An Observational Study of RoActemra/Actemra (Tocilizumab) in Monotherapy in Patients With Rheumatoid Arthritis

Time frame: Month 6

Population: Safety Analysis Set

HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.

Time frame: Baseline, Month 3 and Month 6

Population: The FAS (HAQ) included all data from all participants who had at least a baseline value and one follow up value (Month 3 or Month 6) for HAQ.

The CDAI is the numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and PGA assessed on 0-10 cm VAS; 0 = no disease activity and 10 = worst disease activity. CDAI total score = 0-76. CDAI \<= 2.8 indicates clinical remission, \>2.8 to 10 = low disease activity, \>10 to 22 = moderate disease activity, and \>22 = high (or severe) disease activity.

Time frame: Baseline, Month 3, Month 6

Population: The FAS (CDAI) included all data from all participants who had at least a baseline value and one follow up value (Month 3 or Month 6) for CDAI. n = participants evaluable for this measure at specified timepoint.

DAS28-4 (CRP) was calculated from the SJC and TJC using the 28 joints count, CRP (milligram per liter \[mg/L\]) and patient global assessment (PtGA) of disease activity (measured on a 0 to 100 millimeter \[mm\] Visual Analog Scale \[VAS\]) where 0=no disease activity and 100=worst disease activity). DAS28-4 (CRP) was calculated using the following formula: DAS28-4 (CRP) = 0.56\*square root (sqrt) (TJC28) + 0.28\*sqrt(SJC28) + 0.36\*ln(CRP+1) + 0.014\*PtGA + 0.96. Total score range: 0 to 10, higher score indicated more disease activity. DAS28-4 (CRP) less than or equal to (\<= 3.2) implied low disease activity and greater than (\>) 3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (CRP) less than (\<) 2.6 = clinical remission.

Time frame: Baseline, Month 3, Month 6

Population: The FAS (DAS28-4 \[CRP\]) included all data from all participants who had at least a baseline value and one follow up value (Month 3 or Month 6) for DAS28-4 \[CRP\] assessment. n = participants evaluable for this measure at specified timepoint.

DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (millimeter per hour \[mm/hour\]), and PtGA of disease activity (measured on a 0 to 100 mm VAS where 0=no disease activity and 100=worst disease activity). DAS28-4 (ESR) = 0.56\*sqrt(TJC28) + 0.28\*sqrt(SJC28) + 0.70\*ln(ESR) + 0.014\*PtGA. Total score range: 0-10, higher score=more disease activity. DAS28-4 (ESR) \<= 3.2 implied low disease activity and \>3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (ESR) \<2.6 = clinical remission.

Time frame: Baseline, Month 3, Month 6

Population: The FAS (DAS28-4 \[ESR\]) included all data from all participants who had at least a baseline value and one follow up value (Month 3 or Month 6) for DAS28-4 \[ESR\] assessment. n = participants evaluable for this measure at specified timepoint.

ACR response: improvement in tender or swollen joint counts and improvement in 3 of the following 5 criteria: 1) PGA of disease activity, 2) PtGA of disease activity, 3) patient's assessment of pain, 4) patient's assessment of functional disability via a health assessment questionnaire, and 5) CRP at each visit. ACR response is based on 66/68 total joint count.

Time frame: Baseline to Month 6

Population: Data for ACR response was not reported because in clinical practice the 66/68 joint evaluation needed for this is not performed in the Sweden, Denmark and Norway, the 28 joint count is performed instead.

Time frame: Baseline to Month 6

Population: Safety Analysis Set

Patient Global Assessment of Pain was assessed using a 100 mm VAS (0 to 100) where 0 = no pain to 100 = worst possible pain.

Time frame: Baseline, Month 3, Month 6

Population: The FAS (VAS pain) included all data from all participants who had at least a baseline value and one follow up value (Month 3 or Month 6) for VAS pain. n = participants evaluable for this measure at specified timepoint.

Patient Global Assessment of Disease Activity was measured on a 0 to 100 mm VAS where 0=no disease activity and 100=worst disease activity.

Time frame: Baseline, Month 3, Month 6

Population: The FAS (VAS disease activity \[patient\]) included all data from all participants who had at least a baseline value and one follow up value (Month 3 or Month 6) for VAS disease activity (patient). n = participants evaluable for this measure at specified timepoint.

