Pharmacoepidemiological Study of the Impact of Roactemra® Treatment on Fatigue in Rheumatoid Arthritis Patients in a Real Life Setting

Number of Participants With Clinically Significant Improvement in Fatigue at Month 4 With Respect to Predictive Factors

时间窗: At Month 4

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 \[certain case of HAD\]).

Median Clinically Significant Improvement in C-Reactive Protein as a Predictive Factors After 4 Months of Tocilizumab Treatment

时间窗: At Month 4

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.

Percentage of Participants With a Clinically Significant Improvement in Fatigue After 4 Months of Tocilizumab Treatment

时间窗: At Month 4

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).

Mean Clinically Significant Improvement in Tender Joints and Swollen Joints as Predictive Factors After 4 Months of Tocilizumab Treatment

时间窗: 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.