Use of Tocilizumab for Rheumatoid Arthritis (RA) in Daily Routine

The DAS28 was derived from assessments of erythrocyte sedimentation rate (ESR), tender joint count (TJC), swollen joint count (SJC), and general health according to 100-millimeter (mm) Visual Analog Scale (VAS). DAS28 scores were calculated as \[0.56 × square root of TJC\] + \[0.28 × square root of SJC\] + \[0.70 × natural log (ESR)\] + \[0.014 × VAS\]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in millimeters per hour (mm/h). DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. The score at Baseline was reported.

Time frame: Baseline

Population: All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint.

The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as \[0.56 × square root of TJC\] + \[0.28 × square root of SJC\] + \[0.70 × natural log (ESR)\] + \[0.014 × VAS\]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. The change from Baseline to Week 12 was reported, where negative changes indicated an improvement in disease activity.

Time frame: Baseline to Week 12

Population: All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint.

The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as \[0.56 × square root of TJC\] + \[0.28 × square root of SJC\] + \[0.70 × natural log (ESR)\] + \[0.014 × VAS\]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. The change from Baseline to Week 16 was reported, where negative changes indicated an improvement in disease activity.

Time frame: Baseline to Week 16

Population: All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint.

The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as \[0.56 × square root of TJC\] + \[0.28 × square root of SJC\] + \[0.70 × natural log (ESR)\] + \[0.014 × VAS\]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. The change from Baseline to Week 20 was reported, where negative changes indicated an improvement in disease activity.

Time frame: Baseline to Week 20

Population: All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint.

The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as \[0.56 × square root of TJC\] + \[0.28 × square root of SJC\] + \[0.70 × natural log (ESR)\] + \[0.014 × VAS\]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. The change from Baseline to Week 24 was reported, where negative changes indicated an improvement in disease activity.

Time frame: Baseline to Week 24

Population: All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint.

The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as \[0.56 × square root of TJC\] + \[0.28 × square root of SJC\] + \[0.70 × natural log (ESR)\] + \[0.014 × VAS\]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. The change from Baseline to Week 28 was reported, where negative changes indicated an improvement in disease activity.

Time frame: Baseline to Week 28

Population: All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint.

The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as \[0.56 × square root of TJC\] + \[0.28 × square root of SJC\] + \[0.70 × natural log (ESR)\] + \[0.014 × VAS\]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. The change from Baseline to Week 32 was reported, where negative changes indicated an improvement in disease activity.

Time frame: Baseline to Week 32

Population: All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint.

The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as \[0.56 × square root of TJC\] + \[0.28 × square root of SJC\] + \[0.70 × natural log (ESR)\] + \[0.014 × VAS\]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. The change from Baseline to Week 36 was reported, where negative changes indicated an improvement in disease activity.

Time frame: Baseline to Week 36

Population: All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint.

The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as \[0.56 × square root of TJC\] + \[0.28 × square root of SJC\] + \[0.70 × natural log (ESR)\] + \[0.014 × VAS\]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. The change from Baseline to Week 4 was reported, where negative changes indicated an improvement in disease activity.

Time frame: Baseline to Week 4

Population: All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint.

The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as \[0.56 × square root of TJC\] + \[0.28 × square root of SJC\] + \[0.70 × natural log (ESR)\] + \[0.014 × VAS\]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. The change from Baseline to Week 40 was reported, where negative changes indicated an improvement in disease activity.

Time frame: Baseline to Week 40

Population: All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint.

The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as \[0.56 × square root of TJC\] + \[0.28 × square root of SJC\] + \[0.70 × natural log (ESR)\] + \[0.014 × VAS\]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. The change from Baseline to Week 44 was reported, where negative changes indicated an improvement in disease activity.

Time frame: Baseline to Week 44

Population: All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint.

The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as \[0.56 × square root of TJC\] + \[0.28 × square root of SJC\] + \[0.70 × natural log (ESR)\] + \[0.014 × VAS\]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. The change from Baseline to Week 48 was reported, where negative changes indicated an improvement in disease activity.

Time frame: Baseline to Week 48

Population: All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint.

The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as \[0.56 × square root of TJC\] + \[0.28 × square root of SJC\] + \[0.70 × natural log (ESR)\] + \[0.014 × VAS\]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. The change from Baseline to Week 52 was reported, where negative changes indicated an improvement in disease activity.

