axSpA

▼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.

BIMZELX ACHIEVED A CONSISTENT RESPONSE ACROSS THE axSpA SPECTRUM WHICH WAS SUSTAINED OVER TIME1–9

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.7

CHALLENGE LIMITATIONS IN axSpA WITH BIMZELX

 

EFFICACY
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Explore more in ‘Symptom improvement’ section below

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Explore more in ‘Reductions in disease activity’ section below

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Explore more in ‘Inflammation control’ section below

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Explore more in ‘Inhibition of disease progression’ section below

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Explore more in ‘Resolution of enthesitis’ section below

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Explore more in ‘Patient-reported outcomes’ section below

*In BE MOBILE 1 and BE MOBILE 2, 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; vs 21.4% (27/126) and 22.5% (25/111) with placebo, respectively; p<0.001);6 60.9% (78/128) and 58.4% (129/221) at Week 52, respectively (NRI analysis).6,7 In the open-label treatment period, ASAS 40 was achieved by 50.8% (129/254) of nr-axSpA patients and 55.1% (183/332) of AS patients receiving BIMZELX at Week 104; 48.4% (123/254) and 52.1% (173/332) at Week 164, respectively (NRI analysis).1,8

**In BE MOBILE 1 and the BE MOVING OLE, ASDAS <2.1 was achieved by 46.1% (59/128) at Week 16, 61.6% (79/128) at Week 52,9 61.4% (n=254) at Week 104 and 61.8% (n=254) at Week 164, of patients with nr-axSpA in the BIMZELX treatment arm (pooled randomised set, secondary endpoint, MI analysis).1 In BE MOBILE 2 and the BE MOVING OLE, ASDAS <2.1 was achieved by 44.8% (99/221) at Week 16, 57.1% (126/221) at Week 52,9 63.3% (n=332) at Week 104 and 59.9% (n=332) of patients with AS at Week 164 (pooled randomised set, secondary endpoint, MI analysis).1 In BE MOBILE 1/2 and the BE MOVING OLE, ASDAS-ID was achieved by 28.6% (n=254) of nr-axSpA patients and 31.0% (n=332) of AS patients at Week 164, respectively (MI analysis).1

†BASDAI 50 was achieved by 50.8% (129/254) of nr-axSpA patients and 56.3% (187/332) of AS patients receiving BIMZELX at Week 104 in the BE MOVING OLE (pre-specified endpoint in BE MOVING; NRI analysis).2

‡In BE MOBILE 1 and BE MOBILE 2, at Week 52, 50.8% (32/63) of nr-axSpA patients and 50.0% (38/76) AS patients in the BIMZELX treatment arm achieved remission defined by absence of OSI (MRI SPARCC SIJ <2; Berlin MRI Spine ≤2; SJC=0; hs-CRP (mg/L) ≤5). 152 and 139 patients from the MRI sub-studies of BE MOBILE 1 and BE MOBILE 2, respectively, were included in the post-hoc analysis. Levels of objective signs of inflammation at baseline were similar across treatment arms.3

§In the BE MOVING OLE of BE MOBILE 2, 85.3% (162/190) of AS patients had no spinal radiographic progression (mSASSS ≤0.5) at Week 104 (OC analysis).4

¥In the BE MOVING OLE of BE MOBILE 1 and BE MOBILE 2, complete resolution of enthesitis (exploratory endpoint, MASES=0; NRI analysis) at Week 164 was achieved by 47.8% (n=186) of BIMZELX-treated patients with nr-axSpA and 56.3% (n=199) of patients with AS, respectively.1

¶In pooled analyses of patients with nr-axSpA or AS treated with BIMZELX 160 mg Q4W in BE MOBILE 1 and BE MOBILE 2, respectively, up to 3 years (populations include patients originally randomised to placebo):

  • 34.2% (n=586) achieved BASFI <2 (mNRI)5

  • 66.7% (n=504) achieved ≥4-point improvement in ASQoL (in patients with ASQoL score ≥4 at baseline; mNRI)5

  • 55.5% (n=520) achieved ≥8-point improvement from baseline in FACIT-Fatigue score (in patients with FACIT-Fatigue score ≤44 at baseline)5

