Long-term Treatment Study of Certolizumab Pegol Without Coadministration of Methotrexate in Japanese Rheumatoid Arthritis (RA) Patients

An adverse event (AE) is any untoward medical occurrence in a participant administered study drug which did not necessarily have a causal relationship with the treatment. In this study, events that occurred between the time of informed consent and the start of study medication were included in the adverse events for Study 275-08-003. Any event existing prior to the initiation of study treatment that was aggravated after initiation of study treatment was handled as a new event. The investigator assessed the severity of each AE as follows:

Mild: No disruption of normal daily activities; Moderate: Affected normal daily activities; Severe: Inability to perform daily activities.

A serious adverse event is an AE that results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in an ongoing or significant incapacity or interferes substantially with normal life functions, or causes a congenital anomaly or birth defect.

A participant was an ACR20 responder if the following 3 criteria for improvement from Baseline (before study drug administration in Study 275-08-003) were met:

• ≥ 20% improvement in 68 tender joint count;
• ≥ 20% improvement in 66 swollen joint count; and
• ≥ 20% improvement in at least 3 of the 5 following parameters:

• Patient's assessment of arthritis 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));
• C-Reactive Protein (CRP).

A participant was an ACR50 responder if the following 3 criteria for improvement from Baseline (before study drug administration in Study 275-08-003) were met:

• ≥ 50% improvement in 68 tender joint count;
• ≥ 50% improvement in 66 swollen joint count; and
• ≥ 50% improvement in at least 3 of the 5 following parameters:

• Patient's assessment of arthritis 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));
• C-Reactive Protein (CRP).

A participant was an ACR70 responder if the following 3 criteria for improvement from Baseline (before study drug administration in Study 275-08-003) were met:

• ≥ 70% improvement in 68 tender joint count;
• ≥ 70% improvement in 66 swollen joint count; and
• ≥ 70% improvement in at least 3 of the 5 following parameters:

• Patient's assessment of arthritis 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));
• C-Reactive Protein (CRP).

The DAS28 measures the severity of disease at a specific time and is derived from the following variables:

• 28 tender joint count;
• 28 swollen joint count;
• Erythrocyte sedimentation rate (ESR);
• Patient's global assessment of disease activity.

To obtain the tender joint count and swollen joint count, 28 joints of the shoulder, elbow, wrist, metacarpophalangeal joints, thumb interphalangeal joints, proximal interphalangeal joints, and knee joints were examined.

The data before study drug administration of 275-08-003 Study was utilized for Baseline.

DAS28(ESR) scores range from 0 to approximately 10, with the upper bound dependent on the highest possible ESR. A DAS28 score higher than 5.1 indicates high disease activity, a DAS28 score of 3.2 or less indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission.

X-ray images of extremities (posteroanterior views of both hands and dorsoplantar views of both feet) were independently assessed by at least two radiographic readers.

The degree of joint destruction was graded by assessing bone erosion in 44 joints and joint space narrowing (JSN) in 42 joints.

The joint erosion score is a summary of erosion severity in 32 joints of the hands and 12 joints in the feet. Each joint was scored, according to the surface area involved, from 0 (no erosion) to 5 (complete collapse of bone). The score for erosion ranges from 0 to 160 in the hands and from 0 to 120 in the feet (the maximum erosion score for a joint in the foot is 10). The JSN score summarizes the severity of JSN in 30 joints of the hands and 12 joints of the feet. JSN, including subluxation, was scored from 0 (normal) to 4 (complete loss of joint space, bony ankylosis, or luxation), with a maximum JSN score of 168. The mTSS ranges from 0 (normal) to 448 (worst).