Time frame: Baseline to Week 52

Population: All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint.

The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as \[0.56 × square root of TJC\] + \[0.28 × square root of SJC\] + \[0.70 × natural log (ESR)\] + \[0.014 × VAS\]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. The change from Baseline to Week 8 was reported, where negative changes indicated an improvement in disease activity.

Time frame: Baseline to Week 8

Population: All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint.

A total of 28 joints were assessed for swollenness. The number of swollen joints could range from 0 to 28, where higher values represented more swollen joints. The change from Baseline to Week 12 was reported, where negative changes indicated an improvement in disease activity.

Time frame: Baseline to Week 12

Population: All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint.

A total of 28 joints were assessed for swollenness. The number of swollen joints could range from 0 to 28, where higher values represented more swollen joints. The change from Baseline to Week 24 was reported, where negative changes indicated an improvement in disease activity.

Time frame: Baseline to Week 24

Population: All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint.

A total of 28 joints were assessed for swollenness. The number of swollen joints could range from 0 to 28, where higher values represented more swollen joints. The change from Baseline to Week 36 was reported, where negative changes indicated an improvement in disease activity.

Time frame: Baseline to Week 36

Population: All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint.

A total of 28 joints were assessed for swollenness. The number of swollen joints could range from 0 to 28, where higher values represented more swollen joints. The change from Baseline to Week 52 was reported, where negative changes indicated an improvement in disease activity.

Time frame: Baseline to Week 52

Population: All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint.

A total of 28 joints were assessed for tenderness. The number of tender joints could range from 0 to 28, where higher values represented more tender joints. The change from Baseline to Week 12 was reported, where negative changes indicated an improvement in disease activity.

Time frame: Baseline to Week 12

Population: All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint.

A total of 28 joints were assessed for tenderness. The number of tender joints could range from 0 to 28, where higher values represented more tender joints. The change from Baseline to Week 24 was reported, where negative changes indicated an improvement in disease activity.

Time frame: Baseline to Week 24

Population: All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint.

A total of 28 joints were assessed for tenderness. The number of tender joints could range from 0 to 28, where higher values represented more tender joints. The change from Baseline to Week 36 was reported, where negative changes indicated an improvement in disease activity.

Time frame: Baseline to Week 36

Population: All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint.

A total of 28 joints were assessed for tenderness. The number of tender joints could range from 0 to 28, where higher values represented more tender joints. The change from Baseline to Week 52 was reported, where negative changes indicated an improvement in disease activity.

Time frame: Baseline to Week 52

Population: All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint.

Participant-assessed disease activity was scored on a 100-mm VAS, where the distance from 0 mm represented the participant's self evaluation of disease activity. Higher scores corresponded to increased disease activity (0 mm = no disease activity and 100 mm = maximum disease activity). The change from Baseline to Week 12 was reported, where negative changes indicated a decrease in participant-assessed disease activity.

Time frame: Baseline to Week 12

Population: All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint.

Participant-assessed disease activity was scored on a 100-mm VAS, where the distance from 0 mm represented the participant's self evaluation of disease activity. Higher scores corresponded to increased disease activity (0 mm = no disease activity and 100 mm = maximum disease activity). The change from Baseline to Week 24 was reported, where negative changes indicated a decrease in participant-assessed disease activity.

Time frame: Baseline to Week 24

Population: All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint.

Participant-assessed disease activity was scored on a 100-mm VAS, where the distance from 0 mm represented the participant's self evaluation of disease activity. Higher scores corresponded to increased disease activity (0 mm = no disease activity and 100 mm = maximum disease activity). The change from Baseline to Week 36 was reported, where negative changes indicated a decrease in participant-assessed disease activity.

Time frame: Baseline to Week 36

Population: All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint.

Participant-assessed disease activity was scored on a 100-mm VAS, where the distance from 0 mm represented the participant's self evaluation of disease activity. Higher scores corresponded to increased disease activity (0 mm = no disease activity and 100 mm = maximum disease activity). The change from Baseline to Week 52 was reported, where negative changes indicated a decrease in participant-assessed disease activity.

Time frame: Baseline to Week 52

Population: All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint.

Physician-assessed disease activity was scored on a 100-mm VAS, where the distance from 0 mm represented the physician's evaluation of disease activity. Higher scores corresponded to increased disease activity (0 mm = no disease activity and 100 mm = maximum disease activity). The change from Baseline to Week 12 was reported, where negative changes indicated a decrease in physician-assessed disease activity.

