Efficacy and Safety of Adalimumab in Patients With Rheumatoid Arthritis in Routine Clinical Practice

The Disease Activity Score 28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, the erythrocyte sedimentation rate (ESR), and the patient's assessment of global disease activity (on a visual analog scale \[VAS\] from 0 to 10 cm) are included in the DAS28 score. If the ESR value is missing, the C-reactive protein (CRP) value can be substituted. Scores on the DAS28 range from 0 to 10; higher scores indicate more disease activity. A DAS28 score \>5.1 indicates high disease activity, a DAS28 score \<3.2 indicates low disease activity, and a DAS28 score \<2.6 indicates clinical remission.

Time frame: Baseline and Months 3, 6, 9, 12, 18, and 24

Population: Full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS. n indicates the number of participants with available data at each time point.

Clinical remission is defined as a disease activity score (DAS) 28 score of \< 2.6. The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, the erythrocyte sedimentation rate (ESR), and the patient's assessment of global disease activity (assessed on a visual analog scale \[VAS\] from 0 to 10 cm) are included in the DAS28. If the ESR value is missing, the C-reactive protein (CRP) value can be substituted. Scores on the DAS28 range from 0 to 10; higher scores indicate more disease activity.

Time frame: Months 3, 6, 9, 12, 18, and 24

Population: Full analysis set with available data at each time point (indicated by n)

C-Reactive Protein (CRP) was measured from blood samples as a marker for inflammation. Higher levels are indicative of more inflammation. Normal concentration in healthy human serum is usually lower than 10 mg/L, slightly increasing with age.

Time frame: Baseline and Months 3, 6, 9, 12, 18, and 24

Population: Full analysis set with available data at each time point (indicated by n)

Erythrocyte sedimentation rate (ESR) indirectly measures how much inflammation is in the body. A higher ESR is indicative of increased inflammation.

Time frame: Baseline and Months 3, 6, 9, 12, 18, and 24

Population: Full analysis set with available data at each time point (indicated by n)

A self-administered patient questionnaire used to assess patient function based on 18 questions. The numerically coded responses to the questions are added to provide a total patient score. The FFbH was calculated from this patient score by the following formula: FFbH = (patient score x 100) ÷ 2 (number of valid responses). The resulting FFbH score reflects the degree of remaining functional capacity where 0 indicates maximal impairment and 100 indicates maximal functional capacity.

Time frame: Baseline and Months 3, 6, 9, 12, 18, and 24

Population: Full analysis set with available data at each time point (indicated by n)

Participants reported the number of days they had missed from work in the prior 6 months. The Baseline measurement includes data for the prior 12 months.

Time frame: Baseline and Months 6, 12, 18, and 24

Population: Full analysis set participants who were employed and with available data at each time point (indicated by n)

Participants indicated their level of fatigue over the last 7 days on a visual analog scale (VAS) from 0 (best) to 10 (worst) cm; lower scores indicate better patient status.

Time frame: Baseline and Month 3, 6, 9, 12, 18, and 24

Population: Full analysis set with available data at each time point (indicated by n)

Participants indicated their level of pain over the last 7 days on a visual analog scale (VAS) from 0 (best) to 10 (worst) cm; lower scores indicate better patient status.

Time frame: Baseline and Months 3, 6, 9, 12, 18, and 24

Population: Full analysis set with available data at each time point (indicated by n)

Participants indicated their global assessment of disease activity over the last 7 days on a visual analog scale (VAS) from 0 (best) to 10 (worst) cm; lower scores indicate better patient status.

Time frame: Baseline and Months 3, 6, 9, 12, 18 and 24

Population: Full analysis set with available data at each time point (indicated by n)

Time frame: Baseline and Months 3, 6, 9, 12, 18, and 24

Population: Full analysis set with available data at each time point (indicated by n)

Significant therapeutic response was determined by DAS28 critical difference (Dcrit). A Dcrit response is a statistically determined value that exceeds the threshold of random fluctuation and signifies a positive individual response during treatment. A DAS28-Dcrit individual therapeutic response is defined as a decrease (improvement) in DAS28 from Baseline of ≥ 1.8. The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, the erythrocyte sedimentation rate (ESR), and the patient's assessment of global disease activity (assessed on a visual analog scale \[VAS\] from 0 to 10 cm) are included in the DAS28. If the ESR value is missing, the C-reactive protein (CRP) value can be substituted. Scores on the DAS28 range from 0 to 10; higher scores indicate more disease activity.

Time frame: Baseline and Months 3, 6, 9, 12, 18, and 24

Population: Full analysis set with available data at each time point (indicated by n)

Participants were asked to report how many days of impairment in daily activities they had experienced in the last 4 weeks.

Time frame: Baseline and Months 3, 6, 9, 18, and 24

Population: Full analysis set with available data at each time point

The percentage of participants with in-patient hospitalization in the prior 6 months. Baseline data includes in-patient hospitalizations that occurred within the prior 12 months.

Time frame: Month 6, 12, 18, and 24

Population: Full analysis set with available data at each time point (indicated by n)

The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, the erythrocyte sedimentation rate (ESR), and the patient's assessment of global disease activity (assessed on a visual analog scale \[VAS\] from 0 to 10 cm) are included in the DAS28. If the ESR value is missing, the C-reactive protein (CRP) value can be substituted. Scores on the DAS28 range from 0 to 10; higher scores indicate more disease activity. Low disease activity is defined as a DAS28 score ≤ 3.2; Moderate disease activity as a DAS28 \>3.2 to ≤5.1; High disease activity as a DAS28 \>5.1.

Time frame: Baseline and Months 3, 6, 9, 12, 18, and 24

Population: Full analysis set with available data at each time point

Twenty-eight joints were assessed and classified as swollen/not swollen by pressure and joint manipulation on physical examination.

Time frame: Baseline and Months 3, 6, 9, 12, 18, and 24

Population: Full analysis set with available data at each time point (indicated by n)

Twenty-eight joints were assessed and classified as tender/not tender by pressure and joint manipulation on physical examination.

Time frame: Baseline and Months 3, 6, 9, 12, 18, and 24

Population: Full analysis set with available data at each time point (indicated by n)