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More frequent secukinumab dosing found to benefit overweight psoriasis patients
, results from a multicenter, double-blind, parallel-group trial showed.
The more frequent dosing was also associated with comparable safety, consistent with the established secukinumab safety profile.
“Weight may have an impact on pharmacokinetics and, therefore, on the clinical outcome of biologic treatment for psoriasis,” Matthias Augustin, MD, and colleagues wrote in the study, published recently in the British Journal of Dermatology. “Dose optimization may be highly beneficial for patients with higher body weight,” they noted, adding that their study supports previous study findings and pharmacokinetic/pharmacodynamic modelling data, showing that secukinumab dosed every 2 weeks “leads to a clinically and statistically significant advantage in PASI 90 response,” compared with standard dosing every 4 weeks in patients who weight 90 kg (about 198 pounds) or more, after 16 weeks of treatment, which was maintained until week 52.
For the study, Dr. Augustin, of the Institute for Health Services Research in Dermatology and Nursing at University Medical Center Hamburg-Eppendorf (Germany), and colleagues randomized 331 patients with moderate to severe chronic plaque psoriasis who weighed 90 kg or more to receive secukinumab 300 mg every 2 weeks, or secukinumab 300 mg every 4 weeks. The mean age of the patients was 47 years, 75% were male, 92% were White, and their mean body weight was 111.1 kg, with a mean body mass index of 36.1 kg/m2.
Patients who did not achieve a Psoriasis Area and Severity Index (PASI) 90 at week 16 on the monthly regimen (Q4W) either remained on that regimen or were up-titrated to dosing every 2 weeks (Q2W). Of the 331 patients, 165 received Q2W dosing and 166 received Q4W dosing. The researchers found that, at 16 weeks, patients in the Q2W dosing group had significantly higher PASI 90 responses, compared with those in the Q4W group (73.2% vs. 55.5%, respectively; P = .0003; odds ratio estimate, 2.3).
At 52 weeks, a greater proportion of patients in the Q2W group maintained responses to several outcome measures, compared with those in the Q4W group, including PASI 75 (88.9% vs. 74.8%), PASI 90 (76.4% vs. 52.4%), and PASI 100 (46.7% vs. 27.3%) scores; Investigator’s Global Assessment score of 0 or 1 (75.9% vs. 55.6%); and Dermatology Life Quality Index scores of 0 or 1 (66.1% vs. 48.8%).
In addition, those who had not had a PASI 90 response at week 16 who were up-titrated to Q2W dosing demonstrated higher efficacy responses at week 32, compared with those who remained on the Q4W regimen, with PASI 90 scores of 37.7% versus 16.5%, respectively.
Both regimens were well-tolerated, consistent with the known secukinumab safety profile; safety was comparable in the treatment arms, and there was “no clear dose-response relationship seen” for the incidence of overall adverse events, serious AEs, and AEs leading to discontinuation of the study treatment, “or AEs related to the identified risks” of infections, hypersensitivity, neutropenia and potential risk of major adverse cardiovascular events, the authors wrote.
“Despite more frequent dosing, the incidence of Candida infections was numerically lower in the Q2W group versus the Q4W group,” although there were not many cases, three patients versus six patients, respectively.
Need for individualized treatment
“Despite a decades-long revolution in development of highly efficacious biologic treatments for psoriasis, we are only in the early stages of developing personalized clinical approaches,” said Raj Chovatiya, MD, PhD, a dermatologist at Northwestern University, Chicago, who was asked to comment on the study. “The need for individualized treatment in psoriasis is very real; not every patient may respond to therapy in the same way. Obesity is one important comorbidity of psoriasis, and increased body mass index may be associated with variable treatment outcomes with systemic therapy.”
The data from this study, he added, “suggest that dose optimization may be an important strategy to enhance psoriasis clearance in patients with suboptimal treatment outcomes on standard dosing, including those with increased weight. Future studies should examine optimal regimen of biologic therapy across a variety of patient factors.”
The study was funded by Novartis, the manufacturer of secukinumab (Cosentyx); several authors were company employees. Dr. Augustin disclosed that he has served as a consultant for or has been a paid speaker for clinical trials sponsored by companies that manufacture drugs used for the treatment of psoriasis, including AbbVie, Almirall, Amgen, Biogen, Boehringer Ingelheim, Celgene, Centocor, Eli Lilly, GlaxoSmithKline, Janssen-Cilag, LEO Pharma, Medac, Merck, MSD, Novartis, Pfizer, UCB, and Xenoport. Dr. Chovatiya disclosed that he is a consultant to, a speaker for, and/or a member of the advisory board for AbbVie, Arcutis, Arena, Incyte, Pfizer, Regeneron, and Sanofi Genzyme.
, results from a multicenter, double-blind, parallel-group trial showed.
The more frequent dosing was also associated with comparable safety, consistent with the established secukinumab safety profile.
“Weight may have an impact on pharmacokinetics and, therefore, on the clinical outcome of biologic treatment for psoriasis,” Matthias Augustin, MD, and colleagues wrote in the study, published recently in the British Journal of Dermatology. “Dose optimization may be highly beneficial for patients with higher body weight,” they noted, adding that their study supports previous study findings and pharmacokinetic/pharmacodynamic modelling data, showing that secukinumab dosed every 2 weeks “leads to a clinically and statistically significant advantage in PASI 90 response,” compared with standard dosing every 4 weeks in patients who weight 90 kg (about 198 pounds) or more, after 16 weeks of treatment, which was maintained until week 52.
