In patients with active psoriatic arthritis (PsA), treatment with the fully human anti-interleukin (IL)-17A monoclonal antibody secukinumab vs placebo is associated with early, statistically significant, clinically meaningful, sustained improvements in patient-reported outcomes (PROs), according to study results published in Lancet Rheumatology.
A predefined analysis of the phase 3, randomized, multicenter, parallel-group FUTURE-5 study (ClinicalTrials.gov Identifier: NCT02404350) was conducted to evaluate the effect of treatment with secukinumab on PRO measures.
Adult participants who fulfilled the classification criteria for PsA at screening and had symptoms of moderate to severe PsA for at least 6 months were included in the analysis. Study participants were randomly assigned to receive secukinumab 300 mg; secukinumab 150 mg; secukinumab 150 mg with no loading dose; or placebo from baseline through week 4 and then every 4 weeks thereafter.
The prespecified PROs from the FUTURE5 trial were evaluated in the overall population. Changes from baseline and the percentage of patients who reported improvements greater than or equal to the minimum clinically important differences (MCIDs), as well as scores that were greater than or equal to the normative values for patient global assessments (PGAs) of disease activity, psoriasis and arthritis visual analog scale (VAS) scores, pain VAS, Health Assessment Questionnaire Disability Index (HAQ-DI), 36-item Short Form Health Survey (SF-36), Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F), and quality-of-life (QOL) questionnaires, were recorded.
In the post hoc analysis, patients were stratified and evaluated based on their tumor necrosis factor (TNF) inhibitor status.
Results of the study showed that participants in all secukinumab vs placebo groups reported significant least-squares mean changes at week 16 in all PROs, except the SF-36 mental component summary (MCS), regardless of the use of TNF inhibitors.
These changes included the following:
- PGA (secukinumab 300 mg [difference vs placebo, -12.2; 95% CI, -16.3 to -8.1]; secukinumab 150 mg [difference vs placebo, -8.22; 95% CI, -12.4 to -4.1]; and secukinumab 150 mg no loading dose [difference vs placebo, -8.3; 95% CI, -12.5 to -4.2;]; P <.0001 for all).
- Pain VAS (secukinumab 300 mg [difference vs placebo, -14.3; 95% CI, -18.3 to -10.2]; secukinumab 150 mg [difference vs placebo, -11.5; 95% CI, -15.6 to -7.5]; and secukinumab 150 mg no loading dose [difference vs placebo, -11.3; 95% CI, -15.3 to -7.2;]; P <.0001 for all).
- HAQ-DI (secukinumab 300 mg [difference vs placebo, -0.33; 95% CI, -0.42 to -0.24]; secukinumab 150 mg [difference vs placebo, -0.23; 95% CI, -0.32 to -0.14]; and secukinumab 150 mg no loading dose [difference vs placebo, -0.24; 95% CI, -0.33 to -0.15]; P <.0001 for all).
- FACIT-F (secukinumab 300 mg [difference vs placebo, 4.8; 95% CI, 3.2-6.4]; secukinumab 150 mg [difference vs placebo, 4.2; 95% CI, 2.6-5.8]; and secukinumab 150 mg no loading dose [difference vs placebo, 3.5; 95% CI, 1.9 to -5.1]; P <.0001 for all).
The percentage of patients with improvements that were equal to or superior to the MCID at week 16 was higher in the secukinumab groups compared with the placebo group for the majority of PROs, other than SF-36 MCS, regardless of the use of TNF inhibitors.
A major limitation of the current study was that it was not designed to evaluate differences between the secukinumab doses or to make statistical comparisons with use of the selected MCID cutoffs.
The researchers concluded, “The results of this analysis indicate that secukinumab can provide early and sustained improvements to PROs in patients with [PsA] and complement the clinical and radiographical benefits observed in FUTUR5, showing comprehensive improvement in the treatment of [PsA] regardless of line of therapy.”
Disclosure: Some of the study authors have declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.
Strand V, Kaeley GS, Bergman MJ, et al. The effect of secukinumab on patient-reported outcomes in patients with active psoriatic arthritis in a randomised phase 3 trial. Lancet Rheumatol. 2022;4(3):e208-e219. doi: 10.1016/S2665-9913(21)00354-4