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Research ArticleArticle
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
This work was supported by Horizon Therapeutics. J.K. Botson, MD, RPh, Orthopedic Physicians Alaska, Anchorage, Alaska; J.R. Tesser, MD, R. Bennett, MD, Arizona Arthritis & Rheumatology Associates, P.C., Phoenix, Arizona; H.M. Kenney, MD, Arthritis Northwest, PLLC, Spokane, Washington; P.M. Peloso, MD, MSc, K. Obermeyer, MS, B. LaMoreaux, MD, MS, Horizon Therapeutics, Lake Forest, Illinois; M.E. Weinblatt, MD, Brigham and Women’s Hospital, Boston, Massachusetts; 6J. Peterson, MD, Western Washington Arthritis Clinic, Bothell, Washington, USA. JKB 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. JRT has received research grants/support from Horizon. HMK has received research support from Horizon Therapeutics as a study site and principal investigator, and has served as a speaker. PMP, KO, and BL are employees of and own stock in Horizon Therapeutics. MEW has received grants from Amgen, Bristol Myers Squibb, Crescendo Bioscience, Lilly, and Sanofi; 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; and has stock options in Lycera, Can-Fite BioPharma, Scipher Medicine, Inmedix, and Vorso. JP has received research support from Horizon Therapeutics (study site/investigator), and has also served as an advisor and speaker for Horizon Therapeutics. RB has no financial relationships that pose a potential conflict of interest. Address correspondence to Dr. J.K. Botson, Orthopedic Physicians Alaska, 3801 Lake Otis Parkway, Anchorage, AK 99508, USA. Email: jbotson@opaak.com. Full Release Article. For details see Reprints and Permissions at jrheum.org. Accepted September 11, 2020.
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John R.P. Tesser
This work was supported by Horizon Therapeutics. J.K. Botson, MD, RPh, Orthopedic Physicians Alaska, Anchorage, Alaska; J.R. Tesser, MD, R. Bennett, MD, Arizona Arthritis & Rheumatology Associates, P.C., Phoenix, Arizona; H.M. Kenney, MD, Arthritis Northwest, PLLC, Spokane, Washington; P.M. Peloso, MD, MSc, K. Obermeyer, MS, B. LaMoreaux, MD, MS, Horizon Therapeutics, Lake Forest, Illinois; M.E. Weinblatt, MD, Brigham and Women’s Hospital, Boston, Massachusetts; 6J. Peterson, MD, Western Washington Arthritis Clinic, Bothell, Washington, USA. JKB 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. JRT has received research grants/support from Horizon. HMK has received research support from Horizon Therapeutics as a study site and principal investigator, and has served as a speaker. PMP, KO, and BL are employees of and own stock in Horizon Therapeutics. MEW has received grants from Amgen, Bristol Myers Squibb, Crescendo Bioscience, Lilly, and Sanofi; 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; and has stock options in Lycera, Can-Fite BioPharma, Scipher Medicine, Inmedix, and Vorso. JP has received research support from Horizon Therapeutics (study site/investigator), and has also served as an advisor and speaker for Horizon Therapeutics. RB has no financial relationships that pose a potential conflict of interest. Address correspondence to Dr. J.K. Botson, Orthopedic Physicians Alaska, 3801 Lake Otis Parkway, Anchorage, AK 99508, USA. Email: jbotson@opaak.com. Full Release Article. For details see Reprints and Permissions at jrheum.org. Accepted September 11, 2020.
