HealthDay News — Acupuncture is safe and feasible for patients with irritable bowel syndrome with diarrhea (IBS-D), according to a pilot study published online December 29 in JAMA Network Open.

Ling-Yu Qi, from the Beijing University of Chinese Medicine, and colleagues randomly assigned 90 individuals with IBS-D to acupuncture (either specific acupoints [SA] or nonspecific acupoints [NSA]) or a sham acupuncture (NA) group with all groups receiving 12 30-minute sessions over 4 consecutive weeks.

The researchers observed substantial improvements in the response rate at week 4 for all groups (composite response rates of 46.7% in the SA group, 46.7% in the NSA group, and 26.7% in the NA group). However, the difference between the groups was not statistically significant. Adequate relief at week 4 was achieved by 64.3% in the SA group, 62.1% in the NSA group, and 55.2% in the NA group. Two patients (6.7%) in the SA group and 3 patients (10%) in the NSA or NA group reported adverse events.

“These findings suggest that acupuncture is feasible and safe; a larger, sufficiently powered trial is needed to accurately assess efficacy,” the authors write.

Abstract/Full Text

Adalimumab-adbm injection, a biosimilar to Humira^® (adalimumab), has been made available by Boehringer Ingelheim.

Adalimumab-adbm injection is an interchangeable biosimilar and can be substituted for the reference product without requiring a prescription change. The substitution may occur at the pharmacy similar to how generics are substituted for brand name drugs. According to the Company, Adalimumab-adbm injection has been priced at an 81% discount to Humira.  

Adalimumab-adbm injection is indicated for the treatment of adults with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, moderately to severely active Crohn disease, moderately to severely active ulcerative colitis, moderate to severe plaque psoriasis, moderate to severe hidradenitis suppurativa, and noninfectious intermediate, posterior, and panuveitis.

The product is also approved to treat moderately to severely active Crohn disease in children 6 years of age and older, as well as moderately to severely active polyarticular juvenile idiopathic arthritis in children 2 years of age and older.

Adalimumab-adbm injection is a citrate-free formulation and is supplied as 40mg/0.8mL, 20mg/0.4mL and 10mg/0.2mL prefilled syringes and as a 40mg/0.8mL prefilled autoinjector.

In July 2023, Boehringer Ingelheim launched a branded version of adalimumab-adbm called Cyltezo^®. This product will remain available at a 5% discount to Humira.

“Biosimilars are intended to contribute to the economic sustainability of health care systems, and it is our hope that this dual pricing approach will contribute to that sustainability, improve access to Adalimumab-adbm and help meet the varied needs of people with a variety of chronic inflammatory diseases,” said Stephen Pagnotta, Executive Director and Biosimilar Commercial Lead at Boehringer Ingelheim.

Amjevita (adalimumab-atto), a citrate-free biosimilar to Humira^® (adalimumab), is now available in the US.

Amjevita, a tumor necrosis factor (TNF) blocker, is indicated for:

• Rheumatoid arthritis (RA): reducing signs/symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA; may be used alone or with methotrexate (MTX) or other non-biologic DMARDs.
• Juvenile idiopathic arthritis (JIA): reducing signs/symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and older; may be used alone or with MTX.
• Psoriatic arthritis (PsA): reducing signs/symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA; may be used alone or with non-biologic DMARDs.
• Ankylosing spondylitis (AS): reducing signs/symptoms in adult patients with active AS.
• Crohn disease (CD): moderately to severely active CD in patients 6 years of age and older.
• Ulcerative colitis (UC): moderately to severely active UC in adult patients.
• Plaque psoriasis (PsO): treating adult patients with moderate to severe chronic PsO who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate.

The Food and Drug Administration (FDA) approved Amjevita in September 2016 based on data demonstrating that the biosimilar product and the reference product were highly similar, and that there were no clinically meaningful differences between the agents. Amjevita is not interchangeable with Humira. 

Amjevita is supplied in a 40mg/0.8mL single-dose prefilled SureClick autoinjector, and in 20mg/0.4mL and 40mg/0.8mL single-dose prefilled syringes. 

