Background/Purpose: Nail psoriasis is associated with decreased finger mobility and pain in patients (pts) with moderate to severe plaque psoriasis and psoriatic arthritis (PsA).^1,2 Secukinumab, a fully human IgG1κ monoclonal antibody to interleukin-17A, provides significant and sustained improvements in the signs and symptoms of psoriasis and PsA.^3–5 Here we report the efficacy of secukinumab on skin and nail disease in two randomized, double-blind, placebo (PBO)-controlled phase 3 studies: TRANSFIGURE (NCT01807520), a study in pts with moderate to severe psoriasis with significant nail involvement, and FUTURE 2 (NCT01752634), a study in pts with PsA, a subset of whom had nail involvement.

Methods: In TRANSFIGURE, 198 pts with nail psoriasis were randomized (1:1:1) to subcutaneous (s.c.) secukinumab 300 mg, 150 mg, or PBO at baseline (BL), Weeks (Wks) 1, 2, and 3, and then every 4 wks (q4wk) from Wk 4. In FUTURE 2, 279/397 enrolled pts had nail psoriasis (nail subset) and 192/397 had ≥3% body surface area affected by psoriasis (psoriasis subset) at BL. Pts were randomized (1:1:1:1) to s.c. secukinumab 300 mg, 150 mg, and 75 mg or PBO at BL, Wks 1, 2, and 3, and then q4wk from Wk 4. In TRANSFIGURE, the primary endpoint was the percentage change from BL in total fingernail NAil Psoriasis Severity Index (NAPSI) score at Wk 16. In FUTURE 2, the primary endpoint was the proportion of pts achieving a ≥20% improvement from BL in ACR response criteria at Wk 24, with change from BL in total fingernail modified NAPSI (mNAPSI) score a pre-specified exploratory endpoint in the nail subset. Both studies included additional pre-specified assessments of psoriasis burden, including PASI 90. 

Results: The primary endpoints were met in both studies. In TRANSFIGURE, the mean percentage change from BL in NAPSI was superior with both doses of secukinumab vs. PBO at Wk 16 (P<0.0001). At Wk 16, mean NAPSI score improved (decreased) from BL by 45.3%, 37.9%, and 10.8% for secukinumab 300 mg, 150 mg, and PBO, respectively. In FUTURE 2, mNAPSI scores at Wk 24 were improved vs. PBO with all secukinumab doses (all P<0.01). At Wk 24, mean mNAPSI score improved (decreased) from BL in the nail subset by 66.5%, 55.9%, and 61.6% for secukinumab 300 mg, 150 mg, and 75 mg, respectively, vs. 28.0% with PBO. PASI 90 responses at Wk 16 in TRANSFIGURE were 72.5%, 54.0%, and 1.7% for 300 mg, 150 mg and PBO, respectively; all P<0.0001). In FUTURE 2, PASI 90 responses at week 24 in the subset of pts with psoriasis were 48.8%, 32.8%, 12.0%, and 9.3% for 300 mg, 150 mg, 75 mg, and PBO, respectively (all P<0.01).

Conclusion: Secukinumab improved nail and skin symptoms in pts with psoriasis with significant nail involvement and in pts with concomitant PsA and nail involvement.

References:

1. de Jong EM, et al. Dermatol1996;193:300–3.

2. Sandre MK, et al. J Cutan Med Surg. 2015;pii:1203475415573663.

3. Langley RG, et al. N Engl J Med. 2014;371:326–38.

4. Mclnnes IB, et al. ACR/ARHP Annual Meeting, Boston, MA, USA. November 14-19, 2014. Oral Presentation L1.

5. Reich K, et al. WCD 2015, Vancouver, Canada, June 9–13, 2015. Poster presentation: 6086561

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/secukinumab-reduces-the-burden-of-nail-and-skin-disease-in-patients-with-psoriasis-and-patients-with-psoriatic-arthritis-results-from-two-phase-3-studies/