  • 66.5% (n=586) achieved nocturnal spinal pain score <4 (mNRI)5

  • 32.5% (n=586) achieved total spinal pain score <2 (mNRI)5

  • 63.1% (n=586) achieved morning stiffness score <4 (mean of BASDAI Q5 and 6; mNRI)5

Symptom improvement
BIMZELX provided sustained efficacy (ASAS 40) consistently across the full axSpA spectrum to week 1641,2,6–11

Primary endpoint: ASAS 40 at Week 16 in both studies (p<0.001 versus placebo)6

These are two separate studies and should not be compared directly

 

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To Week 164, 90.4% (519/574) of patients treated with BIMZELX had ≥1 TEAE. The most frequent TEAEs were COVID-19 (14.5 EAIR/100PY), nasopharyngitis (9.9 EAIR/100PY) and upper respiratory tract infection (5.8 EAIR/100PY).1

After Week 16, patients in BE MOBILE 1 and BE MOBILE 2 were aware that they were receiving active treatment, which may have affected the results. All patients, investigator site personnel, and operational staff employed by the sponsor remained blinded to the initial treatment group assignment until completion of the maintenance period at Week 52.7 

*In BE MOBILE 1, ASAS 40 was achieved by 16.4% (21/128) with BIMZELX at Week 1 (vs 1.6% (2/126] with placebo),7 47.7% [61/128] at Week 16 (vs [21.4% 27/126] with placebo; p<0.001), and 60.9% (78/128) at Week 52 of patients with nr-axSpA in the BIMZELX treatment arm (NRI analysis).6,9 In the open-label treatment period, ASAS 40 was achieved by 49.2% (125/254) of patients with nr-axSpA receiving BIMZELX at Week 104, and 48.4% (123/254) at Week 164 (NRI analysis).2,8 In BE MOBILE 2, ASAS 40 was achieved by 16.7% (37/221) with BIMZELX at Week 2 (vs 7.2% [8/111] with placebo),7 44.8% (99/221) at Week 16 (vs 22.5% [25/111] with placebo, p<0.001), and 58.4% (129/221) at Week 52 of patients with AS in the BIMZELX treatment arm (NRI analysis).6,9 In the open-label treatment period, ASAS 40 was achieved by 53.9% (179/332) of patients with AS receiving BIMZELX at Week 104, and 52.1% (173/332) at Week 164 (NRI analysis).2,8 In BE MOBILE 1, 86.6% (220/254) of patients with nr-axSpA remained on BIMZELX at Week 52.9 In BE MOBILE 2, 89.8% (298/332) of patients with AS remained on BIMZELX at Week 52.9**Included patients originally randomised to placebo.1

 

BIMZELX provided sustained ASAS 40 responses up to 5 years in the phase 2b open-label extension study in patients with AS12

 

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The BE AGILE study and its open-label extension were phase 2b studies12 The dose-ranging BE AGILE study consisted of a 12-week double-blind, placebo-controlled period, then a dose-blind period to Week 48 where patients with active AS received BIMZELX 160 mg or 320 mg Q4W. Patients completing Week 48 were eligible to enter the OLE where all patients received BIMZELX 160 mg Q4W to Week 256. Data presented here are for patients who received the licensed dose of BIMZELX 160 mg Q4W to Week 256. The long-term safety profile of BIMZELX in patients with AS was consistent with previous observations, with no new safety signals identified after five years of exposure.

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

*In BE AGILE, a phase 2b study in patients with AS, 97.7% (296/303) of patients entered the dose-blind period and 87.5% (265/303) completed Week 48 of treatment. 84.2% (255/303) then entered the OLE at Week 48 and received ≥1 dose of BIMZELX; 79.2% (202/255) of these patients completed 256 weeks of treatment.13 At Week 256, 49.7% of the NRI analysis dose-blind set (n=296), 59.0% of the NRI analysis OLE full-analysis set (n=249) and 73.1% of the OC analysis dose-blind set (n=201) achieved ASAS 40. In the NRI analysis, patients who did not enter the OLE period were recorded as non-responders from Week 48 to Week 256.12

With BIMZELX, ASAS 40 responses were maintained to 2 years across the full axSpA spectrum*14

 

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Efficacy outcomes are reported from the BE MOBILE 1 and 2 trials and combined open-label treatment period following Week 52 of BE MOBILE 1 and BE MOBILE 2 (BE MOVING). After Week 16 all patients were aware that they were receiving active treatment, which may have affected the results.

