Clinical Edge Journal Scan

Key clinical point: There is favorable agreement between ultrasound (US) and magnetic resonance imaging (MRI) for detecting inflammatory changes in finger joints of patients with psoriatic arthritis (PsA). Additionally, there is a favorable agreement between US, radiography and MRI for detecting destructive changes.

Major finding: The absolute agreement between US and MRI was in the range of good-to-very good for detecting synovitis (85%-96%), flexor tenosynovitis (93%-98%), and extensor paratenonitis (95%-98%). Agreement between US, MRI and radiography was also good-to-very good for detecting erosions (96%-98%) and bone proliferations (71%-93%).

Study details: The data come from a study of 100 consecutive PsA patients who underwent clinical assessment and concomitant radiographic, US and MRI evaluations of the metacarpophalangeal, proximal interphalangeal and distal interphalangeal joints of one hand.

Disclosures: The study was supported by an investigator-initiated research grant sponsored by Johnson and Johnson. The authors declared no conflicts of interest.

Source: Polachek A et al. Rheumatology (Oxford). 2021 Mar 17. doi: 10.1093/rheumatology/keab272.

Key clinical point: There is favorable agreement between ultrasound (US) and magnetic resonance imaging (MRI) for detecting inflammatory changes in finger joints of patients with psoriatic arthritis (PsA). Additionally, there is a favorable agreement between US, radiography and MRI for detecting destructive changes.

Major finding: The absolute agreement between US and MRI was in the range of good-to-very good for detecting synovitis (85%-96%), flexor tenosynovitis (93%-98%), and extensor paratenonitis (95%-98%). Agreement between US, MRI and radiography was also good-to-very good for detecting erosions (96%-98%) and bone proliferations (71%-93%).

Study details: The data come from a study of 100 consecutive PsA patients who underwent clinical assessment and concomitant radiographic, US and MRI evaluations of the metacarpophalangeal, proximal interphalangeal and distal interphalangeal joints of one hand.

Disclosures: The study was supported by an investigator-initiated research grant sponsored by Johnson and Johnson. The authors declared no conflicts of interest.

Source: Polachek A et al. Rheumatology (Oxford). 2021 Mar 17. doi: 10.1093/rheumatology/keab272.

Key clinical point: There is favorable agreement between ultrasound (US) and magnetic resonance imaging (MRI) for detecting inflammatory changes in finger joints of patients with psoriatic arthritis (PsA). Additionally, there is a favorable agreement between US, radiography and MRI for detecting destructive changes.

Major finding: The absolute agreement between US and MRI was in the range of good-to-very good for detecting synovitis (85%-96%), flexor tenosynovitis (93%-98%), and extensor paratenonitis (95%-98%). Agreement between US, MRI and radiography was also good-to-very good for detecting erosions (96%-98%) and bone proliferations (71%-93%).

Study details: The data come from a study of 100 consecutive PsA patients who underwent clinical assessment and concomitant radiographic, US and MRI evaluations of the metacarpophalangeal, proximal interphalangeal and distal interphalangeal joints of one hand.

Disclosures: The study was supported by an investigator-initiated research grant sponsored by Johnson and Johnson. The authors declared no conflicts of interest.

Source: Polachek A et al. Rheumatology (Oxford). 2021 Mar 17. doi: 10.1093/rheumatology/keab272.

Key clinical point: Cognitive impairment may be one of the neurological manifestations of psoriatic arthritis (PsA).

Major finding: Patients with PsA scored worse on the Montreal Cognitive Assessment (MoCA) vs. controls (P = .01). Additionally, the proportion of patients with cognitive impairment according to MoCA was significantly higher among cases vs. controls (91.9% vs. 58.3%, P = .002).

Study details: The data come from a cross-sectional case-control study involving 37 patients with PsA and 36 healthy controls.

Disclosures: The study did not receive any funding. The authors declared no conflicts of interest.

Source: Garcia LOKL et al. Acta Neurol Belg. 2021 Mar 13. doi: 10.1007/s13760-021-01644-y.

Key clinical point: Cognitive impairment may be one of the neurological manifestations of psoriatic arthritis (PsA).

Major finding: Patients with PsA scored worse on the Montreal Cognitive Assessment (MoCA) vs. controls (P = .01). Additionally, the proportion of patients with cognitive impairment according to MoCA was significantly higher among cases vs. controls (91.9% vs. 58.3%, P = .002).

Study details: The data come from a cross-sectional case-control study involving 37 patients with PsA and 36 healthy controls.

Disclosures: The study did not receive any funding. The authors declared no conflicts of interest.

Source: Garcia LOKL et al. Acta Neurol Belg. 2021 Mar 13. doi: 10.1007/s13760-021-01644-y.

Key clinical point: Cognitive impairment may be one of the neurological manifestations of psoriatic arthritis (PsA).

Major finding: Patients with PsA scored worse on the Montreal Cognitive Assessment (MoCA) vs. controls (P = .01). Additionally, the proportion of patients with cognitive impairment according to MoCA was significantly higher among cases vs. controls (91.9% vs. 58.3%, P = .002).

