Plaque Psoriasis Symptom Relief | COSENTYX® (secukinumab)

STUDY DESIGNS

ERASURE^1,2
The ERASURE study was a multicenter, randomized, double-blind, placebo-controlled trial of 738 patients.¹ Patients were randomized to one of 3 arms: COSENTYX 300 mg^* (n=245), COSENTYX 150 mg^* (n=245), or placebo^† (n=248).^1,2 All patients were adults with moderate to severe plaque psoriasis who had a BSA ≥10%, PASI score ≥12, and IGA mod 2011 score ≥3 and were candidates for systemic therapy or phototherapy.²Patients were followed for up to 52 weeks.¹ Coprimary end points were the proportion of subjects who achieved a reduction in PASI score of ≥75% (PASI 75) from baseline to Week 12 and treatment success (clear or almost clear) on the IGA mod 2011 at Week 12.²Other evaluated outcomes included the proportion of subjects who achieved a reduction in PASI score of ≥90% (PASI 90) from baseline at Week 12, maintenance of efficacy (PASI 75 and IGA mod 2011 clear or almost clear) to Week 52 in patients who were responders at Week 12, and improvements in itching, pain, and scaling at Week 12 based on the Psoriasis Symptom Diary^©.²

^*Initial dosing for COSENTYX: once weekly for 5 weeks, Weeks 0, 1, 2, 3, and 4; maintenance: once every 4 weeks, Weeks 8 through 48.²
^†Placebo nonresponders (who did not achieve PASI 75 at Week 12) were rerandomized 1:1 to COSENTYX 150 mg or COSENTYX 300 mg at Weeks 12, 13, 14, 15, and 16, followed by the same dose every 4 weeks.^1,2

FIXTURE^1,3
The FIXTURE study was a multicenter, randomized, double-blind, placebo-controlled trial of 1306 patients.¹ Patients were randomized to one of 4 arms: COSENTYX 300 mg^‡ (n=327), COSENTYX 150 mg^‡(n=327), placebo^§ (n=326) or a biologic active control: etanercept^|| (n=326).^1,3¶All patients were adults with moderate to severe plaque psoriasis who had a BSA ≥10%, PASI score ≥12, and IGA mod 2011 score ≥3 and were candidates for systemic therapy or phototherapy.³ Patients were followed for up to 52 weeks.¹ Coprimary end points were the proportion of subjects who achieved a reduction in PASI score of ≥75% (PASI 75) from baseline to Week 12 and treatment success (clear or almost clear) on the IGA mod 2011 at Week 12.³ Other evaluated outcomes included the proportion of subjects who achieved a reduction in PASI score of ≥90% (PASI 90) from baseline at Week 12, maintenance of efficacy (PASI 75 and IGA mod 2011 clear or almost clear) to Week 52 in patients who were responders at Week 12, and improvements in itching, pain, and scaling at Week 12 based on the Psoriasis Symptom Diary^©.³

^‡Initial dosing: once weekly for 5 weeks, Weeks 0, 1, 2, 3, and 4; maintenance: once every 4 weeks, Weeks 8 through 48.³
^§Placebo nonresponders (who did not achieve PASI 75 at Week 12) were rerandomized 1:1 to COSENTYX 150 mg or COSENTYX 300 mg at Weeks 12, 13, 14, 15, and 16, followed by the same dose every 4 weeks.^1,3
^IIEtanercept 50 mg was administered SC twice per week from randomization until Week 12, followed by 50 mg every week from Week 12 through Week 51. To maintain blinding, patients also received 2 placebo COSENTYX injections at the COSENTYX regimen. COSENTYX patients also received etanercept placebo twice per week from randomization through Week 12, and then once per week until Week 51.³
^¶In this study, n=326 for etanercept represents a randomized set and n=323 was used in the analysis of efficacy end points (PASI 75 and IGA mod 2011 0/1) presented.

FEATURE¹
FEATURE was a multicenter, randomized, double-blind, placebo-controlled trail in 177 adults with PsO. It assessed the safety, tolerability, and usability of COSENTYX self-administration via prefilled syringe for 12 weeks. Patients received subcutaneous treatment at Weeks, 0, 1, 2, 3, and 4, and every 4 weeks thereafter. Coprimary end points were PASI and IGA 0 or 1 (clear of almost clear) at Week 12.¹

JUNCTURE⁴
JUNCTURE was a multicenter, randomized, double-blind, placebo-controlled parallel-group trial in 182 adults with moderate to severe PsO. Patients were stratified by weight (<90 kg or >90 kg) and randomized to receive COSENTYX 300 mg, COSENTYX 150 mg, or placebo (at Weeks 0, 1, 2, 3, and 4, and every 4 weeks thereafter). Coprimary end points were PASI 75 and IGA 0/1 at Week 12. Secondary end points included observer rating of usability of the autoinjector and patient rating of acceptability using SIAQ.⁴

BSA, body surface area; IFU, Instructions for Use; IGA, Investigator's Global Assessment; PASI, Psoriasis Area and Severity Index PsA, psoriatic arthritis; PsO, plaque psoriasis; SC, subcutaneous.

References
1. Cosentyx. Prescribing information. Novartis Pharmaceuticals Corp.
2. Data on file. AIN457A2302 Clinical Study Report. Novartis Pharmaceuticals Corp; September 2013.
3. Data on file. AIN457A2303 Clinical Study Report. Novartis Pharmaceuticals Corp; September 2013.
4. Paul C, Lacour JP, Tedremets L, et al; for the JUNCTURE study group. Efficacy, safety and usability of secukinumab administration by autoinjector/pen in psoriasis: a randomized, controlled trial (JUNCTURE). J Eur Acad Dermatol Venereol. 2015;29(6):1082-1090. doi:10.1111/jdv.12751

Tap to see IMPORTANT SAFETY INFORMATION and INDICATIONS

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS
COSENTYX is contraindicated in patients with a previous serious hypersensitivity reaction to secukinumab or to any of the excipients in COSENTYX. Cases of anaphylaxis have been reported during treatment with COSENTYX...