*Pooled data from patients with nr-axSpA (BE MOBILE 1; n-128) and AS (BE MOBILE 2; n-221) randomised to BIMZELX 160 mg Q4W.6 At Week 16, ASAS 40 was achieved by 45.8% of patients with nr-axSpA or AS (160/349).14 Of those who achieved ASAS 40 at Week 16, 76.3% (n=122/160) maintained this response at Week 104 (NRI analysis).14

Reductions in disease activity
BIMZELX provided sustained reductions in disease activity up to 3 years across the full axSpA spectrum*1
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To Week 164, 90.4% (519/574) of patients treated with BIMZELX had ≥1 TEAE. The most frequent TEAEs were COVID-19 (14.5 EAIR/100PY), nasopharyngitis (9.9 EAIR/1OOPY) and upper respiratory tract infection (5.8 EAIR/100PY).1

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

*Pooled randomised set. Patients treated with BIMZELX 160 mg Q4W include patients originally randomised to placebo.1 In BE MOBILE 1, ASDAS <2 1 was achieved by 61.8% (157/254) of patients with nr-axSpA at Week 164.1 In BE MOBILE 2. ASDAS <2.1 was achieved by 59.9% (199/332) of patients with AS at Week 164.1 ASDAS disease states over time (MI analysis) were exploratory endpoints.6

 

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To Week 164, 90.4% (519/574) of patients treated with BIMZELX had ≥1 TEAE. The most frequent TEAEs were COVID-19 (14.5 EAIR/100PY), nasopharyngitis (9.9 EAIR/100PY) and upper respiratory tract infection (5.8 EAIR/100PY).1

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

*Pooled randomised set. Patients treated with BIMZELX 160 mg Q4W include patients originally randomised to placebo.1 In BE MOBILE 1, ASDAS <2.1 was achieved by 61.8% (157/254) of patients with nr-axSpA at Week 164.1 In BE MOBILE 2, ASDAS <2.1 was achieved by 59.9% (199/332) of patients with AS at Week 164.1 ASDAS disease states over time (MI analysis) were exploratory endpoints.6

 

With BIMZELX, reductions in disease activity were maintained up to 2 years across the full axSpA spectrum*14
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Efficacy outcomes are reported from the BE MOBILE 1 and 2 trials and combined open-label treatment period following Week 52 of BE MOBILE 1 and BE MOBILE 2 (BE MOVING}. After Week 16 all patients were aware that they were receiving active treatment, which may have affected the results.

*Pooled data from patients with nr-axSpA (BE MOBILE 1; n =128) and AS (BE MOBILE 2; n=221) randomised to BIMZELX 160 mg Q4W.14 At Week 16, ASDAS <2.1 was achieved by 43.6% of patients with nr-axSpA or AS (NRI analysis; 152/349).14 Of those who achieved ASDAS-LDA at Week 16, 89.3% maintained this response at Week 104 (MI analysis; n number unavailable).14 At Week 16, ASDAS-ID was achieved by 16.6% of patients with nr-axSpA or AS (NRI analysis; 58/349).14 Of those who achieved ASDAS-ID at Week 16, 76.0% maintained this response at Week 104 (MI analysis; n number unavailable).14

 

Inflammation control
BIMZELX provided sustained reductions in MRI-detected inflammation across the full axSpA spectrum to Week 164*1,17

 

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

*MRI sub-study enrolling patients receiving BIMZELX with baseline MRI SIJ SPARCC ≥2 (nr-axSpA; n=52) or baseline ASspiMRI-a Berlin score >2 (AS; n=31).17

Sustained suppression of inflammation (demonstrated by hs-CRP levels) was shown to Week 164 in patients treated with BIMZELX8

 

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

Adapted from UCB Data on file. 2024. AS0010 and AS0011. 3-Year Data Summary. p1-55.

