PsA

Psa image

▼This medicine is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare Professionals are asked to report any suspected adverse reactions. Adverse events should be reported. Reporting forms and information can be found at yellowcard.mhra.gov.uk for the UK and hpra.ie/homepage/about-us/report-an-issue for Ireland Or, via the MHRA Yellow Card App in the Google Play or Apple App Store. Adverse events should also be reported to UCB Pharma Limited at UCBCares.UK@ucb.com or 0800 2793177.

NICE recommendation
BIMZELX DELIVERED HIGH TREATMENT TARGETS IN PsA 1-4

BIMZELX® (bimekizumab) is indicated for the treatment of: active PsA, alone or in combination with methotrexate, in adults who have had an inadequate response or who have been intolerant to one or more DMARDs; active nr-axSpA, in adults with objective signs of inflammation as indicated by elevated CRP and/or MRI, who have responded inadequately or are intolerant to NSAIDs; and active AS, in adults who have responded inadequately or are intolerant to conventional therapy.3

BIMZELX DELIVERED EFFICACY, SUSTAINED OVER TIME IN PATIENTS WITH PsA (TO WEEK 52) 1–4

 

In two pivotal phase III trials, 43.9% (n=189/431) of biologic-naïve and 43.4% (n=116/267) of TNFi-inadequate responder patients achieved the primary endpoint of ACR 50 at Week 16 with BIMZELX (versus 10.0% [n=28/281] and 6.8% [n=9/133] with placebo, respectively; (p<0.0001 and p<0.001 for each trial respectively)1-3

Joint Efficacy 
BIMZELX PROVIDED SUSTAINED EFFICACY IN THE JOINTS, CONSISTENTLY ACROSS BIOLOGIC-NAIVE and TNFi-IR PATIENTS, AS MEASURED BY ACR 501,2,4,5

 

Primary endpoint in both trials: ACR 50 at Week 16 (p<0.0001 vs placebo)1,2

 

 ACR 50 was achieved by 43.9% (189/431) of biologic-naïve and 43.4% (116/267) of TNFi-IR patients with PsA at Week 16 (primary endpoint in BE OPTIMAL and BE COMPLETE),1–3 54.5% (235/431) and 51.7% (138/267) at Week 52 respectively (NRI analysis).4,5 ASAS 40 was achieved by 47.7% (61/128) of nr-axSpA patients and 44.8% (99/221) of AS patients at Week 16, (primary endpoint in BE MOBILE 1/2);6 60.9% (78/128) and 58.4% (129/221) at Week 52, respectively (NRI analysis).3,6 Rapid onset was demonstrated by numerically higher responder rates (ACR 50) observed when compared with placebo at Week 4 in BE OPTIMAL, 17.6% (76/431), versus 3.2% (9/281); and BE COMPLETE, 16.1% (43/267) versus 1.5% (2/133) respectively.1,2 Rapid separation in ASAS 40 response rates was observed within 1–2 weeks after single a dose of BIMZELX versus placebo; 16.4% (21/128) versus 1.6% (2/126) at Week 1 in BE MOBILE 1, and 16.7% (37/221) versus 7.2% (8/111) at Week 2 in BE MOBILE 2 (NRI analysis).7,8 Reduction of patient limitations was demonstrated using MDA in PsA and ASDAS <2.1 in axSpA. MDA was achieved by 45.0% (194/431) of biologic-naïve and 44.2% (118/267) TNFi-IR patients with PsA at Week 16 (NRI analysis).3 ASDAS <2.1 was achieved by 46.1% (59/128) of nr-axSpA patients and 44.8% (99/221) of AS patients at Week 16, BE MOBILE 1 and BE MOBILE 2 respectively (exploratory endpoint, MI analysis).3

 

 

After Week 16, patients in BE OPTIMAL and BE COMPLETE were aware that they were receiving active treatment, which may have affected the results. Week 52 data are for patients who completed the BE COMPLETE phase III trial (which ran for 16 weeks) and then entered the BE VITAL open-label extension study.1,2,4

 

 

After Week 16, patients in BE OPTIMAL and BE COMPLETE were aware that they were receiving active treatment, which may have affected the results. Week 52 data are for patients who completed the BE COMPLETE phase III trial (which ran for 16 weeks) and then entered the BE VITAL open-label extension study.1,2,4