For the study, Dr. Augustin, of the Institute for Health Services Research in Dermatology and Nursing at University Medical Center Hamburg-Eppendorf (Germany), and colleagues randomized 331 patients with moderate to severe chronic plaque psoriasis who weighed 90 kg or more to receive secukinumab 300 mg every 2 weeks, or secukinumab 300 mg every 4 weeks. The mean age of the patients was 47 years, 75% were male, 92% were White, and their mean body weight was 111.1 kg, with a mean body mass index of 36.1 kg/m2.
Patients who did not achieve a Psoriasis Area and Severity Index (PASI) 90 at week 16 on the monthly regimen (Q4W) either remained on that regimen or were up-titrated to dosing every 2 weeks (Q2W). Of the 331 patients, 165 received Q2W dosing and 166 received Q4W dosing. The researchers found that, at 16 weeks, patients in the Q2W dosing group had significantly higher PASI 90 responses, compared with those in the Q4W group (73.2% vs. 55.5%, respectively; P = .0003; odds ratio estimate, 2.3).
At 52 weeks, a greater proportion of patients in the Q2W group maintained responses to several outcome measures, compared with those in the Q4W group, including PASI 75 (88.9% vs. 74.8%), PASI 90 (76.4% vs. 52.4%), and PASI 100 (46.7% vs. 27.3%) scores; Investigator’s Global Assessment score of 0 or 1 (75.9% vs. 55.6%); and Dermatology Life Quality Index scores of 0 or 1 (66.1% vs. 48.8%).
In addition, those who had not had a PASI 90 response at week 16 who were up-titrated to Q2W dosing demonstrated higher efficacy responses at week 32, compared with those who remained on the Q4W regimen, with PASI 90 scores of 37.7% versus 16.5%, respectively.
Both regimens were well-tolerated, consistent with the known secukinumab safety profile; safety was comparable in the treatment arms, and there was “no clear dose-response relationship seen” for the incidence of overall adverse events, serious AEs, and AEs leading to discontinuation of the study treatment, “or AEs related to the identified risks” of infections, hypersensitivity, neutropenia and potential risk of major adverse cardiovascular events, the authors wrote.
“Despite more frequent dosing, the incidence of Candida infections was numerically lower in the Q2W group versus the Q4W group,” although there were not many cases, three patients versus six patients, respectively.
Need for individualized treatment
“Despite a decades-long revolution in development of highly efficacious biologic treatments for psoriasis, we are only in the early stages of developing personalized clinical approaches,” said Raj Chovatiya, MD, PhD, a dermatologist at Northwestern University, Chicago, who was asked to comment on the study. “The need for individualized treatment in psoriasis is very real; not every patient may respond to therapy in the same way. Obesity is one important comorbidity of psoriasis, and increased body mass index may be associated with variable treatment outcomes with systemic therapy.”
The data from this study, he added, “suggest that dose optimization may be an important strategy to enhance psoriasis clearance in patients with suboptimal treatment outcomes on standard dosing, including those with increased weight. Future studies should examine optimal regimen of biologic therapy across a variety of patient factors.”
The study was funded by Novartis, the manufacturer of secukinumab (Cosentyx); several authors were company employees. Dr. Augustin disclosed that he has served as a consultant for or has been a paid speaker for clinical trials sponsored by companies that manufacture drugs used for the treatment of psoriasis, including AbbVie, Almirall, Amgen, Biogen, Boehringer Ingelheim, Celgene, Centocor, Eli Lilly, GlaxoSmithKline, Janssen-Cilag, LEO Pharma, Medac, Merck, MSD, Novartis, Pfizer, UCB, and Xenoport. Dr. Chovatiya disclosed that he is a consultant to, a speaker for, and/or a member of the advisory board for AbbVie, Arcutis, Arena, Incyte, Pfizer, Regeneron, and Sanofi Genzyme.
, results from a multicenter, double-blind, parallel-group trial showed.
The more frequent dosing was also associated with comparable safety, consistent with the established secukinumab safety profile.
“Weight may have an impact on pharmacokinetics and, therefore, on the clinical outcome of biologic treatment for psoriasis,” Matthias Augustin, MD, and colleagues wrote in the study, published recently in the British Journal of Dermatology. “Dose optimization may be highly beneficial for patients with higher body weight,” they noted, adding that their study supports previous study findings and pharmacokinetic/pharmacodynamic modelling data, showing that secukinumab dosed every 2 weeks “leads to a clinically and statistically significant advantage in PASI 90 response,” compared with standard dosing every 4 weeks in patients who weight 90 kg (about 198 pounds) or more, after 16 weeks of treatment, which was maintained until week 52.
For the study, Dr. Augustin, of the Institute for Health Services Research in Dermatology and Nursing at University Medical Center Hamburg-Eppendorf (Germany), and colleagues randomized 331 patients with moderate to severe chronic plaque psoriasis who weighed 90 kg or more to receive secukinumab 300 mg every 2 weeks, or secukinumab 300 mg every 4 weeks. The mean age of the patients was 47 years, 75% were male, 92% were White, and their mean body weight was 111.1 kg, with a mean body mass index of 36.1 kg/m2.
Patients who did not achieve a Psoriasis Area and Severity Index (PASI) 90 at week 16 on the monthly regimen (Q4W) either remained on that regimen or were up-titrated to dosing every 2 weeks (Q2W). Of the 331 patients, 165 received Q2W dosing and 166 received Q4W dosing. The researchers found that, at 16 weeks, patients in the Q2W dosing group had significantly higher PASI 90 responses, compared with those in the Q4W group (73.2% vs. 55.5%, respectively; P = .0003; odds ratio estimate, 2.3).