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

*Manually calculated.8**Includes patients who were originally assigned to placebo.8

BIMZELX offered sustained resolution of peripheral arthritis (SJC=0)2

 

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*In patients with SJC>0 at baseline.2**At Week 16, 41.9% (n=18/43) and 36.4% (n=8/22) placebo-treated patients achieved SJC=0 in BE MOBILE 1 and BE MOBILE 2, respectively.9,18

†Pooled analysis. Includes patients originally randomised to placebo. 64.3% (n=99/154) of patients with baseline SJC>0 achieved total resolution of peripheral arthritis (SJC=0) with BIMZELX 160 mg Q4W at Week 104 (NRI analysis).2

Inhibition of disease progression
Minimal spinal radiographic progression (as measured by mSASSS) was demonstrated at Week 104 in AS patients treated with BIMZELX*4

 

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After Week 16 all patients were aware that they were receiving active treatment, which may have affected the results. Non-progression was defined as mSASSS CfB of ≤0.5 or <2.0.

*Patients involved are from an X-ray sub-study with valid X-ray assessments at baseline and Week 104 (n=190). Mean absolute change in mSASSS from baseline (SD) was 0.3 (1.9) in patients with AS taking BIMZELX 160 mg Q4W at Week 104 (n=190); mean absolute mSASSS in patients with AS was 7.3 (13.8) at baseline and 7.6 (14.1) at Week 104 (OC analysis).4 mSASSS ranges from 0–72, with lower scores indicating less structural damage.4

Minimal spinal radiographic progression overall at Week 104 in patients with AS with BIMZELX4

 

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After Week 16 all patients were aware that they were receiving active treatment, which may have affected the results. Non-progression was defined as mSASSS CfB of ≤0.5 or <2.0.

*Patients involved are from an X-ray sub-study with valid X-ray assessments at baseline and Week 104 (n=190). Mean absolute change in mSASSS from baseline (SD) was 0.3 (1.9) in patients with AS taking BIMZELX 160 mg Q4W at Week 104 (n=190); mean absolute mSASSS in patients with AS was 7.3 (13.8) at baseline and 7.6 (14.1) at Week 104 (OC analysis).4 mSASSS ranges from 0–72, with lower scores indicating less structural damage.4 **Includes patients who were originally randomised to placebo.4,6,17

Resolution of enthesitis
BIMZELX provided complete resolution of enthesitis for more than 47.8% of patients across the full axSpA spectrum by Week 164*1

 

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*Patients with MASES>0 at baseline.1 In BE MOBILE 1 and BE MOBILE 2, complete resolution of enthesitis (pre-specified endpoint at Week 16, MASES=0; NRI analysis) at Week 104 was achieved by 47.8% (89/186) of BIMZELX-treated patients with nr-axSpA and 56.3% (112/199) of BIMZELX-treated patients with AS, respectively.1

Patient-reported outcomes
Sustained improvements in total spinal pain and nocturnal spinal pain to Week 164 were seen in BIMZELX-treated patients across the full axSpA spectrum*5

 

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Adapted from Navarro-Compán V, et al. 2025. EULAR. Poster POS0921 and Marzo-Ortega. 2024. ACR. Poster 0592.

66.5% of patients with nr-axSpA or AS achieved a nocturnal spinal pain of score <4 (mNRI; n=586)*5 and 32.5% achieved a total spinal pain score of <2 after 3 years of treatment with BIMZELX (mNRI; n=586)*5

After Week 16 all patients were aware that they were receiving active treatment, which may have affected the results. All patients, investigator site personnel, and operational staff employed by the sponsor remained blinded to the initial treatment group assignment until completion of the maintenance period at Week 52.18

*Total spinal pain score was a component of the primary outcome measure, ASAS 40. Nocturnal spinal pain score was a ranked secondary endpoint at Week 16. Pooled randomised set (N=586). Baseline scores are from Week 0 of feeder study. Total score range: 0–10. Improvement indicated by reduced scores. Study participants with missing data at the given timepoint which are preceded by an intercurrent event are imputed using MI. Thresholds for low spinal pain scores were defined as follows: scores <2, indicating minimal (score=1) or no (score=0) spinal pain; scores <4, based on the BE MOBILE 1 and 2 study inclusion criteria of spinal pain ≥4 according to BASDAI Q2.5,18,19 **Includes patients originally randomised to placebo in BE MOBILE 1 or 2.5

BIMZELX provided sustained improvements in morning stiffness across the full axSpA spectrum up to Week 1645

 

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After Week 16 all patients were aware that they were receiving active treatment, which may have affected the results. At Week 52, patients from BE MOBILE 1 and BE MOBILE 2 entered the open-label extension (BE MOVING).

