An Observational Study to Evaluate Safety and Efficacy of Remsima™ in Patients With Ankylosing Spondylitis

* Hepatitis B virus reactivation * Congestive heart failure * Opportunistic infections (excluding tuberculosis) * Serious infections including sepsis (excluding opportunistic infections and tuberculosis) * Tuberculosis (TB) * Serum sickness (delayed hypersensitivity reactions) * Haematological reactions * Systemic lupus erythematosus/lupus-like syndrome * Demyelinating disorders * Lymphoma (not hepatosplenic T cell lymphoma) * Hepatobiliary events * Hepatosplenic T cell lymphoma (HSTCL) * Serious infusion reactions during a re-induction regimen following disease flare * Sarcoidosis/sarcoid-like reactions * Leukaemia * Malignancy (excluding lymphoma) * Skin cancer * Pregnancy exposure * Infusion related reaction (IRR)/hypersensitivity/anaphylactic reaction

Time frame: Duration of study participation (up to 5 years)

Population: All patients data were analyzed; however, there were 0 patients recruited in the Switch to Remicade II groups.

The Bath Ankylosing Spondylitis Functional Index (BASFI) questionnaire consists of 10 component questions measuring functionality. Each item was given a rating by the patient which is a whole number from 0 to 10 inclusive where 0 = Easy and 10 = Impossible. The BASFI score is generated from the mean of the scores for the 10 items. The lowest score is 0 and the highest score is 10, with higher scores indicating a higher degree of functional limitation in patients.

Time frame: Day 0 ~ Month 48 (every 6 months ± 6 weeks)

Population: The Efficacy Analysis set consisted of all patients who received at least one infliximab dose (Remsima or Remicade) and providing at least one post treatment efficacy result during the analysis period. Efficacy analysis was only performed in the Remsima, Switch to Remsima, Remicade and Switch to Remicade analysis groups.

Physician and Patient Global Assessment of disease status was measured by Visual Analogue Scale (VAS) (0-100 mm) for EU patients and Numerical Rating Scale (NRS) (0-10) for Korea patients where higher scores indicated poorer status. Descriptive statistics for actual value of Global Assessment Score were summarized by analysis group and every six months including Day 0. For the summary table, each score of Korea patients in NRS was transformed by multiplying 10. Scores are from 0 to 100, with higher scores indicating more disease activity.

Time frame: Day 0 ~ Month 48 (every 6 months ±6 weeks)

Population: The Efficacy Analysis set consisted of all patients who received at least one infliximab dose (Remsima or Remicade) and providing at least one post treatment efficacy result during the analysis period. Efficacy analysis was only performed in the Remsima, Switch to Remsima, Remicade and Switch to Remicade analysis groups.

Physician and Patient Global Assessment of disease status was measured by Visual Analogue Scale (VAS) (0-100 mm) for EU patients and Numerical Rating Scale (NRS) (0-10) for Korea patients where higher scores indicated poorer status. Descriptive statistics for actual value of Global Assessment Score were summarized by analysis group and every six months including Day 0. For the summary table, each score of Korea patients in NRS was transformed by multiplying 10. Scores are from 0 to 100, with higher scores indicating more disease activity.

Time frame: Day 0 ~ Month 48 (every 6 months ±6 weeks)

Population: The Efficacy Analysis set consisted of all patients who received at least one infliximab dose (Remsima or Remicade) and providing at least one post treatment efficacy result during the analysis period. Efficacy analysis was only performed in the Remsima, Switch to Remsima, Remicade and Switch to Remicade analysis groups.

Patient Assessment of Spinal Pain will be measured by VAS (0-100 mm) for EU patients and NRS (0-10) for Korea patients where higher scores indicates more severe pain. Descriptive statistics for actual value of Spinal Pain Score will be summarized by analysis group and every six months including Day 0. For the summary table, each score of Korea patients in NRS will be transformed by multiplying 10. Scores are from 0 to 100, with higher scores indicating more pain as assessed by the patient.

Time frame: Day 0 ~ Month 48 (every 6 months ±6 weeks)

Population: The Efficacy Analysis set consisted of all patients who received at least one infliximab dose (Remsima or Remicade) and providing at least one post treatment efficacy result during the analysis period. This study's primary objective is to compare RemsimaTM in patients with AS with patients receiving other anti-TNF drugs', especially with 'Remicade'. Therefore Switch to Remsima II and Switch to Other Anti-TNF groups' are excluded from the results.

Efficacy was assessed by the evaluation of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI). The BASDAI questionnaire consists of 6 component questions about the disease activity. For each question the possible answer from the patient is a whole number from 0 to 10 inclusive where 0 = None and 10 = Very severe. The BASDAI score is generated from the set of 6 questions and calculated using the following formula BASDAI = \[Q1+Q2+Q3+Q4+(\[Q5+Q6\]/2)\]/5. The number and percentage of patients achieving BASDAI 50 will be displayed. BASDAI 50 is defined as a 50% decrease of the baseline BASDAI score. Percentages will be calculated using the number of patients who perform the assessment at each time point.

Time frame: Month 6 ~ Month 48 (every 6 months ± 6 weeks)

Population: Efficacy analysis was only performed in the Remsima, Switch to Remsima, Remicade and Switch to Remicade analysis groups.