Psoriasis, a chronic, immune‐mediated skin disease characterized by red, scaly plaques, affects approximately 0.3% of the population in Japan. The aim of this open‐label study was to evaluate the long‐term efficacy and safety of ixekizumab, a humanized, anti‐interleukin‐17A monoclonal antibody, in Japanese patients with plaque psoriasis (n = 78, including 11 psoriatic arthritis), erythrodermic psoriasis (n = 8) and generalized pustular psoriasis (n = 5). Ixekizumab was administrated s.c. at baseline (week 0, 160 mg), from weeks 2 to 12 (80 mg every 2 weeks), and from weeks 16 to 52 (80 mg every 4 weeks). At week 52, 92.3% of patients with plaque psoriasis achieved Psoriasis Area and Severity Index (PASI) 75, 80.8% achieved PASI 90, 48.7% achieved PASI 100, and 52.6% had remission of plaques (by static Physician Global Assessment, sPGA [0]). Difficult to treat areas of psoriasis (nail or scalp) also responded to ixekizumab. All patients with psoriatic arthritis who were assessed (5/5) achieved an American College of Rheumatology 20 response. Most patients with erythrodermic psoriasis or generalized pustular psoriasis responded to ixekizumab and the clinical outcome was maintained over 52 weeks (75% and 60% of patients achieved sPGA [0, 1] at week 52, respectively). Mostly mild or moderate treatment‐emergent adverse events were reported by 79 of 91 patients; the most common were nasopharyngitis, eczema, seborrheic dermatitis, urticaria and injection site reactions. In conclusion, 52‐week ixekizumab treatment was efficacious and well tolerated in Japanese patients with plaque psoriasis. Efficacy was also observed in patients with erythrodermic psoriasis, generalized pustular psoriasis and psoriatic arthritis.

By Week 12, nearly all patients with PP, EP and GPP achieved PASI75. The safety profile was consistent with reported results and no unexpected safety signals were observed.

Abbreviations & Acronyms 5ARI = 5-alpha-reductase inhibitors AE = adverse event ANCOVA = analysis of covariance BII = Benign Prostatic Hyperplasia Impact Index BMI = body mass index BPH = benign prostatic hyperplasia BPH-LUTS = lower urinary tract symptoms suggestive of benign prostatic hyperplasia CGI-I = Clinician Global Impression of Improvement ED = erectile dysfunction EjD = ejaculatory dysfunction IPSS = International Prostate Symptom Score ITT = intention-to-treat LS = least squares LUTS = lower urinary tract symptoms MMRM = mixed-effects model repeated measures PDE5 = phosphodiesterase type 5 PGI-I = Patient Global Impression of Improvement PPS = per protocol set PSA = prostate-specific antigen PVR = postvoid residual volume SAE = serious adverse event SD = standard deviation SE = standard errors TEAE = treatment-emergent adverse event Qmax = peak urinary flow rate QoL = quality of life Objectives: To examine the efficacy and safety of tadalafil in Asian men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia. Methods: Asian men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia were randomized to once-daily placebo (n = 154), tadalafil 2.5 mg (n = 151), tadalafil 5.0 mg (n = 155) or tamsulosin 0.2 mg (active control, n = 152) for 12 weeks. Results: Total International Prostate Symptom Score least-squares mean changes from baseline to end-point significantly improved with tadalafil 2.5 mg (-4.8, P = 0.003) and 5 mg (-4.7, P = 0.004) versus placebo (-3.0). Significant improvement in the International Prostate Symptom Score versus placebo was observed earlier (week 2) for tadalafil 5.0 mg than for tadalafil 2.5 mg (week 8). Significant improvements (P < 0.05) in both tadalafil groups versus placebo were observed for the International Prostate Symptom Score voiding subscore, International Prostate Symptom Score Quality of Life, and for Patient and Clinician Global Impressions of Improvement. Significant improvements versus placebo were observed in the International Prostate Symptom Score storage subscore for tadalafil 5.0 mg (-1.7, P = 0.021), but not tadalafil 2.5 mg (-1.5, P = 0.072). No significant improvements in benign prostatic hyperplasia Impact Index or improvements in peak urinary flow rates were observed with tadalafil 2.5 mg or 5.0 mg versus placebo. Tamsulosin treatment resulted in significant improvements versus placebo across all efficacy parameters, except for peak urinary flow rates. Safety results were consistent with the known tadalafil and tamsulosin safety profiles. Conclusions: Tadalafil once daily represents an effective and well tolerated medical treatment for Asian men presenting with lower urinary tract symptoms suggestive of benign prostatic hyperplasia.

Tadalafil (5.0 mg) had a favorable benefit-to-risk profile, supporting further investigation of tadalafil (5.0 mg) in Japanese men with BPH-LUTS.

Abbreviations & Acronyms 5ARI = 5-α-reductase inhibitor AE = adverse event BPH = benign prostatic hyperplasia BPH-LUTS = lower urinary tract symptoms suggestive of benign prostatic hyperplasia CGI-I = Clinician Global Impression of Improvement CI = confidence interval ED = erectile dysfunction IPSS = International Prostate Symptom Score LS = least squares LUTS = lower urinary tract symptoms mIPSS = modified International Prostate Symptom Score OAB = overactive bladder PDE5 = phosphodiesterase type 5 PGI-I = Patient Global Impression of Improvement PVR = postvoid residual volume Qmax = urinary peak flow rate QoL = quality of life SAE = serious adverse events SD = standard deviation SE = standard error TEAE = treatment-emergent adverse events Objectives: To gain further evidence on the efficacy, safety and tolerability of tadalafil 5 mg once-daily in Asian men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia. Methods: Japanese and Korean men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia were randomized to once-daily tadalafil 5 mg (n = 306) or placebo (n = 304) for 12 weeks. Results: A significantly greater improvement (P < 0.001) in total International Prostate Symptom Score for the change from baseline (week 0) to study end-point (week 12) was observed for tadalafil (−6.0) versus placebo (−4.5). Significantly greater improvements (P < 0.01) in total International Prostate Symptom Score for the change from baseline to weeks 4 and 8 were observed for tadalafil versus placebo. Significantly greater improvements (P < 0.05) in International Prostate Symptom Score voiding and storage subscores, and International Prostate Symptom Score Quality of Life Index were observed for the change from baseline to end-point for tadalafil versus placebo. Significantly greater improvements (P < 0.001) in urinary symptoms were observed for tadalafil versus placebo for both Patient and Clinician Global Impressions of Improvement. No new safety concerns were identified. Conclusions: These findings confirm the efficacy and safety profile of tadalafil 5 mg once-daily in Asian men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia.