What is the appropriate treatment approach for a patient with a history of autoimmune diseases, such as psoriasis, ankylosing spondylitis, or psoriatic arthritis, considering Cosentyx (secukinumab) as a potential treatment option?

Cosentyx (Secukinumab) Treatment Approach

Cosentyx (secukinumab) is a highly effective IL-17A inhibitor that should be initiated as monotherapy at 300 mg subcutaneously at weeks 0,1,2,3, and 4, followed by 300 mg every 4 weeks for patients with moderate-to-severe plaque psoriasis, active psoriatic arthritis, or ankylosing spondylitis who are candidates for systemic therapy. 1, 2

FDA-Approved Indications

Cosentyx is approved for:

• Moderate-to-severe plaque psoriasis in patients ≥6 years who are candidates for systemic therapy or phototherapy 2
• Active psoriatic arthritis in patients ≥2 years of age 2
• Active ankylosing spondylitis in adults 2
• Active non-radiographic axial spondyloarthritis with objective signs of inflammation in adults 2
• Active enthesitis-related arthritis in pediatric patients ≥4 years 2
• Moderate-to-severe hidradenitis suppurativa in adults 2

Pre-Treatment Screening Requirements

Mandatory Screening

• Tuberculosis testing (PPD, QuantiFERON-Gold, or T-Spot) is required before initiating therapy 1, 2
• Active infection screening - do not initiate if active infection present unless instructed by infectious disease specialist 1, 2
• Hepatitis B and C serologic testing (HB surface antigen, anti-HB surface antibody, anti-HB core antibody, hepatitis C antibody) 3
• Complete blood count and comprehensive metabolic panel 3

Contraindications

• Active tuberculosis infection is an absolute contraindication 2
• Severe allergic reaction to secukinumab or any ingredient 2
• Active sepsis or serious infection 2
• Untreated hepatitis B is a relative contraindication 1

Special Considerations

• Inflammatory bowel disease history should be assessed, as secukinumab may increase risk of IBD events or exacerbation 1, 2
• Latex allergy - the needle cap contains latex on certain formulations 2

Dosing Protocol

Standard Adult Dosing

• Loading phase: 300 mg subcutaneously at weeks 0,1,2,3, and 4 1, 2
• Maintenance phase: 300 mg every 4 weeks starting at week 8 1, 2
• The 300 mg dose is superior to 150 mg and should be prioritized 1

Administration Technique

• Inject subcutaneously in upper thighs, abdomen, or upper outer arm 2
• Avoid injecting into areas with active psoriasis 1
• Self-administration is standard after proper training 2

Expected Efficacy Outcomes

Psoriasis

• 79% of patients achieve PASI 90 at week 16 with 300 mg dosing 1
• Response is maintained through 52 weeks and beyond with continued dosing 1
• Strongly recommended (Level A) for moderate-to-severe nail involvement, palmoplantar plaque psoriasis, and psoriasis with psoriatic arthritis 1

Psoriatic Arthritis

• Significant improvements in signs and symptoms of active PsA despite prior NSAID or DMARD therapy 4, 5
• Improvements in enthesitis, dactylitis, and inhibition of radiographic progression 5
• Significant improvements in physical functioning and health-related quality of life 4

Ankylosing Spondylitis

• Approved and effective for active AS 2, 5
• Note: IL-23 inhibitors (not IL-17 inhibitors like secukinumab) lack efficacy in AS and should not be used 6

Treatment Positioning in Algorithm

First-Line Considerations

• For psoriasis: Secukinumab is appropriate for patients with inadequate response to topical therapies alone 1
• For psoriatic arthritis: Recommended when NSAIDs or DMARDs have failed 3, 4
• For ankylosing spondylitis: Use after inadequate response to NSAIDs 3

When to Choose Secukinumab Over Other Biologics

• Prefer secukinumab over TNF inhibitors in patients with severe psoriasis or contraindications to TNF inhibitors 3
• For PsA with predominant enthesitis: TNF inhibitors are first-line, but IL-17 inhibitors like secukinumab are recommended over IL-12/23 inhibitors 3
• For axial PsA: TNF inhibitors are preferred first-line, but IL-17 inhibitors (including secukinumab) are recommended over IL-12/23 inhibitors 3

When NOT to Use Secukinumab

• Do not use in patients with inflammatory bowel disease - secukinumab has been associated with new-onset or exacerbation of Crohn's disease 3, 2
• Avoid in patients with recurrent uveitis - TNF inhibitor monoclonal antibodies (adalimumab, infliximab) are preferred 3

Vaccination Strategy

Before Starting Therapy

• Complete all indicated killed vaccines before starting secukinumab 1
• Live attenuated vaccines must be administered at least 2-4 weeks before initiating therapy 1
• Pneumococcal vaccine is strongly recommended before starting any biologic 1
• Starting the biologic without delaying for killed vaccines is acceptable if disease severity warrants immediate treatment 1

After Starting Therapy

• Live vaccines are absolutely contraindicated once secukinumab is started 1
• Inactivated vaccines are safe to give during treatment 1
• Annual influenza vaccination is recommended 1
• IL-17 inhibitors do not interfere with immune response to pneumococcal or influenza vaccination 1

Combination Therapy Considerations

Acceptable Combinations

• Combination with topical corticosteroids or vitamin D analogues may augment efficacy 1
• Published safety data on combinations is limited 1

Contraindicated Combinations

• Do not combine secukinumab with other biologics - such combinations carry unknown risks 1
• Secukinumab is recommended as monotherapy for all approved indications 1

Safety Monitoring and Adverse Events

Common Adverse Events

• Mucocutaneous candida infections occur at 1.9 per 100 patient-years but are typically mild and responsive to standard treatment 1
• Most common: nasopharyngitis, headache, upper respiratory tract infections 5
• These are typically mild-to-moderate and non-serious 1, 4

Serious Adverse Events

• Serious infections occur at low rates (0.015 per patient-year) but require treatment discontinuation until resolved 1
• Do not administer secukinumab during active serious infection 1, 2
• Neutropenia may occur but is usually mild, transient, and reversible 1

Ongoing Monitoring

• Periodic history and physical examination, including screening for non-melanoma skin cancer 3
• Monitor for signs of infection: fever, sweats, chills, muscle aches, cough, shortness of breath, blood in phlegm, weight loss, warm/red/painful skin or sores, diarrhea, stomach pain, burning with urination 2
• Watch for signs of inflammatory bowel disease - if new-onset or exacerbation occurs, discontinue secukinumab 1
• Yearly TB testing in high-risk patients (contact with active TB, travel, underlying medical conditions) 3
• CBC with differential and CMP at physician's discretion 3

Immunogenicity

• Less than 1% of patients develop antibodies to secukinumab up to 52 weeks of treatment 1

Critical Pitfalls to Avoid

1. Do not use in patients with inflammatory bowel disease - this is a major safety concern specific to IL-17 inhibitors 3, 2
2. Do not delay TB screening - active TB is an absolute contraindication 2
3. Do not administer live vaccines after starting therapy - risk of severe or fatal infections 1
4. Do not combine with other biologics - no safety data exists 1
5. Do not confuse IL-17 inhibitors with IL-23 inhibitors - IL-23 inhibitors lack efficacy in ankylosing spondylitis, while secukinumab (IL-17A inhibitor) is effective 6