 

*In BE OPTIMAL, ACR 50 was achieved by 17.6% (n=76/431) at Week 4 (vs 3.2% n=9/281 with placebo), 43.9% (n=189/431) at Week 16 (vs 10.0% [n=28/281] with placebo, p<0.0001), and 54.5% (n=235/431) at Week 52 of biologic-naïve patients in the BIMZELX treatment arm (NRI analysis).1,5 In BE COMPLETE, ACR 50 was achieved by 16.1% (n=43/267) at Week 4 (vs 1.5% [n=2/133] with placebo), 43.4%(n=116/267) at Week 16 (vs 6.8% [n=9/133] with placebo, p<0.0001), and 51.7% (n=138/267) at Week 52 of TNFi-IR patients in the BIMZELX treatment arm (NRI analysis);2,4 **90.0% (n=388/431) of patients who completed 16 weeks of treatment remained on BIMZELX at Week 52;5 †In BE OPTIMAL, mean vdHmTSS change from baseline was 0.01 at Week 16 (vs 0.36 with placebo) and 0.08 at Week 52 in the overall population BIMZELX treatment arm (n=365; NRI analysis).,5 ‡BIMZELX is approved for Q4W/Q8W dosing with PsA in coexisting moderate-to-severe plaque psoriasis.3

Skin Efficacy

 

BIMZELX PROVIDED SUSTAINED ALMOST COMPLETE OR COMPLETE SKIN CLEARANCE, AS MEASURED BY PASI 90 OR PASI 100 (TO WEEK 52)*1,2,4,5

 

After Week 16 all patients were aware that they were receiving active treatment, which may have affected the results. Week 52 data are for patients who completed the BE COMPLETE phase III trial (which ran for 16 weeks) and then entered the BE VITAL open-label extension study

After Week 16 all patients were aware that they were receiving active treatment, which may have affected the results. Week 52 data are for patients who completed the BE COMPLETE phase III trial (which ran for 16 weeks) and then entered the BE VITAL open-label extension study.

After Week 16 all patients were aware that they were receiving active treatment, which may have affected the results. Week 52 data are for patients who completed the BE COMPLETE phase III trial (which ran for 16 weeks) and then entered the BE VITAL open-label extension study.

 

After Week 16 all patients were aware that they were receiving active treatment, which may have affected the results. Week 52 data are for patients who completed the BE COMPLETE phase III trial (which ran for 16 weeks) and then entered the BE VITAL open-label extension study.

 

*In BE OPTIMAL at Week 16: PASI 90 was achieved by 61.3% (n=133/217) with BIMZELX and 2.9% (n=4/140) with placebo, and PASI 100 was achieved by 47.5% (n=103/217) with BIMZELX and 2.1% (n=3/140) with placebo; at Week 52: PASI 90 was achieved by 71.4% (n=155/217) and PASI 100 was achieved by 60.8% (n=132/217) of patients in the BIMZELX treatment arm (NRI analysis).1,5 In BE COMPLETE, at Week 16: PASI 90 was achieved by 68.8%% (n=121/176) with BIMZELX and 6.8% (n=6/88) with placebo, and PASI 100 (additional efficacy outcome) was achieved by 58.5% (n=103/176) with BIMZELX and 4.5% (n=4/88) with placebo; at Week 52: PASI 90 was achieved by 74.4% (n=131/176) and PASI 100 was achieved by 65.9% (n=116/176) of patients in the BIMZELX treatment arm (NRI analysis);2,4 **PASI response in patients with psoriasis involving at least 3% BSA at baseline.1,2,4,5 †BIMZELX is approved for Q4W/Q8W dosing with PsA in coexisting moderate-to-severe plaque psoriasis.3

‡ For some patients with plaque psoriasis (including psoriatic arthritis with coexistent moderate to severe psoriasis) and a body weight ≥ 120 kg who did not achieve complete skin clearance at week 16, 320 mg every 4 weeks after week 16 may further improve treatment response.3

Disease Activity
BIMZELX DELIVERED SUSTAINED EFFICACY ACROSS MULTIPLE DISEASE DOMAINS, AS MEASURED BY MDA (TO WEEK 104)*1,2,4,5,15-17

 

 

After Week 16, patients in BE OPTIMAL and BE COMPLETE were aware that they were receiving active treatment, which may have affected the results. Week 52 data are for patients who completed the BE COMPLETE phase III trial (which ran for 16 weeks) and then entered the BE VITAL open-label extension study.

