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Background: Bimekizumab (BKZ), a monoclonal antibody inhibitor of interleukin (IL)-17A and IL-17F, demonstrated clinical improvements in joint and skin outcomes up to 108 weeks (wks) in patients (pts) with active psoriatic arthritis (PsA). 1,2
Objectives: To report up to 3-year safety and efficacy of BKZ in pts with active PsA from a 48-week phase 2b dose-ranging study (BE ACTIVE; NCT02969525) and its open-label extension (OLE; NCT03347110).
Methods: BE ACTIVE and OLE study design has been described previously. 1 All OLE pts received BKZ 160 mg Q4W, irrespective of prior dosing regimen. Treatment-emergent adverse events (TEAEs) are reported for the safety set (SS; pts who received ≥1 dose BKZ in the dose-ranging study). Data are presented from dose-ranging study baseline (BL) to Wk 152. Efficacy outcomes are reported for the full analysis set (FAS): ACR50, minimal or very low disease activity (MDA/VLDA), Psoriasis Area and Severity Index (PASI) 90/100, body surface area affected by psoriasis (BSA) 0% and dactylitis/enthesitis resolution.
Results: Over 152 wks, the exposure-adjusted incidence rate (EAIR) per 100 patient-years (PY) was 126.4 for all TEAEs, 4.1 for serious TEAEs, 0.7 for serious infections and 4.6 for
Candida
infections (
Safety and efficacy outcomes up to 3 years
|
Safety (SS
)
|
BKZ
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BKZ
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Total
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|||
| Any TEAE | 114 (90.5) [136.1] | 70 (89.7) [113.3] | 184 (89.3) [126.4] | |||
| Serious TEAEs | 17 (13.5) [5.2] | 5 (6.4) [2.3] | 22 (10.7) [4.1] | |||
| Key TEAEs of special monitoring | ||||||
| Serious infections | 3 (2.4) [0.9] | 1 (1.3) [0.5] | 4 (1.9) [0.7] | |||
| Candida infections | 15 (11.9) [4.7] | 9 (11.5) [4.4] | 24 (11.7) [4.6] | |||
| Inflammatory bowel disease [c] | 1 (0.8) [0.3] | 0 | 1 (0.5) [0.2] | |||
| Malignancies [d] | 1 (0.8) [0.3] | 0 | 1 (0.5) [0.2] | |||
| Injection site reactions | 0 | 3 (3.8) [1.4] | 3 (1.5) [0.5] | |||
| Suicidal ideation | 1 (0.8) [0.3] | 0 | 1 (0.5) [0.2] | |||
| Liver function analyses | 13 (10.3) [4.1] | 11 (14.1) [5.3] | 24 (11.7) [4.6] | |||
| Study discontinuation due to TEAEs | 12 (9.5) [3.5] | 4 (5.1) [1.8] | 16 (7.8) [2.8] | |||
|
Efficacy (FAS
)
|
BKZ
|
BKZ
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Total
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|||
| OC | NRI, % | OC | NRI, % | OC | NRI, % | |
| MDA, Wk 152 | 64/95 (67.4) | 51.6 | 42/62 (67.7) | 51.2 | 106/157 (67.5) | 51.5 |
| VLDA, Wk 152 | 41/95 (43.2) | 33.1 | 21/62 (33.9) | 25.6 | 62/157 (39.5) | 30.1 |
| PASI90 [e] Wk 152 | 51/61 (83.6) | 64.6 | 37/46 (80.4) | 63.8 | 88/107 (82.2) | 64.2 |
| PASI100 [e] Wk 152 | 47/61 (77.0) | 59.5 | 32/46 (69.6) | 55.2 | 79/107 (73.8) | 57.7 |
| BSA 0% [e] Wk 48 | 48/72 (66.7) | 60.8 | 38/55 (69.1) | 65.5 | 86/127 (67.7) | 62.8 |
| Wk 152 | 46/61 (75.4) | 58.2 | 31/45 (68.9) | 53.4 | 77/106 (72.6) | 56.2 |
| Dactylitis [f]/Enthesitis [g] resolution, Wk 48 | – | 70.6/56.9 | – | 84.0/57.1 | – | 76.3/57.0 |
| Wk 152 | – | 67.6/63.1 | – | 76.0/61.9 | – | 71.2/62.6 |
No anaphylactic reactions or major adverse cardiac events were reported. [a] Includes pts within the indicated analysis set originally assigned to all arms who were subsequently re-randomized to 160 mg, or [b] 320 mg, after double-blind period; [c] Microscopic colitis; [d] Malignant melanoma in situ; [e] Pts with BL BSA ≥3%, NRI: n=79, 58, 137 respectively; [f] Pts with BL LDI >0, NRI: n=34, 25, 59 respectively; [g] Pts with BL MASES >0, NRI: n=65, 42, 107 respectively. LDI: Leeds Dactylitis Index; MASES: Maastricht AS Enthesitis Score; OC: observed case.
