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Research ArticleAccepted Article
Open Access

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, Howard M. Kenney, Paul M. Peloso, Katie Obermeyer, Brian LaMoreaux, Michael E. Weinblatt and Jeff Peterson
The Journal of Rheumatology September 2020, jrheum.200460; DOI: https://doi.org/10.3899/jrheum.200460
John K. Botson
Orthopedic Physicians Alaska, Anchorage, AK; Arizona Arthritis & Rheumatology Associates, P.C., Phoenix, AZ; Arizona Arthritis & Rheumatology Associates, P.C., Phoenix, AZ; Arthritis Northwest, PLLC, Spokane, WA; Horizon Therapeutics, Lake Forest, IL; Horizon Therapeutics, Lake Forest, IL; Brigham and Women’s Hospital, Boston, MA; Western Washington Arthritis Clinic, Bothell, WA. Conflict of interest: Dr. Botson has received research support from Horizon Therapeutics and Radius Health as a study site and principal investigator. He has received consulting/speaker fees >10k from Horizon Therapeutics, Celgene, Novartis, and AbbVie. Dr. Tesser has received research grants/support from Horizon. Dr. Bennett has no financial relationships that pose a potential conflict of interest. Dr. Kenney has received research support from Horizon Therapeutics as a study site and principal investigator. He has also served as a speaker for Horizon Therapeutics. Dr. Peloso, Ms. Obermeyer, and Dr. LaMoreaux are employees of and own stock in Horizon Therapeutics. Dr. Weinblatt has received grants from Amgen, Bristol-Myers Squibb, Crescendo Bioscience, Lilly and Sanofi. He has received consulting fees >10k from Bristol Myers Squibb, Corona, and Lilly and <10k from AbbVie, Amgen, Arena, GlaxoSmithKline, Gilead Sciences, Horizon Therapeutics, Lycera, Novartis, Pfizer, Roche, Samsung, Scipher Medicine, and Set Point; he has stock options in Lycera, Can-Fite BioPharma, Scipher Medicine, Inmedix, and Vorso. Dr. Peterson has received research support from Horizon Therapeutics (study site/investigator). He has also served as an advisor and speaker for Horizon Therapeutics. Corresponding Author: John K. Botson, MD, RPh, Orthopedic Physicians Alaska, 3801 Lake Otis Parkway, Anchorage, AK 99508. jbotson@opaak.com
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John R.P. Tesser
Orthopedic Physicians Alaska, Anchorage, AK; Arizona Arthritis & Rheumatology Associates, P.C., Phoenix, AZ; Arizona Arthritis & Rheumatology Associates, P.C., Phoenix, AZ; Arthritis Northwest, PLLC, Spokane, WA; Horizon Therapeutics, Lake Forest, IL; Horizon Therapeutics, Lake Forest, IL; Brigham and Women’s Hospital, Boston, MA; Western Washington Arthritis Clinic, Bothell, WA. Conflict of interest: Dr. Botson has received research support from Horizon Therapeutics and Radius Health as a study site and principal investigator. He has received consulting/speaker fees >10k from Horizon Therapeutics, Celgene, Novartis, and AbbVie. Dr. Tesser has received research grants/support from Horizon. Dr. Bennett has no financial relationships that pose a potential conflict of interest. Dr. Kenney has received research support from Horizon Therapeutics as a study site and principal investigator. He has also served as a speaker for Horizon Therapeutics. Dr. Peloso, Ms. Obermeyer, and Dr. LaMoreaux are employees of and own stock in Horizon Therapeutics. Dr. Weinblatt has received grants from Amgen, Bristol-Myers Squibb, Crescendo Bioscience, Lilly and Sanofi. He has received consulting fees >10k from Bristol Myers Squibb, Corona, and Lilly and <10k from AbbVie, Amgen, Arena, GlaxoSmithKline, Gilead Sciences, Horizon Therapeutics, Lycera, Novartis, Pfizer, Roche, Samsung, Scipher Medicine, and Set Point; he has stock options in Lycera, Can-Fite BioPharma, Scipher Medicine, Inmedix, and Vorso. Dr. Peterson has received research support from Horizon Therapeutics (study site/investigator). He has also served as an advisor and speaker for Horizon Therapeutics. Corresponding Author: John K. Botson, MD, RPh, Orthopedic Physicians Alaska, 3801 Lake Otis Parkway, Anchorage, AK 99508. jbotson@opaak.com
