PsA

Psa image

▼This medicine is subject to additional monitoring. This will allow quick identification of new safety information. 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 Republic of Ireland. Adverse events should also be reported to UCB Pharma Ltd at ucbcares.uk@ucb.com  or 0800 2793177 for the UK and UCB (Pharma) Ireland Ltd at ucbcares.ie@ucb.com or 1800 930075 for Republic of Ireland.

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

Symptom improvement
BIMZELX provided sustained efficacy in the joints to Week 156, as measured by ACR 50*1,5,11
Bimzelx_PsA_Image 7.png

From Week 52, mNRI data are reported from the open-label treatment period. 

After Week 16, patients in BE COMPLETE and BE OPTIMAL 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 3 trial (which ran for 16 weeks) and then entered the BE VITAL open-label extension study. In BE COMPLETE, after Week 16, the investigators and subjects remained blind to the assigned BIMZELX dosing regimen until the final analysis was completed.5 

*In BE COMPLETE, ACR 50 was achieved by 16.1% (43/267) of BIMZELX-treated TNF-IR patients with PsA at Week 4.5 43.4% (116/267) at Week 16 (primary endpoint; p<0.001 vs placebo),4,5 and 51.7% (138/267) at Week 52 (NRI analysis).7 In the open-label treatment period, ACR 50 was achieved by 50.4% of BIMZELX-treated TNFI-IR patients with PsA at Week 52, 54.2% at Week 100, and 55.2% at Week 156 (mNRI analysis; N=400).1 Some n values are unavailable due to the imputation method used. **Of patients who entered the OLE at Week 16, 74.8% (299/400) remained on treatment at Week 156.1 †Includes patients originally randomised to placebo.1,5,11

BIMZELX provided sustained efficacy in the joints to Week 160, as measured by ACR 50*2,6,11
Bimzelx_PsA_Image 8.png

From Week 52, mNRI data are reported from the open-label treatment period.

After Week 16, patients in BE COMPLETE and BE OPTIMAL were aware that they were receiving active treatment, which may have affected the results.

*In BE OPTIMAL, ACR 50 was achieved by 17.6% (076/431) of BIMZELX-treated biologic-naïve patients with PsA at Week 4, 43.9% (189/431) at Week 16 (primary endpoint, p<0.001 vs placebo),4,6,8 and 54.5% (235/431) at Week 52 (NRI analysis).8 In the open-label treatment period, ACR 50 was achieved by 56.1% of BIMZELX-treated biologic-naïve patients with PsA at Week 52, 55.0% at Week 104, and 53.2% at Week 160 (mNRI analysis; N=712).2 Some n values are unavailable due to the imputation method used. **Of patients who entered the OLE at Week 16, 76.7% (546/712) remained on treatment at Week 160.2 †Includes patients originally randomised to placebo.2

With BIMZELX, ACR 50 responses were maintained from Week 16 up to Week 100/104*,**12
Bimzelx_PsA_Image 9.png

After Week 16 all patients were aware that they were receiving active treatment, which may have affected the results. Data shown here are for patients who completed the phase 3 trial (at Week 16 for BE COMPLETE and Week 52 for BE OPTIMAL) and then entered the BE VITAL open-label extension study.

*In BE COMPLETE, ACR 50 was achieved by 43.1% (n=115/267) at Week 16 and maintained by 75.7% (n=87/115) at Week 100 of TNFI-IR patients (NRI analysis).12 In BE OPTIMAL, ACR 50 was achieved by 43.9% (n=189/431) at Week 16 and maintained by 79.4% (n=150/189) at Week 104 of biologic-naive patients in the BIMZELX treatment arm (NRI analysis).12**Efficacy data for the BE VITAL OLE are reported up to Week 100 for BE COMPLETE and Week 104 for BE OPTIMAL.

