Comparison of Efficacy and Safety of Calcipotriol and Apremilast Combination Against Cacipotriol Monotherapy in Psoriasis

Background Potentiating activity of tablet apremilast 30mg BD against psoriasis in combination with 0.005% calcipotriol ointment was studied in comparison with calcipotriol monotherapy. Methods Single centre, prospective, parallel group, open label study compared efficacy and safety of calcipotriol+apremilast combination with calcipotriol monotherapy. Patients of mild to severe psoriasis in age group 18-60 years were randomized to two groups – calcipotriol+apremilast group and calcipotriol group. Calcipotriol+apremilast group received apremilast 30 mg BD p.o. and 0.005% calcipotriol ointment local application BD for 8 weeks. While calcipotriol group received 0.005% calcipotriol ointment local application BD for 8 weeks. Primary endpoint for efficacy was percentage of patients in whom mPASI decreased by 75% from baseline. Safety was also monitored throughout. Results 106 patients were randomized: calcipotriol+apremilast (n = 56) and calcipotriol group (n = 53). More patients of calcipotriol+apremilast achieved treatment success compared to calcipotriol was also higher (51.85% vs 34.61%; p < 0.001). Similar percentage of patients reported adverse events: Calcipotriol+apremilast 45.49% (n = 23) and calcipotriol 42.30% (n = 22) Conclusion Addition of apremilast to calcipotriol is significantly more efficacious than calcipotriol monotherapy. This combination is as safe as monotherapy.

Debunking the myth of ‘Blue Mondays’: No evidence of affect drop after taking clinical MDMA

Background: Incorporating 3,4-methylenedioxymethamphetamine (MDMA) as an adjunct to psychotherapy has shown promise in recent years for treating various mental health conditions, particularly those involving trauma. However, concerns about declines in mood and cognition during the days following dosing, also known as ‘Blue Mondays’, have been raised as limitations to its clinical use. Although these changes have been well-documented among recreational users, there are critical confounds to these reports that limit generalizability to clinically administered MDMA. Aims: Here, we aimed to evaluate the evidence basis for the negative side effects associated with MDMA as well as inform our understanding of the drug’s post-acute effects in a clinical context with an open-label study. Methods: The current open-label study examined MDMA therapy for alcohol use disorder (AUD; N = 14) and measured mood, sleep quality, illicit MDMA consumption and anecdotal reports after the acute drug effects had worn off. Results: Participants maintained a positive mood during the week following drug administration in a clinical context. Relative to baseline, self-reported sleep quality improved at the 3- and 6-month follow-ups. Finally, no participants reported using or desiring to use illicit MDMA, and the anecdotal reports indicated that they perceived the treatment favourably. Conclusion: The results support the overall safety and tolerability of clinically administered MDMA and, importantly, suggest that the ‘come downs’ previously associated with the substance may be explained by confounds in research relating to the illicit sourcing of the drug and specific environmental setting for recreational consumption.