Objective:
To compare the outcomes of causality assessment for SJS/TENfrom the widely used Naranjo algorithm versus an Algorithm ofDrug Causality for Epidermal Necrolysis (ALDEN), exclusivelytailored for EN in order to assess the medication risks & toimprove assessment of drug causality at a case level.
Method:
A study was conducted utilizing case reports of 2 drugs (drug A& B) from a pharmaceutical company’s safety database. Thecase reports were evaluated for the causality of SJS/TEN usingALDEN & Naranjo algorithms. A score with appropriate causalitycategory was provided & then compared for each case.
Results:
Sixty two (62) individual case reports for drug A and 25individual case reports for drug B were retrieved from safetydatabase for causality evaluation of SJS/TEN. Analysis of thescores along with causality category for each case found thatthe scores attributed by ALDEN segregated widely whencompared with Naranjo algorithm. ALDEN pointed to a“probable”/“very probable” causality in 15 cases (24%) forDrug A and 04 cases (16%) for Drug B as compared to 2 cases(3%) for Drug A and 3 cases (12%) for Drug B with theNaranjo algorithm. ALDEN pointed to a “unlikely”/“very unlikely” causality in 35 cases (56%) for Drug A and 09 cases(36%) for Drug B versus none with the Naranjo algorithm.ALDEN pointed to a “possible” causality in 13 cases (21%) forDrug A and 12 cases (48%) for Drug B as compared to 60cases (97%) for Drug A and 22 Cases (88%) for Drug B withthe Naranjo algorithm. Majority of the cases when combined forboth the drugs fell in the “possible” category (92.5%) withNaranjo algorithm whereas the majority fell in the extremes ofcausality categories (“unlikely”/“very unlikely” category (46%)and “probable”/“very probable” category (20%)) utilizingALDEN.
Conclusion:
This study comparing the outcomes of causality assessment forSJS/TEN displayed the scores for Naranjo algorithm whichpointed majorly towards the possible category whereas theALDEN scores were segregated widely as it factored otherparameters in the algorithmic criteria like type of drug(notoriety), pharmacokinetics, and weightage for the similardrug reactions. The segregation results obtained from thisstudy utilizing ALDEN algorithm are in line with the comparativecase-control analysis done by the expert group involved in theSCAR study which in turn correlated well with EuroSCAR andRegiSCAR studies. As ALDEN segregated the scores mainly intothe extremes of the causality categories, it helps physicians todetermine in each patient not only the drug that had mostprobably induced the reaction but also the drugs that weremere innocent bystanders and could safely be administered tothe patient again. ALDEN can be considered as a reference toolin evaluating drug causality for SJS/TEN and clinicians canutilize ALDEN methodology to make an informed decision bysegregating drugs capable of causing the reaction at thepatient level.

ALDEN (an Algorithm of Drug Causality for Epidermal Necrolysis) & Naranjo – a comparative causality assessment

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Pharmacovigilance Strategies Workshop

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