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Ralph Bennett
Orthopedic Physicians Alaska, Anchorage, AK; Arizona Arthritis & Rheumatology Associates, P.C., Phoenix, AZ; Arizona Arthritis & Rheumatology Associates, P.C., Phoenix, AZ; Arthritis Northwest, PLLC, Spokane, WA; Horizon Therapeutics, Lake Forest, IL; Horizon Therapeutics, Lake Forest, IL; Brigham and Women’s Hospital, Boston, MA; Western Washington Arthritis Clinic, Bothell, WA. Conflict of interest: Dr. Botson has received research support from Horizon Therapeutics and Radius Health as a study site and principal investigator. He has received consulting/speaker fees >10k from Horizon Therapeutics, Celgene, Novartis, and AbbVie. Dr. Tesser has received research grants/support from Horizon. Dr. Bennett has no financial relationships that pose a potential conflict of interest. Dr. Kenney has received research support from Horizon Therapeutics as a study site and principal investigator. He has also served as a speaker for Horizon Therapeutics. Dr. Peloso, Ms. Obermeyer, and Dr. LaMoreaux are employees of and own stock in Horizon Therapeutics. Dr. Weinblatt has received grants from Amgen, Bristol-Myers Squibb, Crescendo Bioscience, Lilly and Sanofi. He has received consulting fees >10k from Bristol Myers Squibb, Corona, and Lilly and <10k from AbbVie, Amgen, Arena, GlaxoSmithKline, Gilead Sciences, Horizon Therapeutics, Lycera, Novartis, Pfizer, Roche, Samsung, Scipher Medicine, and Set Point; he has stock options in Lycera, Can-Fite BioPharma, Scipher Medicine, Inmedix, and Vorso. Dr. Peterson has received research support from Horizon Therapeutics (study site/investigator). He has also served as an advisor and speaker for Horizon Therapeutics. Corresponding Author: John K. Botson, MD, RPh, Orthopedic Physicians Alaska, 3801 Lake Otis Parkway, Anchorage, AK 99508. jbotson@opaak.com
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Howard M. Kenney
Orthopedic Physicians Alaska, Anchorage, AK; Arizona Arthritis & Rheumatology Associates, P.C., Phoenix, AZ; Arizona Arthritis & Rheumatology Associates, P.C., Phoenix, AZ; Arthritis Northwest, PLLC, Spokane, WA; Horizon Therapeutics, Lake Forest, IL; Horizon Therapeutics, Lake Forest, IL; Brigham and Women’s Hospital, Boston, MA; Western Washington Arthritis Clinic, Bothell, WA. Conflict of interest: Dr. Botson has received research support from Horizon Therapeutics and Radius Health as a study site and principal investigator. He has received consulting/speaker fees >10k from Horizon Therapeutics, Celgene, Novartis, and AbbVie. Dr. Tesser has received research grants/support from Horizon. Dr. Bennett has no financial relationships that pose a potential conflict of interest. Dr. Kenney has received research support from Horizon Therapeutics as a study site and principal investigator. He has also served as a speaker for Horizon Therapeutics. Dr. Peloso, Ms. Obermeyer, and Dr. LaMoreaux are employees of and own stock in Horizon Therapeutics. Dr. Weinblatt has received grants from Amgen, Bristol-Myers Squibb, Crescendo Bioscience, Lilly and Sanofi. He has received consulting fees >10k from Bristol Myers Squibb, Corona, and Lilly and <10k from AbbVie, Amgen, Arena, GlaxoSmithKline, Gilead Sciences, Horizon Therapeutics, Lycera, Novartis, Pfizer, Roche, Samsung, Scipher Medicine, and Set Point; he has stock options in Lycera, Can-Fite BioPharma, Scipher Medicine, Inmedix, and Vorso. Dr. Peterson has received research support from Horizon Therapeutics (study site/investigator). He has also served as an advisor and speaker for Horizon Therapeutics. Corresponding Author: John K. Botson, MD, RPh, Orthopedic Physicians Alaska, 3801 Lake Otis Parkway, Anchorage, AK 99508. jbotson@opaak.com
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Paul M. Peloso
