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Efficacy and Safety of Bimekizumab As Add-On Ann Rheum Dis: first published as 10.1136/annrheumdis-2018-214943 on 8 June 2019. Downloaded from Rheumatoid arthritis CLINICAL SCIENCE Efficacy and safety of bimekizumab as add-on therapy for rheumatoid arthritis in patients with inadequate response to certolizumab pegol: a proof- of-concept study Sophie Glatt, 1 Peter C Taylor, 2 Iain B McInnes,3 Georg Schett, 4 Robert Landewé,5 Dominique Baeten,5,6 Lucian Ionescu,6 Foteini Strimenopoulou,7 Mark I L Watling,1 Stevan Shaw1 Handling editor Josef S ABStract Key messages Smolen Objective Evaluate the efficacy and safety of dual neutralisation of interleukin (IL)-17A and IL-17F ► Additional material is What is already known about this subject? published online only. To with bimekizumab, a monoclonal IgG1 antibody, in ► Significant increases in circulating T helper 17 view please visit the journal addition to certolizumab pegol (CZP) in patients with cells and interleukin (IL)-17 production have online (http:// dx. doi. org/ 10. rheumatoid arthritis (RA) and inadequate response (IR) been observed following inadequate response 1136annrheumdis- 2018- to certolizumab pegol. 214943). to tumour necrosis factor (TNF) inhibitors (anti- Methods During this phase 2a, double-blind, proof- TNFs) in patients with rheumatoid arthritis. For numbered affiliations see of-concept (PoC) study (NCT02430909), patients with It has been hypothesised that this end of article. moderate-to-severe RA received open-label CZP 400 mg ► compensatory amplification of IL-17 biology at Weeks 0, 2 and 4, and 200 mg at Week 6. Patients may contribute to the impaired response to Correspondence to with IR at Week 8 (Disease Activity Score 28-joint count anti-TNF treatment in some patients; however, Dr Sophie Glatt, Global C-reactive protein (DAS28(CRP))>3.2) were randomised Exploratory Development, UCB clinical data substantiating this hypothesis are Pharma, Slough SL1 3WE, UK; 2:1 to CZP (200 mg every 2 weeks (Q2W)) plus conflicting. copyright. Sophie. Glatt@ ucb. com bimekizumab (240 mg loading dose then 120 mg Q2W) or CZP plus placebo. The primary efficacy and safety What does this study add? Received 18 December 2018 variables were change in DAS28(CRP) between Weeks Revised 17 April 2019 We evaluated the efficacy and safety of dual 8 and 20 and incidence of treatment-emergent adverse ► Accepted 23 April 2019 neutralisation of IL-17A and IL-17F with events (TEAEs). Published Online First bimekizumab, a monoclonal IgG1 antibody, in 8 June 2019 Results Of 159 patients enrolled, 79 had IR at Week 8 addition to certolizumab pegol in patients with and were randomised to CZP plus bimekizumab (n=52) http://ard.bmj.com/ rheumatoid arthritis and inadequate response or CZP plus placebo (n=27). At Week 20, there was a to certolizumab pegol. greater reduction in DAS28(CRP) in the CZP-IR plus Proof-of-concept was confirmed based on the bimekizumab group compared with the CZP-IR plus ► rapid decrease in disease activity achieved placebo group (99.4% posterior probability). The most with 12 weeks of certolizumab pegol and frequent TEAEs were infections and infestations (CZP bimekizumab treatment, with no unexpected or plus bimekizumab, 50.0% (26/52); CZP plus placebo, new safety findings identified. 22.2% (6/27)). on November 19, 2019 at University of Glasgow. Protected by Conclusions PoC was confirmed based on the rapid How might this impact on clinical practice or decrease in disease activity achieved with 12 weeks of CZP future developments? plus bimekizumab. No unexpected or new safety signals These findings support the potential to further were identified when neutralising IL-17A and IL-17F in ► explore concomitant neutralisation of multiple patients with RA concomitantly treated with CZP, but the pathways in other patient populations where rate of TEAEs was higher with dual inhibition. this treatment strategy may provide additional benefits. INTRODUCTION It is well documented that some patients with and infliximab) comprise an effective treatment © Author(s) (or their rheumatoid arthritis (RA), particularly those approach that has considerably improved the employer(s)) 2019. Re-use 2 3 permitted under CC BY-NC. No with poor prognostic factors, have an inadequate success of treatment for RA. However, sustained commercial re-use. See rights response (IR) to initial treatment with conventional disease remission is only achieved by <10% of and permissions. Published synthetic disease-modifying antirheumatic drugs patients, and there remains a group of patients by BMJ. (csDMARDs), such as methotrexate (MTX). In who fail to respond, or do not achieve an adequate 4 To cite: Glatt S, these individuals, add-on treatment with tumour response, even with anti-TNFs. Should patients fail Taylor PC, McInnes IB, necrosis factor (TNF) inhibitors (anti-TNFs) is to respond to one anti-TNF, they may be treated et al. Ann Rheum Dis often considered.1 As a class, anti-TNFs (adalim- with another anti-TNF or a treatment with a 2019;78:1033–1040. umab, certolizumab pegol, etanercept, golimumab different mode of action.1 Glatt S, et al. Ann Rheum Dis 2019;78:1033–1040. doi:10.1136/annrheumdis-2018-214943 1033 Ann Rheum Dis: first published as 10.1136/annrheumdis-2018-214943 on 8 June 2019. Downloaded from Rheumatoid arthritis Significant increases in circulating T helper 17 (Th17) cells and IL-17A and IL-17F in immune-mediated inflammatory disease. interleukin (IL)-17 production have been observed following IR For those patients with RA and IR to anti-TNFs, neutralisation of to anti-TNFs in patients with RA.5–8 It has been hypothesised both IL-17A and IL-17F in addition to TNF inhibition may reduce that this compensatory amplification of IL-17 biology may disease activity compared with inhibition of TNF alone. However, contribute to the impaired response to anti-TNF treatment in the potential safety effects of inhibiting these three cytokines some patients; however, clinical data substantiating this hypoth- together are not known. esis are conflicting. For example, phase 3 studies have shown Here, we report the efficacy and safety results of a phase that IL-17A blockade with secukinumab has minimal efficacy in 2a, randomised, double-blind, placebo-controlled PoC study patients with RA who have IR or intolerance to anti-TNFs,9–11 (NCT02430909) evaluating certolizumab pegol, a Fc-free, suggesting inhibition of IL-17A alone is insufficient to neutralise PEGylated anti-TNF that provides rapid and sustained improve- the inflammatory response in RA. Conversely, a phase 2 study ments to many patients with RA,20 21 in combination with bime- demonstrated a modest but statistically greater American College kizumab in patients with moderate-to-severe RA who had an IR of Rheumatology 20% improvement criteria (ACR20) response to certolizumab pegol. with ixekizumab, another higher affinity anti-IL-17A, compared with placebo after 12 weeks’ treatment in patients with RA with IR to anti-TNF therapy.12 METHODS In addition to IL-17A, Th17 cells secrete a number of Study design and treatment pro-inflammatory cytokines including IL-22, IL-26, interferon This was a multicentre phase 2a, randomised, double-blind, (IFN)-γ, TNF, granulocyte-macrophage colony-stimulating factor, placebo-controlled PoC study (NCT02430909) to assess the C-C motif chemokine ligand 20 and another member of the IL-17 efficacy and safety of certolizumab pegol plus bimekizumab in family, IL-17F.13 Both IL-17A and IL-17F have been shown to patients with moderate-to-severe RA and IR to certolizumab independently co-operate with other cytokines to mediate chronic pegol. This study was conducted in accordance with the prin- inflammation14; they share ~50% structural homology and over- ciples of the Declaration of Helsinki and the International lapping but non-redundant biological functions,15–17 suggesting Conference on Harmonisation Guidance for Good Clinical IL-17F may also play an important role in RA. Bimekizumab is Practice. Independent institutional review board approvals were a monoclonal immunoglobulin G1 antibody that potently and obtained, and all patients provided written informed consent in selectively neutralises the biological function of both IL-17A accordance with local requirements. and IL-17F.18 In a proof-of-concept (PoC) study in patients with During an 8-week open-label, run-in period, patients received psoriatic arthritis, bimekizumab demonstrated rapid, profound certolizumab pegol 400 mg at Weeks 0, 2 and 4, and then 200 mg responses in joint and skin, with no unexpected safety findings.18 In at Week 6 (figure 1). Patients who responded to certolizumab pegol copyright. the phase 2b BE ABLE 1 study, rapid and substantial improvements during the open-label run-in period remained on this treatment. were achieved with bimekizumab in patients with moderate-to-se- Patients with IR to certolizumab pegol at Week 8, defined as Disease vere psoriasis.19 These data support the rationale for targeting both Activity Score 28-joint count C-reactive protein (DAS28(CRP)) http://ard.bmj.com/ on November 19, 2019 at University of Glasgow. Protected by Figure 1 Study design. DAS28(CRP), Disease Activity Score 28-joint count (C-reactive protein); Q2W, once every 2 weeks. 1034 Glatt S, et al. Ann Rheum Dis 2019;78:1033–1040. doi:10.1136/annrheumdis-2018-214943 Ann Rheum Dis: first published as 10.1136/annrheumdis-2018-214943 on 8 June 2019. Downloaded from Rheumatoid arthritis Figure 2 Patient disposition. *Inadequate response was defined as Disease Activity Score 28-joint count (C-reactive protein) >3.2. IR, inadequate response. copyright. >3.2, were randomised 2:1 to certolizumab pegol (200 mg every DAS28(CRP) remission (DAS28(CRP)<2.6) at Week 20, 2 weeks (Q2W)) plus bimekizumab (240 mg loading dose then 120 percentage of improvement in ACR criteria (ACRn), ACR20, mg Q2W) or certolizumab pegol (200 mg Q2W) plus placebo.
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