The first and only approved dual inhibitor of IL-17A and IL-17F1-6
BIMZELX® Demonstrated Deep and Sustained Efficacy to 3 Years Across Multiple Disease Domains of PsA and the Full axSpA Spectrum7-9,a
Disclaimer: Intended for healthcare professionals only.
BIMZELX is indicated for the treatment of: moderate-to-severe plaque psoriasis, in adults who are candidates for systemic therapy; 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; active AS, in adults who have responded inadequately or are intolerant to conventional therapy; and active moderate-to-severe HS (acne inversa), in adults with an inadequate response to conventional systemic HS therapy.5
▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.
Support: Production of this infographic was funded by UCB, who provided the content.
Many patients with SpA do not achieve deep and sustained clinical responses10-27
Achievement of higher treatment targets is linked with greater health-related improvements.28-32
The BIMZELX Summary of Product Characteristics can be found here.
GL-BK-2500331 Date of preparation: January 2026 © UCB Biopharma SRL, 2026. All rights reserved.
Abbreviations:
References:
BIMZELX provided deep efficacy across multiple disease domains of PsA, which was consistent in bDMARD-naïve patients and patients with TNFi-IR and sustained up to 3 years7,8,d
Composite Measures7,8
bDMARD-naïve patients
TNFi-IR patients
BIMZELX inhibited radiographic progression at 2 years in bDMARD-naïve patients with PsA on continuous treatment33,h
Skin Manifestations7,8
PASI100e
Data presented are mNRI (OC).
bDMARD-naïve patients
TNFi-IR patients
Overall Radiographic Population
experienced no radiographic progression
experienced no radiographic progression
At-Risk Populationi
BIMZELX provided deep efficacy across the axSpA spectrum, which was consistent in patients with nr-axSpA and r-axSpA and sustained up to 3 years9,j
axSpA - suppression of MRI inflammation
axSpA - spinal pain
nr-axSpA patients
Responder rates calculated using multiple imputation
r-axSpA patients
Core Symptoms and Disease Activity9
BIMZELX demonstrated a generally well-tolerated long-term safety profile up to 3 years in PsA and axSpA7-9
≥1 TEAE
The incidence rate (EAIR/100 PY) for BIMZELX-treated patients reporting ≥1 TEAE was 164.2 in bDMARD-naïve patients and 88.6 in TNFi-IR patientso
The incidence rate for serious TEAEs was 6.5 and 5.7 for bDMARD-naïve patients and TNFi-IR patients, respectively
The incidence rate of serious TEAEs was 4.9
In BIMZELX-treated patients, 90.4% (519/574) of patients had ≥1 TEAEq
Serious TEAEs
(EAIR/100 PY)
The incidence of inflammatory bowel disease was low for bDMARD-naïve patients (0.4) and TNFi-IR patients (0.1)
The incidence of inflammatory bowel disease was low (0.5)
Inflammatory bowel disease
(EAIR/100 PY)
Incidence of fungal infections
(EAIR/100 PY)
The incidence rate of fungal infections was low in bDMARD-naïve (9.2) and TNFi-IR (5.8) patients. The majority were identified as Candida infections (5.7 and 4.0, respectively); the majority were non-seriousp and none were systemic
The incidence rate of fungal infections was low (9.4). The majority of infections were identified as Candida (5.3), with nearly all Candida cases being mild or moderate; no serious or systemic infections were observed
Uveitis
(EAIR/100 PY)
-
The incidence of uveitis was low (1.5)
aIncludes patients with PsA who were bDMARD-naïve or who had prior TNFi-IR, and patients with nr-axSpA or r-axSpA.7-9
of patients with axSpA do not achieve high treatment targets up to Week 16, such as ASAS40 and ASDAS LDA (<2.1).17-26
ASAS40
ASDAS LDA
40% improvement in disease activity from baseline according to the ASAS response criteria.
ASDAS <2.1, indicating LDA or ID.
Only approximately 25% reach low levels of disease activity within 6 months of starting biologic treatment.27,c
cIn an analysis of 130 patients diagnosed with AS from the CorEvitas’ PsA/SpA Registry, 25% (n=33) achieved ASDAS LDA 6 months after bDMARD initiation.27
of patients with PsA do not achieve high treatment targets at Week 24, such as ACR50 and PASI100.10-15
ACR50
PASI100
≥50% improvement from baseline in ACR response criteria
100% improvement from baseline in PASI score
Only approximately 30% achieve MDA within 6 months of starting bDMARD treatment.16,b
bIn a meta-analysis of 39 observational studies and six RCTs in patients with PsA (n=12,469), the prevalence of MDA at 6 months was 32% in clinical trials and 30% in a real-world context.16
dData from BE OPTIMAL (bDMARD-naïve patients; 3 years [Week 160]: 546/712 [76.7%] patients in the BIMZELX Total group) and BE COMPLETE (TNFi-IR patients; 3 years [Week 156]: 299/400 [74.8%] in the BIMZELX Total group). In BE OPTIMAL, patients were randomised to 3:2:1 to subcutaneous BIMZELX 160 mg Q4W, placebo, or a reference arm (adalimumab 40 mg Q2W). Placebo patients switched to BIMZELX at Week 16; adalimumab patients switched to BIMZELX at Week 52 with no washout between treatments. Patients completing Week 52 were eligible for entry into BE VITAL (OLE) for a period up to 140 weeks. The BIMZELX Total group includes both patients who switched from placebo to BIMZELX at Week 16, and patients who were initially randomised to BIMZELX, providing a total duration of therapy of 144 or 160 weeks, respectively. In BE COMPLETE, patients were randomised 2:1 to subcutaneous BIMZELX 160 mg Q4W or placebo. Patients completing Week 16 were eligible for entry into BE VITAL for a period of up to 140 weeks. The BIMZELX Total group includes both patients who switched from placebo to BIMZELX at the OLE start, and patients who continued BIMZELX treatment, providing a total duration of therapy of 140 or 156 weeks, respectively. For bDMARD-naïve patients, the OC n/N at Year 1 and Year 3 were: SJC=0: 426/633 and 395/522; PASI100: 222/317 and 204/275; MDA: 387/632 and 338/526. For TNFi-IR patients, the OC n/N at Year 1 and Year 3 were: SJC=0: 225/343 and 219/292; PASI100: 169/229 and 165/200; MDA: 168/344 and 178/293.7,8
Differences in responder rates for BIMZELX versus placebo were observed as early as week 4 for joint and skin outcomes1,2
100% improvement from baseline in PASI score.
eIn patients with psoriasis involving ≥3% BSA at baseline (bDMARD-naïve: n=357; TNFi-IR: n=264).7,8
Joints (SJC=0)
Data presented are mNRI (OC).
bDMARD-naïve patients
TNFi-IR patients
Musculoskeletal Manifestations1,7,8
SJC=0 is assessed in 66 joints.
Dactylitis
Data presented are mNRI (OC).
bDMARD-naïve patients
TNFi-IR patients
Musculoskeletal Manifestations1,7,8
Pooled patients
fWeek 16 data are pooled from BE OPTIMAL and BE COMPLETE and reported for patients with enthesitis or dactylitis at baseline (enthesitis: n=249; dactylitis: n=90).1
gFor bDMARD-naïve patients, the OC n/N at Year 3 were 120/157 and 59/61 for LEI and LDI, respectively. For TNFi-IR patients, the OC n/N at Year 3 were 79/102 and 34/36 for LEI and LDI, respectively.7,8
Leeds Dactylitis Index
Leeds Dactylitis Index
Enthesitis
Data presented are mNRI (OC).
