Guselkumab (4) – Tremfya®

Crohn’s disease, previously treated

Characteristics

Start date 01.06.2025 – Marketing authorisation: 05.05.2025
Resolution 20.11.2025
INN Guselkumab
Brand name Tremfya®
Pharm. company Johnson & Johnson
G-BA Procedure ID D-1216
ATC code L04AC16 Interleukin inhibitors (L04AC)
ICD-10 codes (AIS) K50.0Crohn´s disease of small intestine, K50.1Crohn´s disease of large intestine, K50.9Crohn´s disease, unspecified
Alpha-ID codes (AIS) I18518Crohn´s disease, I5645Crohn´s disease of the small intestine, I5647Crohn´s disease of the colon
Therapeutic area Digestive system diseases
Reason for procedure New therapeutic indication

Therapeutic indication of the resolution

Tremfya is indicated for the treatment of adult patients with moderate to severe active Crohn’s disease who have had an inadequate response to, have become unresponsive to, or have been unable to tolerate conventional therapy or biologic therapy.
Subpopulation Indication Comparator
a) Erwachsene mit mittelschwerem bis schwerem aktiven Morbus Crohn, die auf eine konventionelle Therapie unzureichend angesprochen haben, nicht mehr darauf ansprechen oder eine Unverträglichkeit zeigen
b) Erwachsene mit mittelschwerem bis schwerem aktiven Morbus Crohn, die auf ein Biologikum (TNF-α-Antagonist oder Integrin-Inhibitor oder Interleukin-Inhibitor) unzureichend angesprochen haben, nicht mehr darauf ansprechen oder eine Unverträglichkeit zeigen

Studies and Results

  • Clinical trials
    • The GALAXI 1 and GALAXI 2/3 trials were double-blind, multicentre RCTs comparing guselkumab at various doses with ustekinumab and placebo in adults with moderate to severe active Crohn’s disease.
    • The GALAXI 2 and GALAXI 3 trials have an identical study design, investigate the same endpoints and were conducted simultaneously, predominantly at the same centres.

a) Adults with moderate to severe active Crohn’s disease who have had an inadequate response to conventional therapy, no longer respond to it, or are intolerant of it

  • The additional benefit is not proven.
  • mortality
    • The results on overall mortality are based on data on fatal adverse events. No deaths occurred in either the GALAXI 1 or GALAXI 2/3 studies. For the endpoint of overall mortality, there is no statistically significant difference between the treatment arms.
  • Morbidity – Remission (PRO2)
    • For the endpoint of remission, as assessed using PRO2, there was no statistically significant difference between the treatment arms.
  • Morbidity – Corticosteroid-free remission (PRO2)
    • For the endpoint of corticosteroid-free remission, assessed using the PRO2, there was no statistically significant difference between the treatment arms.
  • Morbidity – Bowel symptoms (IBDQ)
    • For the endpoint ‘intestinal symptoms’, assessed using the relevant subscore of the IBDQ, there was no statistically significant difference between the treatment arms.
  • Morbidity – Systemic symptoms (IBDQ)
    • For the endpoint ‘systemic symptoms’, assessed using the relevant subscore of the IBDQ, there was no statistically significant difference between the treatment arms.
  • Morbidity – Fistula-free status
    • For the endpoint ‘fistula-free status’, there was no statistically significant difference between the treatment arms.
  • Morbidity – Fatigue (PROMIS Fatigue SF 7a)
    • For the endpoint ‘fatigue’, assessed using the PROMIS Fatigue SF 7a, there was no statistically significant difference between the treatment arms.
  • Morbidity – Symptoms (PGIC, PGIS)
    • For the endpoints ‘symptoms’, assessed using the PGIC and PGIS respectively, there was no statistically significant difference between the treatment arms in either case.
  • Morbidity – Health status (EQ-5D VAS)
    • For the health status endpoint, assessed using the VAS of the ‘European Quality of Life Questionnaire 5 Dimensions’ (EQ-5D), there was no statistically significant difference between the treatment arms in the proportion of patients showing a clinically relevant improvement of ≥ 15 points.
  • Morbidity – Activity impairment (WPAI-CD Item 6)
    • For the endpoint ‘activity impairment’, assessed using WPAI-CD Item 6, there was no statistically significant difference between the treatment arms.
  • Health-related quality of life – Inflammatory Bowel Disease Questionnaire (IBDQ) total score
    • For health-related quality of life, assessed using the IBDQ total score, there was no statistically significant difference between the treatment arms.
  • Health-related quality of life – PROMIS-29 physical summary score (PHS) and mental summary score (MHS)
    • For health-related quality of life, as assessed using the PROMIS-29, there was no statistically significant difference between the treatment arms in either case.
  • Side effects – Serious adverse events (SAE)
    • For the SAE endpoint, there was no statistically significant difference between the treatment arms.
  • Side effects – Withdrawal due to adverse events (AE)
    • For the endpoint ‘withdrawal due to AEs’, there was no statistically significant difference between the treatment arms.
  • Side effects – Specific AEs (infections)
    • In detail, for the specific AE ‘infections’, defined as infections and parasitic diseases (SOC, AEs), there was no statistically significant difference between the treatment arms.
  • Overall assessment
    • Overall, therefore, for adults with moderate to severe active Crohn’s disease who have responded inadequately to conventional therapy, they no longer respond to it, or show intolerance to it, an additional benefit of guselkumab over ustekinumab is not proven.

