Updated EULAR Recommendations for Early Arthritis; Plus FDA Approves New Abuse-Deterrent Morphine Sulfate

Updated EULAR Recommendations for Early Arthritis
A committee of the European League Against Rheumatism (EULAR) has developed recommendations for managing early arthritis, using evidence from medical literature and expert opinion.¹ The committee comprised 20 rheumatologists, two patients and one healthcare professional, representing 12 European countries. Based on their review, the committee provided the following overarching principles and recommendations.

Principles:

• The management of early arthritis should aim for the best care and must be based on shared-decision making between the patient and rheumatologist;
• Rheumatologists are the specialists who should primarily care for patients with early arthritis; and
• A definitive diagnosis of early arthritis in a patient should be made only after a careful history is taken and a clinical examination, which should be guided by laboratory testing and additional procedures, is conducted.

Recommendations:

• Patients experiencing any joint swelling associated with pain or stiffness (presenting with arthritis) should be referred to and seen by a rheumatologist within six weeks of symptom onset;
• To detect arthritis, a clinical examination is the method of choice, and ultrasonography can be used for confirmation;
• If a definite diagnosis cannot be achieved and the patient has early undifferentiated arthritis, clinicians should consider the patient’s risk factors for persistent or erosive disease, including swollen joints, acute phase reactants, rheumatoid factor, anti-citrullinated protein antigen and imaging findings in management decisions;
• Patients at risk of persistent arthritis should be started on a disease-modifying anti-rheumatic drug (DMARD) within three months of symptoms, even if they do not meet the full criteria for an inflammatory rheumatologic disease;
• Unless contraindicated, methotrexate should be a part of the first treatment regimen used by patients at risk for persistent disease;
• NSAIDs (non-steroidal anti-inflammatory drugs) are useful for symptoms and should be used at the minimum effective dose for the shortest duration possible after evaluation of cardiac, gastrointestinal and renal risks;
• Systemic glucocorticoids reduce pain, swelling and structural progression and should be used at the lowest necessary dose for temporary adjunctive treatment (less than six months). Intra-articular glucocorticoid injections should be considered to relieve local inflammation symptoms;
• Clinical remission is the primary goal of DMARD treatment. Regular monitoring of disease activity, adverse events and comorbidities should guide clinical decisions and treatment strategy changes to achieve remission;
• Until a treatment target is reached, disease activity monitoring should occur at one-month to three-month intervals. This evaluation should include tender and swollen joint counts, patient and physician global assessments, and erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP) values. Radiographic and patient-reported outcome measures, such as functional assessments, may also be used during the assessment;
• Dynamic exercise and occupational therapy should be considered as non-pharmacologic adjuncts to drug treatment;
• Smoking cessation, dental care, weight control, assessment of vaccination status and comorbidity management should be part of overall patient care; and
• Patient education programs for coping with pain, disability, maintenance of ability to work and social participation may be used as adjunct interventions.

FDA Approves New Extended-Release Morphine Sulfate
The U.S. Food and Drug Administration (FDA) has approved a new long-acting morphine product (Armyo ER) for managing pain severe enough to require daily, long-term opioid treatment and for which alternative treatment options are inadequate.²

Using a proprietary technology, the manufacturer developed abuse deterrence that involves a physical and chemical barrier approach without using an opioid antagonist. The tablets are, therefore, difficult to manipulate for purposes of misuse and abuse. In vitro testing compared this treatment with non-abuse-deterrent morphine sulfate extended-release tablets. Armyo ER had an increased resistance to cutting, crushing, grinding or breaking when various tools were used. Additionally, due to its physical and chemical properties, it is expected that injection abuse will be difficult.

However, the FDA advisory panel that reviewed the drug recommended the agent be labeled as an abuse-deterrent product via the oral, nasal and intravenous routes. The FDA typically follows these recommendations.³ This FDA approval will allow the company to claim only that the treatment deters abuse by those seeking to dissolve and inject it. It did not approve claims that the product deters abuse by the oral or nasal routes.

Three dosage strengths have been approved: 15 mg, 30 mg and 60 mg. And the product is expected to be available in the first quarter of 2017.

Michele B. Kaufman, PharmD, BCGP, is a freelance medical writer based in New York City and a pharmacist at New York Presbyterian Lower Manhattan Hospital.

References

1. Combe B, Landewe R, Daien CI, et al. 2016 update of the EULAR recommendations for the management of early arthritis. Ann Rheum Dis. 2016 Dec 15. pii: annrheumdis-2016-210602. doi: 10.1136/annrheumdis-2016-210602. [Epub ahead of print]
2. Egalet Corp. News release: Egalet receives FDA approval for ARYMO ER (morphine sulfate) C-II, an extended-release morphine product formulated with abuse-deterrent properties for treatment of chronic pain. 2017 Jan 9.
3. Clarke T. Egalet painkiller wins FDA approval but label disappoints. Reuters. 2017 Jan 9.