An Observational Study of RoActemra/Actemra (Tocilizumab) As Monotherapy in Rheumatoid Arthritis Patients in Routine Clinical Practice

The number of participants assigned to tocilizumab monotherapy versus tocilizumab combination therapy is reported. A multivariate analysis was performed to search for predictive factors for the initiation of tocilizumab in monotherapy.

Time frame: Day 1

Population: Efficacy population, defined as all participants who received at least one infusion of tocilizumab and who met all inclusion and exclusion criteria.

The HAQ-DI is a participant-reported assessment of ability to perform daily living activities. This composite index score ranges from 0 (normal) to 3 (total functional disability) and includes questions regarding 8 domains (dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week). A decrease in score corresponds to improvement in participant-assessed health state.

Time frame: Baseline; Month 6; Month 12

Population: Participants in the Efficacy population who received at least one infusion of tocilizumab, who met all inclusion and exclusion criteria, and with available data at the respective time point.

The RAID questionnaire is a participant-reported outcome measure evaluating the impact of rheumatoid arthritis on participant quality of life. This composite index score ranges from 0 (best) to 10 (worst) and includes questions regarding 7 domains (pain, functional disability assessment, fatigue, sleep, physical well-being, emotional well-being, coping). A decrease in score corresponds to improvement in participant-assessed health state.

Time frame: Baseline; Month 6, Month 12

Population: Participants in the Efficacy population who received at least one infusion of tocilizumab, who met all inclusion and exclusion criteria, and with available data at the respective time point.

Time frame: Up to 30 months

Population: Efficacy population, defined as all participants who received at least one infusion of tocilizumab and who met all inclusion and exclusion criteria.

DAS28-ESR was calculated from the number of swollen joints and tender joints using the 28-joint count, ESR (mm/hour) and patient's global assessment of disease activity; scores range from 0 to 10, where lower scores indicate less disease activity. A score of ≤3.2 was considered to be DAS28-ESR LDA. Participants with missing data were considered to have failed to achieve the outcome.

Time frame: Month 12

Population: Efficacy population, defined as all participants who received at least one infusion of tocilizumab and who met all inclusion and exclusion criteria.

The percentage of participants who discontinued hydroxychloroquine treatment prior to being assigned to tocilizumab monotherapy is presented by reason for discontinuation.

Time frame: Day 1 (assessment of discontinuations within prior 2 years)

Population: Participants in the Tocilizumab Monotherapy group (Efficacy population) who discontinued hydroxychloroquine and with available data.

The percentage of participants who discontinued leflunomide treatment prior to being assigned to tocilizumab monotherapy is presented by reason for discontinuation.

Time frame: Day 1 (assessment of discontinuations within prior 2 years)

Population: Participants in the Tocilizumab Monotherapy group (Efficacy population) who discontinued leflunomide and with available data.

The percentage of participants who discontinued MTX treatment prior to being assigned to tocilizumab monotherapy is presented by reason for discontinuation. Reason for discontinuation Other Intolerance = intolerance other than cytopenia or hepatic cytolysis.

Time frame: Day 1 (assessment of discontinuations within prior 2 years)

Population: Participants in the Tocilizumab Monotherapy group (Efficacy population) who discontinued MTX and with available data.

The percentage of participants who discontinued sulfasalazine treatment prior to being assigned to tocilizumab monotherapy is presented by reason for discontinuation.

Time frame: Day 1 (assessment of discontinuations within prior 2 years)

Population: Participants in the Tocilizumab Monotherapy group (Efficacy population) who discontinued sulfasalazine and with available data.

The percentage of participants who discontinued treatment with unspecified csDMARDs prior to being assigned to tocilizumab monotherapy is presented by reason for discontinuation.

Time frame: Day 1 (assessment of discontinuations within prior 2 years)

Population: Participants in the Tocilizumab Monotherapy group (Efficacy population) who discontinued treatment with unspecified csDMARDs and with available data.

The percentage of participants who received infusions is presented by category of total infusions received over the study period.

Time frame: Up to 13.4 months

Population: Efficacy population, defined as all participants who received at least one infusion of tocilizumab and who met all inclusion and exclusion criteria.

Participants were asked: If you were to remain in the same condition for the next few months as you have been over the last 8 days, would this be 1) acceptable, 2) unacceptable? The percentage of participants who responded acceptable at each time point is presented.

Time frame: Baseline; Month 6; Month 12

Population: Participants in the Efficacy population who received at least one infusion of tocilizumab, who met all inclusion and exclusion criteria, and with available data at the respective time point.

An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory finding if accompanied by clinical symptoms, results in a change in study treatment, results in a medical intervention or a change in concomitant therapy or clinically significant in the investigator's judgment), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.

Time frame: Up to 30 months

Population: Safety population, defined as participants who received at least one infusion of tocilizumab.

