Japan Post-Marketing Surveillance for Peficitinib to Assess Safety and Effectiveness in the Patients With Rheumatoid Arthritis

Primary outcomes

1. Safety assessed by frequency of adverse events (AEs)

   Time frame: Up to 52 weeks

   An AE is defined as any unwanted medical occurrence after drug administration and which does not necessarily have a causal relationship with the treatment.

2. Safety assessed by frequency of adverse drug reactions (ADRs)

   Time frame: Up to 52 weeks

   AEs whose relationship to the study drugs could not be ruled out is considered adverse drug reaction. AEs that fall under either "Probable" or "Possible" or "Unassessable" should be defined as "AEs whose relationship to the study drugs could not be ruled out."

3. Safety assessed by frequency of serious infections

   Time frame: Up to 156 weeks

   Serious infections include tuberculosis, pneumonia, pneumocystis pneumonia, ichorrhemia and opportunistic infection.

4. Safety assessed by frequency of malignancy

   Time frame: Up to 156 weeks

   Frequency of malignancy found after drug administration.

5. Safety assessed by frequency of events leading to death

   Time frame: Up to 156 weeks

   Any events leading to death will be reported as serious AEs.

6. Safety assessed by frequency of AEs of special interests

   Time frame: Up to 156 weeks

   AEs of special interests include neutrophil decrease, lymphocyte decrease, hemoglobin decrease, Herpes zoster, gastrointestinal perforation, interstitial pneumonia, reactivation of Hepatitis B virus, hepatic function disorder, venous thromboembolism, cardiovascular events, rhabdomyolysis and myopathy.

7. Safety assessed by frequency of serious adverse events (SAEs)

   Time frame: Up to 156 weeks

   An AE is considered "serious" if, in the view of either the investigator, it results in any of the following outcomes: death, life-threatening, persistent or significant disability/incapacity or substantial disruption, congenital anomaly or birth defect, hospitalization or prolongation of hospitalization, or medically important events.

8. Safety assessed by frequency of serious adverse drug reactions (SADRs)

   Time frame: Up to 156 weeks

   SAEs whose relationship to the study drugs could not be ruled out is considered serious ADR. SAEs that fall under either "Probable" or "Possible" or "Unassessable" should be defined as "SAEs whose relationship to the study drugs could not be ruled out."

9. Disease activity score (DAS28) - C-reactive protein (CRP)

   Time frame: Up to 52 weeks

   DAS28-CRP will be calculated using data from Tender Joint Count (TJC) (28 joints), Swollen Joint Count (SJC) (28 joints), C-reactive protein (CRP) and Subject's Global Assessment of Arthritis (SGA) with the formula; DAS28-CRP = 0.56√(TJC) + 0.28√(SJC) + 0.36 ln (CRP (mg/dL) x 10 + 1) + 0.014 x SGA (mm) + 0.96.

   DAS28-CRP exceeding 5.1 is considered high disease activity; exceeding 3.2 and not greater than 5.1, moderate disease activity; exceeding 2.6 and not greater than 3.2, low disease activity.

10. DAS28- erythrocyte sedimentation rate (ESR) score

    Time frame: Up to 52 weeks

    DAS28-ESR will be calculated using data from TJC (28 joints), SJC (28 joints), ESR and SGA with the formula; DAS28- ESR = 0.56√(TJC) + 0.28√(SJC) + 0.70 ln ESR (mm/h) + 0.014 x SGA (mm).

    DAS28-ESR exceeding 5.1 is considered high disease activity; exceeding 3.2 and not greater than 5.1, moderate disease activity; exceeding 2.6 and not greater than 3.2, low disease activity.

11. Simplified Disease Activity Index (SDAI) score

    Time frame: Up to 52 weeks

    SDAI score will be calculated with formula SDAI = TJC + SJC + SGA + Physician's Global Assessment of Arthritis (PGA) + CRP.

    SDAI score exceeding 26 is considered high disease activity; exceeding 11 and not greater than 26, moderate disease activity; exceeding 3.3 and not greater than 11, low disease activity.

12. Clinical Disease Activity Index (CDAI) score

    Time frame: Up to 52 weeks

    CDAI score will be calculated with formula CDAI = TJC + SJC + SGA + PGA. CDAI score exceeding 22 is considered high disease activity; exceeding 10 and not greater than 22, moderate disease activity; exceeding 2.8 and not greater than 10, low disease activity.

13. Tender Joint Count (TJC) (28 joints)

    Time frame: Up to 52 weeks

    The investigator/sub-investigator will examine the participant for tender joints, assessing the 28 joints and confirm the location of each tender joint.

14. Swollen Joint Count (SJC) (28 joints)

    Time frame: Up to 52 weeks

    The investigator/sub-investigator will examine the participants for swollen joints, assessing the 28 joints and confirm the location of the swollen joints.

15. Erythrocyte sedimentation rate (ESR)

    Time frame: Up to 52 weeks

    ESR will be recorded from blood samples collected.

16. C-reactive protein (CRP)

    Time frame: Up to 52 weeks

    CRP will be recorded from blood samples collected.

17. Subject's Global Assessment of Arthritis (SGA) (visual analog scale (VAS))

    Time frame: Up to 52 weeks

    The participant assesses his/her own disease activity on a VAS of 0 - 100 mm, corresponding from 'no disease activity' to 'very severe disease activity', on the questionnaire form.

18. Physician's Global Assessment of Arthritis (PGA) (VAS)

    Time frame: Up to 52 weeks

    The investigator assesses participant's disease activity on a VAS of 0 - 100 mm, corresponding from 'no disease activity' to 'very severe disease activity', on the questionnaire form.

19. European League Against Rheumatism (EULAR) Response Criteria

    Time frame: Up to 52 weeks

    Based on DAS28 scores and changes in DAS28 scores before and after treatment with the study drug, EULAR Response Criteria categorize response to treatment as "No response", "Moderate response," or "Good response."

20. Percentage of participants achieving DAS28-CRP scores for remission

    Time frame: Up to 52 weeks

    Percentage of participants with DAS28 scores less than 2.6.

21. Percentage of participants achieving DAS28-ESR scores for remission

    Time frame: Up to 52 weeks

    Percentage of participants with DAS28 scores less than 2.6.