Time frame: Baseline to Week 12

Population: All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint.

Physician-assessed disease activity was scored on a 100-mm VAS, where the distance from 0 mm represented the physician's evaluation of disease activity. Higher scores corresponded to increased disease activity (0 mm = no disease activity and 100 mm = maximum disease activity). The change from Baseline to Week 24 was reported, where negative changes indicated a decrease in physician-assessed disease activity.

Time frame: Baseline to Week 24

Population: All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint.

Physician-assessed disease activity was scored on a 100-mm VAS, where the distance from 0 mm represented the physician's evaluation of disease activity. Higher scores corresponded to increased disease activity (0 mm = no disease activity and 100 mm = maximum disease activity). The change from Baseline to Week 36 was reported, where negative changes indicated a decrease in physician-assessed disease activity.

Time frame: Baseline to Week 36

Population: All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint.

Physician-assessed disease activity was scored on a 100-mm VAS, where the distance from 0 mm represented the physician's evaluation of disease activity. Higher scores corresponded to increased disease activity (0 mm = no disease activity and 100 mm = maximum disease activity). The change from Baseline to Week 52 was reported, where negative changes indicated a decrease in physician-assessed disease activity.

Time frame: Baseline to Week 52

Population: All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint.

SmPC recommendations were specified in the collection of routine laboratory samples for alanine aminotransferase (ALAT), aspartate aminotransferase (ASAT), absolute neutrophil count (ANC), and low platelet count to guide dose decisions. Laboratory values for ALAT and ASAT were to be categorized in reference to the institution-specific upper limit of normal (ULN). Laboratory values for ANC and platelet count were to be categorized in reference to a normal range outlined in the SmPC. This range was 0.5 to 1 × 10\^9 cells per liter (cells/L) for ANC and 50 to 100 × 10\^3 cells per microliter (cells/μL) for platelet count. The percentage of participants with greater than or equal to (≥) 1 documented/evaluable laboratory value at Baseline was reported, along with the percentage of participants with categorized laboratory data available for each individual parameter.

Time frame: Baseline

Population: All Enrolled Population.

SmPC recommendations were specified in the collection of routine laboratory samples for ALAT, ASAT, ANC, and low platelet count to guide dose decisions. Laboratory values for ALAT and ASAT were to be categorized in reference to the institution-specific ULN. Laboratory values for ANC and platelet count were to be categorized in reference to a normal range outlined in the SmPC. This range was 0.5 to 1 × 10\^9 cells/L for ANC and 50 to 100 × 10\^3 cells/μL for platelet count. The percentage of participants with ≥1 documented/evaluable laboratory value at Week 24 was reported, along with the percentage of participants with categorized laboratory data available for each individual parameter.

Time frame: Week 24

Population: All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint.

SmPC recommendations were specified in the collection of routine laboratory samples for ALAT, ASAT, ANC, and low platelet count to guide dose decisions. Laboratory values for ALAT and ASAT were to be categorized in reference to the institution-specific ULN. Laboratory values for ANC and platelet count were to be categorized in reference to a normal range outlined in the SmPC. This range was 0.5 to 1 × 10\^9 cells/L for ANC and 50 to 100 × 10\^3 cells/μL for platelet count. The percentage of participants with ≥1 documented/evaluable laboratory value at Week 52 was reported, along with the percentage of participants with categorized laboratory data available for each individual parameter.

Time frame: Week 52

Population: All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint.

Response was determined using EULAR criteria based upon DAS28 absolute scores at the Week 12 visit and the DAS28 change from Baseline to Week 12. Participants with a score ≤3.2 and reduction of \>1.2 points were assessed as having a Good response. Participants with a score \>3.2 with reduction of \>1.2 points, or a score ≤5.1 with reduction of \>0.6 to ≤1.2 points, were assessed as having a Moderate response. Participants with a score \>5.1 with reduction of \>0.6 to ≤1.2 points, or any score with reduction ≤0.6 points, were assessed as non-responders with response recorded as No Improvement.

Time frame: Baseline to Week 12

Population: All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint.