*Pooled randomised set. Baseline scores are from Week 0 of feeder study. Morning stiffness was assessed as the mean of BASDAI Q5 and Q6. Total score range: 0–10 with improvement indicated by reduced scores. 5,19 The mean morning stiffness score at baseline was 6.8, the mean change from baseline was –4.2 at Week 52, –4.3 at Week 104, and –4.3 at Week 164.5,19 **This population includes patients originally randomised to placebo.5

BIMZELX provided sustained improvements in fatigue up to Week 164 across the full axSpA spectrum, as measured by FACIT-Fatigue*5,19

 

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Efficacy outcomes are reported from the BE MOBILE 1 and 2 trials and combined open-label treatment period following Week 52 of BE MOBILE 1 and BE MOBILE 2 (BE MOVING). After Week 16 all patients were aware that they were receiving active treatment which may have affected the results.

*Pooled randomised set.5 Improvement in FACIT-Fatigue was indicated by increased scores (ranging from 0-52).19 The mean FACIT-Fatigue score at baseline was 30.9 and the mean change from baseline was +9.9 at Week 52, +9.9 at Week 104 and +9.7 at Week 164.19

Data from Week 52 include patients originally randomised to placebo.5** Includes patients originally randomised to placebo in BE MOBILE 1 and BE MOBILE 2.5 †In patients with FACIT-Fatigue score ≤44 at baseline.5

BIMZELX provided sustained improvements in work productivity across the full axSpA spectrum, as measured by WPAI:axSpA*20

 

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

*In BE MOBILE 1, percentage employment at baseline was 74.2% (n=95/128) of patients with nr-axSpA in the BIMZELX treatment arm vs 73.8% (n=93/126) in the placebo arm.20 In BE MOBILE 2, percentage employment at baseline was 72.9% (n=161/221) of patients with AS in the BIMZELX treatment arm vs 73.9% (n=82/111) in the placebo arm.20 **Overall work impairment defined as a composite of absenteeism and presenteeism.20 †At baseline, 52.2% (n=86) of patients with nr-axSpA in the BIMZELX treatment arm experienced overall work impairment, vs 49.1% (n=84) in the placebo arm. Mean percentage reduction from baseline in overall work impairment was 26.5% (absolute score, 24.9%) at Week 16 (vs 14.1% in the placebo arm [absolute score, 36.6%; nominal p<0.001]), and 31.7% (absolute score, 21.0%) at Week 52 with BIMZELX (vs 24.5% [absolute score, 23.3%] in the group that switched from placebo to BIMZELX 160 mg Q4W at Week 16; OC analysis).20 At baseline, 49.2% (n=149) of patients with AS in the BIMZELX treatment arm experienced overall work impairment, vs 43.9% (n=74) in the placebo arm. Mean percentage reduction from baseline in overall work impairment was 22.2% (absolute score, 26.1%) at Week 16 (vs 6.7% in the placebo arm [absolute score, 35.1%; nominal p<0.001]), and 27.0% (absolute score, 22.9%) at Week 52 with BIMZELX (vs 23.6% [absolute score, 20.2%] in the group that switched from placebo to BIMZELX 160 mg Q4W at Week 16; OC analysis).20

BIMZELX provided sustained improvements in physical function across the full axSpA spectrum up to Week 164*5,21

 

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After Week 16 all patients were aware that they were receiving active treatment, which may have affected the results. At Week 52, patients from BE MOBILE 1 and BE MOBILE 2 entered the open-label extension (BE MOVING). 

*Pooled randomised set. Baseline scores are from Week 0 of feeder study. The mean score at baseline was 5.3, the mean change from baseline was –2.8 at Week 52, –2.9 at Week 104 and –2.9 at Week 164.5,21 BASFI scores range from 0–10. A decrease in BASFI indicates improvement.21 **This population includes patients who were originally randomised to placebo.5,21

BIMZELX provided sustained improvements in patient-reported health-related quality of life across the full axSpA spectrum up to Week 1645,21

 

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After Week 16 all patients were aware that they were receiving active treatment, which may have affected the results. At Week 52, patients from BE MOBILE 1 and BE MOBILE 2 entered the open-label extension (BE MOVING). 