 

After Week 16, patients in BE OPTIMAL and BE COMPLETE were aware that they were receiving active treatment, which may have affected the results. Week 52 data are for patients who completed the BE COMPLETE phase III trial (which ran for 16 weeks) and then entered the BE VITAL open-label extension study.

 

*In BE OPTIMAL, MDA was achieved by 23.4% (n=99/431) at Week 4 (vs 6.8% [n=19/281] with placebo),5 45.0% (n=194/431) at Week 16 (vs 13.2% [n=37/281] with placebo, p<0.0001), 55.0% (n=237/431) of patients in the BIMZELX treatment arm at Week 52,1,15 and 52.4% (n=226/431) of patients in the BIMZELX treatment arm at Week 104 (NRI analysis).16 In BE COMPLETE, MDA was achieved by 17.2% (n=46/267) at Week 4 (vs 4.5% [n=6/133] with placebo),17 44.2% (n=118/267) at Week 16 (vs 6.0% [n=8/133] with placebo, p<0.0001), 47.2% (n=126/267) of patients in the BIMZELX treatment arm at Week 522,4 and 44.9% (n=120/267) of patients in the BIMZELX treatment arm at Week 100 (NRI analysis).16 **BIMZELX is approved for Q4W/Q8W dosing with PsA in coexisting moderate-to-severe plaque psoriasis.3

psa-mda-explained01
9. Safety profile

After Week 16, patients in BE OPTIMAL, BE COMPLETE, BE MOBILE 1 and BE MOBILE 2 were aware that they were receiving active treatment, which may have affected the results. *Week 52 data are from patients who completed BE COMPLETE and entered the BE VITAL open-label extension study.4 Week 52 data are from BE MOBILE 1 and BE MOBILE 2 and are the open-label maintenance phase of the studies.9 **Includes patients who switched from BIMZELX Q4W (events reports after the switch only).5,16 †One death occurred in a patient receiving BIMZELX due to a motorcycle accident.5 ‡One sudden death occurred in a patient with a history of cardiac events.4 ¥One death due to acute myocardial infarction, reported as unrelated to the study drug.16 §Malignancies excluding non-melanoma skin cancer.16

BIMZELX DOSING FOR PATIENTS WITH PsA3

 

           HOW TO USE

 

 

dosingPNG

* The recommended dose for adult patients with active psoriatic arthritis is 160 mg (given as one subcutaneous injection of 160 mg) every 4 weeks. Consideration should be given to discontinuing treatment in patients who have shown no improvement by 16 weeks of treatment;3 **The recommended dose for adult patients with psoriatic arthritis and coexistent moderate-to-severe plaque psoriasis is the same as for plaque psoriasis, 320 mg (given as two subcutaneous injections of 160 mg each) at Week 0, 4, 8, 12, 16, and every 8 weeks thereafter. Consideration should be given to discontinuing treatment in patients who have shown no improvement by 16 weeks of treatment.3 †If a sufficient clinical responsed in the joints cannot be maintained after Week 16, a switch to 160 mg Q4W can be considered.3 

Pivotal phase III study design: BE OPTIMAL
 

Biologic-naïve patients with active PsA21

BE OPTIMAL

Adapted from McInnes IB, et al. Lancet. 2023;401:25-77. Supplementary appendix.

Pivotal phase III study design: BE COMPLETE

 

TNFi-inadequate responder patients with active PsA22

BE COMPLETE

Adapted from Merola JF, et al. Lancet. 2023;401:38-48. Supplementary appendix.

