SAN FRANCISCO -- Three-fourths of men with anogenital warts caused by human papillomavirus (HPV) had clinical remission and the rest had partial responses to a frog-derived enzyme, investigators reported here.

Clinical remission occurred in 18 of 24 evaluable patients in response to ranpirnase, an endoribonuclease derived from the eggs of Rana pipiens, or Northern Leopard frog. The patients received 1 mg/mL BID of a topical formulation of ranpirnase, and remissions occurred, on average, within 33 days of starting treatment, Luis Squiquera, MD, of Tamir Biotechnology, reported at the American Academy of Dermatology meeting.

The remaining six evaluable patients had at least 50% improvement in the lesions.

"This study provides the first clinical evidence of the antiviral efficacy of ranpirnase and supports further assessment of ranpirnase in an expanded clinical study to treat anogenital warts," Squiquera concluded.

Ranpirnase has been evaluated for the treatment of several types of malignancy. In vitro studies confirmed the enzyme's efficacy against HPV-11, and broad activity against papillomavirus was confirmed in studies involving a rabbit model, according to Squiquera. The enzyme has accumulated a favorable toxicity profile in clinical and preclinical studies.

The study was included in a late-breaking research session that focused on new therapeutics.

JAK Inhibitor Generally Safe in Psoriasis

The oral Janus kinase (JAK) inhibitor tofacitinib (Xeljanz) was associated with low rates of major adverse effects, including serious infections, malignancies, and major adverse cardiovascular events (MACE), according to pooled data from clinical trials involving 3,623 patients with psoriasis.

Derived from phase II, phase III, and long-term extension studies, the data reflected adverse events associated with tofacitinib doses of 5 and 10 mg BID. Incidence rates (per 100 patient-years) for serious infection ranged from 1.37 to 2.42 across the trials and herpes zoster rates from 1.00 to 2.55.

Malignancies, excluding nonmelanoma skin cancer, occurred at rates of 0.81 to 1.12/100 patient-years, and rates of nonmelanoma skin cancer ranged from 0.67 to 1.27/100 patient-years. MACE incidence rates were 0.23 to 0.50/100 patient years.

"In the 1-year randomized, controlled trials, the 10 mg versus 5 mg BID hazard ratios included 1 for these events," reported Richard Langley, MD, of Dalhousie University in Halifax, Nova Scotia, meaning that they were not statistically significant.

Other reports at the meeting provided details of tofacitinib safety and efficacy from two pivotal phase III, placebo-controlled trials. The data showed that the proportion of patients with clear or almost clear skin at 16 weeks (primary endpoint) was 59% with tofacitinib, 44% with 5 mg, and 10% with placebo. The most commonly reported adverse events were nasopharyngitis (7% to 8%), upper respiratory infection (4.7% to 6.1%) and headache (5.5% to 5.7%).

IL-17 Neutralizer Achieves High Clearance Rate

The interleukin-17 (IL-17) neutralizing antibody ixekizumab achieved rates of clear and almost clear in about 80% of patients with moderate or severe psoriasis, as rated by treating physicians in a randomized trial of induction and withdrawal.

After 12 weeks of treatment, about 80% of patients randomized to receive ixekizumab every 2 or 4 weeks had static Physician Global Assessment ratings of 0 or 1 versus 3.2% of patients in the placebo arm. The proportion of patients with 75% clearance (PASI 75) was 89.1% in the biweekly group, 82.6% in the monthly group, and 3.9% in the placebo arm PASI 100), reported Kenneth Gordon, MD, of Northwestern University in Chicago. PASI 100 clearance rates were 35.3%, 33.6%, and 0% for the biweekly ixekizumab, monthly ixekizumab, and placebo groups.

The trial involved a total of 1,300 patients. Patients who responded to ixekizumab during the first 12 weeks were randomized a second time to receive placebo or ixekizumab every 4 or 12 weeks for an additional 48 weeks. The data showed that a majority of patients who continued ixekizumab maintained responses during the second treatment period.

Psoriasis Response Maintained for 2 Years

As many as 87% of patients who achieved PASI 75 responses during 1-year phase III trials of secukinumab (Cosentyx) maintained the responses during an additional 1 year of follow-up and continuous treatment.

After completing the 1-year trials (ERASURE, FIXTURE), patients who achieved at least PASI 75 responses with secukinumab were randomized to continue their assigned doses or to crossover to placebo. Follow-up will continue for a total of 60 months, including the initial randomized phase of treatment, reported Andrew Blauvelt, MD, of Oregon Medical Research Center in Portland.

Blauvelt reported interim safety and efficacy data after 104 weeks of follow-up. The data showed that 87.1% of patients who responded to 300 mg of secukinumab maintained the response during an additional 52 weeks of follow-up after randomized treatment, as did 72.8% of patients who responded to the 150-mg dose. In contrast, 16.0% and 12.7% of patients assigned to placebo extension groups maintained responses at 104 weeks.

Among patients who responded to 300 mg of secukinumab and relapsed during placebo treatment, 70.3% attained PASI 90 responses during 12 weeks of retreatment with 300 mg of secukinumab.

Blauvelt reported that no new or unexpected safety issues arose during the second year of follow-up.