ANZUPGO (delgocitinib) - Chronic hand eczema (CHE)

The clinical benefit of ANZUPGO 20 mg/g (delgocitinib) cream is substantial in the MA indication.

Considering:

• evidence of the superiority of delgocitinib 20 mg/g compared to placebo in adults with moderate to severe CHE with a history of inadequate or inappropriate response to topical corticosteroids in two phase 3 studies (DELTA 1 and 2):
  • for the primary endpoint: complete or almost complete clearance of lesions as assessed by the investigator (IGA-CHE score of 0 or 1 with an improvement of ≥ 2 points at week 16),
  • for all the ranked secondary endpoints at week 16, in particular, for an at least 90% improvement in a CHE severity index (HECSI-90), and improvement of patient-reported itch and pain (HESD score);
• evidence of the superiority of delgocitinib 20 mg/g compared to alitretinoin in adults with severe CHE with a history of inadequate response to topical corticosteroids in one phase 3 study (DELTA FORCE):
  • for the primary endpoint: absolute change from baseline in HECSI score at week 12,
  • for all the ranked secondary endpoints at week 12 or 24, in particular for HECSI-90 response, patient-reported improvement of itch and pain (HESD score) or IGA-CHE 0/1 responsewith an at least 2-point improvement;
• the safety profile of delgocitinib, marked primarily by application site reactions, and more favourable than that of alitretinoin (teratogenic, rare psychiatric risks);

But taking into account:

• the modest size effect compared to placebo (DELTA 1 and 2 studies) and alitretinoin (DELTA FORCE):
  • for IGA-CHE 0/1 response, with an improvement ≥ 2 points at W16 in the DELTA 1 (19.7% vs 9.9%; p = 0.006) and DELTA 2 (29.1% vs 6.9%; p < 0.001) studies, with the differences between the two groups at least 30% below the formulated hypotheses,
  • for the absolute change in HECSI score (score from 0 to 360 points) at W12 in the DELTA FORCE study (- 67.6 versus - 51.5; p < 0.001);
• the absence of clinically relevant differences observed for quality of life endpoints (change in DLQI and HEIS) in the placebo-controlled studies (DELTA 1 and 2);
• the open-label methodology of the DELTA FORCE study (assessor-blinded only), limiting the scope of the results for the patient-assessed subjective criteria (DLQI, HESD);

the Committee deems that ANZUPGO 20 mg/g (delgocitinib) cream provides a minor clinical added value (CAV IV) in the care pathway for moderate to severe CHE in adults for whom topical corticosteroids are inadequate or inappropriate.