Biologics in Dermatology in India

Overview of Available Biologics

In India, the primary biologics available for dermatological conditions are etanercept, infliximab, itolizumab, and secukinumab, with biosimilars playing an increasingly important role in expanding access to these therapies. 1

Psoriasis: Eligibility and Treatment Initiation

Disease Severity Criteria

Patients must meet both of the following criteria before biologic initiation 2, 3:

DLQI >10 (indicating significant quality of life impact)
PASI ≥10 OR BSA >10% (indicating extensive disease)

Mandatory Pre-Biologic Treatment Failures

Before initiating biologics, patients must have documented failure, intolerance, or contraindication to BOTH methotrexate and ciclosporin, as well as PUVA therapy. 3 This requirement ensures biologics are reserved for truly refractory cases rather than first-line therapy. 2, 3

Exceptions for Earlier Biologic Use

Biologics may be initiated earlier when patients meet severity criteria AND have any of the following 3:

Active psoriatic arthritis requiring treatment
Rapidly relapsing disease
Severe unstable life-threatening disease (e.g., generalized pustular psoriasis)
Significant drug-related toxicity risk from conventional agents
Significant comorbidity precluding methotrexate or ciclosporin use

Specific Biologic Agents for Psoriasis

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 reduced to once weekly 2, 1
Indication: Moderate-to-severe plaque psoriasis and psoriatic arthritis 2, 1
Response assessment: Evaluate at 12 weeks 2
Co-medication: Consider methotrexate for associated arthropathy or to improve efficacy 1

Infliximab

Dosing: 5 mg/kg intravenous at weeks 0,2,6, then every 8 weeks 2, 1
Indication: Severe plaque psoriasis (PASI ≥20, DLQI ≥18) and moderate-to-severe psoriatic arthritis 2, 1
Response assessment: Evaluate at 3 months (10-14 weeks) 2, 1
Critical caveat: Avoid interrupted therapy due to increased risk of infusion reactions and poorer disease control 1
Reserve for: Very severe disease or when other biologics have failed 4

Adalimumab

Dosing: 80 mg week 0,40 mg week 1, then 40 mg every other week subcutaneously 2
Response assessment: Evaluate at 16 weeks 2
Preferred when: Psoriatic arthritis is a consideration 4

IL-23 Inhibitors (Preferred After TNF Failure)

When adalimumab or other TNF inhibitors fail, IL-23 inhibitors are the optimal next-line class. 5

Guselkumab (if available)

Dosing: 100 mg subcutaneously at weeks 0 and 4, then every 8 weeks 5
Efficacy: 70% achieve PASI 90 at week 16; among adalimumab non-responders switched to guselkumab, 66.1% reached PASI 90 at week 48 5

Risankizumab (if available)

Efficacy: 77% achieve PASI 90 at week 12; 45% achieve complete clearance (PASI 100) 5

IL-17 Inhibitors

Secukinumab

Dosing: 300 mg subcutaneously at weeks 0,1,2,3, then 300 mg every 4 weeks starting week 4 1
Indication: Moderate-to-severe plaque psoriasis and psoriatic arthritis 1
Position: Second-tier option after TNF inhibitor failure, behind IL-23 inhibitors 5

IL-6 Inhibitor (India-Specific)

Itolizumab

Dosing: 1.6 mg/kg intravenous every 2 weeks for 12 weeks, then 1.6 mg/kg every 4 weeks up to 24 weeks 1
Indication: Moderate-to-severe plaque psoriasis 1
Limitation: Long-term data unavailable 1

IL-12/23 Inhibitor

Ustekinumab

Dosing: 45 mg at weeks 0 and 4, then every 12 weeks for patients <100 kg; 90 mg for patients >100 kg 2, 4
Response assessment: Evaluate at 16-28 weeks 2
Position: First-line biologic option for moderate-to-severe psoriasis 4

