This just-published study finds that once your rosacea is under control, Soolantra once a day will likely do a better job at keeping papules and pustules at bay compared to Metrogel 0.75% twice per day.
Why not Metrogel 1%?
Interestingly this study did not compare Soolantra against Metrogel 1%, but Metrogel 0.75%. The leaves us to wonder if the researchers were wary of cannibalising sales of Metrogel 1% – by only wanting to prove that Soolantra was better than the last generation metronidazole gel based treatment.
Relapse Later, Less Relapsing
Researchers were able to show, that once the papules and pustules of rosacea were brought under control, using Soolantra resulted in a longer period before a relapse occured, and that overall it was less likely for symptoms to return using Soolantra.
Soolantra users took on average 115 days before symptoms returned and Metrogel users took 85 days before papules and pustules returned.
At the end of the study period, that is 36 weeks after rosacea symptoms were at first brought into remission, 62.7% of Soolantra users experienced a relapse, and 68.4% of Metrogel users relapsed. This 5.7% difference in relapse rate is considered a statistically different rate and a positive result for Soolantra.
Adverse events had a similar occurrence between both treatment groups.
Study Backed by Galderma
Many of the study authors have worked directly and indirectly for Galderma, and the study itself was funded by Galderma R&D.
All Good News for Galderma
These sorts of results are great for the marketing machine inside Galderma. One can easily imagine that we might see Soolantra promoted as being the best treatment short term, medium term, long term and now for keeping your rosacea in remission for years to come.
If you are already using Metrogel 1%, then this study won’t prove that switching to Soolantra will improve your long term chances of remission, but may hint you could do better.
J Eur Acad Dermatol Venereol. 2015 Dec 21.
BACKGROUND: There are a limited number of approved treatments for papulopustular rosacea (PPR) and remission is difficult to maintain after successful treatment.
OBJECTIVES: To investigate remission over a 36-week extension period in patients with moderate to severe PPR successfully treated with 16 weeks’ treatment with ivermectin 1% cream once daily (QD) or metronidazole 0.75% cream twice daily (BID) in a randomized, parallel-group Phase III study
CONCLUSION: The results of this relapse study showed that an initial successful treatment with ivermectin 1% cream QD significantly extended remission of rosacea compared with initial treatment with metronidazole 0.75% cream BID following treatment cessation.
Some expert comments on the clinical relevance of these trial results have been published. Dr. Friedman is generally impressed with the quality of the research and supportive of the idea that Ivermectin 1% is a worthy addition to the rosacea treatment armament.
… it is rare to see a company structure a superiority head-to-head study, so I will give credit where it is due. However, my guess here is that it was anticipated that ivermectin would at the very least prove noninferior, if not superior, given the poor success rate of this long-standing workhorse.
This should not distract from the fact that a) the studies were thorough and well structured and b) held for a good time frame. The data are certainly compelling, so I don’t want that to be overshadowed by the heavy focus on comparing to metronidazole twice a day. To me, that’s a red herring; had they only compared to placebo, we wouldn’t be having this discussion.
The data herein presented are more than supportive of its addition to our limited armamentarium, but to say first line is premature at this early stage. The once-daily dosing and limited adverse events are supportive features as patient compliance is always an issue. Probably more important, and only time will tell, is will insurance companies cover it? Or, will they reject our prescriptions and continue the current trend of recommending medications that bear no similarity to mechanism of action or efficacy. I am suddenly reminded of the all too frequent notice sent, stating that I should give an acne patient benzoyl peroxide, instead of the retinoid I initially selected.
Kudos to Galderma for keeping innovation alive and bringing a new topical drug forward – curious to see if I can actually prescribe it.
Dr. Adam Friedman