Special Investigation in Patients With Ankylosing Spondylitis (All Patients Investigation)

An adverse drug reaction (ADR) is an injury caused by taking a medication, in which a causative relationship can be shown.

A serious adverse drug reaction is any untoward medical occurrence that at any dose;

• Results in death
• Life threatening
• Requires inpatient hospitalization or prolongation of existing hospitalization
• Results in persistent of significant disability or incapacity

An adverse drug reaction (ADR) is an injury caused by taking a medication, in which a causative relationship can be shown. ADRs are reported by baseline characteristics.

NSAID: non-steroidal anti-inflammatory drug

DMARD: disease-modifying anti-rheumatic drug

BASDAI: Bath Ankylosing Spondylitis Disease Activity Index

An adverse event (AE) is 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. An adverse event (AE) can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.

A serious adverse event (SAE) is defined as any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, may have caused a congenital anomaly/birth defect, or requires intervention to prevent permanent impairment or damage.

Participants were evaluated for improvement at weeks 12 and 24 of treatment or discontinuation of treatment or participation in the survey based on the clinical course from baseline using the following scale:

• Markedly improved, 2. Improved, 3.Not improved, 5. Not assessable

Participants were evaluated for improvement at weeks 12 and 24 of treatment or discontinuation of treatment or participation in the survey based on the clinical course from baseline using the following scale:

• Markedly improved, 2. Improved, 3.Not improved, 5. Not assessable

The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) assesses disease activity by asking the participant to answer 6 questions (each on a 10 point numeric rating scale [NRS]) pertaining to symptoms experienced for the past week. For 5 questions (level of fatigue/tiredness, level of AS neck, back or hip pain, level of pain/swelling in joints, other than neck, back or hips, level of discomfort from any areas tender to touch or pressure, and level of morning stiffness), the response is from 0 (none) to 10 (very severe); for Question 6 (duration of morning stiffness), the response is from 0 (0 hours) to 10 (≥ 2 hours). The overall BASDAI score ranges from 0 to 10 where lower scores indicate less disease activity.