At 52 weeks, a greater proportion of patients in the Q2W group maintained responses to several outcome measures, compared with those in the Q4W group, including PASI 75 (88.9% vs. 74.8%), PASI 90 (76.4% vs. 52.4%), and PASI 100 (46.7% vs. 27.3%) scores; Investigator’s Global Assessment score of 0 or 1 (75.9% vs. 55.6%); and Dermatology Life Quality Index scores of 0 or 1 (66.1% vs. 48.8%).
In addition, those who had not had a PASI 90 response at week 16 who were up-titrated to Q2W dosing demonstrated higher efficacy responses at week 32, compared with those who remained on the Q4W regimen, with PASI 90 scores of 37.7% versus 16.5%, respectively.
Both regimens were well-tolerated, consistent with the known secukinumab safety profile; safety was comparable in the treatment arms, and there was “no clear dose-response relationship seen” for the incidence of overall adverse events, serious AEs, and AEs leading to discontinuation of the study treatment, “or AEs related to the identified risks” of infections, hypersensitivity, neutropenia and potential risk of major adverse cardiovascular events, the authors wrote.
“Despite more frequent dosing, the incidence of Candida infections was numerically lower in the Q2W group versus the Q4W group,” although there were not many cases, three patients versus six patients, respectively.
Need for individualized treatment
“Despite a decades-long revolution in development of highly efficacious biologic treatments for psoriasis, we are only in the early stages of developing personalized clinical approaches,” said Raj Chovatiya, MD, PhD, a dermatologist at Northwestern University, Chicago, who was asked to comment on the study. “The need for individualized treatment in psoriasis is very real; not every patient may respond to therapy in the same way. Obesity is one important comorbidity of psoriasis, and increased body mass index may be associated with variable treatment outcomes with systemic therapy.”
The data from this study, he added, “suggest that dose optimization may be an important strategy to enhance psoriasis clearance in patients with suboptimal treatment outcomes on standard dosing, including those with increased weight. Future studies should examine optimal regimen of biologic therapy across a variety of patient factors.”
The study was funded by Novartis, the manufacturer of secukinumab (Cosentyx); several authors were company employees. Dr. Augustin disclosed that he has served as a consultant for or has been a paid speaker for clinical trials sponsored by companies that manufacture drugs used for the treatment of psoriasis, including AbbVie, Almirall, Amgen, Biogen, Boehringer Ingelheim, Celgene, Centocor, Eli Lilly, GlaxoSmithKline, Janssen-Cilag, LEO Pharma, Medac, Merck, MSD, Novartis, Pfizer, UCB, and Xenoport. Dr. Chovatiya disclosed that he is a consultant to, a speaker for, and/or a member of the advisory board for AbbVie, Arcutis, Arena, Incyte, Pfizer, Regeneron, and Sanofi Genzyme.
FROM THE BRITISH JOURNAL OF DERMATOLOGY
Ultrasound variables could help identify psoriasis patients at risk of progressing to PsA
Key clinical point: Patients with psoriasis who showed ultrasound abnormalities in hand, knee, toe joints, and few other anatomical sites are more likely to progress to psoriatic arthritis (PsA).
Major finding: Hand joint power Doppler (PD) signals (grade 0 and ≥1), knee joint PD signals (grade 0 and ≥1), toe joint PD signals (grade 0 and ≥1), quadriceps tendon and patellar tendon enthesitis (all P < .001), wrist joint synovial thickening (grade 1-3; P = .001), and Achilles tendon and plantar aponeurosis enthesitis (P = .007) were all significant risk predictors for PsA.
Study details: Findings are from a cross-sectional study including 852 patients with psoriasis but without PsA, 261 patients with PsA, and 86 healthy volunteers who underwent an ultrasound examination.
Disclosures: This study was funded by West China Hospital, West China Precision Medicine Industrial Technology Institutes, and Sichuan Provincial Science and Technology Project. The authors declared no conflict of interests.
Source: Wang Y et al. Dermatol Ther (Heidelb). 2021 (Dec 19). Doi: 10.1007/s13555-021-00663-0.
Key clinical point: Patients with psoriasis who showed ultrasound abnormalities in hand, knee, toe joints, and few other anatomical sites are more likely to progress to psoriatic arthritis (PsA).
Major finding: Hand joint power Doppler (PD) signals (grade 0 and ≥1), knee joint PD signals (grade 0 and ≥1), toe joint PD signals (grade 0 and ≥1), quadriceps tendon and patellar tendon enthesitis (all P < .001), wrist joint synovial thickening (grade 1-3; P = .001), and Achilles tendon and plantar aponeurosis enthesitis (P = .007) were all significant risk predictors for PsA.
Study details: Findings are from a cross-sectional study including 852 patients with psoriasis but without PsA, 261 patients with PsA, and 86 healthy volunteers who underwent an ultrasound examination.
Disclosures: This study was funded by West China Hospital, West China Precision Medicine Industrial Technology Institutes, and Sichuan Provincial Science and Technology Project. The authors declared no conflict of interests.
Source: Wang Y et al. Dermatol Ther (Heidelb). 2021 (Dec 19). Doi: 10.1007/s13555-021-00663-0.
Key clinical point: Patients with psoriasis who showed ultrasound abnormalities in hand, knee, toe joints, and few other anatomical sites are more likely to progress to psoriatic arthritis (PsA).
Major finding: Hand joint power Doppler (PD) signals (grade 0 and ≥1), knee joint PD signals (grade 0 and ≥1), toe joint PD signals (grade 0 and ≥1), quadriceps tendon and patellar tendon enthesitis (all P < .001), wrist joint synovial thickening (grade 1-3; P = .001), and Achilles tendon and plantar aponeurosis enthesitis (P = .007) were all significant risk predictors for PsA.
