Jublia (Efinaconazole) for Onychomycosis: Efficacy and Number Needed to Treat
Jublia (efinaconazole 10% topical solution) achieves complete cure in approximately 15-18% of patients with mild-to-moderate toenail onychomycosis after 48 weeks of daily application, yielding a number needed to treat (NNT) of approximately 8-9 patients to achieve one complete cure compared to vehicle. 1, 2, 3
Cure Rate Data
Complete Cure Rates
- 17.8% in Trial 1 and 15.2% in Trial 2 achieved complete cure (defined as 0% clinical involvement plus negative KOH and negative culture) at week 52 (4 weeks after completing 48 weeks of therapy) 1
- Vehicle control achieved only 3.3% and 5.5% complete cure respectively, demonstrating the drug's superiority over placebo 1
- Pooled complete cure rate of 17% across both pivotal trials 2, 3
Mycological Cure Rates
- 55.2% in Trial 1 and 53.4% in Trial 2 achieved mycological cure (negative KOH and negative culture) 1
- Pooled mycological cure rate of 54-56% compared to 17% for vehicle 2, 3
- British Association of Dermatologists guidelines report mycological cure rates approaching 50% after 48 weeks 4, 5
Clinical Treatment Success
- 43-47% of patients achieved clinical treatment success at week 52 3
- Complete or almost complete cure (≤5% affected area with negative mycology) was achieved in 26.4% and 23.4% of patients in the two trials 1
Number Needed to Treat Calculation
For complete cure:
- NNT = 1 ÷ (absolute risk reduction)
- Trial 1: 1 ÷ (0.178 - 0.033) = NNT of 7
- Trial 2: 1 ÷ (0.152 - 0.055) = NNT of 10
- Average NNT: 8-9 patients to achieve one additional complete cure
For mycological cure:
- Trial 1: 1 ÷ (0.552 - 0.168) = NNT of 3
- Trial 2: 1 ÷ (0.534 - 0.169) = NNT of 3
Important Clinical Context
Comparative Efficacy
- Efinaconazole demonstrates superior efficacy compared to other topical agents: ciclopirox 8% achieves only 8% clinical cure and 34% mycological cure, while amorolfine 5% achieves approximately 50% effectiveness but with mycological cure rates typically 30% lower than clinical improvement 4, 5
- The British Association of Dermatologists notes that efinaconazole's mycological cure approaching 50% and complete cure of 15% represents the highest efficacy among topical treatments 4, 5
Predictors of Better Response
Patients more likely to respond to efinaconazole include: 6
- Female patients
- Lower BMI
- Mild onychomycosis (≤25% nail involvement)
- Short disease duration (<1 year shows best results)
- No infected non-target toenails
- When concomitant tinea pedis is treated concurrently (efficacy increases from 16.1% to 29.4%) 7
Critical Caveat
Clinical improvement does not equal mycological cure - the British Association of Dermatologists emphasizes that cure rates are often 30% lower than apparent clinical improvement with all topical antifungals 4, 5
Appropriate Patient Selection
Efinaconazole is recommended for: 4, 5, 6
- Superficial white onychomycosis
- Early distal lateral subungual onychomycosis when <80% of nail plate affected
- No lunula (matrix) involvement
- Patients where systemic antifungals are contraindicated (liver/kidney disease)
- Pediatric onychomycosis (FDA-approved for ages 6 years and older) 1, 8
- Maintenance therapy to prevent relapse 6
Safety Profile
Efinaconazole demonstrates minimal systemic absorption and excellent tolerability, with the most common adverse events being ingrown toenails, application site dermatitis, vesicles, and pain - all mild and transient 1, 6, 2