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Ralph Bennett
This work was supported by Horizon Therapeutics. J.K. Botson, MD, RPh, Orthopedic Physicians Alaska, Anchorage, Alaska; J.R. Tesser, MD, R. Bennett, MD, Arizona Arthritis & Rheumatology Associates, P.C., Phoenix, Arizona; H.M. Kenney, MD, Arthritis Northwest, PLLC, Spokane, Washington; P.M. Peloso, MD, MSc, K. Obermeyer, MS, B. LaMoreaux, MD, MS, Horizon Therapeutics, Lake Forest, Illinois; M.E. Weinblatt, MD, Brigham and Women’s Hospital, Boston, Massachusetts; 6J. Peterson, MD, Western Washington Arthritis Clinic, Bothell, Washington, USA. JKB 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. JRT has received research grants/support from Horizon. HMK has received research support from Horizon Therapeutics as a study site and principal investigator, and has served as a speaker. PMP, KO, and BL are employees of and own stock in Horizon Therapeutics. MEW has received grants from Amgen, Bristol Myers Squibb, Crescendo Bioscience, Lilly, and Sanofi; 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; and has stock options in Lycera, Can-Fite BioPharma, Scipher Medicine, Inmedix, and Vorso. JP has received research support from Horizon Therapeutics (study site/investigator), and has also served as an advisor and speaker for Horizon Therapeutics. RB has no financial relationships that pose a potential conflict of interest. Address correspondence to Dr. J.K. Botson, Orthopedic Physicians Alaska, 3801 Lake Otis Parkway, Anchorage, AK 99508, USA. Email: jbotson@opaak.com. Full Release Article. For details see Reprints and Permissions at jrheum.org. Accepted September 11, 2020.
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Howard M. Kenney
This work was supported by Horizon Therapeutics. J.K. Botson, MD, RPh, Orthopedic Physicians Alaska, Anchorage, Alaska; J.R. Tesser, MD, R. Bennett, MD, Arizona Arthritis & Rheumatology Associates, P.C., Phoenix, Arizona; H.M. Kenney, MD, Arthritis Northwest, PLLC, Spokane, Washington; P.M. Peloso, MD, MSc, K. Obermeyer, MS, B. LaMoreaux, MD, MS, Horizon Therapeutics, Lake Forest, Illinois; M.E. Weinblatt, MD, Brigham and Women’s Hospital, Boston, Massachusetts; 6J. Peterson, MD, Western Washington Arthritis Clinic, Bothell, Washington, USA. JKB 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. JRT has received research grants/support from Horizon. HMK has received research support from Horizon Therapeutics as a study site and principal investigator, and has served as a speaker. PMP, KO, and BL are employees of and own stock in Horizon Therapeutics. MEW has received grants from Amgen, Bristol Myers Squibb, Crescendo Bioscience, Lilly, and Sanofi; 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; and has stock options in Lycera, Can-Fite BioPharma, Scipher Medicine, Inmedix, and Vorso. JP has received research support from Horizon Therapeutics (study site/investigator), and has also served as an advisor and speaker for Horizon Therapeutics. RB has no financial relationships that pose a potential conflict of interest. Address correspondence to Dr. J.K. Botson, Orthopedic Physicians Alaska, 3801 Lake Otis Parkway, Anchorage, AK 99508, USA. Email: jbotson@opaak.com. Full Release Article. For details see Reprints and Permissions at jrheum.org. Accepted September 11, 2020.
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Paul M. Peloso
This work was supported by Horizon Therapeutics. J.K. Botson, MD, RPh, Orthopedic Physicians Alaska, Anchorage, Alaska; J.R. Tesser, MD, R. Bennett, MD, Arizona Arthritis & Rheumatology Associates, P.C., Phoenix, Arizona; H.M. Kenney, MD, Arthritis Northwest, PLLC, Spokane, Washington; P.M. Peloso, MD, MSc, K. Obermeyer, MS, B. LaMoreaux, MD, MS, Horizon Therapeutics, Lake Forest, Illinois; M.E. Weinblatt, MD, Brigham and Women’s Hospital, Boston, Massachusetts; 6J. Peterson, MD, Western Washington Arthritis Clinic, Bothell, Washington, USA. JKB 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. JRT has received research grants/support from Horizon. HMK has received research support from Horizon Therapeutics as a study site and principal investigator, and has served as a speaker. PMP, KO, and BL are employees of and own stock in Horizon Therapeutics. MEW has received grants from Amgen, Bristol Myers Squibb, Crescendo Bioscience, Lilly, and Sanofi; 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; and has stock options in Lycera, Can-Fite BioPharma, Scipher Medicine, Inmedix, and Vorso. JP has received research support from Horizon Therapeutics (study site/investigator), and has also served as an advisor and speaker for Horizon Therapeutics. RB has no financial relationships that pose a potential conflict of interest. Address correspondence to Dr. J.K. Botson, Orthopedic Physicians Alaska, 3801 Lake Otis Parkway, Anchorage, AK 99508, USA. Email: jbotson@opaak.com. Full Release Article. For details see Reprints and Permissions at jrheum.org. Accepted September 11, 2020.
