- |||||||||| Tremfya (guselkumab) / J&J
Enrollment open, Trial completion date: TIG: Guselkumab Immunogenetics (clinicaltrials.gov) - Apr 8, 2021
P4, N=25, Recruiting,
No new safety signals were observed. Not yet recruiting --> Recruiting | Trial completion date: Jan 2024 --> Jan 2023
- |||||||||| [VIRTUAL] DOSING OF BDMARDS IN AXSPA AND PSA IN A REAL WORLD SETTING (Room 5) - Apr 6, 2021 - Abstract #EULAR2021EULAR_1847;
While TNFi are used in licensed doses in most patients, non-TNFi-bDMARDs were often used in higher doses, which corresponds to higher doses approved in other indications like psoriasis. The effectiveness of this treatment strategy in axSpA and PsA needs to be analysed further.
- |||||||||| Tremfya (guselkumab) / J&J
Enrollment closed: A Study of Guselkumab in Participants With Familial Adenomatous Polyposis (clinicaltrials.gov) - Mar 26, 2021
P1b, N=77, Active, not recruiting,
Ixekizumab, risankizumab, and brodalumab had the highest short-term efficacy, and risankizumab had the highest long-term efficacy. Recruiting --> Active, not recruiting
- |||||||||| Tremfya (guselkumab) / J&J
Enrollment open: A Study of Guselkumab in Participants With Systemic Sclerosis (clinicaltrials.gov) - Mar 12, 2021
P2, N=56, Recruiting,
Higher rates of endoscopic response, healing and remission occurred with GUS in the conventional therapy failure sub-population compared with PBO, but small sample sizes limit conclusions. Not yet recruiting --> Recruiting
- |||||||||| Review, Journal: New Treatment Addressing the Pathogenesis of Psoriasis. (Pubmed Central) - Mar 3, 2021
Based on these findings, we summarize currently available oral treatments and biologics. Furthermore, we describe a new treatment option including Janus kinase inhibitor, tyrosine kinase 2 inhibitor, modulator of sphingosine 1-phosphate receptor 1, and Rho-associated kinase 2 inhibitor.
- |||||||||| Simponi (golimumab) / Merck (MSD), Mitsubishi Tanabe, J&J, Tremfya (guselkumab) / J&J
Enrollment closed, Combination therapy: VEGA: A Study of Efficacy and Safety of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis (clinicaltrials.gov) - Feb 25, 2021
P2a, N=214, Active, not recruiting,
Furthermore, we describe a new treatment option including Janus kinase inhibitor, tyrosine kinase 2 inhibitor, modulator of sphingosine 1-phosphate receptor 1, and Rho-associated kinase 2 inhibitor. Recruiting --> Active, not recruiting
- |||||||||| Tremfya (guselkumab) / J&J
Trial completion date, Trial primary completion date: Guselkumab in the Treatment of Pityriasis Rubra Pilaris (PRP) (clinicaltrials.gov) - Feb 25, 2021
P2, N=15, Recruiting,
Recruiting --> Active, not recruiting Trial completion date: Dec 2020 --> Dec 2022 | Trial primary completion date: Jul 2020 --> Jul 2022
- |||||||||| Tremfya (guselkumab) / J&J
Journal: Guselkumab for the treatment of palmoplantar pustulosis. (Pubmed Central) - Feb 23, 2021
However, several issues remain. For example, there is no mouse model of PPP, so careful observation of human PPP patients and establishment of a good experimental PPP model are essential.
- |||||||||| Actemra IV (tocilizumab) / Roche, JW Pharma, Xeljanz (tofacitinib) / Pfizer, Marche Polytechnic University
[VIRTUAL] Combination Therapy with Tofacitinib and IL-17A or IL-23 Inhibition for the Treatment of Refractory Psoriatic Arthritis () - Feb 21, 2021 - Abstract #CRAAHPA2021CRA-AHPA_92;
One patient was treated with tofacitinib and risankizumab, one with tofacitinib and guselkumab and two with tofacitinib and ixekizumab...She was next treated with tofacitinib and tocilizumab...Tofacitinib does not effectively inhibit the IL-17A or IL-23 pathway, which may explain the additive effect seen when tofacitinib is used in combination with IL-17A or IL-23 inhibitors. Further research is warranted to clarify the efficacy and safety of tofacitinib in combination with a bDMARD for the treatment of resistant PsA.
