Is continuation of infliximab (Remicade) at 10mg/kg iv every 4 weeks medically indicated for a patient with hidradenitis suppurativa and type 2 diabetes?

Medical Necessity and Standard of Care for Infliximab Continuation in Hidradenitis Suppurativa

Yes, continuation of infliximab (Remicade) at 10mg/kg IV every 4 weeks is medically necessary and represents standard of care for this patient with moderate-to-severe hidradenitis suppurativa who has failed multiple conventional therapies and is demonstrating clinical response to the current regimen. 1

1. Medical Necessity for the Condition Being Treated

Disease Severity and Treatment History

• This patient has moderate-to-severe HS with documented treatment failures including multiple oral antibiotics (doxycycline, minocycline, clindamycin, rifampin combinations), hormonal therapy (birth control), and topical treatments, establishing medical necessity for biologic therapy 1
• The patient exhibits active inflammatory disease with weeping pustules, papules, folliculocentric plaques, scarring, and tract formation, indicating ongoing severe disease activity requiring advanced therapy 1
• Hormonal triggers (menstrual cycle) and stress-related flares persist despite attempted hormonal management, demonstrating inadequate control with conventional approaches 1

Clinical Response to Current Regimen

• The patient has shown documented improvement on infliximab therapy, with the dose escalation from 7.5 mg/kg to 10 mg/kg every 4 weeks implemented specifically to optimize disease control 2, 3
• Recent prospective data demonstrates that 70.8% of patients achieve clinical response at week 12 with infliximab 7.5 mg/kg every 4 weeks, with dose escalation to 10 mg/kg providing additional benefit in 50% of incomplete responders 2
• The patient requires completion of the 6-month evaluation period following dose adjustment to properly assess therapeutic response, as nearly 40% of initial non-responders achieve response with continued treatment beyond 12 weeks 1

Comorbidity Considerations

• The patient's type 2 diabetes (glucose 203 mg/dL) represents an additional indication for aggressive HS management, as British guidelines specifically recommend considering metformin in HS patients with concomitant diabetes 1
• Uncontrolled HS in diabetic patients carries increased risk of secondary infections and wound healing complications 1

2. Standard of Care and Evidence Base

Guideline-Based Recommendations

Infliximab is explicitly recommended by major international guidelines for moderate-to-severe HS:

• The British Association of Dermatologists (2019) recommends infliximab 5 mg/kg every 8 weeks for moderate-to-severe HS unresponsive to conventional systemic therapy (Strength of Recommendation: ↑) 1
• The North American guidelines (US and Canadian HS Foundations, 2019) recommend infliximab for moderate-to-severe HS, noting that 78% of patients achieved ≥50% improvement in HS Severity Index scores 1
• Both guidelines position infliximab as second-line biologic therapy after adalimumab failure or as alternative first-line biologic 1

Dosing Paradigm and Evidence

The requested 10 mg/kg every 4 weeks dosing represents an evidence-based intensified regimen:

• Standard guideline dosing is 5 mg/kg every 8 weeks 1, but recent high-quality prospective data supports dose intensification for optimal disease control 2, 3
• A 2020 prospective study of 42 patients demonstrated that initiating infliximab at 7.5-10 mg/kg every 4 weeks provides optimal mitigation of HS disease activity, with 47.6% achieving clinical response at week 4 and 70.8% at week 12 2
• A 2019 retrospective cohort of 52 patients found that most patients achieving stable dosing required 10 mg/kg every 6-8 weeks, with 64% requiring dose escalation within the first year 3
• The patient's dose escalation from 7.5 mg/kg to 10 mg/kg every 4 weeks follows this evidence-based treatment paradigm for incomplete initial response 2

Safety Profile

• Infliximab has demonstrated satisfactory safety in HS populations, with a controlled trial showing well-tolerated therapy and significant improvements in quality of life and pain scores 1
• The patient has completed appropriate baseline screening (CBC, CMP, QuantiFERON-TB Gold negative) prior to dose escalation 1
• Long-term prospective data shows good tolerance without therapeutic escape during the first year, with only minor infections as the most common adverse event 4

Not Experimental or Investigational

• Infliximab for HS is supported by Level II evidence (limited-quality patient-oriented evidence) in North American guidelines and has been used for over 15 years in clinical practice 1
• While adalimumab is the only FDA-approved biologic for HS, infliximab represents established off-label standard of care supported by international dermatology societies 1
• The treatment is neither experimental nor investigational, but rather represents guideline-concordant therapy for refractory moderate-to-severe disease 1

Critical Clinical Considerations

Importance of Treatment Continuity

• Discontinuation of infliximab carries risk of disease flare and potential loss of response upon reinitiation due to development of neutralizing antibodies 1, 5
• The patient was explicitly counseled that "once she is off infliximab she cannot reinitiate due to risk of becoming sick", reflecting concern about immunogenicity with interrupted therapy 5
• Completing the planned 6-month evaluation period is medically necessary to properly assess response to the dose-adjusted regimen before considering any treatment changes 2

Treatment Sequencing Appropriateness

• This patient has appropriately failed first-line therapies (oral tetracyclines, clindamycin/rifampin combination) before advancing to biologic therapy 1
• The patient has documented allergies to adalimumab, making infliximab the appropriate first-line biologic choice rather than requiring adalimumab failure 1
• Addition of spironolactone 50 mg daily as adjunctive therapy represents appropriate multimodal management per guidelines 1

Pitfalls to Avoid

• Premature discontinuation before adequate trial duration (minimum 12-24 weeks at stable dosing) can result in missed therapeutic benefit, as response may be delayed 1, 2
• Interrupting therapy without bridging to alternative treatment would likely result in disease flare with significant morbidity impact 4
• Failure to monitor for treatment response using validated measures (inflammatory lesion counts, pain scores, quality of life assessments) limits ability to optimize therapy 1