ATLANTA — Secukinumab provides sustained improvements in nail disease, clinical symptoms of psoriatic arthritis (PsA), physical function, and quality of life in patients with PsA with moderate to severe nail psoriasis, according to research results presented at the 2019 American College of Rheumatology/Association of Rheumatology Professionals (ACR/ARP) Annual Meeting, held November 8 to13, 2019, in Atlanta, Georgia. Study data also demonstrated a low radiographic progression through 52 weeks in this patient population.
To evaluate the efficacy of secukinumab in nail psoriasis and determine radiographic progression in both PsA and nail psoriasis, investigators reviewed data from the 52-week FUTURE 5 study (ClinicalTrials.gov Identifier: NCT02404350). A total of 996 patients with active psoriatic arthritis were randomly assigned to receive a subcutaneous secukinumab loading dose of 300 mg (n=144), 150 mg (n=135), 150 mg no loading dose (n=153), or placebo (n=231). Of these patients, 663 (66.6%) had concomitant nail psoriasis at baseline. Demographics and baseline disease characteristics were similar in the treatment groups in the nail psoriasis subset, which were comparable with the overall population.
All treatment arms received secukinumab or placebo at baseline and at weeks 1, 2, 3, and 4, and then after 4 weeks. The modified Nail Psoriasis Severity Index (mNAPSI), radiographic progression (mTSS), ACR20/50, Psoriasis Area and Severity Index (PASI), Health Assessment Questionnaire Disability Index, Short Form Physical Component Summary, Psoriatic Arthritis Quality of Life, and resolution of dactylitis and enthesitis were used as efficacy assessments through week 52 of the study. Researchers used nonresponder imputation for binary and mixed-effect model repeated measure for continuous variables through week 16 of the study. They also presented observed data for radiographic progression at weeks 24 and 52, and for all efficacy end points at week 52.
Results indicated that the total mean NAPSI score at baseline was 16.4. Secukinumab 300 mg and 150 mg doses improved nail psoriasis compared with placebo at weeks 8, 12, and 16 (P <.0001), with further improvements through week 52. Mean change from baseline in mTSS score at week 24 were -0.04, 0.3 and -0.03 for 300 mg, 150 mg, and the 150 mg no loading dose group, respectively. Investigators noted that at 52 weeks, the mean change from baseline in mTSS scores were -0.2, 0.2, and 0.2 for the 300 mg, 150 mg, and the 150 mg no loading dose group, respectively.
At week 52, 94.0% of patients who received the 300 mg loading dose, 83.5% who received the 150 mg loading dose, and 88.4% who were in the 150 mg no loading dose group demonstrated no radiographic progression from baseline (mTSS ≤0.5). Researchers reported that at week 16, ACR20/50 and PASI 90 responses, resolution of dactylitis and enthesitis, physical function, and quality of life were also improved with secukinumab vs placebo, with sustained improvements through 52 weeks.
Overall, secukinumab demonstrated efficacy in nail psoriasis and showed improvements in signs and symptoms and low radiographic progression in patients with psoriatic arthritis.
Nail psoriasis is associated with “significant pain, psychosocial disability, decreased physical function and quality of life …and is a predictor of severe disease with joint involvement and structural damage,” the researchers wrote.
Disclosure: Several study authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors’ disclosures.
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Nash P, Mease P, Kirkham B, et al. Secukinumab provides improvement in nail psoriasis and inhibition of radiographic progression in psoriatic arthritis patients with nail phenotype: 52-week results from a phase III study. Presented at: 2019 ACR/ARP Annual Meeting; November 8-13, 2019; Atlanta, GA. Abstract 1485.
This article originally appeared on Rheumatology Advisor