Azathioprine versus mycophenolate mofetil in treatment-naive autoimmune hepatitis: 3-year follow-up of the CAMARO-trial.
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Slooter Charlotte D, Snijders Romée Jalm, Stoelinga Anna E C, Gerrits Katinka M A, Gevers Tom J G, Pape Simon, Biewenga Maaike, van der Meer Adriaan J, Tushuizen Maarten E, Beuers Ulrich H W, van den Brand Floris F, Kramer Matthijs, Verdonk Robert C, de Jonge Hendrik J M, Vrolijk Jan Maarten, Bakker Sjoerd F, Vanwolleghem Thomas, Baven Pronk Martine Amc, Gerven Nicole M F van, Sijtsma Marijn G M, Kerkhof Ilona M, van Eijck Brechje C, van IJzendoorn Manon C, van Herwaarden Margot, Bartelink Maartje, Korkmaz Kerem Sebib, van den Berg Aad P, Hotho Daphne M, Guichelaar Maureen M J, Govaert Frank, Jansen Sita, van der Wiel Sanne K, Oterdoom Leendert H, Noach Leslie A, van Dijk Remco, Levens Amar D, van Hoek Bart, de Boer Ynto S, Drenth Joost P H, Dutch Autoimmune Hepatitis Working Group
Аннотация
METHODS: Patients enrolled in the multicenter randomized CAMARO trial were retrospectively followed for up to 3 years after treatment initiation. Co-primary endpoints were trial-assigned treatment with normalized alanine aminotransferase (ALT) at 3 years and time to biochemical response (normalization of ALT and immunoglobulin G).
RESULTS: Three-year follow-up was available for 67 patients (96%; 30 AZA, 37 MMF). At 3 years, 57% versus 76% remained on trial-assigned treatment with normalized ALT (p = 0.099). Median time to biochemical response was 64 versus 16 weeks (adjusted HR 2.74, 95% CI 1.49-5.06; p = 0.001). Among patients without ALT normalization at 24 weeks, 6/12 AZA-treated and 6/11 MMF-treated patients subsequently normalized ALT. Among patients remaining on randomized treatment at 24 weeks, subsequent treatment discontinuation occurred in 5/24 (21%) with AZA and 7/37 (19%) with MMF. Steroid-free ALT normalization (64% vs. 66%) and adverse event rates during year 3 (70% vs. 74%) were comparable (both p > 0.05). Five-year liver-related event-free survival was 70% (95% CI 55-93%) with AZA and 85% (95% CI 71-100%) with MMF (p = 0.080).
CONCLUSIONS: MMF was associated with faster biochemical response and numerically better overall tolerability. Among patients tolerating their assigned treatment during the initial treatment phase, subsequent outcomes were comparable between AZA and MMF. The substantial treatment burden with both therapies highlights the need for improved treatment options.
CLINICAL TRIAL NUMBER: NCT02900443.