Bimekizumab Efficacy through Year 1 in Patients with Moderate to Severe Plaque Psoriasis Who Had Not Achieved a PASI 90 Response by Week 16: A Pooled Analysis from Four Phase 3/3B Trials

Main Article Content

George Han
Alice B. Gottlieb
April Armstrong
Bruce Strober
Jennifer Soung
Heather Herr
Leah Davis
Mark Lebwohl

Keywords

Plaque psoriasis, PASI 90, Clinical trial, Bimekizumab

Abstract

Introduction: Psoriasis Area and Severity Index (PASI) is a commonly used tool for evaluating skin clearance; patients with ≥90% reduction from baseline PASI (PASI 90) have a level of skin clearance that has been associated with improved quality of life.1 Bimekizumab (BKZ) is a monoclonal IgG1 antibody that selectively inhibits interleukin (IL)-17F in addition to IL-17A.2 High PASI 90 response rates have been observed with BKZ, maintained through three years, across four phase 3/3b trials and an open-label extension (OLE).3–7 Here, we evaluate PASI response through Year 1 in patients who had not had a PASI 90 response during at least one visit up to and including Week 16, in four phase 3/3b trials of BKZ in moderate to severe plaque psoriasis.  


Methods: Data were pooled from the double-blinded 52-week BE VIVID,3 56-week BE READY,4 56-week BE SURE,5 phase 3 trials, and the 48-week double-blind period of the BE RADIANT6 phase 3b trial. Included patients were randomized to BKZ 320 mg every 4 weeks (Q4W) to Week 16 and then received either BKZ 320 mg Q4W or Q8W maintenance dosing until end of Year 1 (Week 52 for BE VIVID; Week 48 for other trials). Results are reported as observed case (OC).


Results: Of the 1,362 patients randomized to BKZ across four phase 3/3b trials, 92.6% (n=1,261) had a PASI 90 response during at least one visit up to and including Week 16 while 7.1% (n=97) had not. PASI response was unavailable for 4 patients. The median (minimum, maximum) percent change from baseline PASI among the 97 patients without a PASI 90 response by Week 16 was −77.3 (−89.7, +20.0) at Week 16 (n=78) and −92.9 (−100, +90.7) at Year 1 (n=51).


Overall, 61.9% (60/97) of patients without a PASI 90 response by Week 16 completed their respective phase 3/3b trials and entered an OLE. By Year 1, 55.0% (33/60) achieved PASI 90 during at least one visit.


Conclusion: While the vast majority (92.6%) of patients treated with BKZ had a PASI 90 response during at least one visit up to Week 16, a large proportion of patients without a PASI 90 response by Week 16 who completed the phase 3/3b trials and entered an OLE had a PASI 90 response during at least one visit up to Year 1 (55.0%).

References

1. Rasmussen MK et al. Acta Derm Venereol 2019;99(2):158–63;

2. Papp KA et al. J Am Acad Dermatol 2018;79(2):277–86;

3. Reich K et al. Lancet 2021;397(10273):487–98, NCT03370133;

4. Gordon KB et al. Lancet 2021;397(10273):475–86, NCT03410992;

5. Warren RB et al. N Engl J Med 2021;385(2):130–41, NCT03412747;

6. Reich K et al. N Engl J Med 2021;385(2):142–52, NCT03536884;

7. Strober B et al. Br J Dermatol 2023;188(6):749–59, NCT03598790.

Most read articles by the same author(s)

1 2 3 4 5 6 7 8 9 10 > >>