Response was determined using EULAR criteria based upon DAS28 absolute scores at the Week 24 visit and the DAS28 change from Baseline to Week 24. Participants with a score ≤3.2 and reduction of \>1.2 points were assessed as having a Good response. Participants with a score \>3.2 with reduction of \>1.2 points, or a score ≤5.1 with reduction of \>0.6 to ≤1.2 points, were assessed as having a Moderate response. Participants with a score \>5.1 with reduction of \>0.6 to ≤1.2 points, or any score with reduction ≤0.6 points, were assessed as non-responders with response recorded as No Improvement.

Time frame: Baseline to Week 24

Population: All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint.

Response was determined using EULAR criteria based upon DAS28 absolute scores at the Week 36 visit and the DAS28 change from Baseline to Week 36. Participants with a score ≤3.2 and reduction of \>1.2 points were assessed as having a Good response. Participants with a score \>3.2 with reduction of \>1.2 points, or a score ≤5.1 with reduction of \>0.6 to ≤1.2 points, were assessed as having a Moderate response. Participants with a score \>5.1 with reduction of \>0.6 to ≤1.2 points, or any score with reduction ≤0.6 points, were assessed as non-responders with response recorded as No Improvement.

Time frame: Baseline to Week 36

Population: All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint.

Response was determined using EULAR criteria based upon DAS28 absolute scores at the Week 52 visit and the DAS28 change from Baseline to Week 52. Participants with a score ≤3.2 and reduction of \>1.2 points were assessed as having a Good response. Participants with a score \>3.2 with reduction of \>1.2 points, or a score ≤5.1 with reduction of \>0.6 to ≤1.2 points, were assessed as having a Moderate response. Participants with a score \>5.1 with reduction of \>0.6 to ≤1.2 points, or any score with reduction ≤0.6 points, were assessed as non-responders with response recorded as No Improvement.

Time frame: Baseline to Week 52

Population: All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint.

Response was determined using EULAR criteria based upon DAS28 absolute scores at the Week 4 visit and the DAS28 change from Baseline to Week 4. Participants with a score less than or equal to (≤) 3.2 and reduction of \>1.2 points were assessed as having a Good response. Participants with a score \>3.2 with reduction of \>1.2 points, or a score ≤5.1 with reduction of \>0.6 to ≤1.2 points, were assessed as having a Moderate response. Participants with a score \>5.1 with reduction of \>0.6 to ≤1.2 points, or any score with reduction ≤0.6 points, were assessed as non-responders with response recorded as No Improvement.

Time frame: Baseline to Week 4

Population: All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint.

The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as \[0.56 × square root of TJC\] + \[0.28 × square root of SJC\] + \[0.70 × natural log (ESR)\] + \[0.014 × VAS\]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. LDAS was defined as a DAS28 score ≤3.2 at Week 12.

Time frame: Week 12

Population: All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint.

The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as \[0.56 × square root of TJC\] + \[0.28 × square root of SJC\] + \[0.70 × natural log (ESR)\] + \[0.014 × VAS\]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. LDAS was defined as a DAS28 score ≤3.2 at Week 24.

Time frame: Week 24

Population: All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint.

The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as \[0.56 × square root of TJC\] + \[0.28 × square root of SJC\] + \[0.70 × natural log (ESR)\] + \[0.014 × VAS\]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. LDAS was defined as a DAS28 score ≤3.2 at Week 36.

Time frame: Week 36

Population: All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint.

The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as \[0.56 × square root of TJC\] + \[0.28 × square root of SJC\] + \[0.70 × natural log (ESR)\] + \[0.014 × VAS\]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. LDAS was defined as a DAS28 score ≤3.2 at Week 52.

Time frame: Week 52

Population: All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint.

The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as \[0.56 × square root of TJC\] + \[0.28 × square root of SJC\] + \[0.70 × natural log (ESR)\] + \[0.014 × VAS\]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. LDAS was defined as a DAS28 score ≤3.2 at Baseline.

Time frame: Baseline

Population: All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint.

The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as \[0.56 × square root of TJC\] + \[0.28 × square root of SJC\] + \[0.70 × natural log (ESR)\] + \[0.014 × VAS\]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. MCII was defined as DAS28 reduction of ≥1.2 points from Baseline to Week 24.

Time frame: Baseline to Week 24

Population: All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint.

The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as \[0.56 × square root of TJC\] + \[0.28 × square root of SJC\] + \[0.70 × natural log (ESR)\] + \[0.014 × VAS\]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. MCII was defined as DAS28 reduction of ≥1.2 points from Baseline to Week 36.

Time frame: Baseline to Week 36

Population: All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint.

