- Fecal Incontinence
Certolizumab pegol eases symptoms of interstitial cystitis
Last Updated: 2018-08-13
By Anne Harding
NEW YORK (Reuters Health) - Certolizumab pegol improves symptoms in women with moderate to severe refractory interstitial cystitis/bladder pain syndrome (IC/BPS), a new randomized controlled trial shows.
IC/BPS is a chronic disease that reduces quality of life, and existing treatments aren't helpful to all patients, Dr. Philip C. Bosch of UC San Diego Medical Center and Palomar Medical Center in Escondido, California, notes in his report, online July 30 in European Urology.
There is evidence that IC/BPS may be autoimmune related, he adds, noting that drugs for treating autoimmune disease have relieved symptoms in some patients.
Abbott Labs funded a previous study by Dr. Bosch investigating its drug adalimumab for treating IC/BPS. In the current study, funded by UCB, he evaluated the Belgian company's drug certolizumab, a biologic approved for treating Crohn's disease, rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis.
Dr. Bosch randomly assigned 28 women to receive certolizumab pegol 400 mg and 14 to receive placebo at weeks 0, 2, 4 and 8, and followed them up to week 18; 26 and 13, respectively, completed the study.
At week two, there was no significant improvement in patient-reported global response assessment (GRA), but at week 18, GRAs were significantly improved versus placebo for pain (odds ratio, 17.3; P=0.002), urgency (OR, 9.92; P=0.02) and overall symptoms (OR, 15; P=0.006). [abstract, results]
Many patients in the study had already failed other available treatments, Dr. Bosch noted in a telephone interview with Reuters Health. IC/BPS may flare and then go into remission, he added. Diagnoses is typically delayed because it may be mistaken for a bladder infection in women or confused with prostate symptoms in men, who represent 25% of patients.
"It's just a horrible disease, and no one's been doing anything about it for the past 20 years," he said.
Clinicians should advise patients with IC/BPS to first try lifestyle measures to reduce bladder irritation and stress, which can be highly effective, he added.
Dr. Bosch is now planning a larger multi-center trial of certolizumab pegol, with the goal of having the U.S. Food and Drug Administration approve an IC/BPS indication for the drug.
Eur Urol 2018.