TNFi-IR patients
Pooled patients
bDMARD-naïve patients
Musculoskeletal Manifestations1,7,8
fWeek 16 data are pooled from BE OPTIMAL and BE COMPLETE and reported for patients with enthesitis or dactylitis at baseline (enthesitis: n=249; dactylitis: n=90).1
gFor bDMARD-naïve patients, the OC n/N at Year 3 were 120/157 and 59/61 for LEI and LDI, respectively. For TNFi-IR patients, the OC n/N at Year 3 were 79/102 and 34/36 for LEI and LDI, respectively.7,8
Leeds Enthesitis Index
Leeds Enthesitis Index
hData presented are OC. For the overall radiographic population, the OC n/N at 2 years was 287/340. For the at-risk population, the OC n/N at 2 years was 242/293.33
No radiographic progression was defined as a vdHmTSS change from baseline ≤0.5.
iHigher risk of progression defined as high-sensitivity CRP levels ≥6 mg/L and/or ≥1 bone erosion at baseline.33
jData from BE MOBILE 1 (patients with nr-axSpA) and BE MOBILE 2 (patients with r-axSpA) and their OLE (BE MOVING). In BE MOBILE 1 and 2, patients with nr-axSpA and r-axSpA received BIMZELX Q4W or placebo up to Week 16, respectively. All patients received subcutaneous BIMZELX 160 mg Q4W from Week 16; eligible patients could enter BE MOVING at Week 52 for a period of up to 164 weeks. 586 patients were randomised (nr-axSpA: 254; r-axSpA: 332), and 494 (84.3%) patients entered the OLE at Week 52, with 425/494 (86.0%) completing Week 164 (nr-axSpA: 175; r-axSpA: 250).9
Spinal Pain34,m
Change from baseline in total spinal pain:
at 2 and 3 years (baseline=7.2)
Change from baseline in nocturnal spinal pain:
at 2 and 3 years (baseline=6.7)
mPooled nr-axSpA and r-axSpA data.
Suppression of MRI Inflammation9,n
nData presented are OC. SPARCC SIJ score <2, in patients with SPARCC SIJ score ≥ 2 at baseline and MRI assessments at Weeks 52, 104, and 164 in the MRI sub-study (nr-axSpA only); Berlin spine ≤ 2, in patients with Berlin spine score >2 at baseline and MRI assessments at Weeks 52, 104, and 164 in the MRI sub-study (r-axSpA only). For nr-axSpA and r-axSpA patients, the OC n/N at 3 years were 19/32 and 28/36, respectively.9
of patients with nr-axSpA achieved MRI SPARCC SIJ remission at 3 years
of patients with r-axSpA achieved MRI Berlin spine remission at 3 years
kASDAS <2.1, indicating LDA.
lASDAS <1.3, indicating ID.
oThe three most frequent TEAEs by preferred term in bDMARD-naïve and TNFi-IR patients were COVID-19 infection (EAIR/100 PY: 12.7 and 7.6), nasopharyngitis (7.8 and 4.8), and upper respiratory tract infection (6.1 and 4.1).7,8
qThe most frequent TEAEs by preferred term were COVID-19 infection (EAIR/100 PY: 14.5), nasopharyngitis, (9.9), and upper respiratory tract infection (5.8).9
pIn bDMARD-naïve patients, one case of a serious Candida infection (oropharyngeal candidiasis) was reported up to 3 years.7
Rheumatology
References
McInnes IB et al. Lancet. 2023;401(10370):25-37.
Merola JF et al. Lancet. 2023;401(10370):38-48.
Ritchlin CT et al. Ann Rheum Dis. 2023;82(11):1404-14.
Coates LC et al. RMD Open. 2024;10(1):e003855.
BIMZELX® EU SmPC. 2025. Available at: https://www.ema.europa.eu/en/documents/product-information/bimzelx-epar-product-information_en.pdf. Last accessed: 19 September 2025.
van der Heijde D et al. Ann Rheum Dis. 2023;82(4):515-26.
Gossec L et al. Ann Rheum Dis. 2025;84(Suppl 1):1337.
McInnes IB et al. Ann Rheum Dis. 2025;84(Suppl 1):400.
Baraliakos X et al. Ann Rheum Dis. 2025;84(Suppl 1):947.