Study details: Findings are from a cross-sectional study including 852 patients with psoriasis but without PsA, 261 patients with PsA, and 86 healthy volunteers who underwent an ultrasound examination.
Disclosures: This study was funded by West China Hospital, West China Precision Medicine Industrial Technology Institutes, and Sichuan Provincial Science and Technology Project. The authors declared no conflict of interests.
Source: Wang Y et al. Dermatol Ther (Heidelb). 2021 (Dec 19). Doi: 10.1007/s13555-021-00663-0.
Generally mild/moderate nonserious adverse events in PsA patients treated with tofacitinib
Key clinical point: Patients with psoriatic arthritis (PsA) who received treatment with tofacitinib experienced mostly mild/moderate nonserious adverse events (AE), which persisted for a shorter duration and had a minimum effect on the continuation of tofacitinib treatment.
Major finding: In the first 3 months of treatment, the most frequent nonserious AEs were headache (incidence rate [IR] 16.9-39.2) and diarrhea (IR 15-17) and duration of such AEs was ≤4 weeks with none leading to permanent discontinuation of treatment.
Study details: Findings are from a post hoc analysis of phase 3 studies including 710 patients with active PsA who received 5 mg tofacitinib, 10 mg tofacitinib, or placebo and had a previous inadequate response to ≥1 conventional synthetic disease-modifying antirheumatic drug or ≥1 tumor necrosis factor inhibitor.
Disclosures: This study was funded by Pfizer. Five authors reported being employees and stockholders of AbbVie. The other authors reported ties with several sources including AbbVie.
Source: Dikranian A et al. Rheumatol Ther. 2021 (Dec 17). Doi: 10.1007/s40744-021-00405-w.
Key clinical point: Patients with psoriatic arthritis (PsA) who received treatment with tofacitinib experienced mostly mild/moderate nonserious adverse events (AE), which persisted for a shorter duration and had a minimum effect on the continuation of tofacitinib treatment.
Major finding: In the first 3 months of treatment, the most frequent nonserious AEs were headache (incidence rate [IR] 16.9-39.2) and diarrhea (IR 15-17) and duration of such AEs was ≤4 weeks with none leading to permanent discontinuation of treatment.
Study details: Findings are from a post hoc analysis of phase 3 studies including 710 patients with active PsA who received 5 mg tofacitinib, 10 mg tofacitinib, or placebo and had a previous inadequate response to ≥1 conventional synthetic disease-modifying antirheumatic drug or ≥1 tumor necrosis factor inhibitor.
Disclosures: This study was funded by Pfizer. Five authors reported being employees and stockholders of AbbVie. The other authors reported ties with several sources including AbbVie.
Source: Dikranian A et al. Rheumatol Ther. 2021 (Dec 17). Doi: 10.1007/s40744-021-00405-w.
Key clinical point: Patients with psoriatic arthritis (PsA) who received treatment with tofacitinib experienced mostly mild/moderate nonserious adverse events (AE), which persisted for a shorter duration and had a minimum effect on the continuation of tofacitinib treatment.
Major finding: In the first 3 months of treatment, the most frequent nonserious AEs were headache (incidence rate [IR] 16.9-39.2) and diarrhea (IR 15-17) and duration of such AEs was ≤4 weeks with none leading to permanent discontinuation of treatment.
Study details: Findings are from a post hoc analysis of phase 3 studies including 710 patients with active PsA who received 5 mg tofacitinib, 10 mg tofacitinib, or placebo and had a previous inadequate response to ≥1 conventional synthetic disease-modifying antirheumatic drug or ≥1 tumor necrosis factor inhibitor.
Disclosures: This study was funded by Pfizer. Five authors reported being employees and stockholders of AbbVie. The other authors reported ties with several sources including AbbVie.
Source: Dikranian A et al. Rheumatol Ther. 2021 (Dec 17). Doi: 10.1007/s40744-021-00405-w.
Ultrasound evaluation of entheses helps discriminate psoriatic arthritis from fibromyalgia
Key clinical point: Ultrasound assessment of entheses may help differentiate psoriatic arthritis (PsA) from fibromyalgia syndrome (FMS) as patients with PsA showed more frequent ultrasound changes both in gray scale (GS) and power Doppler (PD) mode than those with FMS.
Major finding: A higher proportion of patients with PsA vs. FMS was detected with ≥1 entheses in GS (P < .0001) and PD (P = .0033) mode, with GS and PD identifying changes in a higher proportion of PsA vs. FMS entheses (P < .0001 for both). Area under the curve values for GS and PD mode were 0.77 and 0.66, respectively, with 3.5 being the best cutoff GS score to discriminate PsA from FMS (sensitivity, 0.75; specificity, 0.63).
Study details: Findings are from a post hoc analysis of the cross‐sectional ULISSE study including 140 and 51 patients with PsA and FMS, respectively.
Disclosures: This study was funded by AbbVie Srl. Three authors declared being employees and shareholders of AbbVie, and some of the authors declared receiving consultancy fees and research support from several sources.
Source: Marchesoni A et al. J Clin Med. 2021;11(1):180 (Dec 29). Doi: 10.3390/jcm11010180.
Key clinical point: Ultrasound assessment of entheses may help differentiate psoriatic arthritis (PsA) from fibromyalgia syndrome (FMS) as patients with PsA showed more frequent ultrasound changes both in gray scale (GS) and power Doppler (PD) mode than those with FMS.
