- |||||||||| Review, Journal, Cytokine storm: Immune system response during viral Infections: Immunomodulators, cytokine storm (CS) and Immunotherapeutics in COVID-19. (Pubmed Central) - Feb 2, 2021
Hence, rationalizing anti-inflammatory therapeutics would be the most judicious approach for significant reduction in COVID-19 mortality. In order to elucidate optimized and rationaled use of different therapeutics in COVID-19, we collated latest available information from emerging scientific evidences, integrated previous attempts as well as clinical successes, and various adopted approaches to mitigate past outbreaks with of SARS-CoV and MERS CoV.
- |||||||||| Cimzia (certolizumab pegol) / Astellas, UCB, Eli Lilly
[VIRTUAL] Certolizumab Pegol for Treatment of Plaque Psoriasis: Pooled Three-year Efficacy Outcomes from Intent-to-treat Population of Two Phase 3 Trials (CIMPASI-1 and CIMPASI-2) () - Jan 30, 2021 - Abstract #CDAI2020CDA-I_87; P3 JAAD 2018;79:302-14.e6. Learning Objective •To gain awareness of the new data of certolizumab pegol in plaque psoriasis clinical development program which includes the two phase 3 trials CIMPASI-1 (NCT02326298) and CIMPASI-2 (NCT02326272).•To understand the effect of continued treatment with certolizumab pegol dosed at 200 mg every two weeks and 400 mg every two weeks over 3 years in patients with plaque psoriasis.•To demonstrate the safety profile of CZP in patients with plaque psoriasis in comparison to previous safety data in plaque psoriasis. Takeaway Message In phase 3 trials in plaque psoriasis, the efficacy of certolizumab pegol dosed at 200 mg every two weeks was sustained over three years. In patients receiving an initial dose of 400 mg every two weeks, responder rates gradually declined following dose reduction to 200 mg every two weeks, indicating that continued treatment of certolizumab pegol dosed at 400 mg every two weeks may be needed to maintain optimal response in some patients.
- |||||||||| Enbrel (etanercept) / Pfizer, Amgen, Cimzia (certolizumab pegol) / Astellas, UCB, Eli Lilly
Review, Journal: Certolizumab Pegol: A Review in Moderate to Severe Plaque Psoriasis. (Pubmed Central) - Jan 28, 2021 Certolizumab pegol was generally well tolerated and no new safety signals were identified in these phase III trials, which complements its established safety profile in other IMIDs. Certolizumab pegol is a useful option for the treatment of moderate to severe plaque psoriasis and provides an important treatment option for women of childbearing age, for whom there are limited options available.
- |||||||||| Clinical, Review, Journal: Biologic Treatment in Elderly Patients With Psoriasis: A Systematic Review. (Pubmed Central) - Jan 21, 2021
However, serious AEs and discontinuation due to AEs were more common in older patients. As elderly patients have a higher burden of comorbid conditions and an increased baseline vulnerability for AE, physicians should continue to be prudent in screening before initiating biologics and monitor patients more closely as AEs tend to be more severe.
- |||||||||| Trial completion date, Checkpoint inhibition: TICIMEL: TNF-Inhibitor as Immune Checkpoint Inhibitor for Advanced MELanoma (clinicaltrials.gov) - Jan 12, 2021
P1, N=30, Recruiting, Patients with low RF and low disease activity after treatment with CZP + MTX may be able to discontinue CZP without risk of loss of response. Trial completion date: Oct 2022 --> Apr 2023
- |||||||||| Clinical, Review, Journal: Comparison of the Efficacy of the Various Treatment Modalities in the Management of Perianal Crohn's Fistula: A Review. (Pubmed Central) - Jan 9, 2021
The second aspect that has to be considered is that we should target the initial stimulation of the Th1/Th17 mediated hypersensitivity instead of a factor/cytokine involved in the inflammation mediation. Although the unknown antigen triggering such hypersensitivity is not clear, we could target the RAR-related orphan receptor γ (RORγ)-T (transcription factor involved in activation of Th17 cells) and the T-bet (transcription factor involved in activation of Th17 cells) within the GI mucosa by a novel target immune therapy.
