Benzinga | Oct 8, 2020 08:19AM EDT

Horizon Therapeutics To Present Data Evaluating KRYSTEXXA At American College Of Rheumatology Convergence 2020 Nov. 5-9

-- Presentations will add to the growing body of evidence on the use of KRYSTEXXA with an immunomodulator to impact patient outcomes --

-- Oral presentation on Nov. 7 at 5:20 p.m. ET discussing data from RECIPE, the randomized controlled trial studying the concomitant use of KRYSTEXXA with the immunomodulator mycophenolate mofetil --

-- Horizon to host an online discussion with co-primary investigator for RECIPE on Nov. 7 at 7 p.m. ET --

Horizon Therapeutics plc (NASDAQ:HZNP) today announced that data from the investigator-initiated trial, REduCing Immunogenicity to PegloticasE (RECIPE), will be presented during ACR Convergence Nov. 5-9, 2020. Additional studies on the concomitant use of KRYSTEXXA (pegloticase injection) with an immunomodulator to optimize the treatment for people living with chronic gout refractory to conventional therapies (also known as uncontrolled gout) will also be presented.

"In partnership with clinicians, we continue to present real-world experiences in uncontrolled gout and highlight the latest imaging research to illustrate the impact of urate deposition throughout the body," said Jeffrey D. Kent, M.D., FACG, FACP, executive vice president, medical affairs and outcomes research, Horizon. "As the urgency to treat uncontrolled gout has become better understood, we've seen a marked change in the approach to treatment. These changes are reflected by the wide array of data being presented at this year's ACR meeting."

Presentations on KRYSTEXXA co-prescribed with an immunomodulator include:

* Reducing immunogenicity of pegloticase (RECIPE) with concomitant use of mycophenolate mofetil in patients with refractory gout-- results of a Phase 2 double blind randomized controlled trial Proof-of-concept Phase 2 trial on the effect of a short-term course of mycophenolate mofetil (MMF) on pegloticase response rates and mitigation of anti-pegloticase antibody production Abstract: 0952, K. Saag (Oral presentation) Saturday, Nov. 7, 2020; 5:20- 5:30 p.m. ET Investigator-initiated trial

* A multi-center efficacy and safety study of methotrexate to increase response rates in patients with uncontrolled gout receiving pegloticase (MIRROR): 12-month results of an open-label study 12-month data from the ongoing open-label MIRROR study provides additional insight on how the addition of methotrexate impacts the KRYSTEXXA response rate among people with uncontrolled gout Abstract: 0677, J. Botson Saturday, Nov. 7, 2020; 9 -- 11 a.m. ET

* Pharmacokinetics of pegloticase and methotrexate polyglutamate(s) in patients with uncontrolled gout receiving pegloticase and co-treatment of methotrexate This analysis reviews the pharmacokinetics and immunogenicity of KRYSTEXXA when combined with methotrexate, adding new insight supporting an immunomodulation approach to advance outcomes Abstract: 0683, M. Weinblatt Saturday, Nov. 7, 2020; 9 -- 11 a.m. ET

* Trends in immunomodulation / pegloticase co-therapy from 2015-2019: A claims database study A new evaluation of claims databases illustrates how immunomodulation approaches with KRYSTEXXA to address uncontrolled gout have been adopted in clinical practice in recent years Abstract: 0665, J. Boston Saturday, Nov. 7, 2020; 9 -- 11 a.m. ET

* The impact of azathioprine on the frequency of persistent responsiveness to pegloticase in patients with chronic refractory gout Open label multicenter study to determine whether co-therapy with azathioprine would increase the frequency of chronic refractory gout patients who had persistent urate lowering from pegloticase therapy Abstract: 0685, P. Lipsky Saturday, Nov. 7, 2020; 9 -- 11 a.m. ET Investigator-initiated trial

* Management of gout with pegloticase; real-world utilization and outcomes from TRIO health and the American Rheumatology Network (ARN) Retrospective study on gout-diagnosed patients who initiated their last pegloticase course between July 2015 and Oct. 2019 to identify variables associated with longer time on therapy Abstract: 1629, N. Solomon Monday, Nov. 9, 2020; 9 -- 11 a.m. ET Independent study

In addition, Horizon will host an online discussion on Nov. 10 at 7 p.m. ET about KRYSTEXXA and immunomodulation, featuring Puja Khanna, M.D., M.P.H., co-primary investigator for RECIPE, and moderated by Brian LaMoreaux, M.D., M.S., Horizon medical director.

The safety and efficacy of KRYSTEXXA concomitantly used with an immunomodulator has not been established by any health authorities.

Please see important safety information for KRYSTEXXA below.

Presentations on risk factors and systemic impact associated with gout include:

* Dual Energy CT Has Additional Prognostic Value Over Clinical Measures in Gout Including Tophi: A Best Evidence Synthesis Best evidence synthesis framework summary of the evidence for Dual Energy CT Scan (DECT) as a prognostic gout tool Abstract: 0648, S. Stauder Saturday, Nov. 7, 2020; 9 -- 11 a.m. ET

* Gout and Serum Urate Levels are Associated with Lumbar Spine Monosodium Urate Deposition and Chronic Low Back Pain: A Dual-Energy CT Study Prospective study using dual-energy CT (DECT) to determine the prevalence and extent of monosodium urate deposition in the lumbosacral spines of patients with gout vs without gout, and with tophaceous vs non-tophaceous gout Abstract: 0681, M. Pillinger Saturday, Nov. 7, 2020; 9 -- 11 a.m. ET Investigator-initiated trial

* Cause-Specific Mortality in Patients with Gout in the Veteran's Health Administration: A Matched Cohort Study Retrospective, matched cohort study, to compare all-cause and cause-specific mortality risk between gout and non-gout patients in the VHA between Jan. 1999 to Sept. 2015 Abstract: 0662, T. Mikuls Saturday, Nov. 7, 2020; 9 -- 11 a.m. ET Investigator-initiated trial

* Change in Tophus Size Measured with Dual-energy CT and Ultrasound: A 1-year Multicenter Follow-up Study Study of the evolution of tophus volume measured with dual energy CT scans and ultrasounds to determine coloration during the first year of urate lowering therapy Abstract: 1550, T. Pascart Monday, Nov. 9, 2020; 9 -- 11 a.m. ET Investigator-initiated trial

* Gout and Heart Failure in the U.S. Review of the Nationwide Inpatient Sample (NIS) database on the clinical and economic consequences of gout and hyperuricemia as significant risk factors for heart failure Abstract: 0657, G. Singh Saturday, Nov. 7, 2020; 9 -- 11 a.m. ET Investigator-initiated trial

* Gout is an Independent Risk Factor for Undergoing an Amputation Procedure A U.S. claims database review to examine the occurrence of amputations (foot, toes, hand, fingers) in adult patients with gout and in those with diabetes Abstract: 0673, S. Neville Saturday, Nov. 7, 2020; 9 -- 11 a.m. ET