Healthcare professionals - Clipper
 
Intended for UK healthcare professionals only. Click here for Adverse events reporting.
Prescribing Information

Healthcare professionals

 
 

Indicated for the treatment of mild or moderate ulcerative colitis in active phase, as add-on therapy to 5-ASA containing drugs in patients who are non-responders to 5-ASA therapy in active phase.1

Keep it simple

 
 

When aminosalicylates (5-ASAs) alone are not enough to induce remission, consider adding Clipper1,2

  • Non-inferior to prednisolone in the treatment of active UC (given as a prodrug – prednisone)3,4
  • Limited systemic steroidal adverse events5
  • Simple to take
 
 
 

Ulcerative colitis

 
 

The management of UC flares presents a significant challenge for healthcare professionals and their patients. 70% of those with active disease and 30% of those in remission in a given year will experience a flare the following year.9 Flare symptoms and severity vary from person to person and may last from a few days to several months.10

 

For patients that do not respond to up titrations of aminosalicylate therapy, further treatment with topical or oral corticosteroids for 4–8 weeks (depending on steroid), is recommended.11

 
 

Gastroenterology backlog prevents ease of seeing a specialist

 
 

392,574

 

gastroenterology appointments

 

23,473 (6%)

 

patients

 

1+ year

 

waiting for an appointment12

 
 

Due to the high number of patients experiencing flares, access to hospital-based specialists is under huge pressure, making it vital that referral from primary care is only for patients that need to see a gastroenterologist.

 

There is currently a backlog of gastroenterology appointments (September 2023) with 23,473 (6%) of patients waiting more than a year for an appointment.12

 
 
 

Improving access to Clipper® in primary care 

 

Any reduction in outpatient appointments and secondary care admissions for patients with  flares could release capacity, keep care closer to home, help to improve the whole system flow, and contribute to delivering a balanced net financial position as aligned with National Health Service objectives.12,13 

The addition of Clipper® to repeat prescriptions of appropriate patients will allow patients to easily access and self-administer the medication in a home setting14 minimising the requirement for outpatient attendance to obtain repeat prescriptions of Clipper® for each subsequent flare.  

 
 

Keep it Simple

 
 

For managing flare ups in mild to moderate ulcerative colitis when 5-ASAs alone are not enough to induce remission1,2

 

Effective


 

Clipper is non-inferior to prednisolone (given as a prodrug – prednisone) in the treatment of active mild to moderate ulcerative colitis3,4

 

Topical steroid
side effect profile

 

Clipper has low systemic
bioavailability and therefore a more favourable side effect profile compared with
conventional steroids1,6

 

Simple


 

One tablet, once a day for up to 4 weeks, with no titration1

 

 

 
 

Need to know more?

 
 

Co-Primary Endpoint – Efficacy of Clipper 3,4

 
 

Clipper is non-inferior to prednisolone (given as a prodrug – prednisone) in improving:

 

Clinical symptoms

 

Endoscopic healing

 

Rectal bleeding

 

The percentage of patients in remission were similar between the two groups.

 

Non-inferiority of Clipper vs. PD was confirmed as the difference between the two treatment groups as −1.56 with a 95% CI of −13.00–9.88 (P= 0.78, ITT population).
Similar results were observed in the PP population.

 

Abbreviations

 

DAI; disease activity indicator, ITT; intention to treat, PD; Prednisone, PP; per protocol.

 

Graph adapted from Van Assche et al.

 
 
 

Study design:

 

Double-blind study comparing efficacy and safety of the topically acting corticosteroid beclomethasone dipropionate to prednisone in patients with active, mild-to-moderate ulcerative colitis. METHODS: Overall, 282 patients were randomized to receive Clipper prolonged release tablets 5 mg once daily for 4 weeks and then every other day for an additional 4 weeks or oral PD 40 mg once daily for the initial 2 weeks tapered of 10 mg every 2 weeks during the 8-week study period.3

 
 

Co-Primary Endpoint – Safety of Clipper3

 
 

The primary safety endpoint was to demonstrate a safety profile versus prednisone in terms of patients who experienced steroid-related AEs and reduction of endogenous cortisol production <150 nmol/l.

 

The study did not meet the
co-primary safety endpoint.

 

Treatment difference
(Clipper-PD): -8.21.
95%CI: -19.72 to 3.30.

 
 
 

A total of 28 steroid-related AEs (10 in the Clipper and 18 in the PD group), were reported in 23 patients in the first 4 weeks of the treatment period, of which 8 patients (5.8%) were in the Clipper group and 15 (10.3%) were in the PD group (P=0.18).

 

 

Regarding morning serum cortisol, a total of 50 (37.9%) patients in the Clipper group and 62 (44.0%) patients in the PD group had levels <150 nmol/l (P =0.31) at the end of 4 weeks of treatment.