ACR20/50/70 response was calculated as improvement (from baseline) of at least 20/50/70% (respectively) of tender and of swollen joints, and improvement from baseline of least 20/50/70% (respectively) in at least 3 of the 5 following parameters: participant's pain assessment, patient's global assessment of disease activity, physician's global assessment of disease activity, health assessment questionnaire disability index (HAQ-DI) score, and ESR (mm/hour) or CRP (mg/L). Participants with missing data were considered to have failed to achieve the outcome.

Time frame: Month 12

Population: Efficacy population, defined as all participants who received at least one infusion of tocilizumab and who met all inclusion and exclusion criteria.

csDMARD intensification was defined as an addition of a csDMARD without suppression of other csDMARD, dose increase of a csDMARD, switch (addition and suppression) of a csDMARD without intolerance, biological abnormality or symptom improvement to the suppressed csDMARD, or modification of the MTX administration route (from oral route to intramuscular/subcutaneous) with dose increase or maintenance.

Time frame: Up to 30 months

Population: Participants in Efficacy population who received at least 1 infusion of tocilizumab, who met all inclusion/exclusion criteria, and with no permanent discontinuation of tocilizumab treatment over the study period. For efficacy criteria with response/non response values, participants with non-evaluable response were considered as non-responders.

CDAI was calculated from the number of swollen joints and tender joints using the 28-joint count and the patient's global assessment of disease activity and physician's global assessment of disease activity; CDAI scores range from 0 to 76, where lower scores indicate less disease activity. A score of ≤2.8 was considered to be CDAI remission. Participants with missing data were considered to have failed to achieve the outcome.

Time frame: Month 12

Population: Efficacy population, defined as all participants who received at least one infusion of tocilizumab and who met all inclusion and exclusion criteria.

CDAI was calculated from the number of swollen joints and tender joints using the 28-joint count and the patient's global assessment of disease activity and physician's global assessment of disease activity; CDAI scores range from 0 to 76, where lower scores indicate less disease activity. A score of ≤10 was considered to be CDAI LDA. Participants with missing data were considered to have failed to achieve the outcome.

Time frame: Month 12

Population: Efficacy population, defined as all participants who received at least one infusion of tocilizumab and who met all inclusion and exclusion criteria.

DAS28-ESR was calculated from the number of swollen joints and tender joints using the 28-joint count, ESR (mm/hour) and patient's global assessment of disease activity; scores range from 0 to 10, where lower scores indicate less disease activity. A score of \<2.6 was considered to be DAS28-ESR remission. Participants with missing data were considered to have failed to achieve the outcome.

Time frame: Month 12

Population: Efficacy population, defined as all participants who received at least one infusion of tocilizumab and who met all inclusion and exclusion criteria.

EULAR response was categorized as good or moderate response and was calculated as the difference between DAS28-ESR scores at baseline and Month 12. DAS28-ESR was calculated from the number of swollen joints and tender joints using the 28-joint count, ESR (mm/hour) and patient's global assessment of disease activity; scores range from 0 to 10, where lower scores indicate less disease activity. * If diminution from baseline \>1.2 and score ≤3.2 at Month 12 = good response * If diminution from baseline \>1.2 and score \>3.2 at Month 12 = moderate response * If diminution from baseline \>0.6 and ≤1.2, and score ≤5.1 at Month 12 = moderate response * If diminution from baseline \>0.6 and ≤1.2, and score \>5.1 at Month 12 = non-response * If diminution from baseline ≤1.2 at Month 12 = non-response * Participants with missing data were considered as non-response

Time frame: Month 12

Population: Efficacy population, defined as all participants who received at least one infusion of tocilizumab and who met all inclusion and exclusion criteria.

The percentage of participants with no modifications (dose modification or discontinuation) is presented.

Time frame: Up to 30 months

Population: Efficacy population, defined as all participants who received at least one infusion of tocilizumab and who met all inclusion and exclusion criteria.

SDAI was calculated from the number of swollen joints and tender joints using the 28-joint count, CRP (mg/L), and the patient's global assessment of disease activity and physician's global assessment of disease activity; SDAI scores range from 0 to 86, where lower scores indicate less disease activity. A score of ≤3.3 was considered to be SDAI remission. Participants with missing data were considered to have failed to achieve the outcome.

Time frame: Month 12

Population: Efficacy population, defined as all participants who received at least one infusion of tocilizumab and who met all inclusion and exclusion criteria.

SDAI was calculated from the number of swollen joints and tender joints using the 28-joint count, C-reactive protein (CRP) (milligrams per liter (mg/L)) per , and the patient's global assessment of disease activity and physician's global assessment of disease activity; SDAI scores range from 0 to 86, where lower scores indicate less disease activity. A score of ≤11 was considered to be SDAI LDA. Participants with missing data were considered to have failed to achieve the outcome.

Time frame: Month 12

Population: Efficacy population, defined as all participants who received at least one infusion of tocilizumab and who met all inclusion and exclusion criteria.