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Clinical Trial
. 2021 Feb;80(2):185-193.
doi: 10.1136/annrheumdis-2019-216835. Epub 2020 Oct 26.

Brodalumab in psoriatic arthritis: results from the randomised phase III AMVISION-1 and AMVISION-2 trials

Philip J Mease  1 , Philip S Helliwell  2 , Kasper Fjellhaugen Hjuler  3 , Kyle Raymond  4 , Iain McInnes  5
Affiliations
Clinical Trial

Brodalumab in psoriatic arthritis: results from the randomised phase III AMVISION-1 and AMVISION-2 trials

Philip J Mease et al. Ann Rheum Dis. 2021 Feb.

Abstract

Objective: To compare the efficacy and safety of brodalumab, an interleukin-17 receptor subunit A inhibitor, with placebo, in patients with psoriatic arthritis (PsA).

Methods: Adult patients with active PsA and inadequate response to, or intolerance to, conventional treatment were enrolled into two phase III studies (NCT02029495 and NCT02024646) and randomised 1:1:1 to receive subcutaneous brodalumab 140 mg or 210 mg or placebo at weeks 0, 1 and every 2 weeks up to 24 weeks. About 30% of patients had prior use of biologics. The primary endpoint for both studies was the American College of Rheumatology 20 (ACR20) response at week 16.

Results: 962 patients were randomised across the studies prior to early termination due to sponsor decision. The primary endpoint was met in both studies. Based on comparable design and eligibility criteria, data from both studies were pooled. Significantly more patients achieved ACR20 at week 16 in both brodalumab treatment groups (45.8% and 47.9% for 140 mg and 210 mg, respectively) versus placebo (20.9%) (p<0.0001). Similar results were observed at week 24. Significantly higher proportions of patients receiving brodalumab achieved ACR50/70, Psoriasis Area and Severity Index 75/90/100 and resolution of dactylitis and enthesitis versus placebo (p<0.01). Adverse event rates were similar across treatments at week 16 (54.4%, 51.6% and 54.5% for placebo, brodalumab 140 mg and 210 mg, respectively). No new safety signals were reported.

Conclusion: Brodalumab was associated with rapid and significant improvements in signs and symptoms of PsA versus placebo. Brodalumab was well tolerated, with a safety profile consistent with other interleukin-17 inhibitors.

Keywords: DMARDs (biologic); autoimmune diseases; psoriatic arthritis.

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Conflict of interest statement

Competing interests: PJM reports, outside the submitted work, grants and personal fees from AbbVie, Amgen, Bristol Myers Squibb, Celgene, Janssen, Eli Lilly, Novartis, SUN Pharma, UCB Pharma; personal fees from Genentech, Boehringer Ingelheim, Galapagos, Gilead and GlaxoSmithKline. PSH reports, outside the submitted work, grants, personal fees and non-financial support from AbbVie; grants from Amgen, Celgene, Janssen, MSD, Pfizer and UCB; and personal fees from Galapagos. KFH was an employee of LEO Pharma at the time this study was conducted. KFH also reports, outside the submitted work, grants from AbbVie, Celgene, LEO Pharma and Novartis; personal fees from AbbVie, CSL Behring, Eli Lilly, Janssen, LEO Pharma, Novartis and Pfizer. KR is an employee of LEO Pharma. IBM reports personal fees from LEO Pharma during the conduct of the study. IBM also reports, outside the submitted work, grants and personal fees from Celgene, Compugen and UCB; grants from AstraZeneca, Novartis and Roche; personal fees from AbbVie, Galvani, Eli Lilly and Pfizer.

Figures

Figure 1
Figure 1
(A) ACR20, (B) ACR50 and (C) ACR70 response rates from baseline to week 24. Full analysis set. Dashed line represents the primary endpoint for each study. Response rates (95% CI) were calculated using a GEE model. NRI was applied following early withdrawal from trial for reasons other than premature study termination, and to subjects who satisfied the inadequate response criteria prior to week 24. GEE analysis assumed missing data due to early trial termination and intermittent missing data were MCAR. ACR responses were modified based on 66/68 joint counts. ACR20/50/70, American College of Rheumatology 20/50/70% improvement criteria; GEE, generalised estimating equation; MCAR, missing completely at random; NRI, non-responder imputation.
Figure 2
Figure 2
Resolution of dactylitis and enthesitis. Full analysis set. Response rates (95% CI) were calculated using a GEE model. NRI was applied following early withdrawal from trial for reasons other than premature trial termination, and to subjects who satisfied the inadequate response criteria prior to week 24. GEE analysis assumed missing data due to early trial termination and intermittent missing data were MCAR. Dactylitis and enthesitis responses were evaluated in patients with these conditions at baseline. Dactylitis was assessed as present (yes/no) on 20 digits (fingers and toes). Enthesitis was assessed as present (yes/no) on six entheses (lateral epicondyle, medial femoral condyle and Achilles’ tendon insertion). GEE, generalised estimating equation; MCAR, missing completely at random; NRI, non-responder imputation.
Figure 3
Figure 3
(A) PASI75, (B) PASI90 and (C) PASI100 response rates from baseline to week 24. PASI responses were calculated using the psoriasis efficacy full analysis set (patients with baseline BSA ≥3%). Response rates (95% CI) were calculated using a GEE model. NRI imputation was applied following early withdrawal from trial for reasons other than premature trial termination, and to subjects who satisfied the inadequate response criteria prior to week 24. GEE analysis assumed missing data due to early trial termination and intermittent missing data were MCAR. BSA, body surface area; GEE, generalised estimating equation; MCAR, missing completely at random; NRI, non-responder imputation; PASI75/90/100, 75/90/100% improvement in Psoriasis Area and Severity Index.
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