Patients with PsA Report Improved Outcomes with Secukinumab in Phase 3 Data

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Phase 3 of the FUTURE 5 trial further examined the efficacious effect that secukinumab had on patients with psoriatic arthritis.

Phase 3 results from the FUTURE 5 trial on the effect of secukinumab in patients with active psoriatic arthritis (PsA) displayed clinical and radiographical efficacy. Patients reported significantly sustained improvements across all doses compared with placebo.

The team of investigators, led by Vibeke Strand, MD, Division of Immunology and Rheumatology, Stanford University, found that the improvements were irrespective of previous tumor necrosis factor (TNF) inhibitor use, in a post-hoc analysis.

The Assessment

The phase 3, multicentre, parallel-group randomized trial included adult patients who met the classification criteria for psoriatic arthritis at the time of screening, and reported moderate-to-severe psoriatic arthritis for at least 6 months.

Patients were randomly assigned to receive secukinumab 300 mg, 150 mg, 150 mg no loading dose (NL), or placebo, on a weekly basis for 4 weeks, and then every 4 weeks after that. The assessment of the prespecified patient-reported outcomes first occurred in the overall population.

Investigators reported mean changes from baseline and the proportion of patients who identified improvements equal to or more than the minimum clinically important differences (MCIDs). Then, patients were stratified and assessed as a post hoc analysis based on their tumor necrosis factor inhibitor status (TNF-naive and TNF-inadequate responder [TNF-IR] populations).

This also applied to scores equal to or more than the normative values for patient global assessments (PtGA) of disease activity; psoriasis and arthritis visual analogue 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 questionnaires.

The Data

The reports made by patients across all secukinumab groups included significant-squares mean changes when compared with placebo at week 16 in all patient-reported outcomes except SF-36 mental component summary (MCS), irrespective of TNF inhibitor use.

Investigators recorded the results:

  • Patient global assessments (300 mg difference vs placebo −12·2 [95% CI −16·3 to −8·1], 150 mg −8·22 [−12·4 to −4·1], 150 mg NL −8·3 [−12·5 to −4·2]; all P<0·0001).
  • Pain visual analogue scale (300 mg −14·3 [−18·3 to −10·2], 150 mg −11·5 [−15·6 to −7·5], 150 mg NL −11·3 [−15·3 to −7·2]; all P<0·0001).
  • Health Assessment Questionnaire Disability Index (300 mg −0·33 [−0·42 to −0·24], 150 mg −0·23 [−0·32 to −0·14], 150 mg NL −0·24 [−0·33 to −0·15]; all P<0·0001).
  • Functional Assessment of Chronic Illness Therapy Fatigue (300 mg 4·8 [3·2 to 6·4], 150 mg 4·2 [2·6 to 5·8], 150 mg NL 3·5 [1·9 to 5·1]; all P<0·0001).

Also, the proportion of patients in the secukinumab group with improvements equal to or better than MCID was higher than that of the placebo group at week 16, for most outcomes minus SF-36 (MCS), regardless of TNF inhibitor use.

“These results indicate that secukinumab provides comprehensive improvement for patients with psoriatic arthritis, regardless of previous therapy,” investigators concluded.

This study, “The effect of secukinumab on patient-reported outcomes in patients with active psoriatic arthritis in a randomised phase 3 trial” was published in The Lancet Rheumatology.