No Increased Adverse Events from Otezla for Psoriatic Arthritis

Long-term safety findings from ongoing clinical trials of oral apremilast (Otezla) for the treatment of psoriasis and psoriatic arthritis were released yesterday at the European Academy of Dermatology and Venereology (EADV) Annual Congress in Vienna.

The findings were based on a 3-year pooled data analyses from the ESTEEM 1 and 2, and PALACE 1-3 trials. The ESTEEM trials examined patients with moderate-to-severe plaque psoriasis who were given 30-mg Otezla twice-daily.

The PALACE trials enrolled patients with active psoriatic arthritis treated with Otezla monotherapy, or in combination with concomitant disease-modifying anti-rheumatic drugs (DMARDs), including methotrexate. Included in the pooled safety analysis were 2242 patients up to 16 weeks (placebo n=913; APR30 n=1329), with 1905 patients (3527.5 patient years) who received Otezla in the APR-exposure period up to 156 weeks.

The results of the analysis revealed there was no increased incidence of adverse events (AEs), or any new safety signals with exposure to Otezla. Additionally there was an improvement in tolerability.

The most common AEs in the Otezla group were diarrhea, headache, nausea, nasopharyngitis, and upper respiratory tract infection, with most diarrhea and nausea cases being mild-to-moderate in severity. AEs occurred during the first 2 weeks of Otezla dosing, and generally was resolved in a month.

For major adverse cardiovascular events, serious infections, and malignancies from Otezla, the rates were comparable to the placebo up to 16 weeks, and remained low with prolonged exposure.

“Psoriasis is a complex, multi-faceted chronic condition which makes treatment challenging,” said Volker Koscielny, MD, head of Medical Affairs for Celgene in Europe. “In addition, a significant number of patients will go on to develop psoriatic arthritis. Physical symptoms and disease impact go beyond the extent of skin involvement and therefore several factors, including individual patient needs, should be taken into account when assessing appropriate treatment options. With over 100,000 patients globally already treated with Otezla since approval, it is important to note the efficacy and safety profile of Otezla in this combined analysis of psoriasis and psoriatic arthritis 3-year data.”