- |||||||||| NN1213 / Novo Nordisk, Cimzia (certolizumab pegol) / Astellas, UCB
Enrollment closed, Trial completion date, Trial primary completion date: Lipids, Inflammation, and CV Risk in RA (clinicaltrials.gov) - Jan 6, 2021 P=N/A, N=74, Active, not recruiting, However, there were no significant differences in IBD-related hospitalizations, IBD-related surgery or corticosteroid use after biologic induction. Recruiting --> Active, not recruiting | Trial completion date: Mar 2021 --> Feb 2022 | Trial primary completion date: Apr 2020 --> Jul 2021
- |||||||||| Remicade (infliximab) / Mitsubishi Tanabe, J&J, Humira (adalimumab) / Eisai, AbbVie, Cimzia (certolizumab pegol) / Astellas, UCB, Eli Lilly
Biomarker, Journal: PREDICTIVE FACTORS FOR LOSS OF RESPONSE TO ANTI-TNF IN CROHN'S DISEASE. (Pubmed Central) - Dec 31, 2020 By improving patient experience, the e-Device may help increase medication adherence. Anemia and prior CD surgery have been linked to loss of anti-TNF response.
- |||||||||| [VIRTUAL] Impact of pharmacist involvement on employee anti-inflammatory disease management () - Dec 26, 2020 - Abstract #ASHP2020ASHP_4064;
Secondary outcomes include measuring quality of life (QOL) improvement by administering a QOL survey, evaluating healthcare utilization, assessing the number of pharmacist interventions, evaluating patients for social determents of health (SDOH) referrals, and medication expenditures. Data will be gathered by electronic medical record chart review and payor data available on the population level.
- |||||||||| [VIRTUAL] Pharmacist Impact on Patient Proportion of Days Covered Scores for Inflammatory Specialty Medications () - Dec 26, 2020 - Abstract #ASHP2020ASHP_2302;
The data collected from eligible patients will include de-identified pre- and post- intervention PDC scores and the specific medication taken. Subgroup analyses will determine variations in PDC improvement among patients taking oral medications versus injectable medications.All patients filling ACTEMRA®, CIMZIA®, DUPIXENT®, ENBREL®, HUMIRA®, ILARIS®, OLUMIANT®, ORENCIA®, OTEZLA®, REMICAIDE®, FENFLEXIS®, SILIQ®, SIMPONI®, TREMFYA® and XELJANZ® specialty inflammatory therapies with a PDC score
- |||||||||| Orencia (abatacept) / BMS, Actemra IV (tocilizumab) / Roche, JW Pharma, Cimzia (certolizumab pegol) / Astellas, UCB, Eli Lilly
Clinical, P4 data, Journal: Active conventional treatment and three different biological treatments in early rheumatoid arthritis: phase IV investigator initiated, randomised, observer blinded clinical trial. (Pubmed Central) - Dec 23, 2020 P4 Non-inferiority analysis indicated that active conventional treatment was non-inferior to certolizumab pegol and tocilizumab, but not to abatacept. The results highlight the efficacy and safety of active conventional treatment based on methotrexate combined with corticosteroids, with nominally better results for abatacept, in treatment naive early rheumatoid arthritis.
- |||||||||| Cimzia (certolizumab pegol) / Astellas, UCB, Eli Lilly
Clinical, Journal: A Case of Minimal Change Disease in a Patient with Rheumatoid Arthritis Treated with Certolizumab. (Pubmed Central) - Dec 18, 2020 Manifestations of renal disease have been reported to develop after tumor necrosis factor-α (TNF-α) inhibition, and they should be considered as a possible complication as TNF-α inhibitors become more prevalent in the treatment of autoimmune inflammatory diseases. We report a case of minimal change disease (MCD) that developed in a woman receiving the TNF-α inhibitor certolizumab and was resolved with high-dose steroids and discontinuation of TNF-α blockade.
- |||||||||| Remicade (infliximab) / Mitsubishi Tanabe, J&J, Humira (adalimumab) / Eisai, AbbVie, Cimzia (certolizumab pegol) / Astellas, UCB, Eli Lilly
[VIRTUAL] Rates of Anti-TNF Drug Persistence in Patients with Crohn’s Disease () - Dec 18, 2020 - Abstract #AIBD2020AIBD_209; Composite persistence, as defined by stable and continuing anti-TNF therapy, was low after 1 year across all sub-populations. No single agent provided consistently higher composite persistence in both treatment-naïve and treatment experienced patients.