References

1. Amjevita (adalimumab-atto), first biosimilar to Humira^®, now available in the United States. News release. Amgen. Accessed January 31, 2023. https://www.prnewswire.com/news-releases/amjevita-adalimumab-atto-first-biosimilar-to-humira-now-available-in-the-united-states-301734177.html.
2. Amjevita. Package insert. Amgen; 2022. Accessed January 31, 2022. https://www.pi.amgen.com/-/media/Project/Amgen/Repository/pi-amgen-com/Amjevita/amjevita_pi_hcp_english.pdf.

Cyltezo^® (adalimumab-adbm), an interchangeable biosimilar to Humira^® (adalimumab), will soon be available in a new autoinjector device, in addition to the prefilled syringe.

Cyltezo is a tumor necrosis factor (TNF) blocker approved for the following indications:

• Rheumatoid arthritis: To reduce signs and symptoms, induce major clinical response, inhibit the progression of structural damage, and improve physical function in adult patients with moderately to severely active rheumatoid arthritis; can be used alone or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (DMARDs).
• Juvenile idiopathic arthritis: To reduce signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older; can be used alone or in combination with methotrexate.
• Psoriatic arthritis: To reduce signs and symptoms, inhibit the progression of structural damage, and improve physical function in adult patients with active psoriatic arthritis; can be used alone or in combination with non-biologic DMARDs.
• Ankylosing spondylitis: To reduce signs and symptoms in adult patients with active ankylosing spondylitis.
• Crohn disease: Treatment of moderately to severely active Crohn disease in adults and pediatric patients 6 years of age and older.
• Ulcerative colitis: Treatment of moderately to severely active ulcerative colitis in adult patients.
• Plaque psoriasis: Treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate; should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician.
• Hidradenitis suppurativa: Treatment of moderate to severe hidradenitis suppurativa in adult patients.

The prefilled Cyltezo Pen 40mg/0.8mL will be available in 2-, 4- and 6-pack options on July 1, 2023. According to Boehringer Ingelheim, the pen was designed with patient-centered features to simplify the administration process.

“The FDA approval of the Cyltezo Pen is great news for patients living with chronic inflammatory diseases who may prefer administering the medication needed to manage their conditions via an autoinjector,” said Stephen Pagnotta, Executive Director and Biosimilar Commercial Lead at Boehringer Ingelheim.

Edward L. Barnes, MD, MPH, from the University of North Carolina at Chapel Hill, and colleagues developed recommendations for the prevention and treatment of pouchitis and cuffitis to support practitioners in their management of these conditions.

The guideline panel made 9 conditional recommendations. The AGA suggests using antibiotics for treatment of pouchitis in patients with ulcerative colitis who have undergone ileal pouch-anal anastomosis and experience intermittent symptoms of pouchitis. Probiotics are suggested for the prevention of recurrent pouchitis in patients who experience recurrent episodes of pouchitis that respond to antibiotics. Chronic antibiotic therapy is suggested to prevent recurrent pouchitis in patients who experience recurrent pouchitis that responds to antibiotics but relapses after stopping antibiotics; however, advanced immunosuppressive therapies approved for treatment of inflammatory bowel disease are suggested for patients who are intolerant to antibiotics or who are concerned about the risks of long-term antibiotic therapy. Advanced immunosuppressive therapies are also suggested for patients with recurrent pouchitis with inadequate response to antibiotics; corticosteroids can also be considered for these patients.

“As providers we struggle to get insurance approval for medications to treat pouchitis, because it has not been a well-defined or recognized entity,” coauthor Siddharth Singh, MD, from the University of California San Diego in La Jolla, said in a statement. “Our intention with this guideline is to help improve access for patients and providers to use these advanced therapies.”

Several authors disclosed ties to the pharmaceutical industry.

Abstract/Full Text

Treatment with risankizumab led to a significant proportion of adults with moderately to severely active ulcerative colitis achieving clinical remission, according to findings from a phase 3 maintenance study.

The 52-week, multicenter, randomized, double-blind, placebo-controlled COMMAND study (ClinicalTrials.gov Identifier: NCT03398135) included 548 adults with moderate to severely active ulcerative colitis who responded to induction treatment in the phase 2b/3 INSPIRE study (ClinicalTrials.gov Identifier: NCT03398148). Patients were re-randomized to receive either risankizumab 180mg subcutaneously (SC), risankizumab 360mg SC, or withdrawal from risankizumab treatment.