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Katie Obermeyer
This work was supported by Horizon Therapeutics. J.K. Botson, MD, RPh, Orthopedic Physicians Alaska, Anchorage, Alaska; J.R. Tesser, MD, R. Bennett, MD, Arizona Arthritis & Rheumatology Associates, P.C., Phoenix, Arizona; H.M. Kenney, MD, Arthritis Northwest, PLLC, Spokane, Washington; P.M. Peloso, MD, MSc, K. Obermeyer, MS, B. LaMoreaux, MD, MS, Horizon Therapeutics, Lake Forest, Illinois; M.E. Weinblatt, MD, Brigham and Women’s Hospital, Boston, Massachusetts; 6J. Peterson, MD, Western Washington Arthritis Clinic, Bothell, Washington, USA. JKB 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. JRT has received research grants/support from Horizon. HMK has received research support from Horizon Therapeutics as a study site and principal investigator, and has served as a speaker. PMP, KO, and BL are employees of and own stock in Horizon Therapeutics. MEW has received grants from Amgen, Bristol Myers Squibb, Crescendo Bioscience, Lilly, and Sanofi; 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; and has stock options in Lycera, Can-Fite BioPharma, Scipher Medicine, Inmedix, and Vorso. JP has received research support from Horizon Therapeutics (study site/investigator), and has also served as an advisor and speaker for Horizon Therapeutics. RB has no financial relationships that pose a potential conflict of interest. Address correspondence to Dr. J.K. Botson, Orthopedic Physicians Alaska, 3801 Lake Otis Parkway, Anchorage, AK 99508, USA. Email: jbotson@opaak.com. Full Release Article. For details see Reprints and Permissions at jrheum.org. Accepted September 11, 2020.
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Brian LaMoreaux
This work was supported by Horizon Therapeutics. J.K. Botson, MD, RPh, Orthopedic Physicians Alaska, Anchorage, Alaska; J.R. Tesser, MD, R. Bennett, MD, Arizona Arthritis & Rheumatology Associates, P.C., Phoenix, Arizona; H.M. Kenney, MD, Arthritis Northwest, PLLC, Spokane, Washington; P.M. Peloso, MD, MSc, K. Obermeyer, MS, B. LaMoreaux, MD, MS, Horizon Therapeutics, Lake Forest, Illinois; M.E. Weinblatt, MD, Brigham and Women’s Hospital, Boston, Massachusetts; 6J. Peterson, MD, Western Washington Arthritis Clinic, Bothell, Washington, USA. JKB 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. JRT has received research grants/support from Horizon. HMK has received research support from Horizon Therapeutics as a study site and principal investigator, and has served as a speaker. PMP, KO, and BL are employees of and own stock in Horizon Therapeutics. MEW has received grants from Amgen, Bristol Myers Squibb, Crescendo Bioscience, Lilly, and Sanofi; 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; and has stock options in Lycera, Can-Fite BioPharma, Scipher Medicine, Inmedix, and Vorso. JP has received research support from Horizon Therapeutics (study site/investigator), and has also served as an advisor and speaker for Horizon Therapeutics. RB has no financial relationships that pose a potential conflict of interest. Address correspondence to Dr. J.K. Botson, Orthopedic Physicians Alaska, 3801 Lake Otis Parkway, Anchorage, AK 99508, USA. Email: jbotson@opaak.com. Full Release Article. For details see Reprints and Permissions at jrheum.org. Accepted September 11, 2020.