- |||||||||| Cimzia (certolizumab pegol) / Astellas, UCB, Eli Lilly
Clinical, Journal: Patient Satisfaction with CIMZIA (Certolizumab Pegol) AutoClicks in the UK. (Pubmed Central) - Dec 17, 2020 Some patients may have been competent (based on nurse opinion), but initially lacked self-confidence. Increasing self-injection experience, together with patient training and continued support, may have facilitated high patient confidence and satisfaction, thereby potentially overcoming some of the barriers to self-injection.
- |||||||||| Enbrel (etanercept) / Pfizer, Amgen, Humira (adalimumab) / Eisai, AbbVie, Cimzia (certolizumab pegol) / Astellas, UCB, Eli Lilly
[VIRTUAL] Certolizumab pegol in a patient with psoriasis and psoriatic arthritis during pregnancy and breastfeeding () - Dec 6, 2020 - Abstract #SIDEMAST2020SIDEMAST_23; It differs from other alpha TNF agents in that it does not contain the crystallizable fragment Fc, to which it is The key role in maternal-fetal active placental transport by binding the fetal Fc receptor has been recognized. CZP transplacental transport is zero or minimal so that the possibility of continuing the treatment emerges with the drug in pregnancy if necessary, with excellent safety profile, for both the mother and the unborn child.
- |||||||||| [VIRTUAL] An Apremilast-induced Psoriasiform Eruption () - Dec 2, 2020 - Abstract #ASDP2020ASDP_315;
The histomorphology, in conjunction with the clinical timing/history, were most consistent with an Apremilast-induced psoriatic eruption. This case highlights paradoxical drug-induced psoriasiform reactions, adding to clinical awareness, while also documenting the first such occurrence in relation to oral PDE-4 therapy.
- |||||||||| Biomarker, Enrollment change, Trial termination: RA-BioStop: Ultrasound and Withdrawal of Biological DMARDs in Rheumatoid Arthritis (clinicaltrials.gov) - Dec 1, 2020
P4, N=40, Terminated, There was a lower risk of non-infectious serious adverse events, but not serious infections, with vedolizumab vs TNF-antagonist therapy, with no significant difference for achieving disease remission. N=110 --> 40 | Recruiting --> Terminated; low recruitment
- |||||||||| Humira (adalimumab) / Eisai, AbbVie, Differin (adapalene) / Galderma, Cimzia (certolizumab pegol) / Astellas, UCB, Eli Lilly
[VIRTUAL] Therapeutic Update () - Nov 26, 2020 - Abstract #FCPANP2020FCPANP_61; Similar concepts have allowed combination of halobetasol .01% and tazarotene .045%, calcipotriene as a foam and halobetasol as a lotion...Goldenberg also highlighted new topicals including tapinarof and a topical PDE-4 inhibitor, roflumilast...Goldenberg then summarized updates on biologics for the management of psoriasis including: the improved hemoglobin A1c and weight control in diabetic patients with psoriasis on Otezla (PDE-4 inhibitor); long-term safety of tumor necrosis factor biologics adalimumab and certolizumab pegol as well as the ability for patients to self-administer certolizumab at home; the enduring efficacy of IL-17 blockers including congruent patient-reported data for ixekizumab, sustained long-term response data for secukinumab to 52 weeks and for brodalumab to 60 weeks; data demonstrating that although IL-17 blockers (specifically secukinumab) may work faster, guselkumab had a higher proportion of patients reach PASI 90/100 by week 48 and that rizankizumab outperformed adalimumab in moderate to severe plaque psoriasis management; and finally promising results for tyrosine kinase 2 inhibitors improving quality of life in psoriasis patients...Goldenberg closed with a brief discussion of advancements in management of viral dermatoses (single-use cantharidin for molluscum, buccal-adhesive acyclovir tablets), personal care moisturizers, and augmenting sun protection with polypodium leucotomos. Overall, regardless of which niche in dermatology you practice in, there are sure to be exciting therapeutic advancements coming your way.
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