Orthopedic Physicians Alaska, Anchorage, AK; Arizona Arthritis & Rheumatology Associates, P.C., Phoenix, AZ; Arizona Arthritis & Rheumatology Associates, P.C., Phoenix, AZ; Arthritis Northwest, PLLC, Spokane, WA; Horizon Therapeutics, Lake Forest, IL; Horizon Therapeutics, Lake Forest, IL; Brigham and Women’s Hospital, Boston, MA; Western Washington Arthritis Clinic, Bothell, WA. Conflict of interest: Dr. Botson has received research support from Horizon Therapeutics and Radius Health as a study site and principal investigator. He has received consulting/speaker fees >10k from Horizon Therapeutics, Celgene, Novartis, and AbbVie. Dr. Tesser has received research grants/support from Horizon. Dr. Bennett has no financial relationships that pose a potential conflict of interest. Dr. Kenney has received research support from Horizon Therapeutics as a study site and principal investigator. He has also served as a speaker for Horizon Therapeutics. Dr. Peloso, Ms. Obermeyer, and Dr. LaMoreaux are employees of and own stock in Horizon Therapeutics. Dr. Weinblatt has received grants from Amgen, Bristol-Myers Squibb, Crescendo Bioscience, Lilly and Sanofi. He has received consulting fees >10k from Bristol Myers Squibb, Corona, and Lilly and <10k from AbbVie, Amgen, Arena, GlaxoSmithKline, Gilead Sciences, Horizon Therapeutics, Lycera, Novartis, Pfizer, Roche, Samsung, Scipher Medicine, and Set Point; he has stock options in Lycera, Can-Fite BioPharma, Scipher Medicine, Inmedix, and Vorso. Dr. Peterson has received research support from Horizon Therapeutics (study site/investigator). He has also served as an advisor and speaker for Horizon Therapeutics. Corresponding Author: John K. Botson, MD, RPh, Orthopedic Physicians Alaska, 3801 Lake Otis Parkway, Anchorage, AK 99508. jbotson@opaak.com
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Katie Obermeyer
Orthopedic Physicians Alaska, Anchorage, AK; Arizona Arthritis & Rheumatology Associates, P.C., Phoenix, AZ; Arizona Arthritis & Rheumatology Associates, P.C., Phoenix, AZ; Arthritis Northwest, PLLC, Spokane, WA; Horizon Therapeutics, Lake Forest, IL; Horizon Therapeutics, Lake Forest, IL; Brigham and Women’s Hospital, Boston, MA; Western Washington Arthritis Clinic, Bothell, WA. Conflict of interest: Dr. Botson has received research support from Horizon Therapeutics and Radius Health as a study site and principal investigator. He has received consulting/speaker fees >10k from Horizon Therapeutics, Celgene, Novartis, and AbbVie. Dr. Tesser has received research grants/support from Horizon. Dr. Bennett has no financial relationships that pose a potential conflict of interest. Dr. Kenney has received research support from Horizon Therapeutics as a study site and principal investigator. He has also served as a speaker for Horizon Therapeutics. Dr. Peloso, Ms. Obermeyer, and Dr. LaMoreaux are employees of and own stock in Horizon Therapeutics. Dr. Weinblatt has received grants from Amgen, Bristol-Myers Squibb, Crescendo Bioscience, Lilly and Sanofi. He has received consulting fees >10k from Bristol Myers Squibb, Corona, and Lilly and <10k from AbbVie, Amgen, Arena, GlaxoSmithKline, Gilead Sciences, Horizon Therapeutics, Lycera, Novartis, Pfizer, Roche, Samsung, Scipher Medicine, and Set Point; he has stock options in Lycera, Can-Fite BioPharma, Scipher Medicine, Inmedix, and Vorso. Dr. Peterson has received research support from Horizon Therapeutics (study site/investigator). He has also served as an advisor and speaker for Horizon Therapeutics. Corresponding Author: John K. Botson, MD, RPh, Orthopedic Physicians Alaska, 3801 Lake Otis Parkway, Anchorage, AK 99508. jbotson@opaak.com
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Brian LaMoreaux
