Multi-country Post-Marketing Observational Study on Maintenance of Effectiveness of Adalimumab (Humira®) in Patients With Ankylosing Spondylitis and Psoriatic Arthritis

• Bath Ankylosing Spondylitis Daily Activity Index (BASDAI) score [ Time Frame: Day 0 to 12 months ] [ Designated as safety issue: No ]
  Primary endpoint is the percentage of patients who exhibit treatment response at the end of the observational period of 12 months as compared with baseline. Response is defined by at least 50% from baseline in case of axial symptoms.
  
  
• Disease Activity Score/28 joints (DAS28) [ Time Frame: Day 0 to 12 months ] [ Designated as safety issue: No ]
  Primary endpoint is the percentage of patients who exhibit treatment response at the end of the observational period of 12 months as compared with baseline. Response is defined as a decrease by at least 1.2 from baseline in case of peripheral symptoms.
  
  
• Ankylosing Spondylitis Disease Score (ASDAS) score [ Time Frame: Day 0 to 12 months ] [ Designated as safety issue: No ]
  Co-primary endpoint is the percentage of patients in remission at the end of the observational period of 12 months. Remission is defined as a score of < 1.3 in case of axial symptoms (which corresponds to Assessment in Ankylosing Spondylitis ASAS partial remission PR criterion).
  
  

• Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score (in case of axial symptoms) and/or Disease Activity Score/28 joints (DAS28) (in case of peripheral symptoms) from study baseline to 12 months [ Time Frame: Day 0 to 12 months ] [ Designated as safety issue: No ]
  Patients with AS (Ankylosing Spondylitis)
  
  
• Change in Ankylosing Spondylitis Disease Activity Score (ASDAS) from study baseline to 12 months [ Time Frame: Day 0 to 12 months ] [ Designated as safety issue: No ]
  Patients with AS (Ankylosing Spondylitis)
  
  
• Correlation between Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and Ankylosing Spondylitis Disease Activity Score (ASDAS) throughout the observational period of 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  Patients with AS (Ankylosing Spondylitis)
  
  
• Predictors of maintained treatment response and/or remission [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  Patients with AS (Ankylosing Spondylitis)
  
  
• Change in Health Assessment Questionnaire Disability Index ( HAQ-DI) score (in case of peripheral symptoms) or Bath Ankylosing Spondylitis Functional Index (BASFI) score (in case of axial symptoms) from baseline to 12 months [ Time Frame: Day 0 to 12 months ] [ Designated as safety issue: No ]
  Patients with AS (Ankylosing Spondylitis)
  
  
• Change in the frequency of extra-articular manifestations (EAMs) from study baseline to 12 months [ Time Frame: Day 0 to 12 months ] [ Designated as safety issue: No ]
  Patients with AS (Ankylosing Spondylitis)
  
  
• Duration of treatment with adalimumab [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  Patients with AS (Ankylosing Spondylitis)
  
  
• Percentage of patients whose co-medication with Nonsteroidal anti-inflammatory drugs (NSAIDs) could be stopped from baseline to 12 months [ Time Frame: Day 0 to 12 months ] [ Designated as safety issue: No ]
  Patients with AS (Ankylosing Spondylitis)
  
  
• Changes in individual components of Work Productivity and Activity Impairment Specific Health Problem Questionnaire [ Time Frame: Day 0 to 12 months ] [ Designated as safety issue: No ]
  Patients with AS (Ankylosing Spondylitis) - (% Presenteeism, % Absenteeism, % Total work productivity impairment, % Total activity impairment) from baseline to 12 months
  
  
• Change in the percentage of patients who have paid work from baseline to 12 months [ Time Frame: Day 0 to 12 months ] [ Designated as safety issue: No ]
  Patients with AS (Ankylosing Spondylitis)
  
  
• Change in Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score (in case of axial symptoms) and/or Disease Activity Score/ 28 joints (DAS28) (in case of peripheral symptoms) from study baseline to 12 months, [ Time Frame: Day 0 to 12 months ] [ Designated as safety issue: No ]
  Patients with PsA (Psoriatic Arthritis)
  
  
• Correlation between Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and Ankylosing Spondylitis Disease Activity Score (ASDAS) throughout the observational period of 12 months, [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  Patients with PsA (Psoriatic Arthritis)
  
  
• Predictors of maintained treatment response and/or remission, [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  Patients with PsA (Psoriatic Arthritis)
  
  
• Change in Health Assessment Questionnaire Disability Index (HAQ-DI) score (in case of peripheral symptoms) or Bath Ankylosing Spondylitis Functional Index (BASFI) score (in case of axial symptoms) from baseline to 12 months [ Time Frame: Day 0 to 12 months ] [ Designated as safety issue: No ]
  Patients with PsA (Psoriatic Arthritis)
  
  
• Changes in individual components of Work Productivity and Activity Impairment-Specific Health Problem Questionnaire score (% Presenteeism, % Absenteeism, % Total work productivity impairment, % Total activity impairment) from baseline to 12 months [ Time Frame: Day 0 to 12 months ] [ Designated as safety issue: No ]
  Patients with PsA (Psoriatic Arthritis)
  
  

This Postmarketing observational study (PMOS) will be conducted in a prospective, single-arm, multicenter, multi-country format.

According to the requirements for non-interventional or observational trials, no additional diagnostic or monitoring procedures will be applied to the patients included in the trial other than those which would ordinarily be applied in the course of the particular therapeutic strategy. Only data which are part of routine will be collected.

As this study is observational in nature, the follow-up visits are not interventional and strictly scheduled, but rather left to the judgment of each investigator within the 12-month study period for each patient.

Failure to observe these usual practice intervals of patient visits will not constitute a breach or violation of the protocol.

To optimize data collection, five (5) patient visits are indicated within the 12-month observational period:

• Visit 0 (V0): Baseline
• Visit 1 (V1): Follow-up at 3 months
• Visit 2 (V2): Follow-up at 6 months
• Visit 3 (V3): Follow-up at 9 months
• Visit 4 (V4): Follow-up at 12 months (Study End). A patient may withdraw from this Postmarketing observational study ( PMOS) at any time without prejudice. If the physician, for any reason, decides it is in the best interest of the patient to permanently discontinue adalimumab, treatment should be stopped. The reason should be documented in the Case report form (CRF). The next routine follow-up visit will be the termination visit for the patient.