Clinical Trials

Date: 2018-02-15

Type of information: Presentation of results at a congress

phase: 2

Announcement: presentation of results at the 13th Congress of ECCO

Company: Celgene (USA - NJ)

Product: Otezla® (apremilast)

Action mechanism:

• phosphodiesterase 4 inhibitor. Apremilast is an oral, small-molecule, selective inhibitor of phosphodiesterase 4 (PDE4) specific for cyclic adenosine monophosphate (cAMP). PDE4 inhibition results in increased intracellular cAMP levels. Otezla® is approved for the treatment of patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy and for the treatment of adults with active psoriatic arthritis.
• Apremilast is not approved for the treatment of ulcerative colitis in any country. In January 2018 , the FDA designated apremilast an Orphan Drug for the potential treatment of pediatric patients with ulcerative colitis.

Disease: ulcerative colitis

Therapeutic area: Autoimmune diseases - Inflammatory diseases - Digestive diseases

Country:

Trial details:

Latest news:

• • On February 15, 2018,  Celgene announced that data from a randomized, placebo-controlled, multi-center, phase II clinical trial of apremilast in patients with active ulcerative colitis who had failed at least one conventional therapy but were naïve to biologic therapy were presented in an oral session  at the 13th Congress of ECCO in Vienna (Abstract OP006). The results showed that a higher proportion of patients taking Otezla® (apremilast) 30 mg twice daily (BID) achieved clinical remission versus placebo (nominally significant, P < 0.05). In the study, a total of 170 patients were randomized to placebo, apremilast 40 mg BID or apremilast 30 mg BID. The primary endpoint of the study was Total Mayo Score (TMS) clinical remission at week 12 for the 40 mg BID arm. At week 12, TMS clinical remission was achieved by 21.8 percent of patients in the apremilast 40 mg BID arm (n=55) versus 13.8 percent in the placebo group (n=58; P=non-significant (NS)). In the apremilast 30 mg BID arm, 31.6 percent of patients (n=57) achieved clinical remission as measured by TMS at week 12 versus 13.8 percent in the placebo group (n=58; nominally significant, P < 0.05).
• Clinical remission as measured by Partial Mayo Score (PMS), a secondary endpoint, was achieved by 59.6 percent of patients in the apremilast 30 mg BID arm versus 36.2 percent in the placebo arm (nominally significant, P=0.0124) at week 12. PMS clinical remission was also achieved by 52.7 percent of patients in the apremilast 40 mg BID arm (P=NS versus placebo).
• Additional secondary endpoints examined in the trial, including endoscopic remission (Mayo Endoscopic Score ?1), TMS clinical response, serum biomarkers and mucosal healing (combined endoscopic and histologic remission), showed clinically meaningful improvements for apremilast 30 mg BID versus placebo.
• Treatment-emergent adverse events reported in at least 5 percent of patients treated with apremilast included headache (23 percent with apremilast 30 mg BID, 26 percent with apremilast 40 mg BID and 7 percent with placebo); viral upper respiratory tract infection (9 percent, 4 percent and 2 percent, respectively); nausea (5 percent, 11 percent and 9 percent); abdominal pain (5 percent, 2 percent and 2 percent); back pain (0 percent, 6 percent and 2 percent); and asthenia (5 percent, 2 percent and 3 percent).

 

Is general: Yes