Major finding: A higher proportion of patients with PsA vs. FMS was detected with ≥1 entheses in GS (P < .0001) and PD (P = .0033) mode, with GS and PD identifying changes in a higher proportion of PsA vs. FMS entheses (P < .0001 for both). Area under the curve values for GS and PD mode were 0.77 and 0.66, respectively, with 3.5 being the best cutoff GS score to discriminate PsA from FMS (sensitivity, 0.75; specificity, 0.63).
Study details: Findings are from a post hoc analysis of the cross‐sectional ULISSE study including 140 and 51 patients with PsA and FMS, respectively.
Disclosures: This study was funded by AbbVie Srl. Three authors declared being employees and shareholders of AbbVie, and some of the authors declared receiving consultancy fees and research support from several sources.
Source: Marchesoni A et al. J Clin Med. 2021;11(1):180 (Dec 29). Doi: 10.3390/jcm11010180.
Key clinical point: Ultrasound assessment of entheses may help differentiate psoriatic arthritis (PsA) from fibromyalgia syndrome (FMS) as patients with PsA showed more frequent ultrasound changes both in gray scale (GS) and power Doppler (PD) mode than those with FMS.
Major finding: A higher proportion of patients with PsA vs. FMS was detected with ≥1 entheses in GS (P < .0001) and PD (P = .0033) mode, with GS and PD identifying changes in a higher proportion of PsA vs. FMS entheses (P < .0001 for both). Area under the curve values for GS and PD mode were 0.77 and 0.66, respectively, with 3.5 being the best cutoff GS score to discriminate PsA from FMS (sensitivity, 0.75; specificity, 0.63).
Study details: Findings are from a post hoc analysis of the cross‐sectional ULISSE study including 140 and 51 patients with PsA and FMS, respectively.
Disclosures: This study was funded by AbbVie Srl. Three authors declared being employees and shareholders of AbbVie, and some of the authors declared receiving consultancy fees and research support from several sources.
Source: Marchesoni A et al. J Clin Med. 2021;11(1):180 (Dec 29). Doi: 10.3390/jcm11010180.
Real-world efficacy and safety of apremilast in patients with psoriatic arthritis
Key clinical point: This real-world study confirms sustained improvements in signs and symptoms of psoriatic arthritis (PsA) with apremilast along with a tolerable safety profile.
Major finding: Overall, 43.5% of patients who received apremilast within 30 days of participating in the study and completed ≥150 days of treatment achieved PsA Response Criteria. In detail, 26.8% and 41.8% of patients with 68-tender joint count >0 and 66-swollen joint count >0 at baseline, respectively, achieved complete joint count resolution at month 6. No new adverse events were reported.
Study details: Findings are from the prospective, observational APOLO study including 107 patients with active PsA, of which 106 patients received ≥1 dose of apremilast.
Disclosures: This study was funded by Celgene. Some of the authors declared receiving research grants and consultancy and speaker fees from Celgene and other sources.
Source: Vlam KD et al. Adv Ther. 2022 (Jan 3). Doi: 10.1007/s12325-021-02016-x.
Key clinical point: This real-world study confirms sustained improvements in signs and symptoms of psoriatic arthritis (PsA) with apremilast along with a tolerable safety profile.
Major finding: Overall, 43.5% of patients who received apremilast within 30 days of participating in the study and completed ≥150 days of treatment achieved PsA Response Criteria. In detail, 26.8% and 41.8% of patients with 68-tender joint count >0 and 66-swollen joint count >0 at baseline, respectively, achieved complete joint count resolution at month 6. No new adverse events were reported.
Study details: Findings are from the prospective, observational APOLO study including 107 patients with active PsA, of which 106 patients received ≥1 dose of apremilast.
Disclosures: This study was funded by Celgene. Some of the authors declared receiving research grants and consultancy and speaker fees from Celgene and other sources.
Source: Vlam KD et al. Adv Ther. 2022 (Jan 3). Doi: 10.1007/s12325-021-02016-x.
Key clinical point: This real-world study confirms sustained improvements in signs and symptoms of psoriatic arthritis (PsA) with apremilast along with a tolerable safety profile.
Major finding: Overall, 43.5% of patients who received apremilast within 30 days of participating in the study and completed ≥150 days of treatment achieved PsA Response Criteria. In detail, 26.8% and 41.8% of patients with 68-tender joint count >0 and 66-swollen joint count >0 at baseline, respectively, achieved complete joint count resolution at month 6. No new adverse events were reported.
Study details: Findings are from the prospective, observational APOLO study including 107 patients with active PsA, of which 106 patients received ≥1 dose of apremilast.
Disclosures: This study was funded by Celgene. Some of the authors declared receiving research grants and consultancy and speaker fees from Celgene and other sources.
Source: Vlam KD et al. Adv Ther. 2022 (Jan 3). Doi: 10.1007/s12325-021-02016-x.
Younger age at psoriasis diagnosis or severe disease tied to delayed transition from psoriasis to PsA
Key clinical point: Patients with psoriasis were more likely to have a delayed onset of psoriatic arthritis (PsA) if they were diagnosed with psoriasis at a younger age or suffered from severe psoriasis.
Major finding: The median time from psoriasis diagnosis to the incidence of PsA was 35.5 months with age at psoriasis onset (odds ratio [OR] per 10-year decrease 1.63; 95% CI 1.26-2.11) and its severity (OR for severe vs. mild 3.65; 95% CI 1.18-11.32) being associated with having a psoriasis diagnosis >1 year prior to incident PsA.
Study details: Findings are from a retrospective nested case-control study including 158 patients with incident PsA, of which 41% had concurrent psoriasis and 59% patients had onset of psoriasis before PsA.
