What are the criteria for using Roflumilast (Daxas) in patients with Chronic Obstructive Pulmonary Disease (COPD)?

Criteria for Roflumilast Use in COPD

Roflumilast is indicated for patients with severe COPD associated with chronic bronchitis and a history of exacerbations to reduce the risk of COPD exacerbations. 1

Patient Selection Criteria

• Roflumilast should be used in patients with severe or very severe airflow obstruction who have a history of exacerbations despite optimal inhaled therapy 2
• Patients must have the chronic bronchitis phenotype (productive cough) and a history of exacerbations to benefit from roflumilast therapy 2, 1
• Roflumilast is indicated for patients with high risk of exacerbations who have moderate to high symptom burden and impaired lung function 2
• Roflumilast is NOT indicated as first-line therapy after COPD diagnosis 1
• Roflumilast is NOT used as a rescue medication for acute symptoms 1
• Roflumilast is NOT indicated solely based on high CAT or mMRC Dyspnea Scale scores 2, 1

Clinical Benefits

• Roflumilast reduces the rate of moderate or severe exacerbations by approximately 15-21% (rate ratio 0.85,95% CI 0.78-0.91) 2, 3
• Roflumilast decreases the proportion of patients who develop exacerbations (risk ratio 0.85,95% CI 0.78-0.94) 2
• Roflumilast prolongs time to next exacerbation (hazard ratio 0.88,95% CI 0.81-0.96) 2
• Roflumilast provides modest improvements in lung function (FEV1 and FVC) 2, 4
• Greatest benefits are observed in patients with severe COPD who have chronic bronchitis and a history of frequent exacerbations 4

Important Considerations for Use

• Roflumilast is not a bronchodilator and should not be used for relief of acute bronchospasm 1
• Roflumilast 250 mcg is only a starting dose for the first 4 weeks of treatment; 500 mcg is the therapeutic dose 1
• Roflumilast can be used concomitantly with long-acting bronchodilators for enhanced efficacy 3, 5
• Roflumilast has shown benefit when added to triple therapy (LABA/ICS/LAMA) in patients with frequent exacerbations 5
• Strong cytochrome P450 enzyme inducers (e.g., rifampicin, phenobarbital, carbamazepine, phenytoin) should not be used with roflumilast as they may reduce its effectiveness 1

Common Side Effects and Monitoring

• Common adverse effects include diarrhea, nausea, weight loss, psychiatric disorders, and sleep disturbance 2, 1
• Higher discontinuation rates due to adverse effects occur with roflumilast compared to placebo (risk ratio 1.80) 2
• Patients should have their weight monitored regularly, as unexplained weight loss may necessitate discontinuation 1
• Monitor for mental health problems including suicidal thoughts, anxiety, depression, or other mood changes 1
• In real-world settings, side effects (mainly gastrointestinal) may occur in up to 69% of patients, with treatment discontinuation in approximately 49% 5

Clinical Application

• Roflumilast should be considered after optimal inhaled therapy has failed to control exacerbations in patients with severe COPD and chronic bronchitis 2, 1
• Roflumilast is not appropriate for acute exacerbation management but rather for long-term prevention of exacerbations 1, 4
• The decision to use roflumilast should be based on exacerbation history and chronic bronchitis phenotype, not solely on symptom scores 2, 1