- |||||||||| Actemra IV (tocilizumab) / Roche, JW Pharma, Cimzia (certolizumab pegol) / Astellas, Dermira, UCB
Journal: Certolizumab pegol in the treatment of Takayasu arteritis. (Pubmed Central) - Aug 15, 2019
Side effects included mild infections (n = 5). Our case series suggests that CZP may be an effective and steroid-sparing treatment option in patients with active TA even if they did not previously respond to other TNF inhibitors or tocilizumab.
- |||||||||| Humira (adalimumab) / Eisai, AbbVie, Cimzia (certolizumab pegol) / Astellas, Dermira, UCB
Clinical, Journal: Defining an Optimal Adherence Threshold for Patients Taking Subcutaneous Anti-TNFs for Inflammatory Bowel Diseases. (Pubmed Central) - Aug 8, 2019
Patients who delay refills >2 days on average every 2 weeks of their subcutaneous biologics have significantly increased risk of flare. Further studies to improve adherence among those patients who consistently delay medication use are necessary.Am J Gastroenterol advance online publication, 12 December 2017; doi:10.1038/ajg.2017.438.
- |||||||||| Real World Safety of Vedolizumab and Anti-TNF Therapies in Biologic-Naïve Ulcerative Colitis and Crohn’s Disease Patients: Results From the EVOLVE Study (Exhibit Halls 3 and 4 (Street Level)) - Aug 8, 2019 - Abstract #ACG2019ACG_2743;
Compared to anti-TNF pts, the VDZ cohort were older (mean [SD] age [years]: VDZ, 47.9 [17.4]; anti-TNF, 39.6 [15.2] [p< 0.01]), were proportionately more male (VDZ, 56.9%; anti-TNF, 49.9% [p=0.02]) and had a longer disease duration (median [range: min-max] disease duration [years]: VDZ, 5.0 [0.04– 54.0]; anti-TNF, 2.0 [< 0.1 – 49.0] [p< 0.01]). Median (range: min-max) follow-up (months) was: VDZ, 15.3 (3.0-47.0); anti-TNF, 16.3 (3.5-51.0).
- |||||||||| Current Treatment Patterns Among Patients With IBD in the U.S. Initiating Biologic Therapy (Exhibit Halls 3 and 4 (Street Level)) - Aug 8, 2019 - Abstract #ACG2019ACG_1850;
Over an average follow-up of 22.9 months, the mean duration of biologic treatment was 13.5 months (CD: 13.7; UC: 13.1). After 12 and 24 months of treatment, 7.0% (CD: 7.2%; UC: 6.8%) and 11.0% (CD: 11.2%; UC: 10.6%) of patients beginning biologic therapy had undergone surgery for IBD, respectively.
- |||||||||| A Case of Hepatosplenic T-cell Lymphoma in a Patient on Vedolizumab for Crohn’s Disease (Exhibit Halls 3 and 4 (Street Level)) - Aug 8, 2019 - Abstract #ACG2019ACG_1012;
To our knowledge, there have not been reports of HSTCL associated with vedolizumab use nor is there a known mechanism by which vedolizumab could cause HSTCL. In our case, TNF-α inhibitor was stopped 5 years prior and thiopurine analog 1 year prior to diagnosis, raising the question as to how long the risk of HSTCL remains elevated after cessation of such agents.
- |||||||||| Clinical Effectiveness of First-Line Anti-TNF Therapies and Second-Line Anti-TNF Therapy Post-Vedolizumab Discontinuation in Patients With Ulcerative Colitis or Crohn’s Disease (Stars at Night Ballroom - B2) - Aug 8, 2019 - Abstract #ACG2019ACG_393;
Proportions of patients in each cohort were: adalimumab (1L: 41.4%; 2L:19.5%), infliximab (1L: 52.7%; 2L: 79.3%), golimumab (1L: 4.8%; 2L: 1.2%) and certolizumab pegol (1L: 0.8%; 2L: 0.0%). Mean (SD) age at index date: 1L, 39.6 (15.2); 2L, 49.4 (18.6) years, male: 1L, 49.9%; 2L, 61.0%, median (range: min-max) disease duration: 1L, 2.0 (< 0.1 – 49.0); 2L, 3.7 (0.1 – 54.0) years.