Disclosures: This study was funded by the Rochester Epidemiology Project supported by National Institute on Aging, National Center for Advancing Translational Sciences, and others. The authors declared serving as consultants or receiving grants, consulting fees, honoraria, and research support from several sources.
Source: Karmacharya P et al. Semin Arthritis Rheum. 2021;151949 (Dec 31). Doi: 10.1016/j.semarthrit.2021.12.013.
Key clinical point: Patients with psoriasis were more likely to have a delayed onset of psoriatic arthritis (PsA) if they were diagnosed with psoriasis at a younger age or suffered from severe psoriasis.
Major finding: The median time from psoriasis diagnosis to the incidence of PsA was 35.5 months with age at psoriasis onset (odds ratio [OR] per 10-year decrease 1.63; 95% CI 1.26-2.11) and its severity (OR for severe vs. mild 3.65; 95% CI 1.18-11.32) being associated with having a psoriasis diagnosis >1 year prior to incident PsA.
Study details: Findings are from a retrospective nested case-control study including 158 patients with incident PsA, of which 41% had concurrent psoriasis and 59% patients had onset of psoriasis before PsA.
Disclosures: This study was funded by the Rochester Epidemiology Project supported by National Institute on Aging, National Center for Advancing Translational Sciences, and others. The authors declared serving as consultants or receiving grants, consulting fees, honoraria, and research support from several sources.
Source: Karmacharya P et al. Semin Arthritis Rheum. 2021;151949 (Dec 31). Doi: 10.1016/j.semarthrit.2021.12.013.
Key clinical point: Patients with psoriasis were more likely to have a delayed onset of psoriatic arthritis (PsA) if they were diagnosed with psoriasis at a younger age or suffered from severe psoriasis.
Major finding: The median time from psoriasis diagnosis to the incidence of PsA was 35.5 months with age at psoriasis onset (odds ratio [OR] per 10-year decrease 1.63; 95% CI 1.26-2.11) and its severity (OR for severe vs. mild 3.65; 95% CI 1.18-11.32) being associated with having a psoriasis diagnosis >1 year prior to incident PsA.
Study details: Findings are from a retrospective nested case-control study including 158 patients with incident PsA, of which 41% had concurrent psoriasis and 59% patients had onset of psoriasis before PsA.
Disclosures: This study was funded by the Rochester Epidemiology Project supported by National Institute on Aging, National Center for Advancing Translational Sciences, and others. The authors declared serving as consultants or receiving grants, consulting fees, honoraria, and research support from several sources.
Source: Karmacharya P et al. Semin Arthritis Rheum. 2021;151949 (Dec 31). Doi: 10.1016/j.semarthrit.2021.12.013.
Dactylitis indicates a more severe disease phenotype in early PsA
Key clinical point: Presence of dactylitis independently confirmed more severe disease burden with higher swollen joint counts (SJC), C-reactive protein (CRP) levels, ultrasound-detected synovitis, and bone erosion in disease-modifying antirheumatic drug (DMARD)-naive patients with early psoriatic arthritis (PsA).
Major finding: Dactylitic vs. nondactylitic PsA was associated with a higher SJC (P < .001) and CRP level (P = .006) and a higher prevalence of ultrasound synovitis (P < .001) and bone erosions (P < .001). After excluding dactylitic digits, SJC was greater (P = .002) and ultrasound-detected synovitis (P < .001) and erosions (P = .008) were more prevalent in dactylitic vs. nondactylitic PsA.
Study details: This study included 177 DMARD-naive patients with early PsA who were stratified by the presence or absence of dactylitis at baseline.
Disclosures: This study was funded by the National Institute for Health Research Leeds Biomedical Research Centre. The authors declared no conflict of interests.
Source: Dubash S et al. Ann Rheum Dis. 2021 (Dec 10). Doi: 10.1136/annrheumdis-2021-220964.
Key clinical point: Presence of dactylitis independently confirmed more severe disease burden with higher swollen joint counts (SJC), C-reactive protein (CRP) levels, ultrasound-detected synovitis, and bone erosion in disease-modifying antirheumatic drug (DMARD)-naive patients with early psoriatic arthritis (PsA).
Major finding: Dactylitic vs. nondactylitic PsA was associated with a higher SJC (P < .001) and CRP level (P = .006) and a higher prevalence of ultrasound synovitis (P < .001) and bone erosions (P < .001). After excluding dactylitic digits, SJC was greater (P = .002) and ultrasound-detected synovitis (P < .001) and erosions (P = .008) were more prevalent in dactylitic vs. nondactylitic PsA.
Study details: This study included 177 DMARD-naive patients with early PsA who were stratified by the presence or absence of dactylitis at baseline.
Disclosures: This study was funded by the National Institute for Health Research Leeds Biomedical Research Centre. The authors declared no conflict of interests.
Source: Dubash S et al. Ann Rheum Dis. 2021 (Dec 10). Doi: 10.1136/annrheumdis-2021-220964.
Key clinical point: Presence of dactylitis independently confirmed more severe disease burden with higher swollen joint counts (SJC), C-reactive protein (CRP) levels, ultrasound-detected synovitis, and bone erosion in disease-modifying antirheumatic drug (DMARD)-naive patients with early psoriatic arthritis (PsA).
Major finding: Dactylitic vs. nondactylitic PsA was associated with a higher SJC (P < .001) and CRP level (P = .006) and a higher prevalence of ultrasound synovitis (P < .001) and bone erosions (P < .001). After excluding dactylitic digits, SJC was greater (P = .002) and ultrasound-detected synovitis (P < .001) and erosions (P = .008) were more prevalent in dactylitic vs. nondactylitic PsA.
