Ixekizumab was more effective than ustekinumab in its ability to clear both skin and nail psoriasis through a 1-year period in the phase 3 IXORA-S trial. Findings from this trial were published in Dermatology and Therapy.
In the head-to-head IXORA-S study, patients with moderate to severe plaque psoriasis were randomized to either ixekizumab (n=136) or ustekinumab (n=166) per label for a total of 52 weeks. Treatment with ixekizumab began at a starting dose of 160 mg, administered in 2 injections of 80 mg each, and was followed by 80 mg injections every 2 weeks for 12 weeks and then 80 mg every 4 weeks. Ustekinumab dosing include either 45 mg or 90 mg, as based on weight, at weeks 0, 4, and every 12 weeks thereafter per label.
In total, 61.8% (n=84) of patients in the ixekizumab arm and 63.3% (n=105) of patients in the ustekinumab arm had fingernail psoriasis at baseline. The mean baseline ages in the ustekinumab and ixekizumab groups were 45.4±12.7 and 43.0±12.0 years, respectively.
An outcome of interest in the trial was the percentage of patients who achieved a 0 score on the Nail Psoriasis Severity Index (NAPSI). In addition, the investigators of the study assessed the NAPSI score change from baseline as well as associations in Psoriasis Area of Severity Index (PASI) and NAPSI improvement over a 52-week period.
The mean baseline NAPSI scores were 28.3 in the ixekizumab group and 24.8 in the ustekinumab group. Both treatments were associated with progressive improvement in nail psoriasis, but significantly more patients with nail psoriasis at baseline achieved complete resolution of their disease with ixekizumab compared with ustekinumab by week 16 (31.0% vs 16.2%, respectively; P =.02) and through week 52 (61.9% vs 28.6%; P <.001).Also, more patients with significant nail psoriasis achieved NASI of 0 with ixekizumab (57.4% vs 17.5%; P <.001). Ustekinumab-treated patients experienced lower plaque psoriasis clearance if they had nail psoriasis compared with patients who did not have nail psoriasis.
Limitations of the IXORA-S trial were the lack of stratification based on nail psoriasis and the somewhat short follow-up period. The investigators suggest longer follow up may be necessary to determine whether nail lesions recur after 1 year with ixekizumab.
In addition to these limitations, the investigators added that ixekizumab and ustekinumab were administered “per label at the approved dosage regimen for the treatment of adult patients with moderate to severe psoriasis, but real-world dosing may differ.”
Disclosure: This clinical trial was supported by Eli Lilly and Company. Several study authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors’ disclosures.
Reference
Wasel N, Thaçi D, French LE, et al. Ixekizumab and ustekinumab efficacy in nail psoriasis in patients with moderate-to-severe psoriasis: 52-week results from a phase 3, head-to-head study (IXORA-S) [published online May 15, 2020]. Dermatol Ther (Heidelb). doi:10.1007/s13555-020-00383-x