Results showed that 40% and 38% of patients treated with risankizumab 180mg and 360mg, respectively, met the primary endpoint achieving clinical remission at week 52 (per Adapted Mayo Score), compared with 25% of patients in the induction-only control group (P <.01).

Additionally, a significantly greater proportion of patients treated with risankizumab 180mg and 360mg achieved endoscopic improvement (51% and 48%, respectively, vs 32%; P <.001), histologic improvement (43% and 42%, respectively, vs 23%; P <.001), and steroid-free clinical remission (40% and 37%, respectively, vs 25%; P <.01) at week 52 compared with patients in the induction-only control group. 

The safety profile of risankizumab was consistent with that observed in previous studies across other indications. The most common adverse events with risankizumab were colitis ulcerative, COVID-19, nasopharyngitis and arthralgia.

“These positive results suggest that risankizumab is a promising therapy to help ulcerative colitis patients with challenging symptoms that disrupt their daily lives,” said Stefan Schreiber, MD, director of department of internal medicine I, University Hospital Schleswig-Holstein, Germany, COMMAND study investigator. “Risankizumab’s achievement of a broad range of difficult-to-reach endpoints encompassing endoscopic-histologic outcomes and many others represents important progress toward addressing the need for additional treatment options for patients with ulcerative colitis.”

Risankizumab, an interleukin-23 inhibitor, is currently marketed under the brand name Skyrizi^® for the treatment of active psoriatic arthritis, moderately to severely active Crohn disease, and moderate to severe plaque psoriasis.

Natalia González-López, from the Hospital Universitario de Canarias in Tenerife, Spain, and colleagues examined whether uptake of FIT screening is superior to uptake of colonoscopy screening in a population of FDRs of patients with CRC. The open-label, parallel-group trial was conducted in 12 centers between February 2016 and December 2021. Eligible participants were FDRs of index cases younger than 60 years or having two or more index cases or a sibling with CRC, regardless of age at diagnosis; 1760 FDRs of 460 index cases were assessed for inclusion: 870 were assigned to undergo one-time colonoscopy or FIT (431 and 439, respectively).

The researchers found that of those assigned to undergo colonoscopy or FIT, 44.0% attended the appointment and signed informed consent: 34.1 and 35.9% underwent colonoscopy-based screening and FIT-based screening, respectively (odds ratio, 1.08; 95% CI, 0.82 to 1.44; P =.564). Compared with the FIT group, the colonoscopy group had a significantly higher detection rate of advanced colorectal neoplasia (odds ratio, 3.64; 95% CI, 1.55 to 8.53; P =.003). Throughout follow-up, there was no change noted in study outcomes.

“In the setting of an opportunistic screening, annual FIT does not increase the screening uptake compared to colonoscopy screening in FDR at high risk of developing CRC, resulting in a significantly lower detection rate of advanced colorectal neoplasia,” the authors write.

Several authors disclosed ties to Sysmex and other companies.

Abstract/Full Text

Darvadstrocel is a dispersion of expanded allogeneic, adipose-derived mesenchymal stem cells. The double-blind, parallel-group, placebo-controlled, ADMIRE-CD II study (ClinicalTrials.gov Identifier: NCT03279081) enrolled 569 patients 18 years of age and older with clinically controlled, inactive or mildly active Crohn disease diagnosed at least 6 months prior to screening and the presence of complex perianal fistulas. Study participants were randomly assigned 1:1 to receive intralesional injection of darvadstrocel or placebo for 24 weeks.

Findings demonstrated that treatment with darvadstrocel did not meet the primary endpoint of combined remission at 24 weeks, defined as the closure of all treated external openings that were draining at baseline despite gentle finger compression, and absence of collection(s) greater than 2cm (in at least 2 dimensions) of the treated perianal fistula(s) confirmed by blinded central MRI assessment. 

“While we are disappointed with this outcome, we recognize that medical research for difficult-to-treat conditions such as complex CPF remains challenging,” said Chinwe Ukomadu, head of the GI & Inflammation Therapeutic Area Unit at Takeda. “We believe there are valuable lessons to learn from ADMIRE-CD II and are grateful to the patients and investigators who made this important research possible.”

Full study results will be presented at a future medical meeting.