The CDAI is the numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and PGA assessed on 0-10 cm VAS; 0 = no disease activity and 10 = worst disease activity. CDAI total score = 0-76. CDAI \<= 2.8 indicates clinical remission, \>2.8 to 10 = low disease activity, \>10 to 22 = moderate disease activity, and \>22 = high (or severe) disease activity.

Time frame: Month 3 and Month 6

Population: FAS (CDAI). N (number of participants analyzed) = participants evaluable for this measure. n = participants evaluable for this measure at specified timepoint.

DAS28-4 (CRP) was calculated from the SJC and TJC using the 28 joints count, CRP (mg/L) and PtGA of disease activity (measured on a 0 to 100 mm VAS where 0=no disease activity and 100=worst disease activity). DAS28-4 (CRP) was calculated using the following formula: DAS28-4 (CRP) = 0.56\*sqrt(TJC28) + 0.28\*sqrt(SJC28) + 0.36\*ln(CRP+1) + 0.014\*PtGA + 0.96. Total score range: 0 to 10, higher score indicated more disease activity. DAS28-4 (CRP) \<= 3.2 implied low disease activity and \> 3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (CRP) \< 2.6 = clinical remission.

Time frame: Month 3 and Month 6

Population: FAS (DAS28-4 \[CRP\]). N (number of participants analyzed) = participants evaluable for this measure. n = participants evaluable for this measure at specified timepoint.

DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour), and PtGA of disease activity (measured on a 0 to 100 mm VAS where 0=no disease activity and 100=worst disease activity). DAS28-4 (ESR) = 0.56\*sqrt(TJC28) + 0.28\*sqrt(SJC28) + 0.70\*ln(ESR) + 0.014\*PtGA. Total score range: 0-10, higher score=more disease activity. DAS28-4 (ESR) \<= 3.2 implied low disease activity and \>3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (ESR) \<2.6 = clinical remission.

Time frame: Month 3 and Month 6

Population: FAS (DAS28-4 \[ESR\]). N (number of participants analyzed) = participants evaluable for this measure. n = participants evaluable for this measure at specified timepoint.

The SDAI is the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and PGA assessed on 0-10 cm VAS; 0 = no disease activity and 10 = worst disease activity, and CRP (mg/dL). SDAI total score = 0-86. SDAI \<=3.3 indicates clinical remission, \>3.4 to 11 = low disease activity, \>11 to 26 = moderate disease activity, and \>26 = high (or severe) disease activity.

Time frame: Month 3 and Month 6

Population: FAS (SDAI). N (number of participants analyzed) = participants evaluable for this measure. n = participants evaluable for this measure at specified timepoint.

A categorical scale (Lickert scale) with the following categories: none, mild, moderate, severe and maximal was used to evaluate disease activity in clinical practice.

Time frame: Baseline, Month 3, Month 6

Population: FAS (categorical scale \[physician\]) included all data from all participants who had at least a baseline value and one follow up value (Month 3 or Month 6) for rheumatoid arthritis illness categorical scale (physician). n = participants evaluable for this measure at specified timepoint.

Time frame: Baseline to Month 6

Population: Safety Analysis Set

Dose modification is any change in dose; this also included participants who stopped treatment with tocilizumab.

Time frame: Baseline to Month 6

Population: Safety Analysis Set

Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness. Duration was recorded as less than (\<) 30 minutes, 30 to 60 minutes, 60 to 120 minutes, 120 to 240 minutes, more than (\>) 240 minutes, or whole day.

Time frame: Baseline, Month 3, Month 6

Population: FAS (morning stiffness). N (number of participants analyzed) = participants evaluable for this measure. n = participants evaluable for this measure at specified timepoint.