Study details: The data come from a cross-sectional case-control study involving 37 patients with PsA and 36 healthy controls.

Disclosures: The study did not receive any funding. The authors declared no conflicts of interest.

Source: Garcia LOKL et al. Acta Neurol Belg. 2021 Mar 13. doi: 10.1007/s13760-021-01644-y.

Key clinical point: In patients with active psoriatic arthritis (PsA), intravenous (IV) golimumab improved health-related quality of life (HRQoL) and productivity as early as 8 weeks and maintained improvement through 1 year; and these improvements were associated with improvements in disease activity and patient functional capability outcomes.

Major finding: At week 8, patients receiving IV golimumab vs. placebo had greater improvements in EuroQol-5 dimension-5 level index (0.14 vs. 0.04) and visual analog scale (VAS; 17.16 vs. 3.69), daily productivity VAS (−2.91 vs. −0.71), and Work Limitations Questionnaire productivity loss score (−2.92 vs. −0.78). At week 52, improvements were similar in the golimumab and placebo-crossover groups. HRQoL and productivity correlated with disease activity and functional capability, with continued association from week 8 through week 52.

Study details: In this phase 3 GO-VIBRANT trial, 480 patients with PsA were randomly assigned to receive IV golimumab 2 mg/kg (n=241) at weeks 0, 4, and then every 8 weeks (q8w) through week 52 or placebo (n=239) at weeks 0, 4, and then q8w, with crossover to IV golimumab 2 mg/kg at weeks 24, 28, and then q8w through week 52.

Disclosures: This study was supported by Janssen Research & Development, LLC, Spring House, PA. Some study investigators are employees of Janssen Global Services, LLC and own stock in Johnson & Johnson, of which Janssen Global Services, LLC is a wholly owned subsidiary. Some study authors reported receiving support from and consulting for Janssen.

Source: Ogdie A et al. Clin Rheumatol. 2021 Mar 2. doi: 10.1007/s10067-021-05639-1.

Key clinical point: In patients with active psoriatic arthritis (PsA), intravenous (IV) golimumab improved health-related quality of life (HRQoL) and productivity as early as 8 weeks and maintained improvement through 1 year; and these improvements were associated with improvements in disease activity and patient functional capability outcomes.

Major finding: At week 8, patients receiving IV golimumab vs. placebo had greater improvements in EuroQol-5 dimension-5 level index (0.14 vs. 0.04) and visual analog scale (VAS; 17.16 vs. 3.69), daily productivity VAS (−2.91 vs. −0.71), and Work Limitations Questionnaire productivity loss score (−2.92 vs. −0.78). At week 52, improvements were similar in the golimumab and placebo-crossover groups. HRQoL and productivity correlated with disease activity and functional capability, with continued association from week 8 through week 52.

Study details: In this phase 3 GO-VIBRANT trial, 480 patients with PsA were randomly assigned to receive IV golimumab 2 mg/kg (n=241) at weeks 0, 4, and then every 8 weeks (q8w) through week 52 or placebo (n=239) at weeks 0, 4, and then q8w, with crossover to IV golimumab 2 mg/kg at weeks 24, 28, and then q8w through week 52.

Disclosures: This study was supported by Janssen Research & Development, LLC, Spring House, PA. Some study investigators are employees of Janssen Global Services, LLC and own stock in Johnson & Johnson, of which Janssen Global Services, LLC is a wholly owned subsidiary. Some study authors reported receiving support from and consulting for Janssen.

Source: Ogdie A et al. Clin Rheumatol. 2021 Mar 2. doi: 10.1007/s10067-021-05639-1.

Key clinical point: In patients with active psoriatic arthritis (PsA), intravenous (IV) golimumab improved health-related quality of life (HRQoL) and productivity as early as 8 weeks and maintained improvement through 1 year; and these improvements were associated with improvements in disease activity and patient functional capability outcomes.

Major finding: At week 8, patients receiving IV golimumab vs. placebo had greater improvements in EuroQol-5 dimension-5 level index (0.14 vs. 0.04) and visual analog scale (VAS; 17.16 vs. 3.69), daily productivity VAS (−2.91 vs. −0.71), and Work Limitations Questionnaire productivity loss score (−2.92 vs. −0.78). At week 52, improvements were similar in the golimumab and placebo-crossover groups. HRQoL and productivity correlated with disease activity and functional capability, with continued association from week 8 through week 52.

Study details: In this phase 3 GO-VIBRANT trial, 480 patients with PsA were randomly assigned to receive IV golimumab 2 mg/kg (n=241) at weeks 0, 4, and then every 8 weeks (q8w) through week 52 or placebo (n=239) at weeks 0, 4, and then q8w, with crossover to IV golimumab 2 mg/kg at weeks 24, 28, and then q8w through week 52.

Disclosures: This study was supported by Janssen Research & Development, LLC, Spring House, PA. Some study investigators are employees of Janssen Global Services, LLC and own stock in Johnson & Johnson, of which Janssen Global Services, LLC is a wholly owned subsidiary. Some study authors reported receiving support from and consulting for Janssen.

Source: Ogdie A et al. Clin Rheumatol. 2021 Mar 2. doi: 10.1007/s10067-021-05639-1.

