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MIRROR open-label trial data published in Journal of Rheumatology shows 79 percent of gout patients achieved a complete response using Krystexxa with methotrexate.- Horizon Therapeutics
Horizon Therapeutics plc announced the publication of the complete dataset on the primary endpoint from its "Methotrexate to Increase Response Rates in Patients With Uncontrolled GOut Receiving Krystexxa (MIRROR) open-label trial in the Journal of Rheumatology [https://doi.org/10.3899/jrheum.200460]".
Horizon’s MIRROR clinical program includes the completed multi-center, open-label trial as well as an ongoing randomized controlled trial (RCT). The trial series seeks to validate clinical practice experience showing that adding commonly-used immunomodulatory therapies, such as methotrexate, to the Krystexxa (pegloticase injection) treatment regimen for chronic gout refractory to conventional therapies – also known as uncontrolled gout – may help to reduce patients’ immune reaction to biologic therapy and thus potentially increase the durability of response.
In the open-label trial, 79 percent of patients who received both Krystexxa and methotrexate (11 of 14 enrolled patients) maintained therapeutic response during Month 6 (defined as sUA <6 mg dl). the safety and efficacy of krystexxa co-prescribed with methotrexate has not been established by any health authorities. in addition, the journal rheumatology and therapy recently published an independent, in-practice case series which showed that 80 percent (8 of 10 patients) received a full course of treatment with the concomitant use of krystexxa and methotrexate. a prospective observational case series presented at eular 2019 showed 100 percent of patients (10 of 10 patients) received a full course of treatment with the concomitant use of krystexxa and methotrexate. 3 no new safety concerns were identified in these studies, but the findings are limited by the study sizes. the company recently announced that the mirror rct has reached target enrollment. patients are randomized to receive methotrexate or placebo for four weeks and then treatment with krystexxa and methotrexate or krystexxa and placebo for 52 weeks. preliminary results are expected in the first half of 2021. more information about the mirror rct is available at clinicaltrials.gov (nct03994731).. see-"pegloticase in combination with methotrexate in patients with uncontrolled gout: a multicenter, open-label study (mirror)"- john k. botson, john r.p. tesser, ralph bennett, et al.the journal of rheumatology september 2020, jrheum.200460; doi: https: doi.org 10.3899 jrheum.200460. see- published: 27 july 2020- "increased efficacy and tolerability of pegloticase in patients with uncontrolled gout co-treated with methotrexate: a retrospective study."- john a. albert, tony hosey & brian lamoreaux ;rheumatology and therapy volume 7, pages639–648(2020).>6>
Condition: Gout
Type: drug