- |||||||||| Tremfya (guselkumab) / J&J
[VIRTUAL] Pityriasis rubra pilaris treated with guselkumab: Interim analysis of a single-arm trial () - Feb 12, 2021 - Abstract #SID2021SID_695;
P2
Patient-reported quality of life as measured by the Dermatology Life Quality Index (DLQI) was also significantly improved from week-0 (21.3, SD=5.7) to week-24 (9.5, SD=9.4) (p=0.0074). Interim results demonstrate the disease burden of untreated PRP and the dramatic improvement in PRP symptomology following a course of guselkumab therapy.
- |||||||||| Journal: Novel Therapeutic Approaches And Targets For Treatment Of Psoriasis. (Pubmed Central) - Feb 9, 2021
OPAT provides a simple alternative to assess psoriasis severity, utilizes both physician and patient perspectives, and can be easily adopted into routine clinical practice. Currently approved novel biologic therapies for moderate to severe psoriasis revealed increasing effectiveness compared to previous biological therapy and a good safety profile.
- |||||||||| Taltz (ixekizumab) / Eli Lilly, Second Xiangya Hospital of Central South University, Tremfya (guselkumab) / J&J
[VIRTUAL] Patient-Reported Outcomes in a Head-to-head, Randomized, Double-blinded Clinical Trial of Ixekizumab and Guselkumab in Patients with Moderate-to-Severe Plaque Psoriasis () - Jan 30, 2021 - Abstract #CDAI2020CDA-I_101;
P4
At Week 4, significantly more patients on ixekizumab vs. guselkumab reported DLQI 0/1 (33.7% ixekizumab vs. 20.9% guselkumab, P < 0.001), and differences remained statistically significant through Week 12 (P < 0.05). Ixekizumab was also superior to guselkumab for itch NRS improvement ≥4 (Weeks 1, 2, 4, 6, and 8, P < 0.05), PatGA 0/1 (Weeks 1, 2, 4, 6, 8, 10, and 12, P < 0.05), and skin pain VAS [0] (Weeks 4, 6, 8, and 10, P < 0.05). Conclusions More patients on ixekizumab than guselkumab reported improvement at early timepoints for quality of life, itch, skin pain, and disease activity. Learning Objective To compare patient-reported outcomes for ixekizumab vs. guselkumab in patients with moderate-to-severe psoriasis. Takeaway Message Ixekizumab showed improvement in quality of life, itch, skin pain, and disease activity at early timepoints compared to guselkumab in patients with moderate-to-severe plaque psoriasis.
- |||||||||| Tremfya (guselkumab) / J&J
[VIRTUAL] Guselkumab, an Anti-IL-23 Monoclonal Antibody, in Patients with Active PSA: WK24 Results of a Phase 3, Randomized, Double-Blind, Placebo-Controlled Study () - Jan 30, 2021 - Abstract #CDAI2020CDA-I_64;
Serious AEs/infections, and death occurred in 9/381 (2.4%), 2/381 (0.5%), and 1/381 (0.3%) pts. Conclusions In pts with active PsA who were biologic-naïve or had been treated with TNFi, both GUS Q4W and Q8W demonstrated effcacy for joint and skin symptoms, physical function, and quality of life relative to PBO. Observed AEs were consistent with GUS safety established in PsO. Learning Objective •Understand the efficacy of guselkumap in patients with active PSA on joint signs and symptoms•Understand the safety of guselkumap in patients with active PSA.•Understand the efficacy of guslekumab on skin signs and symptoms in patients with active PSA Takeaway Message Guselkumab is effective in managing the signs and symptoms of PsA in patients with active disease.