Reductions in disease activity
BIMZELX provided sustained efficacy across multiple disease domains, as measured by MDA up to Week 156*1,5,11
Bimzelx_PsA_Image 10.png

After Week 16, patients in BE COMPLETE and BE OPTIMAL 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 3 trial (which ran for 16 weeks) and then entered the BE VITAL open-label extension study. In BE COMPLETE, after Week 16, the investigators and subjects remained blind to the assigned BIMZELX dosing regimen until the final analysis was completed.5

*In BE COMPLETE, MDA was achieved by 17.2% (46/267) of BIMZELX-treated TNFI-IR patients with PsA at Week 4.13 44.2% (118/267) at Week 16,5 and 46.4% (124/267) at Week 52 (NRI analysis).11 In the open-label treatment period, MDA was achieved by 43.9% of BIMZELX-treated TNFI-IR patients with PsA at Week 52. 48.6% at Week 100, and 48.8% at Week 156 (mNRI analysis; N=400).1 Some n values are unavailable due to the imputation method used. **Includes patients originally randomised to placebo.1,5,11

BIMZELX provided sustained efficacy across multiple disease domains, as measured by MDA up to Week 160*1,5,11
Bimzelx_PsA_Image 11.png

After Week 16, patients in BE COMPLETE and BE OPTIMAL were aware that they were receiving active treatment, which may have affected the results. 

*In BE OPTIMAL, MDA was achieved by 23.4% (99/431) of BIMZELX-treated biologic- naïve patients with PsA at Week 4.8 45.0% (194/431) at Week 16, and 55.0% (237/431) at Week 52 (NRI analysis).6,8 In the open-label treatment period, MDA was achieved by 56.7% of BIMZELX-treated biologic-naïve patients with PsA at Week 52, 55.0% at Week 104, and 52.9% at Week 160 (mNRI analysis; N=712).2 Some n values are unavailable due to the imputation method used. **BIMZELX is approved for Q4W/Q8W dosing in PsA with coexisting moderate to severe plaque psoriasis.4

With BIMZELX, MDA responses were maintained from Week 16 up to Week 100/104*,**12
Bimzelx_PsA_Image 12.png

After Week 16 all patients were aware that they were receiving active treatment, which may have affected the results. Data shown here are for patients who completed the phase 3 trial (at Week 16 for BE COMPLETE and Week 52 for BE OPTIMAL) and then entered the BE VITAL open-label extension study. 

*In BE COMPLETE, MDA was achieved by 43.8% (n=117/267) at Week 16 and maintained by 74.4% (n=87/117) of TNFI-IR patients at Week 100.12 In BE OPTIMAL, MDA was achieved by 45.0% (n=194/431) at Week 16 and maintained by 75.8% (n=147/194) of biologic-naïve patients at Week 104.5,11 **Efficacy data for the BE VITAL OLE are reported up to Week 100 for BE COMPLETE and Week 104 for BE OPTIMAL.

Inhibition of disease progression
BIMZELX provided sustained inhibition of radiographic progression in biologic- naïve patients at Week 104*3,8
Bimzelx_PsA_Image 13.png

After Week 16, all patients were aware that they were receiving active treatment, which may have affected the results. 

*At Week 16, 91.3% (356/390) of biologic-naïve patients in BE OPTIMAL showed no radiographic progression with BIMZELX, vs 88.8% (222/250) with placebo (OC analysis).3,8 At Week 104, 84.2% (282/335) of biologic-naïve patients in BE OPTIMAL showed no radiographic progression with BIMZELX, vs 79.4% (173/218) of biologic-naive patients in the group that switched from placebo to BIMZELX at Week 16 (OC analysis).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; AE, adverse event; ALT, alanine aminotransferase; AS, ankylosing spondylitis; AST, aspartate aminotransferase; axSpA, axial spondyloarthritis; BSA, body surface area; CfB, change from baseline; CRP, c-reactive protein; DMARDs, disease-modifying antirheumatic drugs; EAIR, exposure-adjusted event rate; FACIT-F, Functional Assessment of Chronic Illness Therapy – Fatigue; HAQ-DI, Health Assessment Questionnaire Disability Index; HS, Hidradenitis suppurativa; IBD, inflammatory bowel disease; IL, interleukin; LEI, Leeds Enthesitis Index; LDI, Leeds Dactylitis Index; MACE, major adverse cardiovascular event; MCID, minimum clinically important difference; MeDRA, Medical Dictionary for Regulatory Activities; MDA, minimal disease activity; mNAPSI, modified Nail Psoriasis Severity Index; mNRI, modified non-responder imputation; MRI, magnetic resonance imaging; nr-axSpA, non-radiographic axial spondyloarthritis; NRI, non-responder imputation; NSAIDs, non-steroidal anti-inflammatory drugs; OC, observed case; OLE, open-label extension; PASI 100, 100% improvement from baseline in Psoriasis Area Severity Index; PsA, psoriatic arthritis; PsAID, Psoriatic Arthritis Impact of Disease; PsARC, The Psoriatic Arthritis Response Criteria; PtAAP, Patient's Assessment of Arthritis Pain; PY, patient-years; Q2/4/6/8/12W, every 2/4/6/8/12 weeks; SF-36, Short-Form-36 item Health Survey; SIB, suicidal ideation and behaviour; SIJ, sacroiliac joint; SJC, swollen joint count; SmPC, Summary of Product Characteristics; TEAE, treatment-emergent adverse event; TJC, tender joint count; TNFi-IR, tumour necrosis factor inhibitor-inadequate response; ULN, upper limit of normal; VAS, visual analogue scale; vdHmTSS, van der Heijde modified Total Sharp Score; WPAI-SHP, Work Productivity and Activity Impairment Questionnaire – Specific Health Problem.