Special Psoriasis Variants

Generalized Pustular Psoriasis

Infliximab demonstrates the strongest evidence for generalized pustular psoriasis, with rapid response and complete clearance in multiple case series. 2 Etanercept at 50 mg twice weekly (not 25 mg twice weekly) also shows efficacy, with maintained response up to 48 weeks. 2

Acropustulosis of Hallopeau

TNF antagonists (etanercept, infliximab, adalimumab) show significant benefit in at least 10 case reports for this rare, disabling condition that frequently fails conventional therapy. 2

Atopic Dermatitis

First-Line Biologic

Dupilumab is the only approved biologic for moderate-to-severe atopic dermatitis and represents the standard of care for patients who fail traditional treatments. 6

Emerging Options

Tralokinumab: Promising results in moderate-to-severe atopic dermatitis 6
Nemolizumab: Shows efficacy for atopic dermatitis, particularly for pruritus 6

Hidradenitis Suppurativa

Adalimumab is the established biologic for moderate-to-severe hidradenitis suppurativa, though specific dosing for this indication was not detailed in the provided evidence. 7

Alopecia Areata

The evidence provided does not include specific biologic recommendations for refractory alopecia areata. JAK inhibitors show promise in case reports but lack sufficient data for firm recommendations. 2

Mandatory Pre-Treatment Screening (India-Specific)

Tuberculosis Screening

Before initiating anti-TNF therapy or itolizumab, perform chest X-ray and Mantoux skin test to exclude tuberculosis. 1 This is critical in the Indian context given high TB prevalence.

Maintain high suspicion for TB during treatment and for 6 months post-discontinuation 1
For secukinumab: Effect on TB reactivation is poorly understood; in India, follow the same TB screening guidelines as for TNF inhibitors 1

Additional Screening

Screen for hepatitis B and C reactivation risk before initiating biologics. 2

Treatment Response Assessment

Success Criteria

Treatment success is defined as achieving either 3:

PASI 75 (≥75% improvement), OR
PASI 50 (≥50% improvement) PLUS DLQI improvement >5 points

Assessment Timeline

Etanercept: 12 weeks 2
Adalimumab: 16 weeks 2
Infliximab: 10-14 weeks 2
Ustekinumab: 16-28 weeks 2
IL-17/IL-23 inhibitors: 12-16 weeks 5

If minimal response criteria are not met at these timepoints, switch to another biologic class. 5, 3

Critical Prescribing Requirements

Specialist initiation only: Biologics must be initiated and supervised by physicians experienced in psoriasis diagnosis and treatment 3
Registry enrollment: Enroll all patients in long-term safety registries (BADBIR in UK/Ireland; equivalent registries should be used in India) 3
Formalized monitoring: Establish clear arrangements for drug administration, monitoring, and follow-up 3

Common Pitfalls to Avoid

Do not use biologics as first-line therapy without documented failure of methotrexate, ciclosporin, and PUVA 2, 3
Do not delay switching: If response is inadequate at the designated assessment timepoint, transition promptly to the next-line agent 5
Avoid interrupted infliximab therapy: This increases infusion reaction risk and worsens disease control 1
Do not skip TB screening in the Indian context, even for non-TNF biologics like secukinumab 1
Do not switch to another TNF inhibitor after TNF failure: Switch to IL-23 or IL-17 inhibitors instead 5

Cost Considerations

Biosimilars are increasingly available in India and expected to play a significant role in expanding access to biologic therapy 1
Ustekinumab offers 12-week dosing intervals, potentially reducing long-term costs compared to more frequent dosing schedules 4
Weight-based dosing (ustekinumab, infliximab) affects cost calculations 4
Dose escalation needs (particularly etanercept) should be factored into long-term cost projections 4

What biologic therapies, dosing schedules, safety precautions, and alternative systemic options are available for moderate-to-severe psoriasis, atopic dermatitis, hidradenitis suppurativa, and refractory alopecia areata in India?

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