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

EFFICACY

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 DEEP AND SUSTAINED EFFICACY IN THE JOINTS, AS MEASURED BY ACR 50 (TO WEEK 52)*1,2,4,5

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

*Deep is defined as achievement of the clinical outcomes of ACR 50 in PsA and ASAS 40 in axSpA:  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).6,7 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

 

Biologic-naïve

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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.2,4

 

TNFi-IR

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.2,4

 
Biologic-naïve & TNFi-IR

These are two separate studies and should not be compared directly.

 

 

 

 

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.2,4

 

*In BE OPTIMAL, ACR 50 was achieved by 17.6% (n=76/431) at Week 4 (vs 3.2% n=8/281 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=3/133] 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 **88.9% (n=383/431) 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 0.31 with placebo) and 0.08 at Week 52 in the overall population BIMZELX treatment arm (n=365; NRI analysis).1,6 ‡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

 

Biologic-naïve: PASI 90

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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.

 
Biologic-naïve: PASI 100

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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.

 

TNFi-IR: PASI 90

 

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.

 

TNFi-IR: PASI 100

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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 52)*1,2,4–7

 

Biologic-naïve

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.

 

TNFi-IR

""

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 7.0% [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), and 55.0% (n=237/431) of patients in the BIMZELX treatment arm at Week 52 (NRI analysis).1,5 In BE COMPLETE, MDA was achieved by 17.2% (n=46/267) at Week 4 (vs 4.5% [n=6/133] with placebo),7 44.2% (n=118/267) at Week 16 (vs 6.0% [n=8/133] with placebo, p<0.0001), and 47.2% (n=126/267) of patients in the BIMZELX treatment arm at Week 52 (NRI analysis).2,4 **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

MOA
SAFETY

BIMZELX WAS GENERALLY WELL TOLERATED IN PsA AND axSpA PATIENTS WITH LONG-TERM EXPOSURE UP TO 3 YEARS 11,12

Long-term exposure observed across 3 years of phase IIb open-label extension studies in PsA and AS,12,13 and phase III trials in PsA, nr-axSpA, AS, and moderate-to-severe plaque psoriasis1,2,13-15

 

 

Consistent Safety

Across all four phase III trials in PsA and axSpA, rates of TEAEs and AEs of special monitoring were low, and there were no new safety signals1-6,13,18

 

Most frequently reported adverse reactions were upper respiratory tract infections (14.5% in moderate-to-severe plaque psoriasis, 14.6% in PsA, and 16.3% in axSpA) and oral candidiasis (7.3% in moderate-to-severe plaque psoriasis, 2.3% in PsA, and 3.7% in axSpA)**3

 

  • Most adverse events were mild to moderate and most did not lead to treatment discontinuation1,2,13

  • No additional blood monitoring requirements3 

 

BIMZELX was generally well tolerated across 52 weeks at a dose of 160 mg Q4W in patients with PsA and axSpA1-6,13,18,19

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HOW TO USE

BIMZELX DOSING FOR PATIENTS WITH PsA3

dosing

* 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 PsA20

Be Opt

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 PsA21

BE COMPLETE

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

Phase IIb and open-label extension study design: BE ACTIVE22
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; AE, adverse event; ALT, alanine aminotransferase; AS, ankylosing spondylitis; AST, aspartate aminotransferase; axSpA, axial spondyloarthritis; BSA, body surface area; EAIR, exposure-adjusted incidence rate; EULAR, European League Against Rheumatism; HAQ-DI, Health Assessment Questionnaire Disability Index; IBD, inflammatory bowel disease; MACE, major adverse cardiovascular event; MDA, minimal disease activity; MoA, mechanism of action; nr-axSpA, non-radiographic axial spondyloarthritis; NRI, non-responder imputation; OLE, open-label extension; PASI 90/100, ≥90/100% improvement from baseline in Psoriasis Area and Severity Index; PsA, psoriatic arthritis; Q2W, every two weeks; Q4W, every four weeks; SAE, serious adverse event; SFU, safety follow-up; SIB, suicidal ideation and behaviour; SmPC, Summary of Product Characteristics; TB, tuberculosis; TEAE, treatment-emergent adverse event; TNFi-IR, tumour necrosis factor-α inhibitor-inadequate responder; ULN, upper limit of normal; URTI, upper respiratory tract infection; UTI, urinary tract infection; VAS, visual analogue scale; vdHmTSS, van der Heijde modified Total Sharp Score

References

  1. Mcinnes IB, Asahina A, Coates LC, et al. Bimekizumab in patients with psoriatic arthritis, naive to biologic treatment: a randomised, double-blind, placebo-controlled, phase 3 trial (BE OPTIMAL). Lancet. 2023;401(10370):25–37.
  2. Merola JF, Landewe R, Mcinnes IB, et al. Bimekizumab in patients with active psoriatic arthritis and previous inadequate response or intolerance to tumour necrosis factor-a inhibitors: a randomised, double-blind, placebo-controlled, phase 3 trial (BE COMPLETE) Lancet. 2023;401(10370) 38–48.
  3. BIMZELX® SmPC.
  4. Coates L, Landewé RBM, Mcinnes I, et al. POS0231 Sustained efficacy and safety of bimekizumab in patients with active psoriatic arthritis and prior inadequate response to tumour necrosis factor inhibitors: Results from the phase 3 BE COMPLETE study and its open-label extension up to 1 year. Ann Rheum Dis. 2023;82:346-347.
  5. Ritchlin C, Coates L, McInnes I, et al. Bimekizumab Treatment in Biologic DMARD-Naïve Patients with Active Psoriatic Arthritis: 52-Week Efficacy and Safety Results from a Phase 3, Randomized, Placebo-Controlled, Active Reference Study [abstract]. Arthritis Rheumatol. 2022;74 (suppl 9).
  6. van der Heijde D, Deodhar A, Baraliakos X, et al. Efficacy and safety of bimekizumab in axial spondyloarthritis: results of two parallel phase 3 randomised controlled trials. Ann Rheum Dis. 2023;82(4):515–526.
  7. UCB Data on file. 2022. AS0010 and AS0011.
  8. Gordon, K.B., et al. Poster P1569/ Presented at the European Academy of Dermatology and Venereology (EADV) meeting, September 7-10 2022; Milan, Italy.
  9. van der Heijde D, Deodhar A, Baraliakos X, et al. Efficacy and safety of bimekizumab in axial spondyloarthritis: results of two parallel phase 3 randomised controlled trials. Ann Rheum Dis. 2023;82(4):515–526. Supplementary Appendix.
  10. Update to PsA NICE, 2023. https://www.nice.org.uk/guidance/ta916. Accessed October 2023.
  11. Update to axSpA NICE, 2023. https://www.nice.org.uk/guidance/indevelopment/gid-ta11347. Accessed October 2023.
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IE-BK-2400114

Date of creation: November 2023