References

  1. McInnes, I. B., Merola, J. F., Coates, L. C., Gossec, L., Landewé, R., Proft, F., Tanaka, Y., Asahina, A., Ink, B., Bajracharya, R., Coarse, J., & Mease, P. J. (2025). Dual inhibition of IL-17A and IL-17F with bimekizumab demonstrated long-term safety and efficacy in patients with active psoriatic arthritis and prior inadequate response to tumour necrosis factor inhibitors: Final 3-year results from the phase 3 BE COMPLETE study and its open-label extension. EULAR.
  2. Gossec, L., Coates, L. C., McInnes, I. B., Mease, P. J., Ritchlin, C. T., Tanaka, Y., Asahina, A., Ink, B., Bajracharya, R., Coarse, J., & Merola, J. F. (2025). Bimekizumab, a dual inhibitor of IL-17A and IL-17F, demonstrated long-term safety and efficacy in biologic DMARD-naïve patients with active psoriatic arthritis: Final 3-year results from the phase 3 BE OPTIMAL study and its open-label extension. EULAR.
  3. Coates, L. C., Husni, M. E., Kishimoto, M., Rahman, P., Sewerin, P., Soriano, E. R., Ink, B., Bajracharya, R., Coarse, J., Mease, P. J., & Nash, P. (2025). Inhibition of radiographic progression with bimekizumab treatment observed in bDMARD-naïve patients with active psoriatic arthritis at 2 years: Results from a phase 3 study and its open-label extension. EULAR.
  4. UCB Pharma Limited. (2025). Bimzelx - Summary of Product Characteristics. Medicines.org.uk. https://www.medicines.org.uk/emc/product/12833/smpc
  5. Merola, J. F., Landewé, R., McInnes, I. B., Mease, P. J., Ritchlin, C. T., Tanaka, Y., Asahina, A., Behrens, F., Gladman, D. D., Gossec, L., Gottlieb, A. B., Thaçi, D., Warren, R. B., Ink, B., Assudani, D., Bajracharya, R., Shende, V., Coarse, J., & Coates, L. C. (2023). Bimekizumab in patients with active psoriatic arthritis and previous inadequate response or intolerance to tumour necrosis factor-α inhibitors: a randomised, double-blind, placebo-controlled, phase 3 trial (BE COMPLETE). The Lancet, 401(10370), 38–48.
  6. McInnes, I. B., Asahina, A., Coates, L. C., Landewé, R., Merola, J. F., Ritchlin, C. T., Tanaka, Y., Gossec, L., Gottlieb, A. B., Warren, R. B., Ink, B., Assudani, D., Bajracharya, R., Shende, V., Coarse, J., & Mease, P. J. (2023). Bimekizumab in patients with psoriatic arthritis, naive to biologic treatment: a randomised, double-blind, placebo-controlled, phase 3 trial (BE OPTIMAL). The Lancet, 401(10370), 25–37.
  7. Coates, L. C., Landewé, R., McInnes, I. B., Mease, P. J., Ritchlin, C. T., Tanaka, Y., Asahina, A., Behrens, F., Gladman, D. D., Gossec, L., Orbai, A.-M., Gottlieb, A. B., Warren, R. B., Ink, B., Bajracharya, R., Shende, V., Coarse, J., & Merola, J. F. (2024). Bimekizumab treatment in patients with active psoriatic arthritis and prior inadequate response to tumour necrosis factor inhibitors: 52-week safety and efficacy from the phase III BE COMPLETE study and its open-label extension BE VITAL. RMD Open, 10(1), e003855.
  8. Ritchlin, C. T., Coates, L. C., McInnes, I. B., Mease, P. J., Merola, J. F., Tanaka, Y., Asahina, A., Gossec, L., Gottlieb, A. B., Warren, R. B., Ink, B., Bajracharya, R., Shende, V., Coarse, J., & Landewé, R. B. (2023). Bimekizumab treatment in biologic DMARD-naïve patients with active psoriatic arthritis: 52-week efficacy and safety results from the phase III, randomised, placebo-controlled, active reference BE OPTIMAL study. Annals of the Rheumatic Diseases, 82(11), 1404–1414.