Key clinical point: The presence of depression/anxiety symptoms reduces the probability of achieving sustained minimal disease activity (MDA) in patients with psoriatic arthritis (PsA), regardless of the method used to define depression/anxiety.

Major finding: When depression/anxiety was defined as a score of 38 or lower on the Mental Component Summary of the Short Form-36 questionnaire (definition 1), the odds ratio (OR) for reaching sustained MDA was 0.30 (P less than .0001). The OR values were 0.34 (P less than .0001) and 0.47 (P less than .0001) for a score of 56 or lower on the Mental Health sub-scale (definition 2) and for rheumatologist’s report of a diagnosis or treatment for depression/anxiety (definition 3), respectively.

Study details: The data come from a study of 743 patients with PsA.

Disclosures: No study sponsor was identified. Several of the authors are affiliated with the Psoriatic Disease Program of the Krembil Research Institute of University Health Network in Toronto, which is supported by the Krembil Foundation. Dr. A Wong was supported by a Krembil Psoriatic Arthritis Fellowship and Dr. V Chandran was supported by a Pfizer Chair Rheumatology Research Award from the Department of Medicine, University of Toronto.

Source: Wong A et al. Arthritis Care Res (Hoboken). 2021 Mar 4. doi: 10.1002/acr.24593.

Key clinical point: The presence of depression/anxiety symptoms reduces the probability of achieving sustained minimal disease activity (MDA) in patients with psoriatic arthritis (PsA), regardless of the method used to define depression/anxiety.

Major finding: When depression/anxiety was defined as a score of 38 or lower on the Mental Component Summary of the Short Form-36 questionnaire (definition 1), the odds ratio (OR) for reaching sustained MDA was 0.30 (P less than .0001). The OR values were 0.34 (P less than .0001) and 0.47 (P less than .0001) for a score of 56 or lower on the Mental Health sub-scale (definition 2) and for rheumatologist’s report of a diagnosis or treatment for depression/anxiety (definition 3), respectively.

Study details: The data come from a study of 743 patients with PsA.

Disclosures: No study sponsor was identified. Several of the authors are affiliated with the Psoriatic Disease Program of the Krembil Research Institute of University Health Network in Toronto, which is supported by the Krembil Foundation. Dr. A Wong was supported by a Krembil Psoriatic Arthritis Fellowship and Dr. V Chandran was supported by a Pfizer Chair Rheumatology Research Award from the Department of Medicine, University of Toronto.

Source: Wong A et al. Arthritis Care Res (Hoboken). 2021 Mar 4. doi: 10.1002/acr.24593.

Key clinical point: The presence of depression/anxiety symptoms reduces the probability of achieving sustained minimal disease activity (MDA) in patients with psoriatic arthritis (PsA), regardless of the method used to define depression/anxiety.

Major finding: When depression/anxiety was defined as a score of 38 or lower on the Mental Component Summary of the Short Form-36 questionnaire (definition 1), the odds ratio (OR) for reaching sustained MDA was 0.30 (P less than .0001). The OR values were 0.34 (P less than .0001) and 0.47 (P less than .0001) for a score of 56 or lower on the Mental Health sub-scale (definition 2) and for rheumatologist’s report of a diagnosis or treatment for depression/anxiety (definition 3), respectively.

Study details: The data come from a study of 743 patients with PsA.

Disclosures: No study sponsor was identified. Several of the authors are affiliated with the Psoriatic Disease Program of the Krembil Research Institute of University Health Network in Toronto, which is supported by the Krembil Foundation. Dr. A Wong was supported by a Krembil Psoriatic Arthritis Fellowship and Dr. V Chandran was supported by a Pfizer Chair Rheumatology Research Award from the Department of Medicine, University of Toronto.

Source: Wong A et al. Arthritis Care Res (Hoboken). 2021 Mar 4. doi: 10.1002/acr.24593.

Key clinical point: Alcohol consumption, older age, suffering from fatty liver when less than 45 years old, and elevated high-sensitivity C-reactive protein (hs-CRP) level appear to increase the risk of transition from subclinical to clinical psoriatic arthritis (PsA).

Major finding: Older age (greater than 45 years; odds ratio [OR], 10.15; P = 0.00), alcohol consumption (OR, 3.43; P = .03), and elevated hs-CRP (OR, 1.05; P = 0.03) were associated with an increased risk of progression from subclinical PsA to clinical PsA. For patients aged less than 45 years old, the association between fatty liver and clinical PsA was statistically significant.

Study details: The data come from a retrospective case-control study of 25 patients with clinically confirmed PsA (cases) and 137 controls without confirmed PsA.

Disclosures: This study was funded by the 1.3.5 Project for Disciplines of Excellence, West China Hospital, Sichuan University, Chengdu, Sichuan, China and West China Precision Medicine Industrial Technology Institutes. The authors declared no conflicts of interest.

Source: Wang Y et al. Rheumatol Ther. 2021 Mar 5. doi: 10.1007/s40744-021-00295-y.

Key clinical point: Alcohol consumption, older age, suffering from fatty liver when less than 45 years old, and elevated high-sensitivity C-reactive protein (hs-CRP) level appear to increase the risk of transition from subclinical to clinical psoriatic arthritis (PsA).

