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Abstract
Background Apremilast is an oral phosphodiesterase 4 (PDE-4) inhibitor that reduces disease activity in psoriatic arthritis (PsA) by modulating the expression of inflammatroy cytokines. In December 2015, apremilast received a negative National Institute of Clinical Excellence (NICE) appraisal for its use in PsA, owing to a lack of robust evidence on its long-term impact on patient outcomes and efficacy in improving radiographic progression (TA372).
The role of the drug in the PsA treatment pathway remains uncertain. We present a retrospective analysis of the use of apremilast in 14 patients with PsA within our hospital trust.
Methods Pharmcay funding applications and medication dispensing records were used to identify suitable patients. All patients commenced on apremilast at Imperial College NHS Healthcare Trust (ICHT) for PsA were included in the analysis.
Results A total of 14 patients were initiated on apremilast between June 2015 and September 2016 (table1). Of these patients 9 (64%) achieved an adequate response to treatment, defined by NICE as an improvement in at least 2 of the 4 PsA response criteria (PsARC) scores, with no worsening in any of the four criteria.
Of the 5 patients not achieving response, 3 patients discontinued treatment prior to assessment due to intolerable side effects, whilst 2 further patients didnt acheive the appropriate therapeutic response (primary failure).
From the 9 patients that achieved an adequate response only 5 are currently taking therapy, with intolerable side effects causing discontinuation in a further 4. This gives an overall discontinuation rate of 65% (9 out of 14). In the 5 patients remaining on therapy, one patient needed to reduce the drug dose due to side effects, whilst one continued treatment despite tolerable side effects. Of our 14 patients only 3 remained on treatment in the absence of any side effects.
The most common side effects causing discontinuation were nausea and vomiting (3patients, 21%) and mood changes (2 patients, 14%).
Conclusions Apremilast was poorly tolerated in our population with only 3 patients continuing the drug with response and without ongoing side effects. Discontinuation rates within ICHT were found to be much higher than those in the original trial data (65% versus 15%). Patients who have continued the medication and tolerated side effects, however have shown a good response to treatment.
References
Drugs and therapeutics bulletin. Apremilast for psoriasis and psoriatic arthritis. British Medical Journal , 2015: 105–108.
Kavanaugh, Arthur, and Philip et al Mease. Treatment of psoriatic arthritis in a phase 3 randomised, placebo-controlled trial with apremilast, an oral phosphodiesterase 4 inhibitor. Annal of Rheumatic disease, no. 73 (2014): 1020–1026.
National Institute for Health and Care Excellence. Apremilast for treating active psoriatic arthritis (TA372). 2015. https://www.nice.org.uk/guidance/ta372/resources/apremilast-for-treating-active-psoriatic-arthritis-82602785881285.
References
Acknowledgements Dr Benjamin Ellis, consultant Rheumatologist, Imperial college NHS Healthcare trust. Dr Matthew Pickering, consultant Rheumatologist, Imperial college NHS healthcare trust
Disclosure of Interest None declared