The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as \[0.56 × square root of TJC\] + \[0.28 × square root of SJC\] + \[0.70 × natural log (ESR)\] + \[0.014 × VAS\]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. MCII was defined as DAS28 reduction of ≥1.2 points from Baseline to Week 52.

Time frame: Baseline to Week 52

Population: All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint.

The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as \[0.56 × square root of TJC\] + \[0.28 × square root of SJC\] + \[0.70 × natural log (ESR)\] + \[0.014 × VAS\]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. MCII was defined as DAS28 reduction of ≥1.2 points from Baseline to Week 12.

Time frame: Baseline to Week 12

Population: All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint.

SmPC recommendations were specified in the collection of routine laboratory samples for ALAT, ASAT, ANC, and platelet count to guide dose decisions. Dose adjustment was recommended in response to ALAT/ASAT values \>1 to 3 × ULN. Dose interruption was recommended in response to ALAT/ASAT values \>3 to 5 × ULN, ANC of 0.5 to 1 × 10\^9 cells/L, or platelet count of 50 to 100 × 10\^3 cells/μL, until the values returned to acceptable ranges as per the SmPC. Discontinuation of tocilizumab was recommended for any ALAT/ASAT values \>5 × ULN, ANC \<0.5 × 10\^9 cells/L, or platelet count \<50 × 10\^3 cells/μL. The percentage of participants from each laboratory value category with (Yes) or without (No) tocilizumab dose adjustment or interruption was reported at Week 12.

Time frame: Week 12

Population: All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint. The number of participants who had available data for both the specific laboratory parameter and for the possible dose change at the corresponding visit (n) is shown in the table.

SmPC recommendations were specified in the collection of routine laboratory samples for ALAT, ASAT, ANC, and platelet count to guide dose decisions. Dose adjustment was recommended in response to ALAT/ASAT values \>1 to 3 × ULN. Dose interruption was recommended in response to ALAT/ASAT values \>3 to 5 × ULN, ANC of 0.5 to 1 × 10\^9 cells/L, or platelet count of 50 to 100 × 10\^3 cells/μL, until the values returned to acceptable ranges as per the SmPC. Discontinuation of tocilizumab was recommended for any ALAT/ASAT values \>5 × ULN, ANC \<0.5 × 10\^9 cells/L, or platelet count \<50 × 10\^3 cells/μL. The percentage of participants from each laboratory value category with (Yes) or without (No) tocilizumab dose adjustment or interruption was reported at Week 16.

Time frame: Week 16

Population: All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint. The number of participants who had available data for both the specific laboratory parameter and for the possible dose change at the corresponding visit (n) is shown in the table.

SmPC recommendations were specified in the collection of routine laboratory samples for ALAT, ASAT, ANC, and platelet count to guide dose decisions. Dose adjustment was recommended in response to ALAT/ASAT values \>1 to 3 × ULN. Dose interruption was recommended in response to ALAT/ASAT values \>3 to 5 × ULN, ANC of 0.5 to 1 × 10\^9 cells/L, or platelet count of 50 to 100 × 10\^3 cells/μL, until the values returned to acceptable ranges as per the SmPC. Discontinuation of tocilizumab was recommended for any ALAT/ASAT values \>5 × ULN, ANC \<0.5 × 10\^9 cells/L, or platelet count \<50 × 10\^3 cells/μL. The percentage of participants from each laboratory value category with (Yes) or without (No) tocilizumab dose adjustment or interruption was reported at Week 20.

Time frame: Week 20

Population: All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint. The number of participants who had available data for both the specific laboratory parameter and for the possible dose change at the corresponding visit (n) is shown in the table.

SmPC recommendations were specified in the collection of routine laboratory samples for ALAT, ASAT, ANC, and platelet count to guide dose decisions. Dose adjustment was recommended in response to ALAT/ASAT values \>1 to 3 × ULN. Dose interruption was recommended in response to ALAT/ASAT values \>3 to 5 × ULN, ANC of 0.5 to 1 × 10\^9 cells/L, or platelet count of 50 to 100 × 10\^3 cells/μL, until the values returned to acceptable ranges as per the SmPC. Discontinuation of tocilizumab was recommended for any ALAT/ASAT values \>5 × ULN, ANC \<0.5 × 10\^9 cells/L, or platelet count \<50 × 10\^3 cells/μL. The percentage of participants from each laboratory value category with (Yes) or without (No) tocilizumab dose adjustment or interruption was reported at Week 24.