*Pooled randomised set. Baseline scores are from Week 0 of feeder study. The mean ASQoL score at baseline was 9.1, the mean change from baseline was –5.6 at Week 52, –5.6 at Week 104 and –5.6 at Week 164.5,21 ASQoL scores range from 0–18. A decrease in ASQoL indicates improvement.21 **This population includes patients who were originally randomised to placebo.5,21 †Among patients with ASQoL score ≥4 at baseline.5,21

BIMZELX provided sustained improvements in health-related quality of life and physical function across the full axSpA spectrum, as measured by SF-36 PCS, up to Week 164*5,21

 

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After Week 16 all patients were aware that they were receiving active treatment, which may have affected the results. At Week 52, patients from BE MOBILE 1 and BE MOBILE 2 entered the open-label extension (BE MOVING). 

*Pooled randomised set. Baseline scores are from Week 0 of feeder study. The mean SF-36 PCS score at baseline was 34.0, the mean change from baseline was +12.0 at Week 52, +12.4 at Week 104 and +12.3 at Week 164.5,21 **This population includes patients who were originally randomised to placebo.21

Improvements in BASDAI, a key measure of disease activity, were sustained to Week 104 in BIMZELX-treated patients2,22

 

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*BE MOBILE 1 baseline mean BASDAI scores: 6.9 in the BIMZELX treatment group vs 6.7 in the placebo group.22 BE MOBILE 2 baseline mean BASDAI scores: 6.5 in the BIMZELX treatment group vs 6.5 in the placebo group.22 Includes patients who were originally assigned to placebo.2 Disease activity (BASDAI) was a ranked secondary endpoint in BE MOBILE 1 and 2 and a pre-specified endpoint in BE MOVING.2,22

ASDAS-ID, an established measure of remission, may underestimate the anti-inflammatory effects of BIMZELX3

 

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SAFETY
BIMZELX was generally well tolerated, with long-term exposure up to 3 years13,32
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Adverse events: Refer to SmPC for full information. Very common (≥1/10): Upper respiratory tract infection; Common (≥1/100 to< 1/10): Oral candidiasis, tinea infections, ear infections, herpes simplex infections, oropharyngeal candidiasis, gastroenteritis, folliculitis, headache, dermatitis and eczema, acne, injection site reactions, fatigue; Uncommon (≥1/1,000 to<1/100): Mucosal and cutaneous candidiasis (including oesophageal candidiasis), conjunctivitis, neutropenia, inflammatory bowel disease. *5,862 patients treated in blinded and open-label clinical studies in PsA, nr-axSpA, AS, moderate to severe plaque psoriasis, and moderate-to-severe HS. Of these, over 4,660 patients were exposed to BIMZELX for at least one year.4

BIMZELX has a consistent long-term safety profile in patients with axSpA and PsA26

BIMZELX is generally well tolerated in patients with axSpA and PsA as seen by long-term exposure analyses from phase 2b/3 trials in patients with at least 104 weeks of total study participation26

Pooled analysis of patients with axSpA (nr-axSpA or AS): Overview of TEAEs up to data-cut

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Adapted from Mease P, et al. RMD Open. 2025;11(2):e005026.

 

Data to the July 2022 data-cut shown, including all patients who received ≥1 dose of BIMZELX 160 mg Q4W in the phase 2b/3 studies. After Week 16, all patients were aware that they were receiving active treatment, which may have affected the results. *Including TEAEs leading to death.26 **Per investigator assessment.26 †The intensity of TEAEs was assessed by the investigators as ‘mild’, ‘moderate’ or ‘severe’, independently from seriousness.

Pooled analysis of patients with axSpA (nr-axSpA or AS): Overview of AEs of special monitoring up to data-cut

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Adapted from Mease P, et al. RMD Open. 2025; 11(2):005026.

 

Data to the July 2022 data-cut shown, including all patients who received ≥1 dose of BIMZELX 160 mg Q4W in the phase 2b/3 studies. After Week 16, all patients were aware that they were receiving active treatment, which may have affected the results.