- |||||||||| Peripartum Exposure to Biologic Therapy Does Not Impact Wound Healing After Cesarean Section in Women With Inflammatory Bowel Disease (Stars at Night Ballroom - B2) - Aug 8, 2019 - Abstract #ACG2019ACG_390;
Indications for the 37 C-sections (58%) included: history of perianal disease (n=12, 32%), severely active inflammation (n=1, 3%), ileal pouch anal anastomosis or end ileostomy (n=2, 5%), previous C-section (n=7, 19%), other obstetrical indications (large for gestational age, arrest of labor, malpresentation) (n=14, 38%), or other (n=1, 3%). Twenty six of 37 (70%) women with C-sections were exposed to biologics during pregnancy: infliximab (n=13, 35%), adalimumab (n=5, 14%), ustekinumab (n=3, 8%), vedolizumab (n=4, 11%), and certolizumab (n=1, 3%).
- |||||||||| Trial completion date, Trial primary completion date, Checkpoint inhibition: TICIMEL: TNF-Inhibitor as Immune Checkpoint Inhibitor for Advanced MELanoma (clinicaltrials.gov) - Aug 8, 2019
P1, N=30, Recruiting,
Twenty six of 37 (70%) women with C-sections were exposed to biologics during pregnancy: infliximab (n=13, 35%), adalimumab (n=5, 14%), ustekinumab (n=3, 8%), vedolizumab (n=4, 11%), and certolizumab (n=1, 3%). Trial completion date: Mar 2023 --> Oct 2022 | Trial primary completion date: Jun 2019 --> Dec 2020
- |||||||||| Actemra IV (tocilizumab) / Roche, JW Pharma, Enbrel (etanercept) / Takeda, Pfizer, Amgen, Cimzia (certolizumab pegol) / Astellas, Dermira, UCB
Clinical, Journal: Serious infection across biologic-treated patients with rheumatoid arthritis: results from the British Society for Rheumatolgy Biologics Register for Rheumatoid Arthritis. (Pubmed Central) - Aug 7, 2019
The rate of SI was lower with certolizumab pegol than etanercept in the primary analysis but the result was no longer significant in several sensitivity analyses performed suggesting residual confounding may account for the observed difference. From these results, it would be wrong to conclude that certolizumab pegol has a lower rate of SI than other biologics; however, the risk does not appear to be significantly higher as has previously been suggested.
- |||||||||| Journal: Risankizumab (Skyrizi) for psoriasis. (Pubmed Central) - Aug 6, 2019
Our study revealed that the best predictor of certolizumab effectiveness in unselected patients with RA, PsA, or SpA was a biologic-naïve status and achievement of an early response within 3 months. No abstract available
- |||||||||| Simponi (golimumab) / Merck (MSD), Mitsubishi Tanabe, J&J, Cimzia (certolizumab pegol) / Astellas, Dermira, UCB
Clinical, Journal: Efficacy and safety of certolizumab pegol and golimumab in the treatment of non-infectious uveitis. (Pubmed Central) - Aug 1, 2019
High hopes may be associated with the introduction of stem cells into clinical practice, which is the administration of non-hematopoietic multipotent cells to the fistulas to induce the phenomenon of immunomodulation and tissue healing. GOL and CZP represent effective and safe treatment choices for patients with uveitis also when unsuccessfully treated with other anti-TNF-α drugs, permitting a significant reduction in the frequency of ocular flares and preserving visual function with a good long-term retention rate.
- |||||||||| Trial completion: Impact of Medical Treatment on Sexual Function in Patients With Crohn's Disease (clinicaltrials.gov) - Jul 28, 2019
P=N/A, N=50, Completed,
GOL and CZP represent effective and safe treatment choices for patients with uveitis also when unsuccessfully treated with other anti-TNF-α drugs, permitting a significant reduction in the frequency of ocular flares and preserving visual function with a good long-term retention rate. Active, not recruiting --> Completed
- |||||||||| Enbrel (etanercept) / Takeda, Pfizer, Amgen, Humira (adalimumab) / Eisai, AbbVie, Cimzia (certolizumab pegol) / Astellas, Dermira, UCB
Clinical, Journal: Effects of a 15-month anti-TNF-α treatment on plasma levels of glycosaminoglycans in women with rheumatoid arthritis. (Pubmed Central) - Jul 19, 2019
In axSpA patients with CRP < ULN the CRP test should be repeated after ≥ 4 weeks as there is a substantial chance of finding a positive result for elevated CRP at subsequent testing, thereby allowing the patient access to treatment. Our results suggest that anti-TNF-α therapy has a beneficial effect on extracellular matrix remodeling in the course of RA.
