Key messages
- L’obiettivo del presente studio è stato confrontare l’efficacia, la sicurezza e la tollerabilità del metotrexato orale e sottocutaneo per il trattamento della psoriasi.
- Le somministrazioni orale e quella sottocutanea del metotrexato hanno mostrato un’efficacia simile nel miglioramento del PASI anche ai dosaggi più alti; tuttavia, la somministrazione sottocutanea ha mostrato una maggiore soddisfazione globale del paziente rispetto a quella orale.
- Non sono emerse differenze nella tollerabilità.
Abstract
Background
Evidence demonstrates that parenteral administration of methotrexate (MTX) has a higher drug bioavailability than oral administration. This difference is even more pronounced for medium to high dosages.
Aim
To compare the efficacy, safety, and tolerability of oral and subcutaneous (SC) MTX for treatment of psoriasis.
Methods
A randomized, comparative, single-blind, 32-week study was conducted. The clinical response was evaluated using the Psoriasis Area Severity Index (PASI) and patient global satisfaction was assessed using a visual analogue scale (VAS).
Results
In total, 77 completed the study: 38 in the SC and 39 in the oral MTX group. No significant between-group differences were found in the number attaining PASI improvement of 75% (PASI75), 90% (PASI90) and 100% (PASI100) at Weeks 16 and 32: PASI75 (p = 0.14 and p = 0.21, respectively), PASI90 (p = 0.23 and p = 0.18) and PASI100 (p = 0.62 and p = 0.22). According to the mean VAS, no significant differences between the groups were found at any time points except at Week 32 that the mean VAS was significantly higher in the SC group (p = 0.03). Adverse events were comparable in both groups.
Conclusion
SC and oral administration of MTX had similar efficacies in improving the PASI score even at the highest tolerable dose; however, the SC MTX group had higher overall patient satisfaction than the oral MTX group. No difference in tolerability was found.