Orthopedic Physicians Alaska, Anchorage, AK; Arizona Arthritis & Rheumatology Associates, P.C., Phoenix, AZ; Arizona Arthritis & Rheumatology Associates, P.C., Phoenix, AZ; Arthritis Northwest, PLLC, Spokane, WA; Horizon Therapeutics, Lake Forest, IL; Horizon Therapeutics, Lake Forest, IL; Brigham and Women’s Hospital, Boston, MA; Western Washington Arthritis Clinic, Bothell, WA. Conflict of interest: Dr. Botson has received research support from Horizon Therapeutics and Radius Health as a study site and principal investigator. He has received consulting/speaker fees >10k from Horizon Therapeutics, Celgene, Novartis, and AbbVie. Dr. Tesser has received research grants/support from Horizon. Dr. Bennett has no financial relationships that pose a potential conflict of interest. Dr. Kenney has received research support from Horizon Therapeutics as a study site and principal investigator. He has also served as a speaker for Horizon Therapeutics. Dr. Peloso, Ms. Obermeyer, and Dr. LaMoreaux are employees of and own stock in Horizon Therapeutics. Dr. Weinblatt has received grants from Amgen, Bristol-Myers Squibb, Crescendo Bioscience, Lilly and Sanofi. He has received consulting fees >10k from Bristol Myers Squibb, Corona, and Lilly and <10k from AbbVie, Amgen, Arena, GlaxoSmithKline, Gilead Sciences, Horizon Therapeutics, Lycera, Novartis, Pfizer, Roche, Samsung, Scipher Medicine, and Set Point; he has stock options in Lycera, Can-Fite BioPharma, Scipher Medicine, Inmedix, and Vorso. Dr. Peterson has received research support from Horizon Therapeutics (study site/investigator). He has also served as an advisor and speaker for Horizon Therapeutics. Corresponding Author: John K. Botson, MD, RPh, Orthopedic Physicians Alaska, 3801 Lake Otis Parkway, Anchorage, AK 99508. jbotson@opaak.com
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Michael E. Weinblatt
Orthopedic Physicians Alaska, Anchorage, AK; Arizona Arthritis & Rheumatology Associates, P.C., Phoenix, AZ; Arizona Arthritis & Rheumatology Associates, P.C., Phoenix, AZ; Arthritis Northwest, PLLC, Spokane, WA; Horizon Therapeutics, Lake Forest, IL; Horizon Therapeutics, Lake Forest, IL; Brigham and Women’s Hospital, Boston, MA; Western Washington Arthritis Clinic, Bothell, WA. Conflict of interest: Dr. Botson has received research support from Horizon Therapeutics and Radius Health as a study site and principal investigator. He has received consulting/speaker fees >10k from Horizon Therapeutics, Celgene, Novartis, and AbbVie. Dr. Tesser has received research grants/support from Horizon. Dr. Bennett has no financial relationships that pose a potential conflict of interest. Dr. Kenney has received research support from Horizon Therapeutics as a study site and principal investigator. He has also served as a speaker for Horizon Therapeutics. Dr. Peloso, Ms. Obermeyer, and Dr. LaMoreaux are employees of and own stock in Horizon Therapeutics. Dr. Weinblatt has received grants from Amgen, Bristol-Myers Squibb, Crescendo Bioscience, Lilly and Sanofi. He has received consulting fees >10k from Bristol Myers Squibb, Corona, and Lilly and <10k from AbbVie, Amgen, Arena, GlaxoSmithKline, Gilead Sciences, Horizon Therapeutics, Lycera, Novartis, Pfizer, Roche, Samsung, Scipher Medicine, and Set Point; he has stock options in Lycera, Can-Fite BioPharma, Scipher Medicine, Inmedix, and Vorso. Dr. Peterson has received research support from Horizon Therapeutics (study site/investigator). He has also served as an advisor and speaker for Horizon Therapeutics. Corresponding Author: John K. Botson, MD, RPh, Orthopedic Physicians Alaska, 3801 Lake Otis Parkway, Anchorage, AK 99508. jbotson@opaak.com
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Jeff Peterson
