other Participant Reported Outcomes at Day 0 and Month 4 VAS fatigue : VAS quality of sleep at D0	0.4778 Coefficient of correlation
Correlations Between Fatigue and Other Participant Reported Outcomes at Day 0 and Month 4 VAS fatigue : VAS quality of sleep at M4	0.0708 Coefficient of correlation
Correlations Between Fatigue and Other Participant Reported Outcomes at Day 0 and Month 4 VAS fatigue : SF36 vitality at D0	-0.5741 Coefficient of correlation
Correlations Between Fatigue and Other Participant Reported Outcomes at Day 0 and Month 4 VAS fatigue : SF36 vitality at M4	-0.1268 Coefficient of correlation
Correlations Between Fatigue and Other Participant Reported Outcomes at Day 0 and Month 4 VAS fatigue : HAQ score at D0	0.3156 Coefficient of correlation
Correlations Between Fatigue and Other Participant Reported Outcomes at Day 0 and Month 4 VAS fatigue : HAQ score at M4	0.1320 Coefficient of correlation
Correlations Between Fatigue and Other Participant Reported Outcomes at Day 0 and Month 4 VAS fatigue : HADS Anxiety score at D0	0.2588 Coefficient of correlation
Correlations Between Fatigue and Other Participant Reported Outcomes at Day 0 and Month 4 VAS fatigue : HADS Anxiety score at M4	-0.0186 Coefficient of correlation
Correlations Between Fatigue and Other Participant Reported Outcomes at Day 0 and Month 4 VAS fatigue : HADS Depression score at D0	0.3278 Coefficient of correlation
Correlations Between Fatigue and Other Participant Reported Outcomes at Day 0 and Month 4 VAS fatigue : HADS Depression score at M4	0.0825 Coefficient of correlation

SECONDARY outcome

Timeframe: From Baseline (D0) to M 1, M 2, M 3, and M 4

Participants with tocilizumab treatment were managed according to number of tocilizumab treatment received according to Summary of Product Characteristics recommendations, as 8 mg/kg, dose duration of 1-hour, correct infusion progress; and received DMARD, methotrexate, and corticosteroids concomitantly with tocilizumab during Months 1 to 4.

Outcome measures

Outcome measures
Measure	Tocilizumab n=592 Participants Eligible participants who were receiving tocilizumab according to summary of product characteristics in a real life setting were observed for 4 months.
Number of Participants for Rheumatoid Arthritis Management With Tocilizumab Treatment up to Month 4 Concomitant corticosteroids, M4 (n = 512)	320 Number of Participants
Number of Participants for Rheumatoid Arthritis Management With Tocilizumab Treatment up to Month 4 Dose 8 mg/kg dose, M1 (n = 590)	558 Number of Participants
Number of Participants for Rheumatoid Arthritis Management With Tocilizumab Treatment up to Month 4 Dose 8 mg/kg dose, M2 (n = 575)	540 Number of Participants
Number of Participants for Rheumatoid Arthritis Management With Tocilizumab Treatment up to Month 4 Dose 8 mg/kg dose, M3 (n = 548)	511 Number of Participants
Number of Participants for Rheumatoid Arthritis Management With Tocilizumab Treatment up to Month 4 Dose 8 mg/kg dose, M4 (n = 512)	477 Number of Participants
Number of Participants for Rheumatoid Arthritis Management With Tocilizumab Treatment up to Month 4 Dose duration 60 minutes, M1 (n = 559)	472 Number of Participants
Number of Participants for Rheumatoid Arthritis Management With Tocilizumab Treatment up to Month 4 Dose duration 60 minutes, M2 (n = 547)	463 Number of Participants
Number of Participants for Rheumatoid Arthritis Management With Tocilizumab Treatment up to Month 4 Dose duration 60 minutes, M3 (n = 516)	433 Number of Participants
Number of Participants for Rheumatoid Arthritis Management With Tocilizumab Treatment up to Month 4 Dose duration 60 minutes, M4 (n = 494)	426 Number of Participants
Number of Participants for Rheumatoid Arthritis Management With Tocilizumab Treatment up to Month 4 Correct infusion progress, M1 (n = 527)	520 Number of Participants
Number of Participants for Rheumatoid Arthritis Management With Tocilizumab Treatment up to Month 4 Correct infusion progress, M2 (n = 516)	510 Number of Participants
Number of Participants for Rheumatoid Arthritis Management With Tocilizumab Treatment up to Month 4 Correct infusion progress, M3 (n = 485)	482 Number of Participants
Number of Participants for Rheumatoid Arthritis Management With Tocilizumab Treatment up to Month 4 Correct infusion progress, M4 (n = 447)	442 Number of Participants
Number of Participants for Rheumatoid Arthritis Management With Tocilizumab Treatment up to Month 4 Concomitant DMARD, M1 (n = 591)	389 Number of Participants
Number of Participants for Rheumatoid Arthritis Management With Tocilizumab Treatment up to Month 4 Concomitant DMARD, M2 (n = 577)	381 Number of Participants
Number of Participants for Rheumatoid Arthritis Management With Tocilizumab Treatment up to Month 4 Concomitant DMARD, M3 (n = 549)	359 Number of Participants
Number of Participants for Rheumatoid Arthritis Management With Tocilizumab Treatment up to Month 4 Concomitant DMARD, M4 (n = 512)	338 Number of Participants
Number of Participants for Rheumatoid Arthritis Management With Tocilizumab Treatment up to Month 4 Concomitant Methotrexate, M1 (n = 591)	346 Number of Participants
Number of Participants for Rheumatoid Arthritis Management With Tocilizumab Treatment up to Month 4 Concomitant Methotrexate, M2 (n = 577)	341 Number of Participants
Number of Participants for Rheumatoid Arthritis Management With Tocilizumab Treatment up to Month 4 Concomitant Methotrexate, M3 (n = 549)	325 Number of Participants
Number of Participants for Rheumatoid Arthritis Management With Tocilizumab Treatment up to Month 4 Concomitant Methotrexate, M4 (n = 512)	306 Number of Participants
Number of Participants for Rheumatoid Arthritis Management With Tocilizumab Treatment up to Month 4 Concomitant corticosteroids, M1 (n = 592)	391 Number of Participants
Number of Participants for Rheumatoid Arthritis Management With Tocilizumab Treatment up to Month 4 Concomitant corticosteroids, M2 (n = 577)	379 Number of Participants
Number of Participants for Rheumatoid Arthritis Management With Tocilizumab Treatment up to Month 4 Concomitant corticosteroids, M3 (n = 549)	349 Number of Participants