b) Adults with moderate to severe active Crohn’s disease who have responded inadequately to a biologic (TNF-α antagonist, integrin inhibitor or interleukin inhibitor), no longer respond to it or show intolerance

  • Indication of a minor additional benefit.
  • Despite existing uncertainties, the certainty of the findings is classified as ‘indication’ based on the meta-analytical synthesis of the GALAXI 1 and GALAXI 2/3 studies.
  • mortality
    • The results on all-cause mortality are based on data on fatal adverse events. No deaths occurred in either the GALAXI 1 or GALAXI 2/3 studies. For the endpoint of all-cause mortality, there is no statistically significant difference between the treatment arms.
  • Morbidity – Remission (PRO2)
    • For the endpoint of clinical remission, as assessed using PRO2, there was no statistically significant difference between the treatment arms.
  • Morbidity – Corticosteroid-free remission (PRO2)
    • For the endpoint of corticosteroid-free remission, assessed using the PRO2, there was a statistically significant advantage of guselkumab over ustekinumab.
  • Morbidity – Bowel symptoms (IBDQ)
    • For the endpoint ‘intestinal symptoms’, assessed using the relevant subscore of the IBDQ, there was no statistically significant difference between the treatment arms.
  • Morbidity – Systemic symptoms (IBDQ)
    • For the endpoint ‘systemic symptoms’, assessed using the relevant subscore of the IBDQ, there was no statistically significant difference between the treatment arms.
  • Morbidity – Fistula-free status
    • For the endpoint ‘fistula-free status’, there was no statistically significant difference between the treatment arms.
  • Morbidity – Fatigue (PROMIS Fatigue SF 7a)
    • For the endpoint ‘fatigue’, assessed using the PROMIS Fatigue SF 7a, there was no statistically significant difference between the treatment arms.
  • Morbidity – Symptoms (PGIC, PGIS)
    • For the endpoint ‘symptoms’, assessed using the PGIC and PGIS respectively, there was a statistically significant advantage of guselkumab over ustekinumab in each case.
  • Morbidity – Health status (EQ-5D VAS)
    • For the health status endpoint, assessed using the VAS of the ‘European Quality of Life Questionnaire 5 Dimensions’ (EQ-5D), there was no statistically significant difference between the treatment arms in the proportion of patients with a clinically relevant improvement of ≥ 15 points.
  • Morbidity – Activity impairment (WPAI-CD Item 6)
    • For the endpoint of activity impairment, assessed using WPAI-CD Item 6, there was a statistically significant advantage of guselkumab over ustekinumab.
  • Health-related quality of life – Inflammatory Bowel Disease Questionnaire (IBDQ) total score
    • For health-related quality of life, assessed using the IBDQ total score, there was a statistically significant advantage of guselkumab over ustekinumab.
  • Health-related quality of life – PROMIS-29 physical summary score (PHS) and mental summary score (MHS)
    • For health-related quality of life, as assessed using PROMIS-29, there was no statistically significant difference between the treatment arms in either case.
  • Side effects – Serious adverse events (SAE)
    • No statistically significant difference was observed between the treatment arms for the SAE endpoint.
  • Side effects – Withdrawal due to adverse events (AE)
    • For the endpoint ‘withdrawal due to AEs’, there was no statistically significant difference between the treatment arms.
  • Side effects – Specific AEs (infections)
    • In detail, for the specific AE ‘infections’, defined as infections and parasitic diseases (SOC, AEs), there was no statistically significant difference between the treatment arms.
  • Overall assessment
    • Taking an overall view of the available results, for adults with moderate to severe active Crohn’s disease who have had an inadequate response to, have ceased responding to, or have shown intolerance to a biologic (TNF-α antagonist, integrin inhibitor or interleukin-inhibitor), have an inadequate response to, no longer respond to, or show intolerance to a biologic, a minor additional benefit of guselkumab has been identified, based on the demonstrated advantages in both the morbidity endpoint category and the health-related quality of life.

Courtesy translation only, please refer to the German original.

Associated procedures



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