CONTRAINDICATIONS

COSENTYX is contraindicated in patients with a previous serious hypersensitivity reaction to secukinumab or to any of the excipients in COSENTYX. Cases of anaphylaxis have been reported during treatment with COSENTYX.

WARNINGS AND PRECAUTIONS

Infections

COSENTYX may increase the risk of infections. In clinical trials, a higher rate of infections was observed in COSENTYX treated subjects compared to placebo-treated subjects. In placebo-controlled clinical trials in subjects with moderate to severe PsO, higher rates of common infections, such as nasopharyngitis (11.4% versus 8.6%), upper respiratory tract infection (2.5% versus 0.7%) and mucocutaneous infections with candida (1.2% versus 0.3%) were observed in subjects treated with COSENTYX compared to placebo-treated subjects. A similar increase in risk of infection in subjects treated with COSENTYX was seen in placebo-controlled trials in subjects with PsA, AS and nr-axSpA. The incidence of some types of infections, including fungal infections, appeared to be dose-dependent in clinical trials.

In the postmarketing setting, serious and some fatal infections have been reported in patients treated with COSENTYX.

Exercise caution when considering the use of COSENTYX in patients with a chronic infection or a history of recurrent infection. Instruct patients to seek medical advice if signs or symptoms suggestive of an infection occur. If a patient develops a serious infection, monitor the patient closely and discontinue COSENTYX until the infection resolves.

Pre-treatment Evaluation for Tuberculosis

Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with COSENTYX. Avoid administration of COSENTYX to patients with active TB infection. Initiate treatment of latent TB prior to administering COSENTYX. Consider anti-TB therapy prior to initiation of COSENTYX in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Monitor patients closely for signs and symptoms of active TB during and after treatment.

Inflammatory Bowel Disease

Inflammatory Bowel Disease (IBD) exacerbations, in some cases serious and/or leading to discontinuation of COSENTYX, occurred in COSENTYX treated subjects during clinical trials in PsO, PsA, AS, nr-axSpA, and HS. In adult subjects with HS, the incidence of IBD was higher in subjects who received COSENTYX 300 mg every 2 weeks (Ulcerative Colitis [UC] 1 case, EAIR 0.2/100 subject-years; Crohn’s Disease [CD] 1 case, EAIR 0.2/100 subject-years) compared to subjects who received COSENTYX 300 mg every 4 weeks (IBD 1 case, EAIR 0.2/100 subject-years). In addition, new onset IBD cases occurred in subjects treated with COSENTYX in clinical trials. In an exploratory trial in 59 subjects with active Crohn’s disease [COSENTYX is not approved for the treatment of Crohn’s disease], there were trends toward greater disease activity and increased adverse reactions in subjects treated with COSENTYX as compared to placebo-treated subjects.

Exercise caution when prescribing COSENTYX to patients with IBD. Patients treated with COSENTYX should be monitored for signs and symptoms of IBD.

Eczematous Eruptions

In postmarketing reports, cases of severe eczematous eruptions, including atopic dermatitis-like eruptions, dyshidrotic eczema, and erythroderma, were reported in patients receiving COSENTYX; some cases resulted in hospitalization. The onset of eczematous eruptions was variable, ranging from days to months after the first dose of COSENTYX.

Treatment may need to be discontinued to resolve the eczematous eruption. Some patients were successfully treated for eczematous eruptions while continuing COSENTYX.

Hypersensitivity Reactions

Anaphylaxis and cases of urticaria occurred in COSENTYX treated subjects in clinical trials. If an anaphylactic or other serious allergic reaction occurs, administration of COSENTYX should be discontinued immediately and appropriate therapy initiated.

The removable caps of the COSENTYX Sensoready^® pen and the COSENTYX 1 mL and 0.5 mL prefilled syringes contain natural rubber latex, which may cause an allergic reaction in latex-sensitive individuals. The safe use of the COSENTYX Sensoready pen or prefilled syringe in latex-sensitive individuals has not been studied.

Immunizations

Prior to initiating therapy with COSENTYX, consider completion of all age-appropriate immunizations according to current immunization guidelines. COSENTYX may alter a patient’s immune response to live vaccines. Avoid use of live vaccines in patients treated with COSENTYX.

MOST COMMON ADVERSE REACTIONS

Most common adverse reactions (>1%) are nasopharyngitis, diarrhea, and upper respiratory tract infection.

Please see Full Prescribing Information, including Medication Guide.

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Help patients live with less compromise caused by their disease

Patient-reported outcomes from the Psoriasis Symptom Diary^© (PSD)^1*

Reduction in psoriasis-related pain¹

Improvement in mobility, self-care, and usual activities reported in an exploratory analysis^3†

Please see ERASURE, FIXTURE, FEATURE, and JUNCTURE study design details

Tap to see IMPORTANT SAFETY INFORMATION and INDICATIONS

IMPORTANT SAFETY INFORMATION

INDICATIONS

Definitions and references

Help patients live with less compromise caused by their disease

Patient-reported outcomes from the Psoriasis Symptom Diary© (PSD)1*

Reduction in psoriasis-related pain1

Improvement in mobility, self-care, and usual activities reported in an exploratory analysis3†

Please see ERASURE, FIXTURE, FEATURE, and JUNCTURE study design details

Definitions and references

Patient-reported outcomes from the Psoriasis Symptom Diary^© (PSD)^1*

Reduction in psoriasis-related pain¹

Improvement in mobility, self-care, and usual activities reported in an exploratory analysis^3†