Major finding: Older age (greater than 45 years; odds ratio [OR], 10.15; P = 0.00), alcohol consumption (OR, 3.43; P = .03), and elevated hs-CRP (OR, 1.05; P = 0.03) were associated with an increased risk of progression from subclinical PsA to clinical PsA. For patients aged less than 45 years old, the association between fatty liver and clinical PsA was statistically significant.

Study details: The data come from a retrospective case-control study of 25 patients with clinically confirmed PsA (cases) and 137 controls without confirmed PsA.

Disclosures: This study was funded by the 1.3.5 Project for Disciplines of Excellence, West China Hospital, Sichuan University, Chengdu, Sichuan, China and West China Precision Medicine Industrial Technology Institutes. The authors declared no conflicts of interest.

Source: Wang Y et al. Rheumatol Ther. 2021 Mar 5. doi: 10.1007/s40744-021-00295-y.

Key clinical point: Alcohol consumption, older age, suffering from fatty liver when less than 45 years old, and elevated high-sensitivity C-reactive protein (hs-CRP) level appear to increase the risk of transition from subclinical to clinical psoriatic arthritis (PsA).

Major finding: Older age (greater than 45 years; odds ratio [OR], 10.15; P = 0.00), alcohol consumption (OR, 3.43; P = .03), and elevated hs-CRP (OR, 1.05; P = 0.03) were associated with an increased risk of progression from subclinical PsA to clinical PsA. For patients aged less than 45 years old, the association between fatty liver and clinical PsA was statistically significant.

Study details: The data come from a retrospective case-control study of 25 patients with clinically confirmed PsA (cases) and 137 controls without confirmed PsA.

Disclosures: This study was funded by the 1.3.5 Project for Disciplines of Excellence, West China Hospital, Sichuan University, Chengdu, Sichuan, China and West China Precision Medicine Industrial Technology Institutes. The authors declared no conflicts of interest.

Source: Wang Y et al. Rheumatol Ther. 2021 Mar 5. doi: 10.1007/s40744-021-00295-y.

Key clinical point: Continued ixekizumab (IXE) therapy was superior to IXE withdrawal in maintaining minimal disease activity (MDA) in biologic-naive patients with psoriatic arthritis (PsA). In case of treatment interruption, re-treatment with IXE following relapse may restore disease control.

Major finding: Patients relapsed more rapidly with IXE withdrawal (median, 22.3 weeks) vs. continued IXE treatment (median was not estimable because less than 50% of patients had relapsed by the end of study period; P less than .0001). The cumulative relapse rate from week 24 to week 104 was higher for the withdrawal vs. continued treatment group (85% vs. 38%; P less than .0001). Median time to re-achieving MDA on retreatment was 4.1 weeks; 64 (95.5%) of 67 patients who relapsed with treatment withdrawal re-achieved MDA on retreatment.

Study details: SPIRIT-P3 was a multicenter, randomized, double-blind withdrawal study of 394 biologic-naive patients with PsA who received open-label IXE (160 mg at week 0, 80 mg every 2 weeks) for 36 weeks. Between weeks 36 and 64, 158 patients who achieved sustained MDA (greater than 3 months) were randomized (1:1) to continue on 80 mg IXE every 2 weeks or placebo until week 104.

Disclosures: This study was funded by Eli Lilly and Company. Some study investigators reported owning stock in, being an employee of, receiving support from, and/or consulting for Eli Lilly and Company.

Source: Coates LC et al. Arthritis Rheumatol. 2021 Mar 7. doi: 10.1002/art.41716.

Key clinical point: Continued ixekizumab (IXE) therapy was superior to IXE withdrawal in maintaining minimal disease activity (MDA) in biologic-naive patients with psoriatic arthritis (PsA). In case of treatment interruption, re-treatment with IXE following relapse may restore disease control.

Major finding: Patients relapsed more rapidly with IXE withdrawal (median, 22.3 weeks) vs. continued IXE treatment (median was not estimable because less than 50% of patients had relapsed by the end of study period; P less than .0001). The cumulative relapse rate from week 24 to week 104 was higher for the withdrawal vs. continued treatment group (85% vs. 38%; P less than .0001). Median time to re-achieving MDA on retreatment was 4.1 weeks; 64 (95.5%) of 67 patients who relapsed with treatment withdrawal re-achieved MDA on retreatment.

Study details: SPIRIT-P3 was a multicenter, randomized, double-blind withdrawal study of 394 biologic-naive patients with PsA who received open-label IXE (160 mg at week 0, 80 mg every 2 weeks) for 36 weeks. Between weeks 36 and 64, 158 patients who achieved sustained MDA (greater than 3 months) were randomized (1:1) to continue on 80 mg IXE every 2 weeks or placebo until week 104.

Disclosures: This study was funded by Eli Lilly and Company. Some study investigators reported owning stock in, being an employee of, receiving support from, and/or consulting for Eli Lilly and Company.

Source: Coates LC et al. Arthritis Rheumatol. 2021 Mar 7. doi: 10.1002/art.41716.