Time frame: Week 24

Population: All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint. The number of participants who had available data for both the specific laboratory parameter and for the possible dose change at the corresponding visit (n) is shown in the table.

SmPC recommendations were specified in the collection of routine laboratory samples for ALAT, ASAT, ANC, and platelet count to guide dose decisions. Dose adjustment was recommended in response to ALAT/ASAT values \>1 to 3 × ULN. Dose interruption was recommended in response to ALAT/ASAT values \>3 to 5 × ULN, ANC of 0.5 to 1 × 10\^9 cells/L, or platelet count of 50 to 100 × 10\^3 cells/μL, until the values returned to acceptable ranges as per the SmPC. Discontinuation of tocilizumab was recommended for any ALAT/ASAT values \>5 × ULN, ANC \<0.5 × 10\^9 cells/L, or platelet count \<50 × 10\^3 cells/μL. The percentage of participants from each laboratory value category with (Yes) or without (No) tocilizumab dose adjustment or interruption was reported at Week 28.

Time frame: Week 28

Population: All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint. The number of participants who had available data for both the specific laboratory parameter and for the possible dose change at the corresponding visit (n) is shown in the table.

SmPC recommendations were specified in the collection of routine laboratory samples for ALAT, ASAT, ANC, and platelet count to guide dose decisions. Dose adjustment was recommended in response to ALAT/ASAT values \>1 to 3 × ULN. Dose interruption was recommended in response to ALAT/ASAT values \>3 to 5 × ULN, ANC of 0.5 to 1 × 10\^9 cells/L, or platelet count of 50 to 100 × 10\^3 cells/μL, until the values returned to acceptable ranges as per the SmPC. Discontinuation of tocilizumab was recommended for any ALAT/ASAT values \>5 × ULN, ANC \<0.5 × 10\^9 cells/L, or platelet count \<50 × 10\^3 cells/μL. The percentage of participants from each laboratory value category with (Yes) or without (No) tocilizumab dose adjustment or interruption was reported at Week 32.

Time frame: Week 32

Population: All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint. The number of participants who had available data for both the specific laboratory parameter and for the possible dose change at the corresponding visit (n) is shown in the table.

SmPC recommendations were specified in the collection of routine laboratory samples for ALAT, ASAT, ANC, and platelet count to guide dose decisions. Dose adjustment was recommended in response to ALAT/ASAT values \>1 to 3 × ULN. Dose interruption was recommended in response to ALAT/ASAT values \>3 to 5 × ULN, ANC of 0.5 to 1 × 10\^9 cells/L, or platelet count of 50 to 100 × 10\^3 cells/μL, until the values returned to acceptable ranges as per the SmPC. Discontinuation of tocilizumab was recommended for any ALAT/ASAT values \>5 × ULN, ANC \<0.5 × 10\^9 cells/L, or platelet count \<50 × 10\^3 cells/μL. The percentage of participants from each laboratory value category with (Yes) or without (No) tocilizumab dose adjustment or interruption was reported at Week 36.

Time frame: Week 36

Population: All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint. The number of participants who had available data for both the specific laboratory parameter and for the possible dose change at the corresponding visit (n) is shown in the table.

SmPC recommendations were specified in the collection of routine laboratory samples for ALAT, ASAT, ANC, and platelet count to guide dose decisions. Dose adjustment was recommended in response to ALAT/ASAT values greater than (\>) 1 to 3 × ULN. Dose interruption was recommended in response to ALAT/ASAT values \>3 to 5 × ULN, ANC of 0.5 to 1 × 10\^9 cells/L, or platelet count of 50 to 100 × 10\^3 cells/μL, until the values returned to acceptable ranges as per the SmPC. Discontinuation of tocilizumab was recommended for any ALAT/ASAT values \>5 × ULN, ANC less than (\<) 0.5 × 10\^9 cells/L, or platelet count \<50 × 10\^3 cells/μL. The percentage of participants from each laboratory value category with (Yes) or without (No) tocilizumab dose adjustment or interruption was reported at Week 4.

Time frame: Week 4

Population: All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint. The number of participants who had available data for both the specific laboratory parameter and for the possible dose change at the corresponding visit (n) is shown in the table.