Study details: This study included 177 DMARD-naive patients with early PsA who were stratified by the presence or absence of dactylitis at baseline.
Disclosures: This study was funded by the National Institute for Health Research Leeds Biomedical Research Centre. The authors declared no conflict of interests.
Source: Dubash S et al. Ann Rheum Dis. 2021 (Dec 10). Doi: 10.1136/annrheumdis-2021-220964.
Risankizumab shows promise in PsA patients with inadequate response to csDMARDs
Key clinical point: Risankizumab effectively reduced clinical manifestations of psoriatic arthritis (PsA) in patients with inadequate response to conventional synthetic disease-modifying antirheumatic drugs (csDMARD) with no new adverse events (AE).
Major finding: At week 24, at least a 20% improvement in the American College of Rheumatology score was achieved by a significantly higher proportion of patients receiving risankizumab vs. placebo (57.3% vs. 33.5%; P < .001). Treatment-emergent AEs were mild/moderate and reported at similar frequencies in risankizumab (40.4%) and placebo (38.7%) groups.
Study details: Findings are from a double-blind, phase 3 KEEPsAKE 1 study including 964 patients with active PsA and inadequate response to ≥1 csDMARDs who were randomly assigned to receive 150 mg risankizumab or placebo at weeks 0, 4, and 16.
Disclosures: This study did not report any source of funding. The authors declared serving as speaker, consultant, investigator, or receiving honoraria, fees, and grants from several sources. Five authors declared being employees or shareholders of AbbVie.
Source: Kristensen LE et al. Ann Rheum Dis. 2021;81:225-231 (Dec 15). Doi: 10.1136/annrheumdis-2021-221019.
Key clinical point: Risankizumab effectively reduced clinical manifestations of psoriatic arthritis (PsA) in patients with inadequate response to conventional synthetic disease-modifying antirheumatic drugs (csDMARD) with no new adverse events (AE).
Major finding: At week 24, at least a 20% improvement in the American College of Rheumatology score was achieved by a significantly higher proportion of patients receiving risankizumab vs. placebo (57.3% vs. 33.5%; P < .001). Treatment-emergent AEs were mild/moderate and reported at similar frequencies in risankizumab (40.4%) and placebo (38.7%) groups.
Study details: Findings are from a double-blind, phase 3 KEEPsAKE 1 study including 964 patients with active PsA and inadequate response to ≥1 csDMARDs who were randomly assigned to receive 150 mg risankizumab or placebo at weeks 0, 4, and 16.
Disclosures: This study did not report any source of funding. The authors declared serving as speaker, consultant, investigator, or receiving honoraria, fees, and grants from several sources. Five authors declared being employees or shareholders of AbbVie.
Source: Kristensen LE et al. Ann Rheum Dis. 2021;81:225-231 (Dec 15). Doi: 10.1136/annrheumdis-2021-221019.
Key clinical point: Risankizumab effectively reduced clinical manifestations of psoriatic arthritis (PsA) in patients with inadequate response to conventional synthetic disease-modifying antirheumatic drugs (csDMARD) with no new adverse events (AE).
Major finding: At week 24, at least a 20% improvement in the American College of Rheumatology score was achieved by a significantly higher proportion of patients receiving risankizumab vs. placebo (57.3% vs. 33.5%; P < .001). Treatment-emergent AEs were mild/moderate and reported at similar frequencies in risankizumab (40.4%) and placebo (38.7%) groups.
Study details: Findings are from a double-blind, phase 3 KEEPsAKE 1 study including 964 patients with active PsA and inadequate response to ≥1 csDMARDs who were randomly assigned to receive 150 mg risankizumab or placebo at weeks 0, 4, and 16.
Disclosures: This study did not report any source of funding. The authors declared serving as speaker, consultant, investigator, or receiving honoraria, fees, and grants from several sources. Five authors declared being employees or shareholders of AbbVie.
Source: Kristensen LE et al. Ann Rheum Dis. 2021;81:225-231 (Dec 15). Doi: 10.1136/annrheumdis-2021-221019.
Psoriatic arthritis management should target both clinical and biochemical inflammation
Key clinical point: In patients with psoriatic arthritis (PsA), clinical inflammation monitored by swollen joint counts (SJC) and biochemical inflammation monitored by C-reactive protein (CRP) level, have a direct effect on structural progression.
Major finding: Progression was significantly higher in patients with active vs. inactive time-averaged SJC (odds ratio [OR] 1.24; P = .016) and time-averaged CRP (OR 6.08; P = .036). Progression was greatest in presence of both clinical and biochemical inflammation and lowest in absence of both (P = .05).
Study details: Findings are secondary analysis of patient data from the IMPACT 2 trial, including 145 patients with PsA.
Disclosures: The study did not report any source of funding. The authors declared serving as associate editor or receiving grants and honoraria from several sources.
Source: Borst C et al. RMD Open. 2021;7:e002038 (Dec 8). Doi: 10.1136/rmdopen-2021-002038.
Key clinical point: In patients with psoriatic arthritis (PsA), clinical inflammation monitored by swollen joint counts (SJC) and biochemical inflammation monitored by C-reactive protein (CRP) level, have a direct effect on structural progression.
Major finding: Progression was significantly higher in patients with active vs. inactive time-averaged SJC (odds ratio [OR] 1.24; P = .016) and time-averaged CRP (OR 6.08; P = .036). Progression was greatest in presence of both clinical and biochemical inflammation and lowest in absence of both (P = .05).
Study details: Findings are secondary analysis of patient data from the IMPACT 2 trial, including 145 patients with PsA.
