In the randomised, double-blind, placebo-controlled, Phase III (registration) study for Jorveza^® in adult patients with active EoE, 57.6% of patients receiving the 1 mg BID regimen were in clinicohistologic remission at week 6 (primary endpoint) vs. 0% in the placebo group (p<0.00001). When Jorveza^® treatment was extended to a total of 12 weeks, the clinicohistologic remission rate increased to 84.7% (Fig. 1). Furthermore, 93.7% of patients in the Jorveza^® group were in histologic remission at week 6 (vs. 0% of the placebo group; p<0.0001)¹, highlighting the importance of achieving histologic remission first to allow oesophageal healing before symptom improvement can occur.

Fig. 1: % Patients in clinicohistologic remission at week 6 or week 12 following Jorveza^® 1 mg BID treatment¹

Furthermore, a complete normalisation of oesophageal appearance was documented in 61% of patients receiving Jorveza^® vs 0% in placebo group; p<0.0001)¹, based on a treatment-blinded assessment using the Endoscopic Reference Score (EREFs). [The EREFs is used to determine severity of key endoscopic findings: oedema, rings, exudates (markers of inflammation) and furrows, strictures and crepe-paper oesophagus (markers of fibrosis). Each of these findings is graded from normal/none to severe/present/absent, related to the specific parameter]. 

Fig. 2: Percentage of Patients in Endoscopic Remission with Jorveza Treatment (1 mg BID) at week 6.¹

As a chronic inflammatory disease, the risk of histologic and thus clinical relapse in EoE patients is high following successful induction treatment if long-term and effective maintenance therapy is not initiated. To evaluate the efficacy and safety of long-term maintenance therapy with Jorveza^® (1 mg BID) in adult EoE patients in clinicohistologic remission following prior placebo-controlled induction treatment with Jorveza^®, patients were enrolled in a prospective, randomised (1:1:1), double-blind study to receive either Jorveza^® 0.5 mg BID or Jorveza^® 1 mg BID, or matching placebo and were followed for 48 weeks.² The primary endpoint was the percentage of patients without treatment failure (i.e. maintaining clinicohistologic remission), defined fulfilling ALL of the following criteria as: absence of clinical relapse; absence of histological relapse; absence of food impaction requiring endoscopic intervention; no need of dilation and/or no premature withdrawal for any reason. At week 48, 73.5% and 75.0% of the patients in the Jorveza^® 0.5 mg or Jorveza^® 1 mg BID treatment groups, respectively, were still in clinicohistologic remission vs. 4.4% with placebo (p<0.001; see Fig. 3).³

Fig. 3: Maintenance of clinicohistologic remission over 48 weeks in adult patients with EoE with
Jorveza^® treatment, following prior induction of clinicohistologic remission with Jorveza^®.³

In addition, in the placebo group, 89.7% of subjects experienced histological relapse (≥48 eos/mm² hpf; ≥15 eos/hpf) versus 10.3% of subjects treated with 1 mg Jorveza^® BID and 13.2% of subjects treated with 0.5 mg Jorveza^® BID regimens.³

Based on the documented rate of clinical relapse, the time to clinical relapse was also estimated for the 3 treatment groups (Fig. 4). For the placebo group, the median time to relapse was 87 days, while for the two Jorveza^® treatment groups, this was >350 days.³

Fig. 4: Time to clinical relapse for two Jorveza^® regimens (0.5 mg BID or 1 mg BID) vs. placebo in the 48-week maintenance study.³

Recommended Dosage for Induction & Maintenance Treatment for Jorveza^®

The recommended daily dose for induction treatment is 2 mg Jorveza^® as one 1 mg tablet in the morning and one 1 mg tablet in the evening. The usual duration of induction treatment is 6 weeks. For patients who are not appropriately responding during the 6 weeks, treatment can be extended up to 12 weeks.⁴

The recommended daily dose for maintenance of remission is 1 mg Jorveza^® as one 0.5 mg tablet in the morning and one 0.5 mg tablet in the evening, or 2 mg Jorveza^® as one 1 mg tablet morning and one 1 mg tablet in the evening, depending on the individual clinical requirement of the patient.⁴

*The maintenance dose of 1.0 mg Jorveza^® twice daily is recommended for patients with a long-standing disease history and/or high extent of oesophageal inflammation in their acute disease state.⁴

PLEASE REVIEW PRODUCT INFORMATION BEFORE PRESCRIBING.
COPIES OF THE PRODUCT INFORMATION FOR JORVEZA^® CAN BE REQUESTED BY CALLING DR FALK PHARMA AUSTRALIA PTY LTD ON 1800 DRFALK (1800 373 233), OR AT THERAPEUTIC GOODS ADMINISTRATION.