SECONDARY outcome

Timeframe: Up to 4 months

Population: Safety population consisted of all participants included in the study, who respected the inclusion and non-inclusion criteria and who at least one tocilizumab infusion.

An Any Adverse Events (AEs) is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. An Serious Adverse Events (SAEs) is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect.

Outcome measures

Outcome measures
Measure	Tocilizumab n=693 Participants Eligible participants who were receiving tocilizumab according to summary of product characteristics in a real life setting were observed for 4 months.
Number of Participants With Any Adverse Events and Serious Adverse Events Any AEs	272 Number of Participants
Number of Participants With Any Adverse Events and Serious Adverse Events Any SAEs	27 Number of Participants

Adverse Events

Tocilizumab

Serious events: 27 serious events

Other events: 117 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Tocilizumab n=693 participants at risk Eligible participants who were receiving tocilizumab according to summary of product characteristics in a real life setting were observed for 4 months.
Infections and infestations Arthritis bacterial	0.29% 2/693 • Up to Month 4 Adverse event is reported for safety population which consist of all participants who received at least one tocilizumab infusion.
Infections and infestations Diverticulitis	0.29% 2/693 • Up to Month 4 Adverse event is reported for safety population which consist of all participants who received at least one tocilizumab infusion.
Infections and infestations Appendicitis	0.14% 1/693 • Up to Month 4 Adverse event is reported for safety population which consist of all participants who received at least one tocilizumab infusion.
Infections and infestations Cellulitis	0.14% 1/693 • Up to Month 4 Adverse event is reported for safety population which consist of all participants who received at least one tocilizumab infusion.
Infections and infestations Implant site infection	0.14% 1/693 • Up to Month 4 Adverse event is reported for safety population which consist of all participants who received at least one tocilizumab infusion.
Infections and infestations Sepsis	0.14% 1/693 • Up to Month 4 Adverse event is reported for safety population which consist of all participants who received at least one tocilizumab infusion.
Infections and infestations Septic shock	0.14% 1/693 • Up to Month 4 Adverse event is reported for safety population which consist of all participants who received at least one tocilizumab infusion.
Infections and infestations Subdiaphragmatic abscess	0.14% 1/693 • Up to Month 4 Adverse event is reported for safety population which consist of all participants who received at least one tocilizumab infusion.
Blood and lymphatic system disorders Neutropenia	0.29% 2/693 • Up to Month 4 Adverse event is reported for safety population which consist of all participants who received at least one tocilizumab infusion.
Blood and lymphatic system disorders Anaemia	0.14% 1/693 • Up to Month 4 Adverse event is reported for safety population which consist of all participants who received at least one tocilizumab infusion.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.29% 2/693 • Up to Month 4 Adverse event is reported for safety population which consist of all participants who received at least one tocilizumab infusion.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.14% 1/693 • Up to Month 4 Adverse event is reported for safety population which consist of all participants who received at least one tocilizumab infusion.
Injury, poisoning and procedural complications Foot fracture	0.14% 1/693 • Up to Month 4 Adverse event is reported for safety population which consist of all participants who received at least one tocilizumab infusion.
Injury, poisoning and procedural complications Subdural haematoma	0.14% 1/693 • Up to Month 4 Adverse event is reported for safety population which consist of all participants who received at least one tocilizumab infusion.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Anal cancer	0.14% 1/693 • Up to Month 4 Adverse event is reported for safety population which consist of all participants who received at least one tocilizumab infusion.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Diffuse large B-cell lymphoma	0.14% 1/693 • Up to Month 4 Adverse event is reported for safety population which consist of all participants who received at least one tocilizumab infusion.
