Biologics in Dermatology in India
Overview of Available Agents
In India, four biologic agents are currently available for moderate-to-severe inflammatory skin diseases: etanercept, infliximab, secukinumab, and itolizumab (a CD6-targeted agent unique to India). 1 Biosimilar versions have also been available for several years and are expected to play an increasingly significant role given cost constraints. 1
Eligibility Criteria for Biologic Therapy
Before initiating any biologic, patients must meet both of the following criteria: 2
Mandatory treatment failures: Documented failure, intolerance, or contraindication to both methotrexate and ciclosporin, as well as PUVA therapy, must be established before biologics are considered. 2 Biologics must never be used as first-line therapy without meeting these requirements. 2
Earlier initiation is justified when: 2
- Active psoriatic arthritis requiring treatment exists
- Rapidly relapsing or severe unstable life-threatening disease is present
- Significant drug-related toxicity risk or unrelated comorbidity precludes use of methotrexate or ciclosporin
Pre-Treatment Screening Requirements
All patients must undergo tuberculosis screening before anti-TNF therapy or itolizumab. 1 In India, chest X-ray and Mantoux skin test remain the preferred screening tests in patients not on immunosuppression. 1 During treatment and for 6 months following discontinuation, maintain a high index of suspicion for TB. 1
Additional mandatory screening: 2
- Hepatitis B and hepatitis C serology (particularly for anti-TNF agents and itolizumab) 2
TNF-α Inhibitors
Etanercept
- Dosing: 25 mg or 50 mg subcutaneously twice weekly for up to 24 weeks; alternatively 50 mg twice weekly for 12 weeks then once weekly 2, 1
- Indications: Moderate-to-severe plaque psoriasis and moderate-to-severe psoriatic arthritis 2, 1
- Response assessment: Evaluate at 12 weeks 2
- Methotrexate co-medication: May be recommended where required for associated arthropathy or to improve efficacy 1
Infliximab
- Dosing: 5 mg/kg IV at weeks 0,2,6, then every 8 weeks 2, 1
- Indications: Severe plaque psoriasis (PASI ≥20, DLQI ≥18) and moderate-to-severe psoriatic arthritis 2, 1
- Response assessment: Evaluate at 10–14 weeks 2
- Critical safety note: Interrupted therapy must be avoided due to increased risk of infusion reactions and poorer disease control 2, 1
- Dose escalation: May be administered at more frequent intervals and/or at higher doses up to 10 mg/kg for better disease control 3
Adalimumab
- Dosing: 80 mg week 0,40 mg week 1, then 40 mg every other week subcutaneously 2, 4
- Indications: Moderate-to-severe plaque psoriasis; preferred when psoriatic arthritis is a concern 2
- Response assessment: Evaluate at 16 weeks 2
- Dose escalation: Can be increased to 40 mg weekly for better control 4
IL-12/23 Inhibitor
Ustekinumab
- Dosing: 2, 4
- ≤100 kg: 45 mg SC at weeks 0,4, then every 12 weeks
100 kg: 90 mg SC at weeks 0,4, then every 12 weeks
- Positioning: First-line biologic option for moderate-to-severe psoriasis due to superior efficacy, favorable safety profile, and excellent drug survival rates 4
- Response assessment: Between weeks 16 and 28 2
IL-17 Inhibitor
Secukinumab
- Dosing: 300 mg subcutaneously weekly for the first four weeks, then every 4 weeks 2, 1
- Indications: Moderate-to-severe plaque psoriasis and psoriatic arthritis 1
- Positioning: Second-tier option after TNF-inhibitor failure 2
- TB screening: In the Indian scenario, follow the same guidelines for ruling out latent TB as with anti-TNF agents, as the effect on TB reactivation is poorly understood 1
- Contraindication: Avoid in patients with inflammatory bowel disease or at risk for it, as IL-17 inhibitors may cause paradoxical worsening 4
CD6-Targeted Agent (India-Specific)
Itolizumab
- Dosing: 1.6 mg/kg IV infusions every 2 weeks for 12 weeks initially, then 1.6 mg/kg every 4 weeks up to 24 weeks 1
- Indications: Moderate-to-severe plaque psoriasis 1
- Limitation: Long-term data are unavailable 1
- TB screening: Same pre-treatment chest X-ray and Mantoux requirements as anti-TNF agents 1
IL-23 Inhibitors (Post-TNF Failure)
IL-23 blockade (e.g., guselkumab, risankizumab) is the optimal next-line class after TNF-inhibitor failure. 2 Network meta-analysis demonstrates that risankizumab and guselkumab perform relatively stable with respect to both efficacy and safety. 5
Special Psoriasis Variants
Generalized Pustular Psoriasis
- Infliximab shows the strongest evidence for rapid response and complete clearance. 2
- Etanercept 50 mg twice weekly also demonstrates sustained efficacy up to 48 weeks 2
Acropustulosis of Hallopeau
- TNF antagonists (etanercept, infliximab, adalimumab) have provided significant benefit in ≥10 reported cases when conventional therapy fails 2
Treatment Response Assessment
Success is defined as either: 2
- PASI 75 (≥75% improvement), or
- PASI 50 plus a DLQI improvement >5 points
Assessment timelines by agent: 2
- Etanercept: 12 weeks
- Adalimumab: 16 weeks
- Infliximab: 10–14 weeks
- Ustekinumab: 16–28 weeks
If minimal response criteria are not met at the designated timepoint, switch to another biologic class. 2
Cost and Access Considerations in India
Cost is the major factor preventing biologic use in India. 6 A 2022 survey of Indian dermatologists found that 70% had used biologics, but the majority used them in fewer than 2 cases per month. 6 Secukinumab was the most commonly used biologic, followed by etanercept. 6 The factors determining choice of biologics were convenience, cost, previous experience, comorbid conditions, and expert recommendations. 6
Biosimilars are expected to play a significant role in improving access given their lower cost. 1
Prescribing Requirements and Safety Monitoring
- Initiation and supervision must be by specialist physicians experienced in psoriasis diagnosis and treatment. 2
- Enroll patients in long-term safety registries when available. 2
- Regular monitoring should include: 3
- Periodic history and physical examination
- Consideration of yearly tuberculosis testing
- Periodic complete blood count and liver function tests
Common Pitfalls to Avoid
- Do not use biologics as first-line therapy without documented failure of both methotrexate and ciclosporin 2
- Do not interrupt infliximab therapy due to increased infusion-reaction risk and worsened disease control 2, 1
- Do not use IL-17 inhibitors in patients with inflammatory bowel disease or at risk for it 4
- Do not neglect TB screening before anti-TNF or itolizumab therapy, and maintain high suspicion during treatment and for 6 months after discontinuation 1