Apremilast in the Treatment of Chronic Prostatitis/Chronic Pelvic Pain Syndrome: A Pilot Study.

OBJECTIVE: Chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) is a disease with an uncertain cause and limited effective treatments. Apremilast (Celgene Corporation, Summit, NJ, USA) is a selective phosphodiesterase type 4 (PDE4) inhibitor that modulates the immune system. An open-label, one-arm, pilot study was conducted to explore its potential for improving CP/CPPS symptoms.

METHODS: Males ≥ 18 years of age were treated with 20 mg oral apremilast twice daily for up to 12 weeks. Outcomes were measured with Global Response Assessment (GRA), pain visual analog scale (VAS), Chronic Prostatitis Symptom Index (CPSI), Pittsburgh Sleep Quality Index (PSQI), SF-12 mental (MCS) and physical (PCS) health-related quality of life subscales, and voiding diaries. Repeated measures and paired t-tests evaluated changes from baseline to end of treatment, and at a final visit 4 weeks off the drug.

RESULTS: Seventeen men (94% Caucasian; mean age 48.2 ± 10 years) were treated (mean 115.8 ± 56.1 doses). Mean VAS (3.4 ± 2.0 vs 1.8 ± 1.7; P = 0.0011), PSQI (9.4 ± 4.4 vs 7.4 ± 4.2; P = 0.037) and CPSI (26.1 ± 5.0 vs 17.2 ± 8.3; P = 0.0016) scores improved from baseline to end of treatment. Incontinence episodes per day improved slightly (P = 0.042). When only those completing at least 8 weeks of treatment were examined (n = 9), significant changes in CPSI, VAS, and PSQI were still observed. At the final visit, 8/9 (88.9%) men also reported some improvement in pain related to sex. Side-effects were generally mild and well tolerated.

CONCLUSION: These results suggest that apremilast may improve CP/CPPS symptoms with only mild side-effects. However, placebo controlled studies are necessary to determine efficacy.