Chemical formula: C₆₅₈₄H₁₀₁₃₄N₁₇₅₄O₂₀₄₂S₄₄
Secukinumab interacts in the following cases:
Live vaccines should not be given concurrently with secukinumab.
Cases of new or exacerbations of Crohn’s disease and ulcerative colitis have been reported. Caution should be exercised when prescribing secukinumab to patients with inflammatory bowel disease, including Crohn’s disease and ulcerative colitis. Patients should be closely monitored.
There are no adequate data from the use of secukinumab in pregnant women.
Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. As a precautionary measure, it is preferable to avoid the use of secukinumab during pregnancy.
It is not known whether secukinumab is excreted in human milk. Immunoglobulins are excreted in human milk and it is not known if secukinumab is absorbed systemically after ingestion. Because of the potential for adverse reactions in nursing infants from secukinumab, a decision on whether to discontinue breast-feeding during treatment and up to 20 weeks after treatment or to discontinue therapy with secukinumab must be made taking into account the benefit of breast-feeding to the child and the benefit of therapy to the woman.
Women of childbearing potential should use an effective method of contraception during treatment and for at least 20 weeks after treatment.
The effect of secukinumab on human fertility has not been evaluated. Animal studies do not indicate direct or indirect harmful effects with respect to fertility.
Secukinumab has no or negligible influence on the ability to drive and use machines.
The most frequently reported adverse drug reactions (ADRs) are upper respiratory tract infections (most frequently nasopharyngitis, rhinitis).
ADRs from clinical studies and post-marketing reports are listed by MedDRA system organ class. Within each system organ class, the ADRs are ranked by frequency, with the most frequent reactions first. Within each frequency grouping, adverse drug reactions are presented in order of decreasing seriousness. In addition, the corresponding frequency category for each adverse drug reaction is based on the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); and not known (cannot be estimated from the available data).
Over 17,900 patients have been treated with secukinumab in blinded and open-label clinical studies in various indications (plaque psoriasis, psoriatic arthritis, ankylosing spondylitis and other autoimmune conditions), representing 29,978 patient years of exposure. Of these, over 11,700 patients were exposed to secukinumab for at least one year. The safety profile of secukinumab is consistent across all indications.
List of adverse reactions in clinical studies1 and post-marketing experience:
Very common: Upper respiratory tract infections
Common: Oral herpes
Uncommon: Oral candidiasis, Tinea pedis, Otitis externa, Lower respiratory tract infections
Not known: Mucosal and cutaneous candidiasis (including oesophageal candidiasis)
Uncommon: Neutropenia
Rare: Anaphylactic reactions
Uncommon: Conjunctivitis
Common: Rhinorrhoea
Common: Diarrhoea
Uncommon: Inflammatory bowel disease
Uncommon: Urticaria
Rare: Exfoliative dermatitis2
1 Placebo-controlled clinical studies (phase III) in plaque psoriasis, PsA and AS patients exposed to 300 mg, 150 mg, 75 mg or placebo up to 12 weeks (psoriasis) or 16 weeks (PsA and AS) treatment duration.
2 Cases were reported in patients with psoriasis diagnosis.
In the placebo-controlled period of clinical studies in plaque psoriasis (a total of 1,382 patients treated with secukinumab and 694 patients treated with placebo for up to 12 weeks), infections were reported in 28.7% of patients treated with secukinumab compared with 18.9% of patients treated with placebo. The majority of infections consisted of non-serious and mild to moderate upper respiratory tract infections, such as nasopharyngitis, which did not necessitate treatment discontinuation. There was an increase in mucosal or cutaneous candidiasis, consistent with the mechanism of action, but the cases were mild or moderate in severity, non-serious, responsive to standard treatment and did not necessitate treatment discontinuation. Serious infections occurred in 0.14% of patients treated with secukinumab and in 0.3% of patients treated with placebo.
Over the entire treatment period (a total of 3,430 patients treated with secukinumab for up to 52 weeks for the majority of patients), infections were reported in 47.5% of patients treated with secukinumab (0.9 per patient-year of follow-up). Serious infections were reported in 1.2% of patients treated with secukinumab (0.015 per patient-year of follow-up).
Infection rates observed in psoriatic arthritis and ankylosing spondylitis clinical studies were similar to those observed in the psoriasis studies.
In psoriasis phase 3 clinical studies, neutropenia was more frequently observed with secukinumab than with placebo, but most cases were mild, transient and reversible. Neutropenia <1.0-0.5x109/l (CTCAE grade 3) was reported in 18 out of 3,430 (0.5%) patients on secukinumab, with no dose dependence and no temporal relationship to infections in 15 out of 18 cases. There were no reported cases of more severe neutropenia. Non-serious infections with usual response to standard care and not requiring discontinuation of secukinumab were reported in the remaining 3 cases.
The frequency of neutropenia in psoriatic arthritis and ankylosing spondylitis is similar to psoriasis.
Rare cases of neutropenia <0.5x109/l (CTCAE grade 4) were reported.
In clinical studies, urticaria and rare cases of anaphylactic reaction to secukinumab were observed.
In psoriasis, psoriatic arthritis and ankylosing spondylitis clinical studies, less than 1% of patients treated with secukinumab developed antibodies to secukinumab up to 52 weeks of treatment. About half of the treatment-emergent anti-drug antibodies were neutralising, but this was not associated with loss of efficacy or pharmacokinetic abnormalities.
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