Orthopedic Physicians Alaska, Anchorage, AK; Arizona Arthritis & Rheumatology Associates, P.C., Phoenix, AZ; Arizona Arthritis & Rheumatology Associates, P.C., Phoenix, AZ; Arthritis Northwest, PLLC, Spokane, WA; Horizon Therapeutics, Lake Forest, IL; Horizon Therapeutics, Lake Forest, IL; Brigham and Women’s Hospital, Boston, MA; Western Washington Arthritis Clinic, Bothell, WA. Conflict of interest: Dr. Botson has received research support from Horizon Therapeutics and Radius Health as a study site and principal investigator. He has received consulting/speaker fees >10k from Horizon Therapeutics, Celgene, Novartis, and AbbVie. Dr. Tesser has received research grants/support from Horizon. Dr. Bennett has no financial relationships that pose a potential conflict of interest. Dr. Kenney has received research support from Horizon Therapeutics as a study site and principal investigator. He has also served as a speaker for Horizon Therapeutics. Dr. Peloso, Ms. Obermeyer, and Dr. LaMoreaux are employees of and own stock in Horizon Therapeutics. Dr. Weinblatt has received grants from Amgen, Bristol-Myers Squibb, Crescendo Bioscience, Lilly and Sanofi. He has received consulting fees >10k from Bristol Myers Squibb, Corona, and Lilly and <10k from AbbVie, Amgen, Arena, GlaxoSmithKline, Gilead Sciences, Horizon Therapeutics, Lycera, Novartis, Pfizer, Roche, Samsung, Scipher Medicine, and Set Point; he has stock options in Lycera, Can-Fite BioPharma, Scipher Medicine, Inmedix, and Vorso. Dr. Peterson has received research support from Horizon Therapeutics (study site/investigator). He has also served as an advisor and speaker for Horizon Therapeutics. Corresponding Author: John K. Botson, MD, RPh, Orthopedic Physicians Alaska, 3801 Lake Otis Parkway, Anchorage, AK 99508. jbotson@opaak.com
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Abstract

Objective To examine the efficacy and safety of pegloticase in combination with methotrexate in patients with uncontrolled gout in an exploratory, open-label clinical trial (NCT03635957) prior to a randomized, controlled trial.

Methods A multicenter, open-label, efficacy and safety study of pegloticase with methotrexate cotreatment was conducted in patients with uncontrolled gout. Patients were administered oral methotrexate (15 mg/week) and folic acid (1 mg/day) 4 weeks prior to and throughout pegloticase treatment. The primary study outcome was the proportion of responders, defined as sUA <6 mg/dL for ≥80% of the time during month 6 (weeks 20, 22, and 24). All analyses were performed on a modified intent-to-treat population, defined as patients who received ≥1 pegloticase infusion.

Results Seventeen patients were screened and 14 patients (all men, average age: 49.3 ± 8.7 years) were enrolled. On Day 1, mean sUA was 9.2 ± 2.5 mg/dL and 12 of the 14 patients had visible tophi. At the 6 month timepoint, 11/14 (78.6%, 95%CI 49.2-95.3%) met the responder definition, with 3 patients discontinuing after meeting protocol-defined treatment discontinuation rules (pre-infusion sUA values greater than 6 mg/dL at 2 consecutive scheduled visits). All patients tolerated methotrexate. No new safety concerns were identified.

Conclusion In this study, an increased proportion of patients maintained therapeutic response at 6 months when treated concomitantly with methotrexate and pegloticase when compared to the previously reported 42% using pegloticase alone. These results support the need for a randomized study of methotrexate or placebo with pegloticase to validate these open label findings.

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The Journal of Rheumatology
Vol. 49, Issue 7
1 Jul 2022
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Accepted manuscript
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, Howard M. Kenney, Paul M. Peloso, Katie Obermeyer, Brian LaMoreaux, Michael E. Weinblatt, Jeff Peterson
The Journal of Rheumatology Sep 2020, jrheum.200460; DOI: 10.3899/jrheum.200460

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Accepted manuscript
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, Howard M. Kenney, Paul M. Peloso, Katie Obermeyer, Brian LaMoreaux, Michael E. Weinblatt, Jeff Peterson
The Journal of Rheumatology Sep 2020, jrheum.200460; DOI: 10.3899/jrheum.200460
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