SmPC recommendations were specified in the collection of routine laboratory samples for ALAT, ASAT, ANC, and platelet count to guide dose decisions. Dose adjustment was recommended in response to ALAT/ASAT values \>1 to 3 × ULN. Dose interruption was recommended in response to ALAT/ASAT values \>3 to 5 × ULN, ANC of 0.5 to 1 × 10\^9 cells/L, or platelet count of 50 to 100 × 10\^3 cells/μL, until the values returned to acceptable ranges as per the SmPC. Discontinuation of tocilizumab was recommended for any ALAT/ASAT values \>5 × ULN, ANC \<0.5 × 10\^9 cells/L, or platelet count \<50 × 10\^3 cells/μL. The percentage of participants from each laboratory value category with (Yes) or without (No) tocilizumab dose adjustment or interruption was reported at Week 40.

Time frame: Week 40

Population: All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint. The number of participants who had available data for both the specific laboratory parameter and for the possible dose change at the corresponding visit (n) is shown in the table.

SmPC recommendations were specified in the collection of routine laboratory samples for ALAT, ASAT, ANC, and platelet count to guide dose decisions. Dose adjustment was recommended in response to ALAT/ASAT values \>1 to 3 × ULN. Dose interruption was recommended in response to ALAT/ASAT values \>3 to 5 × ULN, ANC of 0.5 to 1 × 10\^9 cells/L, or platelet count of 50 to 100 × 10\^3 cells/μL, until the values returned to acceptable ranges as per the SmPC. Discontinuation of tocilizumab was recommended for any ALAT/ASAT values \>5 × ULN, ANC \<0.5 × 10\^9 cells/L, or platelet count \<50 × 10\^3 cells/μL. The percentage of participants from each laboratory value category with (Yes) or without (No) tocilizumab dose adjustment or interruption was reported at Week 44.

Time frame: Week 44

Population: All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint. The number of participants who had available data for both the specific laboratory parameter and for the possible dose change at the corresponding visit (n) is shown in the table.

SmPC recommendations were specified in the collection of routine laboratory samples for ALAT, ASAT, ANC, and platelet count to guide dose decisions. Dose adjustment was recommended in response to ALAT/ASAT values \>1 to 3 × ULN. Dose interruption was recommended in response to ALAT/ASAT values \>3 to 5 × ULN, ANC of 0.5 to 1 × 10\^9 cells/L, or platelet count of 50 to 100 × 10\^3 cells/μL, until the values returned to acceptable ranges as per the SmPC. Discontinuation of tocilizumab was recommended for any ALAT/ASAT values \>5 × ULN, ANC \<0.5 × 10\^9 cells/L, or platelet count \<50 × 10\^3 cells/μL. The percentage of participants from each laboratory value category with (Yes) or without (No) tocilizumab dose adjustment or interruption was reported at Week 48.

Time frame: Week 48

Population: All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint. The number of participants who had available data for both the specific laboratory parameter and for the possible dose change at the corresponding visit (n) is shown in the table.

SmPC recommendations were specified in the collection of routine laboratory samples for ALAT, ASAT, ANC, and platelet count to guide dose decisions. Dose adjustment was recommended in response to ALAT/ASAT values \>1 to 3 × ULN. Dose interruption was recommended in response to ALAT/ASAT values \>3 to 5 × ULN, ANC of 0.5 to 1 × 10\^9 cells/L, or platelet count of 50 to 100 × 10\^3 cells/μL, until the values returned to acceptable ranges as per the SmPC. Discontinuation of tocilizumab was recommended for any ALAT/ASAT values \>5 × ULN, ANC \<0.5 × 10\^9 cells/L, or platelet count \<50 × 10\^3 cells/μL. The percentage of participants from each laboratory value category with (Yes) or without (No) tocilizumab dose adjustment or interruption was reported at Week 52.

Time frame: Week 52

Population: All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint. The number of participants who had available data for both the specific laboratory parameter and for the possible dose change at the corresponding visit (n) is shown in the table.

SmPC recommendations were specified in the collection of routine laboratory samples for ALAT, ASAT, ANC, and platelet count to guide dose decisions. Dose adjustment was recommended in response to ALAT/ASAT values \>1 to 3 × ULN. Dose interruption was recommended in response to ALAT/ASAT values \>3 to 5 × ULN, ANC of 0.5 to 1 × 10\^9 cells/L, or platelet count of 50 to 100 × 10\^3 cells/μL, until the values returned to acceptable ranges as per the SmPC. Discontinuation of tocilizumab was recommended for any ALAT/ASAT values \>5 × ULN, ANC \<0.5 × 10\^9 cells/L, or platelet count \<50 × 10\^3 cells/μL. The percentage of participants from each laboratory value category with (Yes) or without (No) tocilizumab dose adjustment or interruption was reported at Week 8.

