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Secukinumab improves disease manifestations, QoL in PsA across phenotypes
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Secukinumab is beneficial for patients with psoriatic arthritis across the spectrum of clinical phenotypes for the disease, according to findings published in the Journal of Rheumatology.
“The ACR response rates, which assess the level of response in arthritis signs and symptoms globally, do not translate very well to clinical practice [in PsA],” Ana-Maria Orbai, MD, MHS, of the Johns Hopkins University School of Medicine, told Healio Rheumatology. “This is because PsA does not affect only the joints but also entheses and tendons, digits, the spine, the skin and the nails. It also presents differently from person to person.”
“In the clinic, we need to know what the chance of improvement is for the patient with PsA in front of us, with their own unique pattern of PsA manifestations,” she added. “Having efficacy data on each possible manifestation of PsA helps the clinician put together an individualized treatment plan and prognosis for each patient.”
To compare the efficacy of secukinumab (Cosentyx, Novartis) with placebo across the GRAPPA-OMERACT core domains of PsA, Orbai and colleagues conducted a post hoc analysis of data pooled four phase 3 studies of patients with PsA, as well as on phase 3 trial for ankylosing spondylitis. The four PsA studies, FUTURE 2 through 5, included a 150 mg secukinumab load arm, and a primary endpoint of 20% improvement in ACR20 criteria at week 16. In the AS study, MEASURE 2, patients received secukinumab 150 mg at baseline and weeks 1, 2, 3, 4 and every 4 weeks thereafter.
The researchers included 2,049 patients from the FUTURE 2 through 5 studies — of whom 461 received 300 mg doses of secukinumab, 572 were treated with 150 mg doses, 335 received secukinumab 150 mg no load, and 681 received a placebo — in their final analysis. The primary outcome was the efficacy of secukinumab in all GRAPPA-OMERACT domains for PsA at week 16. These domains included musculoskeletal disease activity, skin disease activity, pain, patient global assessment, physical function, health-related quality of life, fatigue, and systemic inflammation. They used the MEASURE 2 study to assess spine symptoms at week 16.
According to the researchers, secukinumab was efficacious across all GRAPPA-OMERACT PsA core domains, with the 300 mg dose demonstrating the greatest response rates across most domains, compared with placebo at week 16.
“Based on this analysis we can expect 34.3% of patients with active PsA to achieve complete resolution of swollen joints by week 16 of treatment with secukinumab,” Orbai told Healio Rheumatology. “Similarly, for tender joints, we can expect 19.5% to achieve resolution of all swollen joints.”
In addition, 53.2% of those in the 300 mg treatment group achieved complete resolution of enthesitis, while 61.5% demonstrated complete resolution of dactylitis. Orbai also noted that “psoriasis resolution was achieved by 33.2% at week 16 using the PASI score and by 52.3% using an [Investigator Global Assessment] score of 0 or 1 — none to almost clear psoriasis.”
The researchers also noted significant improvements in axial symptoms, pain, fatigue, and quality of life by week 16 in the treatment arms compared with the placebo groups.
“IL-17 inhibition is a psoriatic disease-specific mechanism of action that covers the spectrum of psoriatic arthritis manifestations,” Orbai said. “Importantly, disease resolution can be achieved in a subset of patients. However, it is also clear that many patients with active PsA are not able to achieve disease resolution, and defining predictors of response to IL-17 inhibition and other mechanisms of action is an important unmet clinical need.” – by Jason Laday
Disclosure: Orbai reports grant support from AbbVie, Celgene, Horizon, Janssen, Lilly, Novartis and the NIH National Institute of Arthritis and Musculoskeletal and Skin Diseases, as well as consulting fees from Janssen, Lilly, Novartis, Pfizer and UCB. Please see the study for all other authors’ relevant financial disclosures.
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