Key clinical point: Continued ixekizumab (IXE) therapy was superior to IXE withdrawal in maintaining minimal disease activity (MDA) in biologic-naive patients with psoriatic arthritis (PsA). In case of treatment interruption, re-treatment with IXE following relapse may restore disease control.

Major finding: Patients relapsed more rapidly with IXE withdrawal (median, 22.3 weeks) vs. continued IXE treatment (median was not estimable because less than 50% of patients had relapsed by the end of study period; P less than .0001). The cumulative relapse rate from week 24 to week 104 was higher for the withdrawal vs. continued treatment group (85% vs. 38%; P less than .0001). Median time to re-achieving MDA on retreatment was 4.1 weeks; 64 (95.5%) of 67 patients who relapsed with treatment withdrawal re-achieved MDA on retreatment.

Study details: SPIRIT-P3 was a multicenter, randomized, double-blind withdrawal study of 394 biologic-naive patients with PsA who received open-label IXE (160 mg at week 0, 80 mg every 2 weeks) for 36 weeks. Between weeks 36 and 64, 158 patients who achieved sustained MDA (greater than 3 months) were randomized (1:1) to continue on 80 mg IXE every 2 weeks or placebo until week 104.

Disclosures: This study was funded by Eli Lilly and Company. Some study investigators reported owning stock in, being an employee of, receiving support from, and/or consulting for Eli Lilly and Company.

Source: Coates LC et al. Arthritis Rheumatol. 2021 Mar 7. doi: 10.1002/art.41716.

Key clinical point: Brodalumab demonstrated significant and rapid improvements in signs and symptoms of psoriatic arthritis (PsA) vs. placebo in 2 phase 3 trials.

Major finding: The percentage of patients achieving American College of Rheumatology (ACR)20 response at week 16 was significantly higher in the 140 mg and 210 mg brodalumab treatment groups than in the placebo group (45.8% and 47.9%, respectively vs. 20.9%; P less than .0001). Results were similar at week 24. The proportion of brodalumab-treated patients achieving ACR50/70, Psoriasis Area and Severity Index 75/90/100 and resolution of dactylitis and enthesitis was significantly higher than placebo-treated patients (P less than .01). Brodalumab was well tolerated.

Study details: In the AMVISION-1 and AMVISION-2 trials, a total of 962 adult patients with active PsA refractory to conventional treatment were randomly assigned (1:1:1) to either subcutaneous brodalumab 140 mg or 210 mg or placebo at weeks 0, 1 and every 2 weeks up to 24 weeks.

Disclosures: The trials were funded by LEO Pharma. K Raymond is an employee of LEO Pharma. KF Hjuler was an employee of LEO Pharma at the time the study was conducted. PJ Mease, PS Helliwell, KF Hjuler and IB McInnes reported ties with various pharmaceutical companies.

Source: Mease PJ et al. Ann Rheum Dis. 2021 Feb. doi: 10.1136/annrheumdis-2019-216835.

Key clinical point: Brodalumab demonstrated significant and rapid improvements in signs and symptoms of psoriatic arthritis (PsA) vs. placebo in 2 phase 3 trials.

Major finding: The percentage of patients achieving American College of Rheumatology (ACR)20 response at week 16 was significantly higher in the 140 mg and 210 mg brodalumab treatment groups than in the placebo group (45.8% and 47.9%, respectively vs. 20.9%; P less than .0001). Results were similar at week 24. The proportion of brodalumab-treated patients achieving ACR50/70, Psoriasis Area and Severity Index 75/90/100 and resolution of dactylitis and enthesitis was significantly higher than placebo-treated patients (P less than .01). Brodalumab was well tolerated.

Study details: In the AMVISION-1 and AMVISION-2 trials, a total of 962 adult patients with active PsA refractory to conventional treatment were randomly assigned (1:1:1) to either subcutaneous brodalumab 140 mg or 210 mg or placebo at weeks 0, 1 and every 2 weeks up to 24 weeks.

Disclosures: The trials were funded by LEO Pharma. K Raymond is an employee of LEO Pharma. KF Hjuler was an employee of LEO Pharma at the time the study was conducted. PJ Mease, PS Helliwell, KF Hjuler and IB McInnes reported ties with various pharmaceutical companies.

Source: Mease PJ et al. Ann Rheum Dis. 2021 Feb. doi: 10.1136/annrheumdis-2019-216835.

Key clinical point: Brodalumab demonstrated significant and rapid improvements in signs and symptoms of psoriatic arthritis (PsA) vs. placebo in 2 phase 3 trials.

Major finding: The percentage of patients achieving American College of Rheumatology (ACR)20 response at week 16 was significantly higher in the 140 mg and 210 mg brodalumab treatment groups than in the placebo group (45.8% and 47.9%, respectively vs. 20.9%; P less than .0001). Results were similar at week 24. The proportion of brodalumab-treated patients achieving ACR50/70, Psoriasis Area and Severity Index 75/90/100 and resolution of dactylitis and enthesitis was significantly higher than placebo-treated patients (P less than .01). Brodalumab was well tolerated.

