H Morph Hormone Therapy Improves Quality of Life for Some with Rheumatic Disease

BIRMINGHAM, Ala. – Patients with rheumatic disease who received improved quality of life and reduced pain activity had fewer pain-related visits, fewer pain exchanges, fewer nociceptive examinations, and greater positive health and quality-of-life ratings. Results from a retrospective study led by researchers at the University of Alabama at Birmingham’s Biomedical Sciences Division show the hormone therapy numbs and treatment duration increased satisfaction with life, increased efficiency of care, and increased patient safety. Results appear in Clinical Pharmacology: Clinical & Translational Research.

“Nearly 80% of patients with rheumatic disease favor treatment with short-acting drugs and approximately 15% take long-acting and/or newer nonpharmacological therapies,” said senior author Mikhail Tereshnikov, MD, the Jack and Christine Price Professor of Rheumatic Disease at the University of Alabama at Birmingham and director of the UAB Biomedical Sciences Division. “In contrast, patients who continue to receive opioids for pain, and prefer to administer them, are falling short of the treatment recommendations. My study aimed to examine the effectiveness of numbing agents and other nonpharmacologic therapies inside the joint in treating rheumatic disease patients using the amelin receptor antagonist noscarsone.”

Noscarsone is a investigational nonopioid nasal receptor antagonist used in the treatment of psoriasis and cutaneous T-cell leukemia, as well as in the treatment of rheumatic diseases. It is approved by the U.S. Food and Drug Administration in combination with other investigational medications.

Noscarsone is given to patients three times a day. The dose is initially low – about 100 mg/day in patients with active disease – and gradually increases up to 600 mg/day. Patients in this range are considered high-risk because of the potentially lethal effects of opioid withdrawal.

Sixteen patients in the study received compounding-based nausea and vomiting suppositories, three times a day. Three patients received nociceptive examinations every four weeks or so. Nine patients received pain assessments twice-daily (five with nociceptive examinations every two weeks) or twice weekly (four with nociceptive examinations every two weeks).The researchers, who had blinded participants, evaluated pain and well-being – quality of life and clinical convenience – three times a day. During the three-month study period, approximately 40 percent of patients received intensive care unit drug and nonopioid-treatment therapy. Those who received extended-release or extended-release subcutaneous nociceptive agents (extended-release hookahs, applicators, or lozenges) actually filled within the recommended range of dose (100 mg/day) and severity (moderate to severe pain, defined by the American College of Rheumatic Diseases and the Centers for Disease Control and Prevention Morbidity and Mortality Weekly Report data).The researchers found that patients had fewer nonpharmacologic adverse events and increased quality-of-life ratings, if any, than they would have without the extended-release drug and opioid treatment. In terms of patient safety, nine patients (two who received extended-release drug and three who received extended-release opioid) were killed. No deaths were reported among those who had fluid in the affected arm, because of adverse events.

“I don’t know if numbing agents will work to patients with chronic pain who have been successfully treated with opioid for a number of years,” Tereshnikov said. “I think it’s entirely possible that those improving and/or satisfied with their condition will not use numbing agents, with many of them staying away from the market.”

Dr. Tereshnikov is a member of the UAB Committee on Rheumatology Research. He serves as the graduate medical educator and is the lead author of several publications on rheumatology. Please see his website for more information about his research.