Upadacitinib in patient with Psoriatic Athritis and an inadequate response to non biologic therapy: 56 week data from the Phase 3 SELECT-PsA 1 study

1. By:
Farah Adibah Kasmin
Supervisor:
A.P Dr Hazlyna Baharuddin
Journal Club
Upadacitinib in patient with Psoriatic
Athritis and an inadequate response to
non biologic therapy: 56 week data from
the phase 3 SELECT-PsA 1 study.
UITM I 27.09.2023

2. Today's Agenda
Case study
Paper's Discussion
Overview of PsA
Conclusion

3. Case study
June 2019
Multiple joint
pain with EMS
x6/12
35 years old man
Underlying Psoriasis since 2015
Started on
NSAIDS,
Sulfasalazine
January 2020
30% thick
plaques
psoriasis.
Initiated MTX
7.5mg EOW
July 2020
Achieved
clinical
remission
October 2021
Chest pain with
tenderness at
costochondral and
sternoclavicular
joint
January 2022
Increased MTX
12.5mg EOW
March 2022
Persistent chest
pain
Tender at bilateral
costochondral
joint, iliac crest
and supraspinatus
Started on
targeted
synthetic
DMARDS.

4. Overview

5. Overview

6. Maximize patient outcomes
Treatment
Control the
inflammation.
1. 3.
2.
Prevent
disabillity.
Prevent
irreversible joint
damage.

7. Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA),
2014.

8. Taiwan Rheumatology Association and the Taiwanese Association
for Psoriasis and Skin Immunology, 2020.

9. Measuring Outcomes.

10. Measuring Outcomes.

13. About SELECT-PsA 1 Study

14. 1st Period
1.Patients ≥ 18 years of age.
2. Fulfillment of the ClASsification
criteria for Psoriatic ARthritis (CASPAR).
3. Active or documented history of
plaque psoriasis.
4. Inadequate responses to ≥ 1 non-
bDMARD at maximal titrated dose.
5. 3 or more SJC / TJC at baseline.
6. Either 1 or more erosion on Xray or
CRP > upper limit normal during
screening.
Prior exposure to any bDMARDs.
1.
2. Prior exposure to any JAK inhibitor.
3. Current treatment with > 2 non-
bDMARDs.
4. Current or past history of infection.
5. Underlying medical diseases or
problems.
Inclusion Criteria
Exclusion Criteria

15. 2nd Period
Mainly, to evaluate the long term safety, tolerability and efficacy of Upadacitinib 15 and
Upadacitinib 30 in subjects with PsA from SELECT PsA 1.

16. About SELECT-PsA 1 Study

17. About SELECT-PsA 1 Study

18. About SELECT-PsA 1 Study

19. 1st Period

20. For binary endpoints, treatments were compared using
Cochran Mantel Haenszel test.
Statistical Analysis
For non radiographic continous endpoint analyses used mixed-
effects model repeated measures (MMRM).
Analyses for radiographic endpoints were based on analysis of
covariance model.

21. End Points and Assessment
Key Secondary
Analysis
Improvement in Psoriasis Area Severity
Index (PASI75/90/100 response).
Primary End Points
ACR20/50/70 response.
Minimal disease activity (MDA).
Changes from baseline in Bath Ankylosing
Spondylitis Disease Activity Index (BASDAI)
and Ankylosing spondylitis Disease
Activity Score (ASDAS).
Improvement in PsARC.

22. End Points and Assessment
Patient Outcomes
Change from baseline in Health Assessment Questionnaire-
Disability Index (HAQ-DI), Functional Assessment of Chronic
Illness Therapy-Fatigue (FACIT-F) total, Short Form Health
Survey, questionnaire (SF-36), Physical Component Summary
(PCS) and Mental Component Summary (MCS) scores, Work
Productivity and Activity Impairment (WPAI).
1.
Safety Outcomes
Infection
Liver and kidney impairment
Venous thromboembollism
Malignancy
1.
2.
3.
4.

23. Results

24. Results

25. Results

26. Results
The proportion of patients achieving
Psoriatic Arthritis Response Criteria
(PsARC).

27. Results
The proportions of overall patients
achieving MDA.

28. Results
Skin Outcomes.

29. Results
Skin Outcomes

30. Results
Skin Outcomes

31. Results
Skin Outcomes

32. Results
≥30% reduction in baseline pain
at week 56.

33. Results
≥50% reduction in baseline pain
at week 56.

34. Results
Patients achieving HAQ-DI over 56
weeks.

35. Results
Change from baseline over 56 weeks in
HAQ-DI.

36. Results

37. Results

38. Results
Safety
Rates of TEAEs were higher with upadacitinib
30 mg versus upadacitinib 15 mg and
adalimumab:
(333.9 vs 281.1 and 265.9 E/100 PY, respectively)

39. Results
Safety

40. Results
Safety

41. Strength Limitation
Large study size
No axial images to assess psoriatic
spondylitis.
It included Adalimumab as a side by
side comparison.
No placebo group available for
comparison after week 24.
Dose ranging study is helpful and
provide understanding how the dose
might impact the response rate and its
adverse events.
Majority involve white population, not
represent data of the Asians.
Discussion

42. Conclusion
JAKinibs - Fast release that can last
Efficacy response were maintained with Upadacitinib 15 mg and 30 mg treatment over 56 weeks.
1.
3. Improvementt in efficacy were observed in patient switched from placebo to Upadacitinib.

43. Conclusion
JAKinibs - Fast release that can last

44. Conclusion
JAKinibs - Fast release that can last
U.S. Food and Drug Administration (FDA) has approved Updacitinib 15mg OD for the treatement of Psoariatic
Athritis who have had an inadequate response or intolerance to one or more tumor necrosis factor (TNF)
blockers in December 2021.