Study details: In the AMVISION-1 and AMVISION-2 trials, a total of 962 adult patients with active PsA refractory to conventional treatment were randomly assigned (1:1:1) to either subcutaneous brodalumab 140 mg or 210 mg or placebo at weeks 0, 1 and every 2 weeks up to 24 weeks.

Disclosures: The trials were funded by LEO Pharma. K Raymond is an employee of LEO Pharma. KF Hjuler was an employee of LEO Pharma at the time the study was conducted. PJ Mease, PS Helliwell, KF Hjuler and IB McInnes reported ties with various pharmaceutical companies.

Source: Mease PJ et al. Ann Rheum Dis. 2021 Feb. doi: 10.1136/annrheumdis-2019-216835.

Key clinical point: Pain intensity has limited predictive value for preterm or excess mortality, whereas recent glucocorticoid use and comorbidities were associated with an increased risk of early mortality in patients with psoriatic arthritis.

Major finding: Higher mean pain intensity was associated with an increased risk of mortality (odds ratio [OR], 1.06; 95% confidence interval [CI], 1.02-1.10). However, this association attenuated after adjusting for additional confounders. Recent glucocorticoid use (OR, 5.60; 95% CI, 3.71-8.45), concurrent chronic obstructive pulmonary disease (OR, 1.72; 95% CI, 1.06-2.80), diabetes mellitus (OR, 1.86; 95% CI, 1.19-2.90), cancer (OR, 7.17; 95% CI, 4.70-10.93), and cardiovascular disease (OR, 3.04; 95% CI, 2.06-4.49) were all associated with early mortality.

Study details: This nested case-control study included 276 patients with psoriatic arthritis who died (cases) and 1,187 matched controls using data from the nationwide DANBIO register and Danish healthcare registers.

Disclosures: This study was supported by the Danish Psoriasis Foundation Grant, the Danish Rheumatism Foundation Grant, and a grant from Aalborg University and Aalborg University hospital. The authors declared no conflicts of interest.

Source: Vela J et al. Rheumatology (Oxford). 2021 Mar 1. doi: 10.1093/rheumatology/keab192.

Key clinical point: Pain intensity has limited predictive value for preterm or excess mortality, whereas recent glucocorticoid use and comorbidities were associated with an increased risk of early mortality in patients with psoriatic arthritis.

Major finding: Higher mean pain intensity was associated with an increased risk of mortality (odds ratio [OR], 1.06; 95% confidence interval [CI], 1.02-1.10). However, this association attenuated after adjusting for additional confounders. Recent glucocorticoid use (OR, 5.60; 95% CI, 3.71-8.45), concurrent chronic obstructive pulmonary disease (OR, 1.72; 95% CI, 1.06-2.80), diabetes mellitus (OR, 1.86; 95% CI, 1.19-2.90), cancer (OR, 7.17; 95% CI, 4.70-10.93), and cardiovascular disease (OR, 3.04; 95% CI, 2.06-4.49) were all associated with early mortality.

Study details: This nested case-control study included 276 patients with psoriatic arthritis who died (cases) and 1,187 matched controls using data from the nationwide DANBIO register and Danish healthcare registers.

Disclosures: This study was supported by the Danish Psoriasis Foundation Grant, the Danish Rheumatism Foundation Grant, and a grant from Aalborg University and Aalborg University hospital. The authors declared no conflicts of interest.

Source: Vela J et al. Rheumatology (Oxford). 2021 Mar 1. doi: 10.1093/rheumatology/keab192.

Key clinical point: Pain intensity has limited predictive value for preterm or excess mortality, whereas recent glucocorticoid use and comorbidities were associated with an increased risk of early mortality in patients with psoriatic arthritis.

Major finding: Higher mean pain intensity was associated with an increased risk of mortality (odds ratio [OR], 1.06; 95% confidence interval [CI], 1.02-1.10). However, this association attenuated after adjusting for additional confounders. Recent glucocorticoid use (OR, 5.60; 95% CI, 3.71-8.45), concurrent chronic obstructive pulmonary disease (OR, 1.72; 95% CI, 1.06-2.80), diabetes mellitus (OR, 1.86; 95% CI, 1.19-2.90), cancer (OR, 7.17; 95% CI, 4.70-10.93), and cardiovascular disease (OR, 3.04; 95% CI, 2.06-4.49) were all associated with early mortality.

Study details: This nested case-control study included 276 patients with psoriatic arthritis who died (cases) and 1,187 matched controls using data from the nationwide DANBIO register and Danish healthcare registers.

Disclosures: This study was supported by the Danish Psoriasis Foundation Grant, the Danish Rheumatism Foundation Grant, and a grant from Aalborg University and Aalborg University hospital. The authors declared no conflicts of interest.

Source: Vela J et al. Rheumatology (Oxford). 2021 Mar 1. doi: 10.1093/rheumatology/keab192.

The OS was similar between the two arms, although the analysis was underpowered.  Nausea, diarrhea, and vomiting were the most frequently occurring treatment-emergent adverse events for oral azacitidine vs placebo (76% vs 23%, 68% vs 23%, 63% vs 9%). While oral azacitidine is not approved for MDS and trial was stopped early, it can provide meaningful reduction in RBC transfusions in low grade MDS, and further evaluation is needed in MDS.

