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Good News for Risankizumab, Tremfya, Otezla, and Taltz at AAD Meeting
Promising new findings in the treatment of plaque psoriasis, oral ulcers, and genital psoriasis have been reported at the 2018 American Academy of Dermatology Annual Meeting in San Diego.
Risankizumab Outperforms Stelara
More patients with plaque psoriasis treated with risankizumab (AbbVie/ Boehringer Ingelheim) than with ustekinumab (Janssen) achieved clear skin in the pivotal phase 3 ultIMMa-1 and ultIMMa-2 replicate clinical trials.
At week 16 using the static Physician Global Assessment (sPGA 0), 37% and 51% of patients with plaque psoriasis treated with risankizumab achieved clear skin (sPGA 0) compared to ustekinumab (14% and 25%). At one year, 58% and 60% of patients with plaque psoriasis treated with risankizumab achieved clear skin (sPGA 0) compared to ustekinumab) (21% and 30%). Both trials evaluated the safety and efficacy of risankizumab (150 mg) compared to placebo or ustekinumab (45 or 90 mg, based on patient weight). Risankizumab is an investigational interleukin-23 inhibitor.
In October 2017, AbbVie announced positive top-line results from these two trials, including the Psoriasis Area and Severity Index (PASI 90 and PASI 100) at 16 weeks and one year and clear or almost clear skin (sPGA 0/1) at 16 weeks. The newly presented sPGA skin clearance rates are consistent with the previously reported PASI 100 rates at one year. Risankizumab is being evaluated for the potential to deliver long-term skin clearance for psoriasis patients with 12-week dosing.
Tremfya Benefits Patients for 72 Weeks
Most patients with moderate to severe plaque psoriasis receiving guselkumab (Tremfya, Janssen) who achieved at least 90% improvement in the Psoriasis Area and Severity Index (PASI 90) at week 28 maintained a PASI 90 response with continuous treatment through 72 weeks, according to long-term findings from the phase 3 VOYAGE 2 study.
Among patients who achieved PASI 90 response at week 28 with guselkumab, 86% who continued receiving guselkumab maintained a PASI 90 response through week 72, while only 11.5% of patients who were withdrawn from treatment maintained PASI 90 response. Of 173 patients who lost PASI 90 response after withdrawal from guselkumab, 87.6% recaptured PASI 90 response six months following retreatment.
Otezla Reduces Oral Ulcers
Apremilast (Otezla, Celgene Corporation) led to statistically significant reductions in oral ulcers compared with placebo in patients with active Behçet’s Disease, according to findings of the phase 3 RELIEF clinical trial.
A total of 207 patients were randomized to apremilast 30 mg twice daily or placebo. At week 12, the area under the curve (AUC) for the number of oral ulcers was statistically significantly reduced with apremilast versus placebo (129.5 versus 222.1), the trial’s primary endpoint. The AUC assesses the change in the number of oral ulcers over time, accounting for the clinical characteristic that oral ulcers repeatedly remit and recur. Apremilast is an oral selective inhibitor of phosphodiesterase 4.
Taltz Helps Ease Genital Psoriasis
Patients with moderate-to-severe genital psoriasis treated with ixekizumab (Taltz, Eli Lilly and Company) reported a greater decrease in the impact of their condition on sexual activity compared to placebo in a phase 3b trial.
In the study, 149 patients were randomized to receive ixekizumab (80 mg every two weeks, following a 160-mg starting dose) or placebo. The impact of genital psoriasis on sexual activity was measured using pre-specified patient-reported outcomes.
At 12 weeks, among patients treated with ixekizumab compared to patients treated with placebo, 92.0% versus 56.8% reported no or little sexual difficulty caused by skin symptoms; 78.4% versus 21.4% reported the frequency of sexual activity was either never or rarely limited by genital psoriasis; and 76.7% versus 25.7% reported never or rarely avoiding sexual activity due to genital psoriasis.