Secukinumab Reduces the Burden of Nail and Skin Disease in Patients with Psoriasis and Patients with Psoriatic Arthritis: Results from Two Phase 3 Studies

Alice B. Gottlieb¹, Kristian Reich², Zailong Wang³, Marina Milutinovic⁴ and Shephard Mpofu⁴, ¹Dermatology, Tufts Medical Center, Boston, MA, ²Dermatologikum Hamburg and Georg-August-University Göttingen, Hamburg, Germany, ³Novartis Pharmaceuticals Corporation, East Hanover, NJ, ⁴Novartis Pharma AG, Basel, Switzerland

Meeting: 2015 ACR/ARHP Annual Meeting

Date of first publication: September 29, 2015

Keywords: Biologic agents, psoriasis and psoriatic arthritis

Session Information

Date: Tuesday, November 10, 2015

Title: Spondylarthropathies and Psoriatic Arthritis - Clinical Aspects and Treatment Poster III: Therapy

Session Type: ACR Poster Session C

Session Time: 9:00AM-11:00AM

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.^3–5Here 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

Disclosure: A. B. Gottlieb, Amgen Inc., Astellas, Akros, Centocor (Janssen), Inc. Celgene Corp., Bristol Myers Squibb Co., Beiersdorf, Inc., Abbott Labs. (Abbvie), DUSA, TEVA, Actelion, UCB, Novo Nordisk, Novartis, Dermipsor Ltd., Incyte, Pfizer, Canfite, Lilly, Coronado, Vertex, Ka, 5,Centocor (Janssen), Amgen, Abbott (Abbvie), Novartis, Celgene, Pfizer, Lilly, Coronado, Levia, Merck, Xenoport, 2; K. Reich, AbbVie, Amgen, Biogen-Idec, Celgene, Centocor, Covagen, Forward Pharma, GlaxoSmithKline, Janssen-Cilag, Leo, Lilly, Medac, MSD, Novartis, Pfizer, Takeda, and Vertex., 5,AbbVie, Amgen, Biogen-Idec, Celgene, Centocor, Covagen, Forward Pharma, GlaxoSmithKline, Janssen-Cilag, Leo, Lilly, Medac, MSD, Novartis, Pfizer, Takeda, and Vertex., 8,AbbVie, Amgen, Biogen-Idec, Celgene, Centocor, Covagen, Forward Pharma, GlaxoSmithKline, Janssen-Cilag, Leo, Lilly, Medac, MSD, Novartis, Pfizer, Takeda, and Vertex., 9; Z. Wang, Novartis Pharmaceutical Corporation, 3; M. Milutinovic, Novartis Pharmaceutical Corporation, 3; S. Mpofu, Novartis Pharmaceutical Corporation, 3,Novartis Pharmaceutical Corporation, 1.

To cite this abstract in AMA style:

Gottlieb AB, Reich K, Wang Z, Milutinovic M, Mpofu S. Secukinumab Reduces the Burden of Nail and Skin Disease in Patients with Psoriasis and Patients with Psoriatic Arthritis: Results from Two Phase 3 Studies [abstract]. Arthritis Rheumatol. 2015; 67 (suppl 10). 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/. Accessed .

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