Phase IIb and open-label extension study design: BE ACTIVE23

 

BE ACTIVE

Adapted from Coates LC. et al. Arthritis Rheumatol. 2022;74:1959-1970. Supplementary appendix

Abbreviations

ACR 50, ≥50% response in the American College of Rheumatology criteria; ALT, alanine aminotransferase; AS, ankylosing spondylitis; ASAS 40, ≥40% improvement in the Assessment of SpondyloArthritis International Society criteria; ASDAS, Ankylosing Spondylitis Disease Activity Score; axSpA, axial spondyloarthritis; BSA, body surface area; CRP, c-reactive protein; EAIR, exposure-adjusted event rate; IBD, inflammatory bowel disease; IL, interleukin; MDA, minimal disease activity; MHRA, Medicines and Healthcare products Regulatory Agency; MI, multiple imputation; MRI, magnetic resonance imaging; NICE, The National Institute for Health and Care Excellence; NSAIDs, non-steroidal anti-inflammatory drugs; nr-axSpA, non-radiographic axial spondyloarthritis; NRI, non-responder imputation; PASI 90, ≥90% improvement from baseline in Psoriasis Area and Severity Index; PsA, psoriatic arthritis; SmPC, summary of product characteristics; PY, patient-years; SIB, suicidal ideation and behaviour; TB, tuberculosis; TEAE, treatment-emergent event; TNFi-IR, tumour necrosis factor inhibitor-inadequate response; UTI, urinary tract infection; Q4W, every 4 weeks; Q8W, every 8 weeks.

References

1. McInnes IB, et al. Lancet. 2023;401(10370):25-37.
2. Merola JF, et al. Lancet. 2023;401(10370):38-48.
3. BIMZELX® SmPC.
4. Coates LC, et al. RMD Open. 2024;10(1):e003855.
5. Ritchlin CT, et al. Ann Rheum Dis. 2023;82(11):1404-1414.
6. van der Heijde D, et al. Ann Rheum Dis. 2023;82(4):515-526.
7. UCB Data on file. 2023. AS0010 Clinical Study Report.
8. UCB Data on file. 2023. AS0011 Clinical Study Report.
9. Baraliakos X, et al. Ann Rheum Dis. 2024;83(2):199-213. 
10. Update to PsA NICE, 2023. https://www.nice.org.uk/guidance/ta916. Accessed August 2024
11. Update to axSpA NICE, 2023. https://www.nice.org.uk/guidance/indevelopment/gid-ta11347. Accessed August 2024.
12. Gordon KB, et al. Poster P1569/ Presented at the European Academy of Dermatology and Venereology (EADV) meeting, September 7-10 2022; Milan, Italy.
13. Gossec L, McGonagle D, Korotaeva T, et al. J Rheumatol. 2018;45(1):6-13.14. 
14. Reich K, Warren RB, Lebwohl M, et al. N Engl J .Med. 2021;385(2):142-152.
15. Ritchlin CT, et al. Ann Rheum Dis. 2023;82(11):1404-1414. Supplementary appendix.
16. Coates LC, et al. 2024. EULAR. Poster POS0969.
17. UCB Data on file. 2022. PA0011/PA0012 Table 8.4.12. p2.
18. Gordon KB, Foley, P, Krueger JG, et al. Lancet. 2021;397(10273):475-486.
19. Reich K, Papp KA, Bauvelt A, et al. Lancet. 2021;397(10273):487-498.
20. Warren RB, Blauvelt A, Bagel, et al. N Eng J Med. 2021;385(2):130-141.
21. McInnes IB, et al. Lancet. 2023;401(10370):25-37. Supplementary appendix.
22. Merola JF, et al. Lancet. 2023;401(10370):38-48. Supplementary appendix.
23. Coates LC, et al. Arthritis Rheumatol. 2022;74;1959-1970. Supplementary appendix.
24. Pope JE, Khanna D, Norrie D, et al. J Rheumatol. 2009;36(2):254-259. 
25. Stanford University School of Medicine. The Health Assessment Questionnaire. Available at: https://www.niehs.nih.gov/research/resources/assets/docs/haq_instructions_508.pdf  Accessed August 2024.
26. Nikiphorou E, Radner H, Chatzidionysiou K, et al. Arthritis Res Ther. 2016;18(1):251.

27. UCB Data on file. 2022. PA0010. Clinical Study Report. p73-77

28. UCB Data on file. 2022. PA0011/PA0012. Table 11.1.1.1.3. pl.

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Date of creation: November 2024