The DAS28-4 (ESR) \[described in Outcome Measure 7\] based EULAR response criteria were used to measure individual response as good, moderate, or no response depending on the extent of change from baseline in DAS28 score and the level of disease activity (low, moderate or high) reached. Good responders: change from baseline \>1.2 with DAS28 \<= 3.2; moderate responders: change from baseline \>1.2 with DAS28 in the range of \>3.2 to \<=5.1 or change from baseline in the range of \>0.6 to \<=1.2 with DAS28 in the range of \>3.2 to \<=5.1 or change from baseline \>1.2 with DAS28 \>5.1 or change from baseline in the range of \>0.6 to \<=1.2 with DAS28 \<=3.2; non-responders: change from baseline \<= 0.6 or change from baseline in the range of \>0.6 to \<=1.2 with DAS28 \>5.1 or change from baseline \<=0.6 with DAS28 \<=3.2 or in the range of \>3.2 to \<=5.1.

Time frame: Month 3 and Month 6

Population: FAS (DAS28-4 \[ESR\]). N (number of participants analyzed) = participants evaluable for this measure. n = participants evaluable for this measure at specified timepoint.

The DAS28-4 (CRP) \[described in Outcome Measure 5\] based EULAR response criteria were used to measure individual response as good, moderate, or no response depending on the extent of change from baseline in DAS28 score and the level of disease activity (low, moderate or high) reached. Good responders: change from baseline \>1.2 with DAS28 \<= 3.2; moderate responders: change from baseline \>1.2 with DAS28 in the range of \>3.2 to \<=5.1 or change from baseline in the range of \>0.6 to \<=1.2 with DAS28 in the range of \>3.2 to \<=5.1 or change from baseline \>1.2 with DAS28 \>5.1 or change from baseline in the range of \>0.6 to \<=1.2 with DAS28 \<=3.2; non-responders: change from baseline \<= 0.6 or change from baseline in the range of \>0.6 to \<=1.2 with DAS28 \>5.1 or change from baseline \<=0.6 with DAS28 \<=3.2 or in the range of \>3.2 to \<=5.1.

Time frame: Month 3 and Month 6

Population: FAS (DAS28-4 \[CRP\]). N (number of participants analyzed) = participants evaluable for this measure. n = participants evaluable for this measure at specified timepoint.

The percentage of participants with morning stiffness (yes, no, or do not know) was assessed at each visit.

Time frame: Baseline, Month 3, Month 6

Population: FAS (morning stiffness) included all data from all participants who had at least a baseline value and one follow up value (Month 3 or 6) for morning stiffness. n = participants evaluable for this measure at specified timepoint.

Physician Global Assessment of Disease Activity was measured on a 0 to 100 mm VAS where 0=no disease activity and 100=worst disease activity.

Time frame: Baseline, Month 3, Month 6

Population: The FAS (VAS disease activity \[physician\] included all data from all participants who had at least a baseline value and one follow up value (Month 3 or Month 6) for VAS disease activity (physician). n = participants evaluable for this measure at specified timepoint.

The SDAI is the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and physician global assessment (PGA) assessed on 0-10 centimeter (cm) VAS; 0 = no disease activity and 10 = worst disease activity, and CRP (mg/dL). SDAI total score = 0-86. SDAI \<=3.3 indicates clinical remission, \>3.4 to 11 = low disease activity, \>11 to 26 = moderate disease activity, and \>26 = high (or severe) disease activity.

Time frame: Baseline, Month 3, Month 6

Population: The FAS (SDAI) included all data from all participants who had at least a baseline value and one follow up value (Month 3 or Month 6) for SDAI. n = participants evaluable for this measure at specified timepoint.

Number of swollen joints was determined by examination of 28 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1; total was calculated by adding all the joints for a maximum score of 28. A reduction in number of swollen joints compared to baseline indicates improvement.

Time frame: Baseline, Month 3, Month 6

Population: The Full Analysis Set (FAS) (swollen joint counts) included all data from all participants who had at least a baseline value and one follow up value (Month 3 or Month 6) for swollen joints. n = participants evaluable for this measure at specified timepoint.

Number of tender joints was determined by examining 28 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 each visit, no tenderness = 0, tenderness = 1; total was calculated by adding all the joints for a maximum score of 28. A reduction in number of tender joints compared to baseline indicates improvement.

Time frame: Baseline, Month 3, Month 6

Population: The FAS (tender joint counts) included all data from all participants who had at least a baseline value and one follow up value (Month 3 or Month 6) for tender joints. n = participants evaluable for this measure at specified timepoint.