 

Abbreviations

 

AEs; adverse events, PD; Prednisone

 
 

As Clipper is gastro-resistant prolonged released and used for up to 4 weeks, it offers efficacy with a low potential for systemic consequences1,5,8

 
 

In vivo disintegration visualisation for an enteric coated modified release beclomethasone dipropionate delivery system

 

28 minutes


 

 

Passage through the stomach

 

117 minutes


 

 

Clipper remains intact for 57-118 min

 

253 minutes


 

 

Entering the colon

 

379 minutes


 

 

Dissolution ending

 
 

Gamma scintigraphy data in healthy volunteers demonstrated that Clipper remains intact for 57-118 minutes before initial disintegration begins.

 

Clipper dissolution process over time (scintigraphic data). Adapted from International Journal of Pharmaceutics 1994;112:199-205

 
 

Posology of Clipper1

 
 
 

Adults

  • One Clipper 5 mg tablet a day to be taken in the morning before or after a light breakfast.
  • Tablets must be swallowed whole with a little liquid. The tablets should not be broken or chewed.
  • Therapy cycles of not more than 4 weeks are recommended.
 
 

No special dose adjustment is recommended. However, experience with Clipper in the elderly is limited.

 

Clipper is not recommended
for use in children.

 

Refer to the SmPC for further information

 
 
 

 
 

Download our resources

 
 
 

 

Clipper
Formulary Application Support Pack
 

 

Clipper
Prescribing Protocol
 

 

Clipper
Patient Information Leaflet
 
 

Would you like to be notified when further resources
become available?

 
 

Contact Us

 
 

We’re here to help!

Whether you have questions about our services, need assistance with a product, or simply want to share your feedback, our dedicated teams are ready to assist you.

Please reach out to us using the contact information below, and we’ll get back to you as soon as possible.

 

 

Medical enquiries

 

 

Sales enquires

 
 
 

 

Something else?

 

Contact our UK head office

 

Chiesi Limited, 333 Styal Road, Manchester, M22 5LG, United Kingdom

 

info@chiesi.uk.com

 

+44 (0)161 488 5555

 

+44 (0)161 488 5566

 
 

References

  1. Clipper Summary of Product Characteristics, https://www.medicines.org.uk/emc/product/6417/smpc Accessed May 2024.
  2. UC Flare Pathway; IBD UK; https://ibduk.org/ibd-standards/flare-management/flare-pathways; Accessed May 2024.
  3. Van Assche et al. Oral Prolonged Release Beclomethasone Dipropionate and Prednisone in the Treatment of Active Ulcerative Colitis: Results From a Double-Blind, Randomized, Parallel Group Study; Am J Gastroenterol. 2015;110(5):708-15
  4. Frey, B. et al. Clinical Pharmacokinetics of Prednisone and Prednisolone; Clinical Pharmacokinetics; Volume 19, pages 126–146 (1990); https://doi.org/10.2165/00003088-199019020-00003
  5. Rizzello et al. Oral beclometasone dipropionate in the treatment of active ulcerative colitis: a double-blind placebo-controlled study; Aliment Pharmacol Ther 2002;16,1109-1116 https://onlinelibrary.wiley.com/doi/epdf/10.1046/ .1365-2036.2002.01298.
  6. Blackwell J, et al. Steroid use and misuse: a key performance indicator in the management of IBD; Frontline Gastroenterology 2021;12:207–213. doi:10.1136/flgastro-2019-101288.
  7. Carter M J, Lobo A J, Travis S P L, on behalf of the IBD Section of the British Society of Gastroenterology. Guidelines for the management of inflammatory bowel disease in adults. Gut 2004;53(Suppl V):v1–v16).
  8. Rizzello et al. The safety of beclomethasone dipropionate in the treatment of ulcerative colitis; Expert Opinion On Drug Safety. 2018;17(9):963–969.
  9. Inflammatory bowel disease.net, 2019
  10. Crohn’s & Colitis UK, 2023
  11. National Institute for Health and Care Excellence guideline. Ulcerative colitis: management [NG130]) (NICE 2019)
  12. NHS England, 2023
  13. NHS, 2019
  14. D’Amico et al, 2022
 
 

UK-CLI-2400011 | November 2024

 

Adverse event reporting
For the UK: Adverse events should be reported. Reporting forms and information can be found at https://yellowcard.mhra.gov.uk/ or search for MHRA Yellow Card in the Google Play or Apple App Store. Adverse events should also be reported to Chiesi Limited on 0800 0092329 (UK) or PV.UK@Chiesi.com.

For Ireland: Adverse events should be reported to HPRA Pharmacovigilance – www.hpra.ie. Adverse events should also be reported to Chiesi Limited on 1800 817459 (IE) or PV.UK@Chiesi.com.