Table 4 Main characteristics of considered studies evaluating the best strategy in terms of efficacy and safety for the long-term (> 8 weeks) topical treatment of psoriasis
Author, year | Study design | Study population | Treatment and vehicle | Main conclusions on the strategy in terms of efficacy and safety for the long-term treatment |
|---|---|---|---|---|
Jalili (2022) [22] | Post-hoc analysis of PSO-LONG | 545 patients | Cal/BD foam | Proactive management was associated with a significantly higher DLQI and a numerically lower EQ-5D-5L-PSO mean area under the curve score than proactive management |
Lebwohl (2021) [43] | Phase III, multicenter trial (PSO-LONG) | 545 patients | Cal/BD foam | Proactive management reduced the median time to first relapse and the number of relapses and increased the days in remission compared with reactive management The Cal/BD foam was well tolerated |
Lebwohl (2009) [20] | Open-label, multicenter study | 324 patients | Calcitriol ointment | A marked improvement in psoriasis symptoms from baseline was reported BSA was stable or improved in 97.7% of patients at 52 weeks Adverse events deemed related to study treatment were noted for 45 participants (14%), none was severe |
Koo (2006) [33] | Phase II, multicenter, investigator-blind randomized study | 86 patients | Clobetasol foam + calcipotriene ointment (6 months) followed by 6 months of weekday calcipotriene ointment ± clobetasol foam weekend pulse therapy | Combination therapy in the first 24 weeks decreased psoriasis scores compared with either agent The weekend pulse clobetasol foam was associated with a trend toward greater maintenance of remission than the vehicle |
Kragballe (2006) [21] | Randomized clinical trial | 422 patients | Cal/BD gel applied for 52 weeks vs 52 weeks of alternating 4 weeks of Cal/BD gel and calcipotriol (alternating group, n = 213) or 4 weeks of the Cal/BD gel + 48 weeks of calcipotriol | Adverse drug reactions of concern associated with long-term topical corticosteroids were comparable among the three groups, suggesting that Cal/BD gel is safe and well tolerated in the long term whether used on its own or alternating every 4 weeks with calcipotriol treatment |
Sharma (2003) [37] | Prospective, randomized study | 30 patients | Coal tar ointment on one side of the lesion and calcipotriol ointment on the other side | Calcipotriol ointment produced a faster initial response, although after a long period of treatment, i.e., 12 weeks, coal tar ointment had comparable efficacy There was no statistically significant difference in the relapse rates between the two modalities |