Time frame: Week 8

Population: All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint. The number of participants who had available data for both the specific laboratory parameter and for the possible dose change at the corresponding visit (n) is shown in the table.

The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as \[0.56 × square root of TJC\] + \[0.28 × square root of SJC\] + \[0.70 × natural log (ESR)\] + \[0.014 × VAS\]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. Remission was defined as a DAS28 score \<2.6 at Baseline.

Time frame: Baseline

Population: All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint.

The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as \[0.56 × square root of TJC\] + \[0.28 × square root of SJC\] + \[0.70 × natural log (ESR)\] + \[0.014 × VAS\]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. Remission was defined as a DAS28 score \<2.6 at Week 12.

Time frame: Week 12

Population: All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint.

The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as \[0.56 × square root of TJC\] + \[0.28 × square root of SJC\] + \[0.70 × natural log (ESR)\] + \[0.014 × VAS\]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. Remission was defined as a DAS28 score \<2.6 at Week 24.

Time frame: Week 24

Population: All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint.

The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as \[0.56 × square root of TJC\] + \[0.28 × square root of SJC\] + \[0.70 × natural log (ESR)\] + \[0.014 × VAS\]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. Remission was defined as a DAS28 score \<2.6 at Week 36.

Time frame: Week 36

Population: All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint.

The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as \[0.56 × square root of TJC\] + \[0.28 × square root of SJC\] + \[0.70 × natural log (ESR)\] + \[0.014 × VAS\]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. Remission was defined as a DAS28 score \<2.6 at Week 52.

Time frame: Week 52

Population: All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint.

The percentage of participants with any tocilizumab dose adjustment during the study was reported among all reasons given for tocilizumab dose adjustments, as provided in the CRF. The sum of all reasons may add up to \>100 percent (%) because more than one reason could be given for each dose change. In the table presented, Other Reasons refers to any reason other than those specified in categories. Similarly, Other Laboratory Change refers to a change in any laboratory parameter other than those specified in categories.

Time frame: Baseline to end of treatment (up to 12 months)

Population: All Enrolled Population. The Number of Participants Analyzed reflects the number of participants who had at least one tocilizumab dose adjustment during the study.

A total of 28 joints were assessed for swollenness. The number of swollen joints at Baseline was reported and could range from 0 to 28, where higher values represented more swollen joints.

Time frame: Baseline

Population: All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint.

A total of 28 joints were assessed for tenderness. The number of tender joints at Baseline was reported and could range from 0 to 28, where higher values represented more tender joints.

Time frame: Baseline

Population: All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint.

Participant-assessed disease activity was scored on a 100-mm VAS, where the distance from 0 mm represented the participant's self evaluation of disease activity. Higher scores corresponded to increased disease activity (0 mm = no disease activity and 100 mm = maximum disease activity). The VAS score at Baseline was reported.

Time frame: Baseline

Population: All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint.

Physician-assessed disease activity was scored on a 100-mm VAS, where the distance from 0 mm represented the physician's evaluation of disease activity. Higher scores corresponded to increased disease activity (0 mm = no disease activity and 100 mm = maximum disease activity). The VAS score at Baseline was reported.

Time frame: Baseline

Population: All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint.

An AE was defined as any unfavorable and unintended sign, symptom, or disease associated with the use of tocilizumab. Worsened pre-existing conditions and laboratory or clinical tests that resulted in change or discontinuation of treatment were reported as AEs. The percentage of participants with treatment-related AEs (also known as adverse drug reactions) was reported as a separate endpoint and included both serious and non-serious AEs. Those AEs with a causal relationship reported as definite, probably, possible, or unlikely were considered to be related to tocilizumab. If the causal relationship was reported as unrelated, the AE was considered not related to tocilizumab treatment. Terms were reported verbatim as coded using Medical Dictionary for Regulatory Activities (MedDRA) Version 12.0. The most common treatment-related AEs were reported, using those from the 10 highest incidence rate levels.

Time frame: Baseline to end of treatment (up to 12 months)

Population: All Enrolled Population