Nervous system disorders Headache	0.14% 1/693 • Up to Month 4 Adverse event is reported for safety population which consist of all participants who received at least one tocilizumab infusion.
Nervous system disorders Sciatica	0.14% 1/693 • Up to Month 4 Adverse event is reported for safety population which consist of all participants who received at least one tocilizumab infusion.
Surgical and medical procedures Meniscus removal	0.14% 1/693 • Up to Month 4 Adverse event is reported for safety population which consist of all participants who received at least one tocilizumab infusion.
Surgical and medical procedures Vascular operation	0.14% 1/693 • Up to Month 4 Adverse event is reported for safety population which consist of all participants who received at least one tocilizumab infusion.
Cardiac disorders Arteriospasm coronary	0.14% 1/693 • Up to Month 4 Adverse event is reported for safety population which consist of all participants who received at least one tocilizumab infusion.
Gastrointestinal disorders Intestinal perforation	0.14% 1/693 • Up to Month 4 Adverse event is reported for safety population which consist of all participants who received at least one tocilizumab infusion.
Gastrointestinal disorders Peritonitis	0.14% 1/693 • Up to Month 4 Adverse event is reported for safety population which consist of all participants who received at least one tocilizumab infusion.
General disorders Disease progression	0.14% 1/693 • Up to Month 4 Adverse event is reported for safety population which consist of all participants who received at least one tocilizumab infusion.
Immune system disorders Hypersensitivity	0.14% 1/693 • Up to Month 4 Adverse event is reported for safety population which consist of all participants who received at least one tocilizumab infusion.
Pregnancy, puerperium and perinatal conditions Pregnancy	0.14% 1/693 • Up to Month 4 Adverse event is reported for safety population which consist of all participants who received at least one tocilizumab infusion.
Skin and subcutaneous tissue disorders Rash erythematous	0.14% 1/693 • Up to Month 4 Adverse event is reported for safety population which consist of all participants who received at least one tocilizumab infusion.
Vascular disorders Thrombophlebitis	0.14% 1/693 • Up to Month 4 Adverse event is reported for safety population which consist of all participants who received at least one tocilizumab infusion.

Other adverse events

Other adverse events
Measure	Tocilizumab n=693 participants at risk Eligible participants who were receiving tocilizumab according to summary of product characteristics in a real life setting were observed for 4 months.
Infections and infestations Bronchitis	2.6% 18/693 • Up to Month 4 Adverse event is reported for safety population which consist of all participants who received at least one tocilizumab infusion.
Gastrointestinal disorders Aphthous stomatitis	2.6% 18/693 • Up to Month 4 Adverse event is reported for safety population which consist of all participants who received at least one tocilizumab infusion.
Skin and subcutaneous tissue disorders Pruritus	2.3% 16/693 • Up to Month 4 Adverse event is reported for safety population which consist of all participants who received at least one tocilizumab infusion.
General disorders Asthenia	2.7% 19/693 • Up to Month 4 Adverse event is reported for safety population which consist of all participants who received at least one tocilizumab infusion.
Nervous system disorders Headache	4.0% 28/693 • Up to Month 4 Adverse event is reported for safety population which consist of all participants who received at least one tocilizumab infusion.
Blood and lymphatic system disorders Neutropenia	3.3% 23/693 • Up to Month 4 Adverse event is reported for safety population which consist of all participants who received at least one tocilizumab infusion.
Hepatobiliary disorders Cytolytic hepatitis	2.0% 14/693 • Up to Month 4 Adverse event is reported for safety population which consist of all participants who received at least one tocilizumab infusion.

Additional Information

Roche Trial Information Hotline

F. Hoffmann-La Roche AG

Phone: +41 616878333

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