Paroxysmal nocturnal hemoglobinuria (PNH) clones have been observed in bone marrow failure syndromes including MDS and aplastic anemia (AA). Fattizzo et al analyzed PNH clone size with clinical outcomes in MDS and AA in a cohort of 3085 patients tested for PNH at King’s College Hospital in London. 20.3% of MDS patients had presence of PNH clone; PNH cases occurred more in hypoplastic MDS, and lower risk IPSS MDS patients. The presence of PNH clone was a predictor of response to immunosuppressive therapy and to allogeneic stem cell transplant (84% vs 45%, p=0.01, 71% vs 57%, p=0.09), but not to azacitidine. MDS patients with PNH clone had lower rate of progression by IPSS and AML transformation, and higher OS accounting for MDS with excess blasts. Each 10% increase in clone size resulted in a 1% decrease in cumulative incidence of death. PNH testing is often done especially in cases with hypoplastic MDS; the underlying mechanism and role for monitoring PNH clones in MDS needs further investigation.

Outcomes in MDS patients after azacitidine therapy are generally poor. Clavio et al analyzed outcomes of 402 MDS patients post-azacitidine in the Italian MDS Registry. At azacitidine discontinuation, 20% of patients still derived response to azacitidine, 35% had primary resistance, and 44% had adaptive resistance, which was defined as loss of response or progression after achievement of a response. As expected, OS was longer for patients who stopped treatment due to planned allogeneic stem cell transplant (median OS not reached), compared to patients with primary resistance (median OS 4 months), or adaptive resistance (median OS 5 months), or patients intolerant or noncompliant to azacitidine (median OS 4 months, p=0.004). The North American MDS Consortium scoring system was evaluated in the study cohort; patients with high risk had worse OS than low risk (3 and 7 months, p<0.001). This retrospective analysis confirms the poor outlook of MDS patients after treatment of azacitidine, and effective therapy in this patient population is an unmet need.

The OS was similar between the two arms, although the analysis was underpowered.  Nausea, diarrhea, and vomiting were the most frequently occurring treatment-emergent adverse events for oral azacitidine vs placebo (76% vs 23%, 68% vs 23%, 63% vs 9%). While oral azacitidine is not approved for MDS and trial was stopped early, it can provide meaningful reduction in RBC transfusions in low grade MDS, and further evaluation is needed in MDS.

Paroxysmal nocturnal hemoglobinuria (PNH) clones have been observed in bone marrow failure syndromes including MDS and aplastic anemia (AA). Fattizzo et al analyzed PNH clone size with clinical outcomes in MDS and AA in a cohort of 3085 patients tested for PNH at King’s College Hospital in London. 20.3% of MDS patients had presence of PNH clone; PNH cases occurred more in hypoplastic MDS, and lower risk IPSS MDS patients. The presence of PNH clone was a predictor of response to immunosuppressive therapy and to allogeneic stem cell transplant (84% vs 45%, p=0.01, 71% vs 57%, p=0.09), but not to azacitidine. MDS patients with PNH clone had lower rate of progression by IPSS and AML transformation, and higher OS accounting for MDS with excess blasts. Each 10% increase in clone size resulted in a 1% decrease in cumulative incidence of death. PNH testing is often done especially in cases with hypoplastic MDS; the underlying mechanism and role for monitoring PNH clones in MDS needs further investigation.

Outcomes in MDS patients after azacitidine therapy are generally poor. Clavio et al analyzed outcomes of 402 MDS patients post-azacitidine in the Italian MDS Registry. At azacitidine discontinuation, 20% of patients still derived response to azacitidine, 35% had primary resistance, and 44% had adaptive resistance, which was defined as loss of response or progression after achievement of a response. As expected, OS was longer for patients who stopped treatment due to planned allogeneic stem cell transplant (median OS not reached), compared to patients with primary resistance (median OS 4 months), or adaptive resistance (median OS 5 months), or patients intolerant or noncompliant to azacitidine (median OS 4 months, p=0.004). The North American MDS Consortium scoring system was evaluated in the study cohort; patients with high risk had worse OS than low risk (3 and 7 months, p<0.001). This retrospective analysis confirms the poor outlook of MDS patients after treatment of azacitidine, and effective therapy in this patient population is an unmet need.

The OS was similar between the two arms, although the analysis was underpowered.  Nausea, diarrhea, and vomiting were the most frequently occurring treatment-emergent adverse events for oral azacitidine vs placebo (76% vs 23%, 68% vs 23%, 63% vs 9%). While oral azacitidine is not approved for MDS and trial was stopped early, it can provide meaningful reduction in RBC transfusions in low grade MDS, and further evaluation is needed in MDS.

