Guselkumab (2) – Tremfya®

Psoriatic arthritis (PA)

Characteristics

Start date 01.12.2020 – Marketing authorisation: 20.11.2020
Resolution 20.05.2021
INN Guselkumab
Brand name Tremfya®
Pharm. company Janssen-Cilag GmbH
G-BA Procedure ID D-625
ATC code L04AC16 Interleukin inhibitors (L04AC)
ICD-10 codes (AIS) L40.5Arthropathic psoriasis
DDD 1.79 mg P
Therapeutic area Skin diseases Psoriatic Arthritis (PA)
Reason for procedure New therapeutic indication
Specialty ACT change

Therapeutic indication of the resolution

Tremfya, alone or in combination with methotrexate (MTX), is indicated for the treatment of active psoriatic arthritis in adult patients who have had an inadequate response or who have been intolerant to a prior disease-modifying antirheumatic drug (DMARD) therapy.
Subpopulation Indication Comparator
a) Adult patients with active psoriatic arthritis who have had an inadequate response to, or have not tolerated, previous disease-modifying antirheumatic (DMARD) therapy. A TNF-alpha antagonist (adalimumab or certolizumab pegol or etanercept or golimumab or infliximab) or an interleukin inhibitor (ixekizumab or secukinumab or ustekinumab), possibly in combination with methotrexate.
b) Adult patients with active psoriatic arthritis who have had an inadequate response to, or have not tolerated, previous therapy with disease-modifying biological antirheumatic drugs (bDMARDs) Switching to another biological disease-modifying antirheumatic drug (adalimumab or certolizumab pegol or etanercept or golimumab or infliximab or ixekizumab or secukinumab or ustekinumab), possibly in combination with methotrexate

Studies and Results

No. of studies
(best subpopulation) 		2 (COSMOS, DISCOVER 1)
Study design
(best subpopulation) 		H2H vs. non-ACT + ITC (Bucher)
Meta analysis
(best subpopulation) 		no
Reason for dividing into subpopulations (G-BA) Previous treatment
ACT change 07.07.2020 – Änderungen der Leitlinien

  • Clinical trials
    • The VOYAGE 1 and VOYAGE 2 studies were randomised, double-blind trials.
    • In both trials, guselkumab was compared with placebo and adalimumab in adult patients with plaque psoriasis.
    • The COSMOS trial is a double-blind RCT comparing guselkumab with placebo.
    • The DISCOVER 1 trial is a double-blind RCT comparing guselkumab with placebo.
    • The PSUMMIT 2 study is a double-blind RCT comparing ustekinumab with placebo.

a) Adult patients with active psoriatic arthritis who have had an inadequate response to, or are intolerant of, prior disease-modifying antirheumatic drug (DMARD) therapy.

  • The additional benefit is not proven.
  • On the basis of the data presented, it is therefore not possible to draw any conclusions regarding the additional benefit of guselkumab over adalimumab for the indication of psoriatic arthritis.
  • morbidity
    • However, no data on the characterisation of psoriatic arthritis were recorded at the start of the study; consequently, information on the extent, severity and number of affected joints, as well as the degree of joint damage, is lacking.

b) Adult patients with active psoriatic arthritis who have responded inadequately to, or have been unable to tolerate, prior treatment with disease-modifying biological antirheumatic drugs (bDMARDs).

  • The additional benefit is not proven.
  • The adjusted indirect comparison presented, comparing guselkumab with ustekinumab via the bridge comparator placebo, is therefore not suitable for drawing conclusions regarding additional benefit due to methodological limitations.
  • Side effects
    • The proportion of patients experiencing a so-called ‘early escape’ due to lack of response by week 16 was very high in both the COSMOS and PSUMMIT 2 studies; consequently, the potential for bias across endpoints in the results of the COSMOS and PSUMMIT 2 studies is assessed as high.
    • Irrespective of the methodological limitations described, the IQWiG states that, in an indirect comparison, there is no statistically significant difference between guselkumab and ustekinumab for any of the endpoints included by the pharmaceutical manufacturer.

Courtesy translation only, please refer to the German original.

Associated procedures



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