Evidence map›Paper›PMID 39678124›Full record

ArticleRheumatology advances in practice2024

Quality of life and clinical gout assessments during pegloticase with and without methotrexate co-therapy: MIRROR randomized controlled trial exploratory findings.

John Botson, Katie Obermeyer, Brian LaMoreaux, Lissa Padnick-Silver, Supra Verma, Michael E Weinblatt, Jeff Peterson

Registry-linked trialAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Rheumatology advances in practice, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03994731 (A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Efficacy and Safety Study of Methotrexate to Increase Response Rates in Patients With Uncontrolled Gout Receiving KRYSTEXXA®), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03994731 phase4completednot on this map

A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Efficacy and Safety Study of Methotrexate to Increase Response Rates in Patients With Uncontrolled Gout Receiving KRYSTEXXA® (Pegloticase) (MIRROR Randomized Controlled Trial [RCT])

TypeinterventionalSponsorAmgenRan2019 to 2022Enrolled152ConditionsGoutArmsPegloticase, methotrexate, placebo, folic acid, gout flare prophylaxis regimen
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors.

John BotsonRheumatology and Bone Health Management, Orthopaedic Physicians Alaska, Anchorage, AK, USA.
Katie ObermeyerUS Medical Rare Disease, Amgen, Inc., Thousand Oaks, CA, USA.
Brian LaMoreauxUS Medical Rare Disease, Amgen, Inc., Thousand Oaks, CA, USA.ORCID https://orcid.org/0000-0001-7521-241X
Lissa Padnick-SilverUS Medical Rare Disease, Amgen, Inc., Thousand Oaks, CA, USA.ORCID https://orcid.org/0000-0002-4199-4844
Supra VermaUS Medical Rare Disease, Amgen, Inc., Thousand Oaks, CA, USA.
Michael E WeinblattDivision of Rheumatology, Immunology and Allergy, Brigham and Women's Hospital, Boston, MA, USA.
Jeff PetersonRheumatology, Western Washington Arthritis Clinic, Bothell, WA, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Objectives: Pegloticase lowers serum urate (SU) but is limited by anti-drug antibodies. Methotrexate (MTX) co-administration increases urate-lowering response rate and decreases infusion reaction risk. This is of importance in uncontrolled gout patients who have few treatment options and highly impacted quality of life (QOL). Here, we report exploratory QOL/clinical endpoints of MIRROR RCT (NCT03994731). Methods: Patients with uncontrolled gout (sUA ≥ 7 mg/dl, urate-lowering tehraoy (ULT) failure/intolerance, and ≥1 gout sign/symptom [≥1 tophus, ≥2 flares in past year, chronic gouty arthritis]) were administered pegloticase (biweekly 8 mg infusion; 52 weeks) with oral MTX (15 mg/week) or placebo co-therapy. Key exploratory outcomes included change from baseline (CFB) in Physician Global Assessment of Gout [PhGA, score: 0-10], CFB in tender/swollen joint counts [TJC/SJC, score: 0-68/0-66], and gout chronic response rate (GCR50, GCR70; 50%/70% reduction in ≥3 of TJC, SJC, HAQ-Health, HAQ-Pain). Least-square mean (±S.E.) CFB to week 52 was estimated using a mixed model for repeated measures. Results: In total, 100 patients were randomized to pegloticase + MTX; 52 to pegloticase + PBO. At baseline, patients had poor overall health (HAQ-Health [MTX, PBO]: 44.9 ± 28.6, 39.1 ± 27.4; PhGA: 5.5 ± 2.1, 5.4 ± 2.2) and many affected joints (TJC: 5.4 ± 7.8, 6.7 ± 8.4; SJC: 8.3 ± 12.2, 11.0 ± 15.9). QOL progressively improved during treatment, with similar CFB at week 52 in MTX vs. PBO groups in PhGA (-4.2 ± 0.2 vs. -3.8 ± 0.3) and TJC/SJC (-6.1 ± 0.5 vs. -7.0 ± 0.8/-5.1 ± 0.4 vs. -6.0 ± 0.6). However, at week 52, more MTX patients met GCR50 (58.0% vs. 38.5%) and GCR70 (52.0% vs. 30.8%) criteria. Conclusion: In the MIRROR RCT, pegloticase treatment with or without MTX co-therapy led to meaningful clinical/QOL improvements in uncontrolled gout patients. However, patients receiving MTX co-therapy had greater benefits because of a higher sustained SU-lowering rate (60.0% vs. 30.8% in the PBO group at week 52). Trial registration: ClinicalTrials.gov, http://clinicaltrials.gov, NCT03994731.

Indexed as

goutjoint symptomsMTXpegloticasequality of life

Identifiers

PMID39678124
PMCPMC11646119

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.