BackgroundApremilast, an oral, small‐molecule phosphodiesterase 4 inhibitor, has demonstrated efficacy in patients with moderate‐to‐severe psoriasis.ObjectiveEvaluate efficacy and safety of apremilast vs. placebo in biologic‐naive patients with moderate‐to‐severe plaque psoriasis and safety of switching from etanercept to apremilast in a phase IIIb, randomized, double‐blind, placebo‐controlled study (NCT01690299).MethodsTwo hundred and fifty patients were randomized to placebo (n = 84), apremilast 30 mg BID (n = 83) or etanercept 50 mg QW (n = 83) through Week 16; thereafter, all patients continued or switched to apremilast through Week 104. The primary efficacy endpoint was achievement of PASI‐75 at Week 16 with apremilast vs. placebo. Secondary endpoints included achievement of PASI‐75 at Week 16 with etanercept vs. placebo and improvements in other clinical endpoints vs. placebo at Week 16. Outcomes were assessed through Week 52. This study was not designed for apremilast vs. etanercept comparisons.ResultsAt Week 16, PASI‐75 achievement was greater with apremilast (39.8%) vs. placebo (11.9%; P < 0.0001); 48.2% of patients achieved PASI‐75 with etanercept (P < 0.0001 vs. placebo). PASI‐75 response was maintained in 47.3% (apremilast/apremilast), 49.4% (etanercept/apremilast) and 47.9% (placebo/apremilast) of patients at Week 52. Most common adverse events (≥5%) with apremilast, including nausea, diarrhoea, upper respiratory tract infection, nasopharyngitis, tension headache and headache, were mild or moderate in severity; diarrhoea and nausea generally resolved in the first month. No new safety or tolerability issues were observed through Week 52 with apremilast.ConclusionApremilast demonstrated significant efficacy vs. placebo at Week 16 in biologic‐naive patients with psoriasis, which was sustained over 52 weeks, and demonstrated safety consistent with the known safety profile of apremilast. Switching from etanercept to apremilast did not result in any new or clinically significant safety findings, and efficacy was maintained with apremilast through Week 52.

Background: FMX101 4% is a novel FDA-approved minocycline-containing topical foam for the treatment for acne vulgaris. Objective: Compare the efficacy of FMX101 4% vs vehicle foam for acne based on the integrated analysis of 3 Phase 3 studies. Methods: In 3 multicenter, randomized, double-blind, Phase 3 studies (FX2014-04, N¼466; FX2014-05, N¼495; FX2017-22, N¼1488), FMX101 4% was compared to vehicle in subjects with moderate-tosevere acne. Subjects applied the study drug once daily for 12 weeks. The co-primary efficacy endpoints were the absolute change from baseline at week 12 in inflammatory lesions and the proportion of subjects with Investigator Global Assessment (IGA) treatment success. Percent change from baseline at week 12 in noninflammatory lesions was a secondary endpoint. Results: The integrated population included 2449 subjects (FMX101 4%, n¼1378; vehicle, n¼1071). FMX101 4% demonstrated statistically significant benefit vs vehicle for both coprimary endpoints. There was a significantly greater reduction in inflammatory lesions from baseline at week 12 in the FMX101 4% group compared to vehicle (P<.0001), and a significantly greater percent of FMX101 4% subjects who achieved IGA treatment success at week 12 compared to vehicle (P<.0001). The effect of FMX101 4% was observed as early as week 3, and was maintained throughout the 12-week trial. There was a significantly (P¼.0019) greater percent reduction in noninflammatory lesions at week 12 in the FMX101 4% group vs vehicle. Conclusions: FMX101 4% demonstrated statistically significant benefits compared to vehicle in treating moderate-to-severe acne vulgaris in the pooled population of 3 Phase 3 studies.