  9. Mease, P. J., Gladman, D., Gossec, L., Nash, P., Ink, B., Coarse, J., Lyris, N., Willems, D., & Tillett, W. R. (2023). Bimekizumab Treatment Impact on Work Productivity in Biologic DMARD‑Naïve and TNFi-IR Patients with Active Psoriatic Arthritis: Results up to 1 Year from Two Phase 3 Studies.
  10. Tillett, W., Lin, C.-Y., Zbrozek, A., Sprabery, A. T., & Birt, J. (2019). A threshold of meaning for work disability improvement in psoriatic arthritis measured by the Work Productivity and activity impairment questionnaire. Rheumatology and Therapy, 6(3), 379–391.
  11. Mease, P. J., Merola, J. F., Tanaka, Y., Gossec, L., McInnes, I. B., Ritchlin, C. T., Landewé, R. B. M., Asahina, A., Ink, B., Heinrichs, A., Bajracharya, R., Shende, V., Coarse, J., & Coates, L. C. (2024). Safety and efficacy of bimekizumab in patients with psoriatic arthritis: 2-year results from two phase 3 studies. Rheumatology and Therapy, 11(5), 1363–1382.
  12. Walsh, J. A., Merola, J. F., Ritchlin, C. T., Tanaka, T., Favalli, E. G., McGonagle, D., Thaçi, D., Ink, B., Bajracharya, R., Coarse, J., & Tillett, W. (2024). Bimekizumab Maintained Efficacy Responses in Patients with Active Psoriatic Arthritis: Up to 2-Year Results from Two Phase 3 Studies. ACR Meeting Abstracts.
  13. UCB Pharma Limited. (2024). PA0011/PA0012.
  14. UCB Pharma Limited. (2025). PA0010/PA0012.
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  16. Mease, P., Tillett, W., de Wit, M., Gossec, L., Husni, M., Proft, F., Ink, B., Bajracharya, R., Coarse, J., Lambert, J., Coates, L., & A., G. (2024). Bimekizumab-Treated Patients with Active Psoriatic Arthritis Showed Sustained Improvements in Pain and Fatigue: Up to 2-Year Results from Two Phase 3 Studies. Arthritis Rheumatol; 76 (Suppl 9).
  17. Mease, P., Tillett, W., de Wit, M., Gossec, L., Husni, M., Proft, F., Ink, B., Bajracharya, R., Coarse, J., Lambert, J., Coates, L., & A., G. (2024). Bimekizumab-Treated Patients with Active Psoriatic Arthritis Showed Sustained Improvements in Pain and Fatigue: Up to 2-Year Results from Two Phase 3 Studies. Arthritis Rheumatol; 76 (Suppl 9).
  18. Husni, M., Mease, P., Merola, J., Behrens, F., Favalli, E., McGonagle, D., Tillett, W., Tsuji, S., Ink, B., Bajracharya, R., Lambert, J., Coarse, J., & L., G. (n.d.). Bimekizumab Treatment Impact on Pain and Fatigue in Patients with Active Psoriatic Arthritis who were Biologic DMARD‑Naïve or had Inadequate Response or Intolerance to TNF-α Inhibitors: 1-Year Results from Two Phase 3 Studies. Arthritis Rheumatol. 2023; Abstract 0527.
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  26. Gordon, K. B., Foley, P., Krueger, J. G., Pinter, A., Reich, K., Vender, R., Vanvoorden, V., Madden, C., White, K., Cioffi, C., & Blauvelt, A. (2021). Bimekizumab efficacy and safety in moderate to severe plaque psoriasis (BE READY): a multicentre, double-blind, placebo-controlled, randomised withdrawal phase 3 trial. The Lancet, 397(10273), 475–486.
