In an interview with PharmaShots, Jan Wehkamp, M.D., Vice President, Gastroenterology Disease Area Leader for the Immunology Therapeutic Area at Janssen Research & Development shared his views on the data from 13 P-II & III studies of Stelara (ustekinumab) for the treatment of IBD and other approved indications

Shots:

• The company has reported the data from 13 P-II & III studies, including 6 studies in CD or UC and seven studies in PsO or PsA to evaluate Stelara (ustekinumab) vs PBO in patients aged ≥60yrs.
• The results showed that the rates of serious AEs & infections were similar b/w Stelara & PBO. Additionally, no increased risk of malignancy was observed. The safety profile of Stelara-treated patients from the long-term pooled safety dataset across approved indications did not show higher rates on Stelara vs PBO
• The company presented 13 total abstracts at UEGW including two late-breakers i.e., new data from the STELARA STARDUST long-term extension and a new analysis from the STELARA SEAVUE study

Tuba: Let us first discussed about the design and population of the pooled analysis presented during UEGW?

Jan Wehkamp: Happy to. For this analysis, data from 13 Phase 2 and 3 studies, including six studies in Crohn’s disease/ulcerative colitis and seven studies in psoriasis/psoriatic arthritis for STELARA® (ustekinumab), were pooled. Concomitant immunomodulators and corticosteroids were permitted for inflammatory bowel disease and psoriatic arthritis, but not psoriasis studies. Safety outcomes were presented as events per 100 patient-years (PY) of follow-up and 95% confidence interval (CIs). Of patients 60 years old and older with moderate to severe Crohn’s disease or ulcerative colitis, 214 received STELARA, the equivalent of 311 patient-years (PYs) of follow up, and 120 received placebo, the equivalent of 97 PYs. Across additional approved indications, 811 received STELARA (1,590 PYs) and 272 received placebo (143 PYs).

Tuba: Can we discuss the efficacy and safety of the pooled analysis?

Jan Wehkamp: Certainly. Results from the pooled analysis showed that rates of key safety events among adults 60 years and older treated with STELARA for up to five years were similar to rates observed with placebo during the control phase of these trials. Key safety events included adverse events (AEs), rates for infections, rates of serious AEs, and serious infections. Overall, rates for AEs per 100 PYs were no greater for STELARA (269.12) than placebo (455.9). In infections, overall rates per 100 PYs were similar between STELARA (75.49) and placebo (86.44). Additionally, rates of serious AEs (STELARA: 19.88; placebo: 27.19) and serious infections (STELARA: 3.33; placebo: 3.49) were similar between STELARA and placebo treatment groups.

Notably, no increased risk of malignancy with STELARA was observed based on a comparison of observed versus expected malignancies, which is an important finding in a high-risk population such as this one. 

Tuba: Did Janssen presented other study data also during UEGW? What were those?

Jan Wehkamp: Yes, Janssen presented 13 total abstracts at UEGW. This included two late-breakers: new data from the STELARA STARDUST long-term extension and a new analysis from the STELARA SEAVUE study. 

Results from the STARDUST study showed adult patients with moderately to severely active Crohn’s disease who were treated with STELARA maintained clinical and endoscopic response and remission through 104 weeks. Additionally, results showed that flexible STELARA dosing enabled the preservation of the proportions of patients in clinical and endoscopic response and remission during the LTE. 

Results from the SEAVUE study, which evaluated immunogenicity, as shown by the development of anti-drug antibodies, showed that immunogenicity was greater with adalimumab than STELARA at both week 16 and week 52 in adult patients with moderate to severe Crohn’s disease:

• At week 16, 1.7 percent (3/179) of patients had anti-STELARA antibodies versus 63.3 percent (112/177) of patients with anti-adalimumab antibodies. At week 52, 1.9 percent (3/156) of patients had anti-STELARA antibodies versus 73.6 percent (106/144) of patients with anti-adalimumab antibodies.

Additionally, new interim analyses from the TREMFYA® (guselkumab) GALAXI study in adults with moderately to severely active Crohn’s disease were presented, evaluating PRO-2 remission and Inflammatory Bowel Disease Questionnaire (IBDQ) scores. GALAXI is a Phase 2, double-blind, placebo-controlled study of TREMFYA, an IL-23 antagonist, for the treatment of patients with moderately to severely active Crohn’s disease. In the IBDQ analysis, results showed that TREMFYA-treated patients reported greater improvement in IBDQ scores compared to those receiving placebo as early as week 8 and also at week 12. In the PRO-2 remission analysis, TREMFYA-treated patients achieved greater reductions in abdominal pain, stool frequency, and higher rates of PRO-2 remission at weeks 4, 8, and 12 compared to those receiving placebo.

Tuba: Why only 60+ years aged patients/ older patients? Any specific reason?

Jan Wehkamp: We sought to study this population for a few reasons. First, little data exists about the safety profile of biologics in patients aged 60 and older with inflammatory bowel disease, as this population is often limited in number in clinical trials. Additionally, this population is considered at a higher risk of disease and therapy-associated morbidity, which can result in disease management challenges. We hope that providing data in this age group will better support physicians in making treatment decisions for their older patients. 

Tuba: How is Stelara better than any other drug in the market for the older population?

Jan Wehkamp: We are committed to continuing to evaluate our marketed medicines in inflammatory bowel disease to help providers make informed treatment decisions for their older patients. This was the first examination of safety events in the 60 and over sub-population across STELARA indications and underscores our commitment to developing meaningful therapies for people of all ages who are living with an untreated or undertreated immune-mediated disease.

Tuba: Do you think Stelara offers better QoL than its competitors for the geriatric population?

Jan Wehkamp: At Janssen, we understand how important it is for patients to achieve relief from symptoms as they navigate their chronic disease. Data from the long-term pooled safety analysis demonstrated that STELARA is a safe treatment option for the 60 years and older population living with moderate to severe Crohn’s disease and ulcerative colitis versus placebo. As previously mentioned, treatment with STELARA also demonstrated no increased risk of malignancy, which can be detrimental to a patient’s health. These data build on the body of evidence supporting the safety profile of STELARA in a range of age groups.

Tuba: Is Janssen working on the digital initiative for patient engagement, patient adherence, HCP engagement? If yes, can you share more details on that.

Jan Wehkamp: At Janssen, we recognize the importance of understanding patient needs and raising awareness of gastroenterological diseases. Currently, our teams are leading two patient-driven initiatives, “Peace Within”, intended to showcase Janssen’s commitment to supporting people living with immune-mediated diseases such as IBD and the “My IBD Journey” animation series, an online resource created by Janssen Immunology in collaboration with The European Federation of Crohn’s and Ulcerative Colitis Associations (EFCCA) for IBD patients containing important information, hints, and tips on managing IBDs like UC and CD. 

Additional Janssen digital patient initiatives include a podcast called “Gutcast,” the first IBD podcast in Ireland with the mission of informing and empowering patients to manage their condition, and Janssen Italy’s digital initiative “Fatti Più In Là” ("Go further - Let's move away from Crohn's disease and ulcerative colitis") in collaboration with the National Association for Chronic Inflammatory Bowel Diseases.

Readers can also learn more about our commitment to gastroenterology here: https://www.janssen.com/gastroenterology 

Source: Rappler

About Author: Jan Wehkamp is the Vice President, Gastroenterology Disease Area Leader for the Immunology Therapeutic Area at Janssen. He received his M.D. from the University of Lübeck in Germany and completed his post-doctoral work in immunology and microbiology at the Cleveland Clinic in Ohio and the University of California in Davis, California

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