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Published on 18 September 2017

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New two-year data for guselkumab following positive CHMP opinion

Janssen Research & Development has presented new longer-term data from the open-label extension of the VOYAGE 1 trial demonstrating consistent rates of skin clearance with guselkumab treatment through week 100 among patients with moderate to severe plaque psoriasis receiving the subcutaneously administered anti-interleukin (IL)-23 monoclonal antibody.1

 

Janssen Research & Development has presented new longer-term data from the open-label extension of the VOYAGE 1 trial demonstrating consistent rates of skin clearance with guselkumab treatment through week 100 among patients with moderate to severe plaque psoriasis receiving the subcutaneously administered anti-interleukin (IL)-23 monoclonal antibody.1

 

The longer-term findings from the Phase III VOYAGE 1 study, presented at the 26th European Academy of Dermatology and Venereology (EADV) Congress, showed more than 80% of patients receiving guselkumab, including those initially treated with placebo or the anti-tumour necrosis factor (TNF)-alpha agent adalimumab, achieved at least a 90% improvement in the Psoriasis Area Severity Index (PASI 90), or near complete skin clearance, and an Investigator’s Global Assessment (IGA) score of cleared (0) or minimal disease (1) at week 100.1 The findings, presented during an EADV late-breaker session, follow the recent European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommendation for approval of guselkumab, and the United States Food and Drug Administration (FDA) approval of guselkumab in July.

 

These data show the rates of skin clearance with guselkumab were consistent at weeks 52 and 100 with every eight-week maintenance therapy.  These important new findings contribute to the scientific evidence for targeting IL-23 in the treatment of moderate to severe plaque psoriasis,” said Professor Chris Griffiths, Foundation Professor of Dermatology at the University of Manchester, UK, VOYAGE 1 study steering committee member.  “Also noteworthy is that skin clearance rates in patients transitioned to guselkumab from adalimumab improved and the rates were consistent at weeks 52 and 100.”

 

Results from the open-label extension of the Phase III VOYAGE 1 study showed that at week 100, among patients initially randomised to guselkumab, 82.4% achieved an IGA score of 0/1 (cleared or minimal disease) and 82.1% achieved a PASI 90 score (near complete skin clearance).1  In addition, at week 100, 53.8% of patients achieved an IGA score of 0 and 49.0% of patients achieved a PASI 100 score.1  These measures represent skin completely cleared of plaques and were consistent with PASI 100 and IGA 0 results demonstrated at week 52.1  Among patients initially randomised to receive adalimumab and transitioned to guselkumab at week 52, the proportion of patients achieving a PASI 90 score increased from 50.5% at week 52 to 81.1% at week 100, and the proportion of patients achieving an IGA 0/1 increased from 60.4% at week 52 to 84% at week 100.1  The proportion of patients who achieved PASI 100 and IGA 0 scores increased from 24.0% and 27.3%, respectively, at week 52 to 51.6% and 55.6%, respectively, at week 100.1  Results among patients initially randomised to placebo and crossed over to guselkumab at weeks 16 and 20 demonstrated consistent levels of skin clearance at weeks 52 and 100.1

 

Scores from the Psoriasis Symptoms and Signs Diary (PSSD), which evaluates patient-reported symptoms (i.e., itch, pain, stinging, burning and skin tightness) and signs (i.e., skin dryness, cracking, scaling, shedding or flaking, redness, and bleeding),and the Dermatology Life Quality Index (DLQI), which assesses the impact of disease and disease improvement following therapy on study participants’ quality of life, were consistent over the two-year period with guselkumab treatment.1  Patients initially randomised to receive adalimumab therapy in VOYAGE 1 and crossed over to guselkumab demonstrated substantial improvement in PSSD and DLQI scores from week 48 to week 100.1  The proportion of patients reporting PSSD symptom scores of 0 (0–10 scale where a higher score indicates more severe symptoms of psoriasis) improved from 23.1% at week 48 (during adalimumab treatment) to 41.8% at week 100 (during guselkumab treatment).1  The proportion of patients reporting DLQI scores of 0/1 improved from 38.9% at week 48 (during adalimumab treatment) to 74.0% at week 100 (during guselkumab treatment).1

 

Through week 100, there were no disproportionate increases in rates of adverse events (AEs) compared with rates through week 48. Serious AE rates were low and remained stable. No cases of active tuberculosis, opportunistic infections or serious hypersensitivity reactions were reported.1

 

We are committed to advancing innovative therapies for immune-mediated diseases, like psoriasis, as we seek to improve outcomes for patients,” said Newman Yeilding, MD, Head of Immunology Development, Janssen Research & Development, LLC.  “We look forward to continued collaborations with regulators as we work to bring guselkumab to patients around the world who may benefit from this novel therapy.”

 

Reference

  1. Griffiths C et al. 26th European Academy of Dermatology and Venereology Congress (EADV 2017) 13–17 Sept, 2017; Geneva, Switzerland; D3T01.1I


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