In the JUNCTURE study, adult subjects with moderate to severe PsO reported their experiences with the Sensoready® pen1*†:
At week 12, patients reported nearly no pain or reaction during or after the injection
N=182, mean SIAQ score (9.68-9.69) out of 10, with 10 indicating no pain/reaction
Each pen contains 150 mg/mL of COSENTYX3
Each 300 mg dose is supplied in a carton containing two 150 mg/mL Sensoready® pens
Each 150 mg dose is supplied in a carton containing one 150 mg/mL Sensoready® pen
Prefilled syringes are also available—each contains 150 mg/mL or 75 mg/mL3
The removable cap of the COSENTYX Sensoready® pen and the prefilled syringe contains natural rubber latex and should not be handled by latex-sensitive individuals. The safe use of the COSENTYX Sensoready® pen or prefilled syringe in latex-sensitive individuals has not been studied.3
*Co-primary end points of the JUNCTURE study were efficacy of COSENTYX vs placebo at Week 12 based on PASI 75 responses and scores of 0 or 1 and a ≥2-grade improvement from baseline on the IGA mod 2011 scale. Secondary end points included usability of the autoinjector, determined by observer rating of successful, hazard-free self-injection, and subject rating of autoinjector acceptability.1
†In the JUNCTURE study, satisfaction with self-injection was evaluated in 182 adults with moderate to severe plaque psoriasis patients using the SIAQ (secondary end point). Responses were scored on a scale of 0 (worst experience) to 10 (best experience), with higher scores indicating a more positive experience. At baseline, the mean score for satisfaction with self-injection was 6.68, and at Week 12, the mean score was 9.03.1
‡Based on safety analysis of 4 pivotal randomized, placebo-controlled trials in patients with moderate to severe plaque psoriasis (N=2399, with n=1382 exposed to any dose of COSENTYX).2
§Individual results may vary.
Important Safety Information
CONTRAINDICATIONS
COSENTYX® (secukinumab) 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® (secukinumab) 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 plaque psoriasis, 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 with COSENTYX compared with placebo. A similar increase in risk of infection was seen in placebo-controlled trials in subjects with psoriatic arthritis, ankylosing spondylitis and non-radiographic axial spondyloarthritis. The incidence of some types of infections appeared to be dose-dependent in clinical studies. In the postmarketing setting, serious and some fatal infections have been reported in patients receiving 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
Caution should be used when prescribing COSENTYX to patients with inflammatory bowel disease. Exacerbations, in some cases serious, occurred in COSENTYX treated subjects during clinical trials in plaque psoriasis, psoriatic arthritis, ankylosing spondylitis and non-radiographic axial spondyloarthritis. In addition, new onset inflammatory bowel disease cases occurred in clinical trials with COSENTYX. In an exploratory trial in 59 subjects with active Crohn’s disease, there were trends toward greater disease activity and increased adverse events in the secukinumab group as compared to the placebo group. Patients who are treated with COSENTYX should be monitored for signs and symptoms of inflammatory bowel disease.
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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Indications
COSENTYX is indicated for the treatment of moderate to severe plaque psoriasis in patients 6 years and older who are candidates for systemic therapy or phototherapy.
COSENTYX is indicated for the treatment of active psoriatic arthritis (PsA) in patients 2 years of age and older...
COSENTYX is indicated for the treatment of moderate to severe plaque psoriasis in patients 6 years and older who are candidates for systemic therapy or phototherapy.
COSENTYX is indicated for the treatment of active psoriatic arthritis (PsA) in patients 2 years of age and older.
COSENTYX is indicated for the treatment of adult patients with active ankylosing spondylitis (AS).
COSENTYX is indicated for the treatment of adult patients with active non-radiographic axial spondyloarthritis (nr‑axSpA) with objective signs of inflammation.
COSENTYX is indicated for the treatment of active enthesitis-related arthritis (ERA) in patients 4 years of age and older.
Definitions
PsA, psoriatic arthritis; PsO, plaque psoriasis; SIAQ, Self-Injection Assessment Questionnaire.
References
1. Paul C 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.
2. Data on file. AIN457A Summary of Clinical Safety. Novartis Pharmaceuticals Corp; October 2013.
3. Cosentyx. Prescribing information. Novartis Pharmaceuticals Corp.