Disclosures: The study did not report any source of funding. The authors declared serving as associate editor or receiving grants and honoraria from several sources.
Source: Borst C et al. RMD Open. 2021;7:e002038 (Dec 8). Doi: 10.1136/rmdopen-2021-002038.
Key clinical point: In patients with psoriatic arthritis (PsA), clinical inflammation monitored by swollen joint counts (SJC) and biochemical inflammation monitored by C-reactive protein (CRP) level, have a direct effect on structural progression.
Major finding: Progression was significantly higher in patients with active vs. inactive time-averaged SJC (odds ratio [OR] 1.24; P = .016) and time-averaged CRP (OR 6.08; P = .036). Progression was greatest in presence of both clinical and biochemical inflammation and lowest in absence of both (P = .05).
Study details: Findings are secondary analysis of patient data from the IMPACT 2 trial, including 145 patients with PsA.
Disclosures: The study did not report any source of funding. The authors declared serving as associate editor or receiving grants and honoraria from several sources.
Source: Borst C et al. RMD Open. 2021;7:e002038 (Dec 8). Doi: 10.1136/rmdopen-2021-002038.
PsA: Upadacitinib shows similar benefits as monotherapy or in combination with nbDMARDs
Key clinical point: Upadacitinib showed similar efficacy and a consistent safety profile as monotherapy or in combination with nonbiologic disease-modifying antirheumatic drugs (nbDMARDs) in patients with psoriatic arthritis (PsA).
Major finding: At week 12, ≥20% improvement in the American College of Rheumatology score was achieved by a similar proportion of patients receiving 15 mg upadacitinib or 30 mg upadacitinib as monotherapy (15 mg: 33.7%; 95% CI, 24.4%-43.1%; 30 mg: 45.7%; 95% CI, 36.9%-54.5%) or combination therapy (15 mg: 34.0%; 95% CI, 27.9%-40.1%; 30 mg: 39.6%; 95% CI, 33.7%-45.5%). Adverse events were generally similar with monotherapy and combination therapy.
Study details: This is a pooled analysis of 2 phase 3 trials, SELECT-PsA 1 and SELECT-PsA 2, including 1,916 patients with active PsA with an inadequate response to ≥1 nbDMARD/bDMARD who were randomly assigned to placebo, 15 mg upadacitinib, or 30 mg upadacitinib as monotherapy or in combination with ≤2 nbDMARDs for 24 weeks.
Disclosures: This work was supported by AbbVie. Six authors reported being employees and stockholders of AbbVie. The other authors reported ties with several sources including AbbVie.
Source: Nash P et al. Rheumatology (Oxford). 2021;keab905 (Dec 3). Doi: 10.1093/rheumatology/keab905.
Key clinical point: Upadacitinib showed similar efficacy and a consistent safety profile as monotherapy or in combination with nonbiologic disease-modifying antirheumatic drugs (nbDMARDs) in patients with psoriatic arthritis (PsA).
Major finding: At week 12, ≥20% improvement in the American College of Rheumatology score was achieved by a similar proportion of patients receiving 15 mg upadacitinib or 30 mg upadacitinib as monotherapy (15 mg: 33.7%; 95% CI, 24.4%-43.1%; 30 mg: 45.7%; 95% CI, 36.9%-54.5%) or combination therapy (15 mg: 34.0%; 95% CI, 27.9%-40.1%; 30 mg: 39.6%; 95% CI, 33.7%-45.5%). Adverse events were generally similar with monotherapy and combination therapy.
Study details: This is a pooled analysis of 2 phase 3 trials, SELECT-PsA 1 and SELECT-PsA 2, including 1,916 patients with active PsA with an inadequate response to ≥1 nbDMARD/bDMARD who were randomly assigned to placebo, 15 mg upadacitinib, or 30 mg upadacitinib as monotherapy or in combination with ≤2 nbDMARDs for 24 weeks.
Disclosures: This work was supported by AbbVie. Six authors reported being employees and stockholders of AbbVie. The other authors reported ties with several sources including AbbVie.
Source: Nash P et al. Rheumatology (Oxford). 2021;keab905 (Dec 3). Doi: 10.1093/rheumatology/keab905.
Key clinical point: Upadacitinib showed similar efficacy and a consistent safety profile as monotherapy or in combination with nonbiologic disease-modifying antirheumatic drugs (nbDMARDs) in patients with psoriatic arthritis (PsA).
Major finding: At week 12, ≥20% improvement in the American College of Rheumatology score was achieved by a similar proportion of patients receiving 15 mg upadacitinib or 30 mg upadacitinib as monotherapy (15 mg: 33.7%; 95% CI, 24.4%-43.1%; 30 mg: 45.7%; 95% CI, 36.9%-54.5%) or combination therapy (15 mg: 34.0%; 95% CI, 27.9%-40.1%; 30 mg: 39.6%; 95% CI, 33.7%-45.5%). Adverse events were generally similar with monotherapy and combination therapy.
Study details: This is a pooled analysis of 2 phase 3 trials, SELECT-PsA 1 and SELECT-PsA 2, including 1,916 patients with active PsA with an inadequate response to ≥1 nbDMARD/bDMARD who were randomly assigned to placebo, 15 mg upadacitinib, or 30 mg upadacitinib as monotherapy or in combination with ≤2 nbDMARDs for 24 weeks.
Disclosures: This work was supported by AbbVie. Six authors reported being employees and stockholders of AbbVie. The other authors reported ties with several sources including AbbVie.
Source: Nash P et al. Rheumatology (Oxford). 2021;keab905 (Dec 3). Doi: 10.1093/rheumatology/keab905.