Paroxysmal nocturnal hemoglobinuria (PNH) clones have been observed in bone marrow failure syndromes including MDS and aplastic anemia (AA). Fattizzo et al analyzed PNH clone size with clinical outcomes in MDS and AA in a cohort of 3085 patients tested for PNH at King’s College Hospital in London. 20.3% of MDS patients had presence of PNH clone; PNH cases occurred more in hypoplastic MDS, and lower risk IPSS MDS patients. The presence of PNH clone was a predictor of response to immunosuppressive therapy and to allogeneic stem cell transplant (84% vs 45%, p=0.01, 71% vs 57%, p=0.09), but not to azacitidine. MDS patients with PNH clone had lower rate of progression by IPSS and AML transformation, and higher OS accounting for MDS with excess blasts. Each 10% increase in clone size resulted in a 1% decrease in cumulative incidence of death. PNH testing is often done especially in cases with hypoplastic MDS; the underlying mechanism and role for monitoring PNH clones in MDS needs further investigation.

Outcomes in MDS patients after azacitidine therapy are generally poor. Clavio et al analyzed outcomes of 402 MDS patients post-azacitidine in the Italian MDS Registry. At azacitidine discontinuation, 20% of patients still derived response to azacitidine, 35% had primary resistance, and 44% had adaptive resistance, which was defined as loss of response or progression after achievement of a response. As expected, OS was longer for patients who stopped treatment due to planned allogeneic stem cell transplant (median OS not reached), compared to patients with primary resistance (median OS 4 months), or adaptive resistance (median OS 5 months), or patients intolerant or noncompliant to azacitidine (median OS 4 months, p=0.004). The North American MDS Consortium scoring system was evaluated in the study cohort; patients with high risk had worse OS than low risk (3 and 7 months, p<0.001). This retrospective analysis confirms the poor outlook of MDS patients after treatment of azacitidine, and effective therapy in this patient population is an unmet need.

Key clinical point: Adding stanozolol to decitabine after effective decitabine treatment may improve progression-free survival (PFS) and reduce the severity of neutropenia in patients with high-risk myelodysplastic syndrome (MDS).

Major finding: PFS was significantly longer in the stanozolol group vs. stanozolol+decitabine group (15.0 vs. 9.0 months; hazard ratio [HR], 0.35; P = .0005). The proportion of patients with grade 3-4 neutropenia was lower in stanozolol group (76.2% vs. 95.1%; P = .039).

Study details: Findings are from a retrospective analysis of 62 patients with newly diagnosed high-risk MDS who achieved at least partial remission after 4 cycles of decitabine. For maintenance treatment, 21 patients received stanozolol and decitabine and 41 patients received decitabine alone.

Disclosures: This study was partly supported by the National Natural Science Foundation of China, the Natural Science Foundation of Tianjin China, Key Technology Research and Development Program of Tianjin China, Beijing Natural Science Foundation, and Chinese Academy of Medical Sciences innovation for medical sciences. The authors declared no conflicts of interest.

Source: Liu Y et al. Int J Hematol. 2021 Mar 1. doi: 10.1007/s12185-021-03115-9.

Key clinical point: Adding stanozolol to decitabine after effective decitabine treatment may improve progression-free survival (PFS) and reduce the severity of neutropenia in patients with high-risk myelodysplastic syndrome (MDS).

Major finding: PFS was significantly longer in the stanozolol group vs. stanozolol+decitabine group (15.0 vs. 9.0 months; hazard ratio [HR], 0.35; P = .0005). The proportion of patients with grade 3-4 neutropenia was lower in stanozolol group (76.2% vs. 95.1%; P = .039).

Study details: Findings are from a retrospective analysis of 62 patients with newly diagnosed high-risk MDS who achieved at least partial remission after 4 cycles of decitabine. For maintenance treatment, 21 patients received stanozolol and decitabine and 41 patients received decitabine alone.

Disclosures: This study was partly supported by the National Natural Science Foundation of China, the Natural Science Foundation of Tianjin China, Key Technology Research and Development Program of Tianjin China, Beijing Natural Science Foundation, and Chinese Academy of Medical Sciences innovation for medical sciences. The authors declared no conflicts of interest.

Source: Liu Y et al. Int J Hematol. 2021 Mar 1. doi: 10.1007/s12185-021-03115-9.

Key clinical point: Adding stanozolol to decitabine after effective decitabine treatment may improve progression-free survival (PFS) and reduce the severity of neutropenia in patients with high-risk myelodysplastic syndrome (MDS).

Major finding: PFS was significantly longer in the stanozolol group vs. stanozolol+decitabine group (15.0 vs. 9.0 months; hazard ratio [HR], 0.35; P = .0005). The proportion of patients with grade 3-4 neutropenia was lower in stanozolol group (76.2% vs. 95.1%; P = .039).

Study details: Findings are from a retrospective analysis of 62 patients with newly diagnosed high-risk MDS who achieved at least partial remission after 4 cycles of decitabine. For maintenance treatment, 21 patients received stanozolol and decitabine and 41 patients received decitabine alone.

Disclosures: This study was partly supported by the National Natural Science Foundation of China, the Natural Science Foundation of Tianjin China, Key Technology Research and Development Program of Tianjin China, Beijing Natural Science Foundation, and Chinese Academy of Medical Sciences innovation for medical sciences. The authors declared no conflicts of interest.

Source: Liu Y et al. Int J Hematol. 2021 Mar 1. doi: 10.1007/s12185-021-03115-9.