Article Text
Abstract
Background Apremilast is the first oral selective inhibitor of phosphodiesterase 4 (PDE4) indicated for adults with active psoriatic arthritis (PsA) and moderate to severe plaque psoriasis (Pso). Pso and PsA are chronic disorders with significant morbidity, and patients experience diminished health related quality of life (QoL).
Purpose The primary objective was to assess changes in QoL and satisfaction of patients starting treatment with apremilast. Secondary objectives were to evaluate effectiveness and safety profile.
Material and methods This was a prospective, observational and analytic study (from April 2016 to September 2016) of Pso and PsA patients treated with apremilast in a general teaching hospital. QoL and satisfaction were measured with a questionnaire developed ‘ad hoc’ (utility score 0–1, satisfaction scale 0–10), before and after apremilast treatment (3 months later). Effectiveness and safety profile evaluation were based on subjective and objective clinical response. Demographic and clinical data were collected from the electronic clinical record. Statistical analysis was performed with SPSS 21.0 (Wilcoxon signed-rank test).
Results In total, 21 patients met the inclusion criteria: 11 women (52.4%), mean age 52±6.8 years, 15 (76.2%) Pso and 6 (23.8%) PsA, mean treatment duration 3.6±0.5 months. The utility mean difference was 0.08 (p=0.195) for all patients, 0.12 (p=0.092) in Pso patients and 0.06 (p=0.139) in PsA patients. The satisfaction mean difference was 1.5 (p=0.121) for all patients, 1.7 (p=0.099) in Pso patients and 1.1 (p=0.156) in PsA patients. Related to effectiveness, 16 (76.2%) patients reached clinical goals (14 Pso vs 2 PsA, p=0.231) and 5 (23.8%) patients had premature discontinuation of treatment, 3 (14.3%) patients who had no clinical response and 2 (9.5%) who suffered AEs (nausea and vomiting). There were no statistically significant differences in QoL and satisfaction in terms of sex, age groups or effectiveness.
Conclusion Overall, apremilast was well tolerated in this population and appeared to be effective in the adequate control of Pso and PsA with a slight improvement in QoL and patient satisfaction. Additional long term studies are needed to further elucidate its place in therapy.
References and/or acknowledgements Dr Cristina Schoendorff.
No conflict of interest