- |||||||||| Tremfya (guselkumab) / J&J
[VIRTUAL] Real-world Experience with Guselkumab in Treating Plaque Psoriasis () - Jan 30, 2021 - Abstract #CDAI2020CDA-I_51;
A majority of these patients achieved clinically significant clearance of their psoriasis with no serious adverse events. It is our hope that this study informs dermatologists on the utility and safety of guselkumab in treating psoriasis.
- |||||||||| Humira (adalimumab) / Eisai, AbbVie, Tremfya (guselkumab) / J&J
[VIRTUAL] Maintenance of Response with up to 4 Years of Continuous Guselkumab Treatment: Results from the VOYAGE 1 Phase 3 Trial () - Jan 30, 2021 - Abstract #CDAI2020CDA-I_7;
Proportions of patients with PSSD summary scores = 0 and DLQI score = 0/1 were sustained from Wk76 through Wk204. No new safety signals were identified. Conclusions High efficacy response rates were maintained up to 4 years of continuous GUS treatment regardless of the analysis method. Learning Objective •Understand the long term efficacy of guslekumab in the treatment of moderate to severe patients.•Understand the lng terma safety of guslekumab in the treatment of moderate to severe patients.•Understand the durability of the treatment of guslekumab in the treatment of moderate to severe patients. Takeaway Message High efficacy response rates of guselkumab were maintained with up to 4 years of continuous GUS treatment.
- |||||||||| Stelara (ustekinumab) / J&J, Tremfya (guselkumab) / J&J
Trial completion: Study of Guselkumab and Ustekinumab Following a Single Intravenous or Subcutaneous Administration in Healthy Chinese Participants (clinicaltrials.gov) - Jan 29, 2021
P1, N=60, Completed,
No new safety signals were identified. Conclusions High efficacy response rates were maintained up to 4 years of continuous GUS treatment regardless of the analysis method. Learning Objective •Understand the long term efficacy of guslekumab in the treatment of moderate to severe patients.•Understand the lng terma safety of guslekumab in the treatment of moderate to severe patients.•Understand the durability of the treatment of guslekumab in the treatment of moderate to severe patients. Takeaway Message High efficacy response rates of guselkumab were maintained with up to 4 years of continuous GUS treatment. Active, not recruiting --> Completed
- |||||||||| Journal: Biologics in the treatment of pustular psoriasis. (Pubmed Central) - Jan 28, 2021
Anti-IL-17A can be used in the pustular psoriasis patients who failed to respond to anti-TNF agents and anti-IL-12/23. Therapeutic efficacy of biologics in pustular psoriasis might have no association with IL-36 RN mutation status.
- |||||||||| Tremfya (guselkumab) / J&J
Clinical, Review, Journal: Clinical Utility of Guselkumab in the Treatment of Moderate-to-Severe Plaque Psoriasis. (Pubmed Central) - Jan 26, 2021
The previously demonstrated long-term efficacy of guselkumab has been corroborated by many recently published studies. The effective and safe profile, convenient dosing, and improved quality of life in patients make gulselkumab a viable first-line treatment option for moderate-to-severe psoriasis.
- |||||||||| Review, Journal: Treatment of erythrodermic psoriasis with biologics: A systematic review. (Pubmed Central) - Jan 23, 2021
The effective and safe profile, convenient dosing, and improved quality of life in patients make gulselkumab a viable first-line treatment option for moderate-to-severe psoriasis. Patients with EP treated with biologics demonstrated positive responses and treatment was well-tolerated, with a weak recommendation and limited quality of evidence in favor of infliximab, ustekinumab, ixekizumab, and guselkumab.
- |||||||||| 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.
- |||||||||| [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
- |||||||||| Tremfya (guselkumab) / J&J
Trial completion: COSMOS: A Study of Guselkumab in Participants With Active Psoriatic Arthritis and an Inadequate Response to Anti-Tumor Necrosis Factor Alpha (Anti-TNF Alpha) Therapy (clinicaltrials.gov) - Dec 24, 2020
P3b, N=285, Completed,
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 Active, not recruiting --> Completed
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