  27. Reich, K., Papp, K. A., Blauvelt, A., Langley, R. G., Armstrong, A., Warren, R. B., Gordon, K. B., Merola, J. F., Okubo, Y., Madden, C., Wang, M., Cioffi, C., Vanvoorden, V., & Lebwohl, M. (2021). Bimekizumab versus ustekinumab for the treatment of moderate to severe plaque psoriasis (BE VIVID): efficacy and safety from a 52-week, multicentre, double-blind, active comparator and placebo controlled phase 3 trial. The Lancet, 397(10273), 487–498.
  28. Warren, R. B., Blauvelt, A., Bagel, J., Papp, K. A., Yamauchi, P., Armstrong, A., Langley, R. G., Vanvoorden, V., De Cuyper, D., Cioffi, C., Peterson, L., Cross, N., & Reich, K. (2021). Bimekizumab versus Adalimumab in Plaque Psoriasis. The New England Journal of Medicine, 385(2), 130–141.
  29. Reich, K., Warren, R. B., Lebwohl, M., Gooderham, M., Strober, B., Langley, R. G., Paul, C., De Cuyper, D., Vanvoorden, V., Madden, C., Cioffi, C., Peterson, L., & Blauvelt, A. (2021). Bimekizumab versus Secukinumab in Plaque Psoriasis. The New England Journal of Medicine, 385(2), 142–152.
  30. Baraliakos, X., Deodhar, A., van der Heijde, D., Van den Bosch, F., Magrey, M., Maksymowych, W. P., Tomita, T., Xu, H., Massow, U., Vaux, T., Prajapati, C., Manente, M., Marten, A., & Gensler, L. S. (2025). Long-term safety and efficacy of bimekizumab in axial spondyloarthritis: 2-year results from two phase 3 studies. Rheumatology (Oxford, England), 64(6), 3534–3546.
  31. Mease, P. J., Gensler, L. S., Orbai, A.-M., Warren, R. B., Bajracharya, R., Ink, B., Marten, A., Massow, U., Shende, V., Manente, M., Peterson, L., White, K., Landewé, R., & Poddubnyy, D. (2025). Long-term safety of bimekizumab in adult patients with axial spondyloarthritis or psoriatic arthritis: pooled results from integrated phase IIb/III clinical studies. RMD Open, 11(2). https://doi.org/10.1136/rmdopen-2024-005026
  32. van der Horst-Bruinsma, I. E., Brown, M. A., van Gaalen, F., Haroon, N., Gensler, L. S., Marten, A., Manente, M., Stojan, G., Vaux, T., White, K., Deodhar, A., & Rudwaleit, M. (2024, September 1). Low Uveitis Rates in Patients with Axial Spondyloarthritis or Psoriatic Arthritis Treated with Bimekizumab: Long-Term Results from Phase 2b/3 Trials. ACR Meeting Abstracts. https://acrabstracts.org/abstract/low-uveitis-rates-in-patients-with-axial-spondyloarthritis-or-psoriatic-arthritis-treated-with-bimekizumab-long-term-results-from-phase-2b-3-trial/
  33. Tillett, W.R., Ink B., Bajracharya R., Taieb V., Sharma P., McGonagle D., Coates L.C., McInnes I.B. (2024) Sustained and Consistent Efficacy of Bimekizumab in Patients with Active Psoriatic Arthritis Regardless of Prior TNF-inhibitor Status: Results from the Phase 3 BE OPTIMAL and BE COMPLETE Trials. BSR Abstract E070.
  34. Coates, L., Kristensen, L., Ogdie, A., Tillet, W., Ink, I., Goldammer, N., Bajracharya, R., Coarse, J., Orbai, A.M. (2024) Bimekizumab-treated patients with active psoriatic arthritis showed sustained achievement of minimal disease activity and remission: up to 2-year results from two phase 3 studies. EULAR Poster POS0969.
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Date of creation: November 2024