Methods: Seventy three patients with new T1R were randomized to receive Adalimumab or Prednisolone for 20 weeks. TNF-α levels were corelated before and after the intervention.
Results: Recovery rates in skin signs was similar in both groups (91% vs 88%). Improvements in nerve function both, new and old, sensory (66% vs 49%) and motor (75% vs 74%) loss were higher (but not significantly so) in the patients on Adalimumab. Recurrences rates of T1R (85%) were high in both groups, and recurrences occurred significantly earlier (8 weeks) in patients Adalimumab, who needed 10% more additional prednisolone. Serious major and minor adverse events rates were much lesser with Adalimumab as compared to Prednisolone alone. Both groups had a significant improvement in their quality of life after the study, measured by the Short form survey SF-36.
Conclusion: This is the first double-blind RCT assessing adalimumab, in the management of T1R. It could be a safe alternative second-line drug for patients with T1R who are not improving with prednisolone or are experiencing adverse events related to prednisolone. TNF-α levels could be an important diagnostic marker to diagnose and prognisticate cases of Type 1 Lepra reaction, which if not treated in time can lead to irreversible nerve damage.
D. Mitra, None
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