Mease PJ et al. Ann Rheum Dis. 2017;76(1):79-87.
Nash P et al. Lancet. 2017;389(10086):2317-27.
Nash P et al. Arthritis Res Ther. 2018;20(1):47.
Kristensen LE et al. Rheumatology (Oxford). 2023;62(6):2113-21.
Deodhar A et al. Lancet. 2020;395(10230):1115-25.
Gladman D et al. N Engl J Med. 2017;377(16):1525-36.
Zardin-Moraes M et al. J Rheumatol. 2020;47(6):839-46.
Deodhar A et al. Arthritis Rheumatol. 2021;73(1):110-20.
Next
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
16.
17.
Deodhar A et al. Lancet. 2022;400(10349):369-79.
Sieper J et al. Ann Rheum Dis. 2013;72(6):815-22.
van der Heijde D et al. Lancet. 2018;392(10163):2441-51.
Deodhar A et al. Arthritis Rheumatol. 2019;71(4):599-611.
Baeten D et al. N Engl J Med. 2015;373(26):2534-48.
Deodhar A et al. Ann Rheum Dis. 2021;80(8):1004-13.
Deodhar A et al. Arthritis Rheumatol. 2022;74(1):70-80.
van der Heijde D et al. Ann Rheum Dis. 2022;81(11):1515-23.
van der Heijde D et al. Ann Rheum Dis. 2009;68(6):922-9.
Mease P et al. Arthritis Rheumatol. 2021;73(Suppl 9).
Coates LC et al. BMC Rheumatol. 2018;2:24.
Smolen JS et al. Arthritis Rheumatol. 2018;70(Suppl 9).
Kavanaugh A et al. Arthritis Care Res (Hoboken). 2016;68(2):267-74.
van der Heijde D et al. Rheumatology (Oxford). 2016;55(1):80-8.
Llop M et al. Arthritis Res Ther. 2022;24(1):30.
Coates LC et al. Ann Rheum Dis. 2025;84(Suppl 1):1309.
Navarro-Compán V et al. Ann Rheum Dis. 2025;84(Suppl 1):1049.
18.
19.
20.
21.
22.
23.
24.
25.
26.
27.
28.
29.
30.
31.
32.
33.
34.
Previous
Abbreviations:
ACR50: ≥ 50% improvement from baseline in American College of Rheumatology response criteria; AS: ankylosing spondylitis; ASAS: Assessment of SpondyloArthritis international Society; ASDAS: Axial Spondyloarthritis Disease Activity Score; axSpA: axial spondyloarthritis; bDMARD: biologic disease-modifying antirheumatic drug; BSA: body surface area; COVID-19: coronavirus disease 2019; CRP: C-reactive protein; DAPSA: disease activity in psoriatic arthritis; DMARD: disease-modifying antirheumatic drug; EAIR/100 PY: exposure-adjusted incidence rate per 100 patient-years; HS: hidradenitis suppurativa; ID: inactive disease; IL: interleukin; LDA: low disease activity; LDI: Leeds Dactylitis Index; LEI: Leeds Enthesitis Index; MDA: minimal disease activity; MI: multiple imputation; mNRI: modified non-responder imputation; nr-axSpA: non-radiographic axSpA; NSAID: non-steroidal anti-inflammatory drug; OC: observed case; OLE: open-label extension; PASI100: 100% improvement from baseline in Psoriasis Area and Severity Index score; PsA: psoriatic arthritis; QXW: every X weeks; r-axSpA: radiographic axSpA; REM: remission; SIJ: sacroiliac joint; SJC: swollen joint count; SpA: spondyloarthritis; SPARCC: Spondyloarthritis Research Consortium of Canada; SmPC: Summary of Product Characteristics; TEAE: treatment-emergent adverse event; TNFi-IR: tumour necrosis factor inhibitor inadequate response; vdHmTSS: van der Heijde-modified Total Sharp Score; WCI: worst-category imputation.
Composite Measures7,8
bDMARD-naïve patients
TNFi-IR patients
Data presented are mNRI (OC).