*Shown by MedDRA preferred term in online supplemental table 2.26 **NEC denotes groupings of miscellaneous terms that do not readily fit into other hierarchical classifications within a specific SOC in the MedDRA.26 †Not including one serious case of oropharyngeal candidiasis in a patient with PsA, which was identified as an opportunistic infection after the July 2022 data-cut.26 ‡At baseline, 46 (5.4%) patients with axSpA and 34 (2.4%) patients with PsA had a history of ongoing/latent tuberculosis (phase 2B/3 pool).26 §Identified using the SMQ ‘Malignant tumours’.26 ¶Includes the preferred terms ‘Autoimmune uveitis’, ‘Iridocyclitis’, ‘Iritis’ and ‘Uveitis’.26 ††Includes events in the SMQ ‘Drug-related hepatic disorders—comprehensive search’, excluding the sub-SMQs ‘Liver neoplasms, benign (including cysts and polyps)’ and ‘Liver neoplasms, malignant and unspecified’.26 §§Elevated liver enzymes include the following preferred terms reported as adverse events: Increased/abnormal levels of ALT, AST, blood bilirubin, gamma-glutamyltransferase, hepatic enzyme, liver function test or transaminases.26 ¶¶n=411 for axSpA; n=1405 for PsA.26 †††Includes preferred terms identified based on UCB-defined search criteria.26 §§§Hypersensitivity reactions identified via the SMQ ‘Hypersensitivity’.26 ¶¶¶Identified using the HLTs ‘Administration site reactions NEC’ and ‘Injection site reactions’.26

  • No new safety signals were reported26

  • The three most common TEAEs were SARS-COV-2 (COVID-19) infection, nasopharyngitis, and upper respiratory tract infection 

  • Incidence rate of oral candidiasis decreased over time and infrequently led to discontinuation

Low incidence of uveitis was seen in patients with axSpA across pooled phase 3 trials27

 

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*Of 349 patients randomised to BIMZELX treatment across BE MOBILE 1 and BE MOBILE 2, 14.9% (n=52) had a history of uveitis at baseline (pooled data).6 

**Of 848 patients randomised to BIMZELX across the phase 2b and phase 3 trials (pooled data), 15.3% (n=130) had a history of uveitis at baseline.27 

†All uveitis events were mild-to-moderate and only one event led to discontinuation.27

Low incidence of uveitis was seen in patients with axSpA across pooled phase 2b/3 trials*28

 

Bimzelx_axSpA_Image 32.png

Pooled safety set including all patients who received ≥1 dose of BIMZELX 160 mg Q4W in the phase 2b/3 studies. Uveitis rates and EAIRs/100 PY were reported over median durations of approximately 2.8 years (axSpA) and 2.7 years (PsA); the data cut-off for both patient populations was set at July 2023.29

*In patients with nr-axSpA and AS across pooled data from phase 2b/3 trials, overall uveitis occurred in n=31/848 (3.7%) patients (EAIR [95% CI]: 1.3/100 PY [0.9, 1.8]).29 Overall exposure across the pooled phase 2b/3 trials was 2,514 PY.29 All events were mild or moderate and one led to treatment discontinuation.29

How to use
BIMZELX dosing regimen1
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The recommended dose for adult patients with axSpA is 160 mg (given as one subcutaneous injection of 160 mg) every 4 weeks.7 The recommended dose for adult patients with active PsA is 160 mg (given as one subcutaneous injection of 160 mg) every 4 weeks.7 Consideration should be given to discontinuing treatment in patients who have shown no improvement by 16 weeks of treatment.7

*The pre-filled syringe or pen may be stored at room temperature (up to 25 °C) for up to 25 days. Once removed from the refrigerator and stored under these conditions, discard after 25 days or by the expiry date printed on the container, whichever occurs first. A field for the date is provided on the carton to record the date removed from the refrigerator.7

Clinical study designs

Pivotal phase 3 study design

 

Bimzelx_axSpA_Image 34.png

Secondary efficacy endpoints were: ASAS 40 response at Week 16 in anti-TNF-naive patients; change from baseline in BASDAI total score at Week 16; ASAS 20 response at Week 16; ASAS-PR response at Week 16; ASDAS-MI response at Week 16; ASAS 5/6 response at Week 16; change from baseline in BASFI at Week 16; change from baseline in nocturnal spinal pain score (numerical rating scale) at Week 16; change from baseline in ASQoL score at Week 16; change from baseline in SF-36 Physical Component Summary at Week 16; change score from baseline in BASMI at Week 16; change from baseline in MASES at Week 16 in patients with enthesitis at baseline; enthesitis-free state (MASES) response at Week 16 in patients with enthesitis at baseline.18