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Michael E. Weinblatt
This work was supported by Horizon Therapeutics. J.K. Botson, MD, RPh, Orthopedic Physicians Alaska, Anchorage, Alaska; J.R. Tesser, MD, R. Bennett, MD, Arizona Arthritis & Rheumatology Associates, P.C., Phoenix, Arizona; H.M. Kenney, MD, Arthritis Northwest, PLLC, Spokane, Washington; P.M. Peloso, MD, MSc, K. Obermeyer, MS, B. LaMoreaux, MD, MS, Horizon Therapeutics, Lake Forest, Illinois; M.E. Weinblatt, MD, Brigham and Women’s Hospital, Boston, Massachusetts; 6J. Peterson, MD, Western Washington Arthritis Clinic, Bothell, Washington, USA. JKB 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. JRT has received research grants/support from Horizon. HMK has received research support from Horizon Therapeutics as a study site and principal investigator, and has served as a speaker. PMP, KO, and BL are employees of and own stock in Horizon Therapeutics. MEW has received grants from Amgen, Bristol Myers Squibb, Crescendo Bioscience, Lilly, and Sanofi; 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; and has stock options in Lycera, Can-Fite BioPharma, Scipher Medicine, Inmedix, and Vorso. JP has received research support from Horizon Therapeutics (study site/investigator), and has also served as an advisor and speaker for Horizon Therapeutics. RB has no financial relationships that pose a potential conflict of interest. Address correspondence to Dr. J.K. Botson, Orthopedic Physicians Alaska, 3801 Lake Otis Parkway, Anchorage, AK 99508, USA. Email: jbotson@opaak.com. Full Release Article. For details see Reprints and Permissions at jrheum.org. Accepted September 11, 2020.
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Jeff Peterson
This work was supported by Horizon Therapeutics. J.K. Botson, MD, RPh, Orthopedic Physicians Alaska, Anchorage, Alaska; J.R. Tesser, MD, R. Bennett, MD, Arizona Arthritis & Rheumatology Associates, P.C., Phoenix, Arizona; H.M. Kenney, MD, Arthritis Northwest, PLLC, Spokane, Washington; P.M. Peloso, MD, MSc, K. Obermeyer, MS, B. LaMoreaux, MD, MS, Horizon Therapeutics, Lake Forest, Illinois; M.E. Weinblatt, MD, Brigham and Women’s Hospital, Boston, Massachusetts; 6J. Peterson, MD, Western Washington Arthritis Clinic, Bothell, Washington, USA. JKB 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. JRT has received research grants/support from Horizon. HMK has received research support from Horizon Therapeutics as a study site and principal investigator, and has served as a speaker. PMP, KO, and BL are employees of and own stock in Horizon Therapeutics. MEW has received grants from Amgen, Bristol Myers Squibb, Crescendo Bioscience, Lilly, and Sanofi; 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; and has stock options in Lycera, Can-Fite BioPharma, Scipher Medicine, Inmedix, and Vorso. JP has received research support from Horizon Therapeutics (study site/investigator), and has also served as an advisor and speaker for Horizon Therapeutics. RB has no financial relationships that pose a potential conflict of interest. Address correspondence to Dr. J.K. Botson, Orthopedic Physicians Alaska, 3801 Lake Otis Parkway, Anchorage, AK 99508, USA. Email: jbotson@opaak.com. Full Release Article. For details see Reprints and Permissions at jrheum.org. Accepted September 11, 2020.
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Abstract

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

Methods A multicenter, open-label efficacy and safety study of pegloticase with MTX co-treatment was conducted in patients with uncontrolled gout. Patients were administered oral MTX (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 serum uric acid (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 (preinfusion sUA values > 6 mg/ dL at 2 consecutive scheduled visits). All patients tolerated MTX. 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 MTX and pegloticase as compared to the previously reported 42% using pegloticase alone. These results support the need for a randomized study of MTX or placebo with pegloticase to validate these open-label findings.

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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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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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