- |||||||||| Simponi (golimumab) / Merck (MSD), Mitsubishi Tanabe, J&J, Cimzia (certolizumab pegol) / Astellas, Dermira, UCB
Journal: MAbTope: A Method for Improved Epitope Mapping. (Pubmed Central) - Jul 19, 2019
We show that MAbTope predicts the correct epitope for each of 129 tested examples of Ab/Ag complexes of known structure. We further validated this method through the successful determination, and experimental validation (using human embryonic kidney cells 293), of the epitopes recognized by two therapeutic Abs targeting TNF-α: certolizumab and golimumab.
- |||||||||| Cimzia (certolizumab pegol) / Astellas, Dermira, UCB
Pseudolymphoma by certolizumab (e-Poster Hall) - Jul 16, 2019 - Abstract #EADV2019EADV_1234;
- |||||||||| Cimzia (certolizumab pegol) / Astellas, Dermira, UCB
Clinical, Journal: Efficacy of certolizumab pegol with and without concomitant use of disease-modifying anti-rheumatic drugs over 4 years in psoriatic arthritis patients: results from the RAPID-PsA randomized controlled trial. (Pubmed Central) - Jul 4, 2019
P3
Long-term improvements in PsA symptoms were observed with CZP monotherapy or concomitant DMARDs, across important psoriatic disease domains, including joint disease, psoriasis, nail disease, dactylitis, and enthesitis. NCT01087788.
- |||||||||| Cimzia (certolizumab pegol) / Astellas, Dermira, UCB
Clinical, Journal: Efficacy and tolerability of certolizumab pegol in Crohn's disease in clinical practice. (Pubmed Central) - Jun 19, 2019
During the remission induction phase, maintenance of drug trough level above effective blood concentration is paramount, while the tapering and withdrawal of TNF inhibitors may be considered after achieving sustained remission. The obtained results demonstrate the efficacy and tolerability profile of CP appropriate for long-term CD therapy in real clinical practice.
- |||||||||| Review, Journal: Systemic rheumatic diseases: From biological agents to small molecules. (Pubmed Central) - Jun 19, 2019
In fact, we live in a period characterized by the need to rationalize costs of these drugs, to allow treating a higher number of patients and to maintain a homogeneous possibility of treatment choice. For these reasons, we need to follow scientific guidelines and patients' clinical conditions to choose the correct treatment, also based on the economic burden of therapies.
- |||||||||| Clinical, Review, Journal: Down-titration and discontinuation strategies of tumour necrosis factor-blocking agents for rheumatoid arthritis in patients with low disease activity. (Pubmed Central) - Jun 19, 2019
Disease activity-guided dose tapering of anti-TNF is comparable to continuation of treatment with respect to the proportion of participants with persistent remission and may be comparable regarding disease activity.Caveats of this review are that available data are mainly limited to etanercept and adalimumab, the heterogeneity between studies, and the use of superiority instead of non-inferiority designs.Future research should focus on the anti-TNF agents infliximab and golimumab; assessment of disease activity, function, and radiographic outcomes after longer follow-up; and assessment of long-term safety, cost-effectiveness, and predictors for successful down-titration. Also, use of a validated flare criterion, non-inferiority designs, and disease activity-guided tapering instead of fixed-dose reduction or discontinuation would allow researchers to better interpret study findings and generalise to clinical practice.
- |||||||||| Cimzia (certolizumab pegol) / Astellas, Dermira, UCB
Journal: Certolizumab pegol in treatment of Crohn's disease with perianal lesions. (Pubmed Central) - Jun 17, 2019
Also, use of a validated flare criterion, non-inferiority designs, and disease activity-guided tapering instead of fixed-dose reduction or discontinuation would allow researchers to better interpret study findings and generalise to clinical practice. This study showed that CP therapy is effective in treatment of CD with perianal lesions.
- |||||||||| Review, Journal: TNF-α inhibitors in the treatment of hidradenitis suppurativa. (Pubmed Central) - Jun 14, 2019
There is limited data on other TNF-α inhibitors such as certolizumab-pegol and golimumab. This review outlines the history, dosing, response, and adverse effects of TNF-α inhibitors in the treatment of HS.
- |||||||||| Stelara (ustekinumab) / J&J, Cimzia (certolizumab pegol) / Astellas, Dermira, UCB
Clinical, Journal, Adverse events: A safety review of recent advancements in the treatment of psoriasis: analysis of clinical trial safety data. (Pubmed Central) - Jun 6, 2019
The conclusions that can be drawn from clinical trial safety data are limited given that many clinical trials are not large enough to detect rare safety events, and there may be differences in safety experienced in clinical practice that are not well documented. Data from registries provide important complementary information on long-term safety but there are limitations including a lack of randomized assignment between drug treatments.
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