Phase 3 and open-label extension study design

 

Bimzelx_axSpA_Image 35.png
Phase 2b and open-label extension study design

 

Bimzelx_axSpA_Image 36.png

Prespecified secondary efficacy endpoints included. Proportion of patients achieving ASAS 20/40, the ASAS 5/6 criteria, ASAS-PR, ASDAS-CRP, ASDAS-CII and BASDAI 50. 31

Abbreviations

AE, adverse event; ALT, alanine aminotransferase; AS, ankylosing spondylitis; ASAS 20/40, ≥20/40% Improvement in the Assessment of SpondyloArthritis international Society criteria; ASAS-PR, Assessment of SpondyloArthritis international Society criteria-Partial Remission; ASDAS, Ankylosing Spondylitis Disease Activity Score; ASDAS-CII, Ankylosing Spondylitis Disease Activity Score showing clinically important improvement; ASDAS-CRP, Ankylosing Spondylitis Disease Activity Score using CRP; ASDAS-ID, Ankylosing Spondylitis Disease Activity Score-inactive disease; ASDAS-LDA, Ankylosing Spondylitis Disease Activity Score-low disease activity; ASDAS-MI, Ankylosing Spondylitis Disease Activity Score-major improvement; ASQoL, Ankylosing Spondylitis Quality of Life; ASspiMRI, ankylosing spondylitis spinal magnetic resonance imaging; AST, aspartate aminotransferase; axSpA, axial spondyloarthritis; BASDAI, Bath Ankylosing Spondylitis Disease Activity Index; BASDAI 50, ≥50% response in the Bath Ankylosing Spondylitis Disease Activity Index; BASFI, Bath Ankylosing Spondylitis Functional Index; BASMI, Bath Ankylosing Spondylitis Metrology Index; BKZ, bimekizumab; CfB, change from baseline; CI, Confidence Interval; COVID-19, Coronavirus Disease 2019; CRP, C-reactive protein; DBS, dose-blind set; DMARD, disease-modifying antirheumatic drug; EAIR, exposure-adjusted event rate; EULAR, European Alliance of Associations for Rheumatology; FACIT-F, Functional Assessment of Chronic Illness Therapy – Fatigue; FAS, full analysis set; HLT, High Level Term; HS, hidradenitis suppurativa; hs-CRP, high sensitivity C-reactive protein; IBD, inflammatory bowel disease; ID, inactive disease; IL, interleukin; MACE, major adverse cardiovascular event; MASES, Maastricht Ankylosing Spondylitis Enthesitis Score; MedDRA, Medical Dictionary for Regulatory Activities; MI, multiple imputation; MRI, magnetic resonance imaging; mNRI, modified non-responder imputation; MRI SPARCC, SpondyloArthritis Research Consortium of Canada MRI score; mSASSS, modified Stoke Ankylosing Spondylitis Spinal Score; NEC, not elsewhere classified; NMSC, Non-melanoma Skin Cancer; nr-axSpA, non-radiographic axial spondyloarthritis; NRI, non-responder imputation; NSAID, non-steroidal anti-inflammatory drug; OC, observed case; OLE, open-label extension; OR, odds ratio; OSI, objective signs of inflammation; PRO, patient-reported outcome; PsA, psoriatic arthritis; PY, patient-years; Q2/4/6/8/12W, every 2/4/6/8/12 weeks; QoL, quality of life; SD, standard deviation; SF-36, Short-Form 36-item Health Survey; SF-36 PCS, Short Form-36 Physical Component Summary; SFU, safety follow-up; SIB, suicidal ideation and behaviour; SIJ, sacroiliac joints; SJC, swollen joint count; SmPC, Summary of Product Characteristics; SMQ, Standardised MedDRA Query; SOC, System Organ Class; SPARCC, SPondyloArthritis Research Consortium of Canada; TEAE, treatment-emergent adverse event; TNFi- naïve, TNF inhibitor-naive; TNFi-IR, tumour necrosis factor inhibitor-inadequate responder; ULN, upper limit of normal; WPAI:Work Productivity and Activity Impairment Questionnaire adapted to measure axial spondyloarthritis impact.

References

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Date of creation: October 2025