Background/Purpose:   Psoriasis is a chronic immune-medicated inflammatory condition that affects 2-3% of the population , which is characterized by rash, silver scaling of the skin and can lead to psoriatic arthritis. There are multiple regimens for the treatment of psoriasis including biologic agent, phototherapy and apremilast. Apremilast is an oral phosphodiesterase inhibitor that has been approved as a mono therapy by the FDA in March 2014 for the treatment of psoriatic arthritis and September 2014 for the treatment of moderate to severe plaque psoriasis. While monotherapy with biologic agents is effective for many patients with psoriasis some patients are not satisfied by the outcome and require combination therapy. No data exist on the safety of apremilast as a component of combination therapy with biological therapies.  The aim of the study was to determine the safety of apremilast in combination of biologic therapies in the treatment of plaque psoriasis and psoriatic arthritis.

Methods:  This was retrospective study, open label study carried out at a single center. Twenty-two patients diagnosed with plaque psoriasis and psoriatic arthritis according to American college of Rheumatology criteria-participated. Apremilast was added to their current biologic agent. Patients were permitted to continue their current biologic treatment.

Results:   : 22 patients were treated by biologic agents then added Apremilast with a mean treatment of 8 months (1 Month is the shortest and 24 Months is the longest). Out of these 22 patients, 14 Females (63.6%) and 8 males (36.4%) were in the study. Out of these 22 patients, 5 patients were on ustekinumab and apremilast (27.3%), 3 patients out of the 5 experienced nausea and/or sever diarrhea (50%) and 1 out of the 3 stopped apremilast (33.3%). 6 patients were on adalimumab and apremilast (36.4%), 1 out of the 6 patients experienced nausea (12.5%) but tolerated and 0 patients stopped it. 2 patients were on etanercept and apremilast (9.1%) and 0 patient experienced side effect and was well tolerated. 2 patients were on certolizumab pegol and apremilast (9.1%), 1 patient stopped apremilast due to stomachache (50%). 4 patients were on infliximab and apremilast (18.2%) and 0 patients experienced side effect. 3 patients were on golimumab and apremilast (13.6%) weight loss was observed in 1 patient (33.3%), 1 patient couldn’t tolerate and stopped the apremilast (33.3%). 19 patients (86.4%) continued on apremilast with good improvement. 3 patients (13.6%) stopped apremilast due to GIT side effects nausea and/or diarrhea and stomachache. weight loss was observed in 1 patient (4.5%). Nausea and/or Diarrhea were reported by 5 patients (22.7%). No major side effects of cancer or sever infection were reported. There is a mean decrease in the C-reactive protein of 8.68. Patients reported improvement of the rash and pain by more than 50% .

Conclusion:  Apremilast can be safely and effectively combined with biologic agents in patients with plaque psoriasis or psoriatic arthritis not responding adequately to these agents alone. No major side effects of cancer or sever infection were reported other than nausea and/or vomiting that were manageable in some patients

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/combination-therapy-of-apremilast-and-biologic-agent-as-a-safe-option-of-psoriatic-arthritis-and-psoriasis/