Cosentyx (Secukinumab) is a human IgG1 monoclonal antibody that selectively binds to and neutralizes the proinflammatory cytokine interleukin 17A (IL-17A). IL-17A is a naturally occurring cytokine that is involved in normal inflammatory and immune responses and plays a key role in the pathogenesis of plaque psoriasis.
COSENTYX 150 MG PRE-FILLED PEN is a human IgG1 monoclonal antibody that selectively binds to and neutralizes the proinflammatory cytokine interleukin 17A (IL-17A). IL-17A is a naturally occurring cytokine that is involved in normal inflammatory and immune responses and plays a key role in the pathogenesis of plaque psoriasis.
Active Ingredient Of COSENTYX 150 MG PRE-FILLED PEN
Therapeutic indications of COSENTYX 150 MG PRE-FILLED PEN
Adult plaque psoriasis
Doctors prescribe Cosentyx for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.
Paediatric plaque psoriasis
Doctors prescribe Cosentyx for the treatment of moderate to severe plaque psoriasis in children and adolescents from the age of 6 years who are candidates for systemic therapy.
To start with, cosentyx, alone or in combination with methotrexate (MTX), doctors prescribe Cosentyx for the treatment of active psoriatic arthritis in adult patients when the response to previous disease-modifying anti-rheumatic drug (DMARD) therapy has been inadequate.
Ankylosing spondylitis (AS, radiographic axial spondyloarthritis). Doctors prescribe Cosentyx for the treatment of active ankylosing spondylitis in adults who have responded inadequately to conventional therapy.
Non-radiographic axial spondyloarthritis
Doctors prescribe Cosentyx for the treatment of active non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) evidence in adults who have responded inadequately to non-steroidal anti-inflammatory drugs (NSAIDs).
Mechanism of action of COSENTYX 150 MG PRE-FILLED PEN
At the beginning, Secukinumab is a human IgG1 monoclonal antibody that selectively binds to the interleukin-17A (IL-17A) cytokine and inhibits its interaction with the IL-17 receptor. IL-17A is a naturally occurring cytokine involved in normal inflammatory and immune responses. Secukinumab inhibits the release of proinflammatory cytokines and chemokines.
Method of Administration
You can must take it by subcutaneous route of administration.
Infection: Infection (29% to 48%; serious infection: ≤1%)
Respiratory: Nasopharyngitis (11% to 12%)
Dermatologic: Urticaria (≤1%)
Endocrine & metabolic: Hypercholesterolemia (≥2%)
Gastrointestinal: Diarrhea (3% to 4%), inflammatory bowel disease (≤1%; Crohn’s disease, exacerbation of Crohn’s disease, exacerbation of ulcerative colitis, ulcerative colitis: <1%)
Actual patient photos representative of the average response taken by investigators during PsO clinical trials. Individual results may vary.
In FUTURE 2, in patients with coexistent plaque psoriasis receiving COSENTYX (n=99), the skin lesions of psoriasis improved with treatment, relative to placebo, as measured by the PASI.7
66% PASI 90 response, 150 mg (n=84)15
38% of patients with PsA and PsO in the COSENTYX 150-mg arm were up-titrated to 300 mg starting at Week 52, at the investigator’s discretion14
In FUTURE 5, PASI 90 was a prespecified exploratory end point at 2 years. Results were as observed in a subgroup of biologic-naive patients with PsA and PsO. No clinical or statistical conclusions can be drawn.1,15
Significant improvement in axial symptoms
In the MAXIMISE study of axial symptoms in biologic-naive patients with PsA
At Week 12 (primary end point)4
63% experienced relief on COSENTYX 300 mg vs 31% with placebo, as measured by ASAS20 responses (MI) (P<0.0001) (n=164)4
In the 150-mg arm (key secondary end point), 66% of biologic-naive patients achieved ASAS20 (MI) (n=157)4
69% achieved ASAS40 on COSENTYX 300 mg (n=139)18
80% and 65% achieved ASAS20 and ASAS40, respectively, on COSENTYX 150 mg (n=141)18
The components of ASAS are relevant to your patients and include7:
In MAXIMISE, ASAS20 AND ASAS40 were prespecified exploratory end points at Week 52. Results were as observed. No clinical or statistical conclusions can be drawn.18
Data from the MAXIMISE trial whose study design, patient population, and dosing regimen are consistent with that of FUTURE 2. In the FUTURE 2 trial, 20% of patients had spondylitis with peripheral arthritis.
ASAS=Assessment of SpondyloArthritis international Society criteria; BASFI=Bath Ankylosing Spondylitis Functional Index; MI=multiple imputation.
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
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.
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.
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 of using COSENTYX 150 MG PRE-FILLED PEN
Most common adverse reactions (>1%) are nasopharyngitis, diarrhea, and upper respiratory tract infection.