Conclusion: The safety profile of BKZ in pts with PsA reflects previous observations 1,2 for up to 3 years. High threshold disease control was achieved by >50% of BKZ-treated pts up to 3 years, reflected in long-term improvements in joint and skin outcomes.
REFERENCES:
[1]Ritchlin CT. Lancet 2020;395:427–40;
[2]McInnes I. Ann Rheum Dis 2020;79:1153–4.
Acknowledgements: This study was funded by UCB Pharma. Editorial services were provided by Costello Medical.
Disclosure of Interests: Laura C Coates Speakers bureau: AbbVie, Amgen, Biogen, Celgene, Gilead, GSK, Janssen, Lilly, Medac, Novartis, Pfizer, UCB Pharma, Consultant of: AbbVie, Amgen, Biogen, Boehringer Ingelheim, Celgene, Domain, Gilead, Janssen, Lilly, Grant/research support from: AbbVie, Amgen, Celgene, Gilead, Janssen, Lilly, Novartis, Pfizer, UCB Pharma, Richard B. Warren Consultant of: AbbVie, Almirall, Amgen, Arena, Avillion, BMS, Boehringer Ingelheim, Celgene, Eli Lilly, Janssen, LEO Pharma, Novartis, Pfizer, Sanofi, UCB Pharma, Grant/research support from: AbbVie, Almirall, Amgen, Janssen, LEO Pharma, Novartis, UCB Pharma, Christopher T. Ritchlin Consultant of: Amgen, AbbVie, Lilly, Pfizer, Novartis, Gilead, Janssen, UCB Pharma, Grant/research support from: AbbVie, Amgen, UCB Pharma, Laure Gossec Speakers bureau: AbbVie, Amgen, Biogen, BMS, Celgene, Janssen, Lilly, Novartis, Pfizer, Samsung, Sanofi, UCB Pharma, Consultant of: AbbVie, Amgen, Biogen, BMS, Celgene, Janssen, Lilly, Novartis, Pfizer, Samsung, Sanofi, UCB Pharma, Grant/research support from: Eli Lilly, Pfizer, Sandoz, Joseph F. Merola Consultant of: AbbVie, Amgen, Bayer, Biogen, BMS, Celgene, Eli Lilly, Janssen, Novartis, Sanofi-Regeneron, Pfizer, UCB Pharma, Grant/research support from: AbbVie, Amgen, Bayer, Biogen, BMS, Celgene, Eli Lilly, Janssen, Novartis, Sanofi-Regeneron, Pfizer, UCB Pharma, Principal investigator for Dermavant, LEO Pharma, UCB Pharma, Deepak Assudani Employee of: UCB Pharma, Jason Coarse Employee of: UCB Pharma, Jason Eells Shareholder of: UCB Pharma, Employee of: UCB Pharma, Barbara Ink Shareholder of: GSK, UCB Pharma, Employee of: UCB Pharma, Iain McInnes Consultant of: AbbVie, BMS, Boehringer Ingelheim, Celgene, Lilly, Janssen, Novartis, UCB Pharma, Grant/research support from: BMS, Boehringer Ingelheim, Celgene, Janssen, UCB Pharma.