A 3-year Study Following up Patients With Moderate to Severe Rheumatoid Arthritis Treated With Humira in Greece

An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.

If an adverse event meets any of the following criteria, it is considered a serious adverse event (SAE): Results in death, is life-threatening, results in hospitalization or the prolongation of hospitalization, is a congenital anomaly or a persistent or significant disability/incapacity, is an event that results in a condition that substantially interferes with the activities of daily living of the participant, is an important medical event requiring medical or surgical intervention to prevent a serious outcome, spontaneous abortion or miscarriage experienced by the participant, or an elective abortion performed on the participant.

The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C reactive protein, and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. 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.

A EULAR response reflects an improvement in disease activity and an attainment of a lower degree of disease activity based on the DAS28 score. The DAS28 score ranges from 0-10, with higher scores indicating more disease activity.

A Good EULAR Response is defined as an improvement (decrease) in the DAS28 of > 1.2 compared with Baseline and attainment of a DAS28 score of ≤ 3.2.

A Moderate EULAR Response is defined as either:

• an improvement (decrease) in the DAS28 of > 0.6 and ≤ 1.2 from Baseline and attainment of a DAS28 score of ≤ 5.1, or
• an improvement (decrease) in the DAS28 of > 1.2 from Baseline and attainment of a DAS28 score of > 3.2.

No Response is defined as either:

• an improvement (decrease) in the DAS28 of ≤ to 0.6, or
• an improvement (decrease) in the DAS28 of > 0.6 and ≤ 1.2 and attainment of a DAS28 of > 5.1.

American College of Rheumatology 20% (ACR20) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:

• ≥ 20% improvement in tender joint count;
• ≥ 20% improvement in swollen joint count; and
• ≥ 20% improvement in at least 3 of the 5 following parameters:

• Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);
• Patient's global assessment of disease activity (measured on a 100 mm VAS);
• Physician's global assessment of disease activity (measured on a 100 mm VAS);
• Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]);
• Acute phase reactant value (C-reactive protein [CRP]).

American College of Rheumatology 50% (ACR50) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:

• ≥ 50% improvement in tender joint count;
• ≥ 50% improvement in swollen joint count; and
• ≥ 50% improvement in at least 3 of the 5 following parameters:

• Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);
• Patient's global assessment of disease activity (measured on a 100 mm VAS);
• Physician's global assessment of disease activity (measured on a 100 mm VAS);
• Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]);
• Acute phase reactant value (C-reactive protein [CRP]).

American College of Rheumatology 70% (ACR70) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:

• ≥ 70% improvement in tender joint count;
• ≥ 70% improvement in swollen joint count; and
• ≥ 70% improvement in at least 3 of the 5 following parameters:

• Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);
• Patient's global assessment of disease activity (measured on a 100 mm VAS);
• Physician's global assessment of disease activity (measured on a 100 mm VAS);
• Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]);
• Acute phase reactant value (C-reactive protein [CRP]).

Compliance to study treatment was measured by the percentage of participants who missed at least one dose of Humira during each time interval between study visits.