Psoriatic Arthritis

Key clinical point: Disease-modifying antirheumatic drug (DMARD)-naive patients with moderate vs high disease activity at baseline were more likely to achieve Clinical Disease Activity Index for Psoriatic Arthritis (PsA) treatment targets following apremilast therapy.

Major finding: At week 52, remission or low disease activity was achieved by approximately twice the number of patients with moderate vs high disease activity (61.7% vs 28.2%) at baseline, regardless of one or multiple PsA manifestations.

Study details: Findings are from a post hoc analysis of the phase 3 PALACE 4 study including 175 DMARD-naive patients with active PsA who received 30 mg apremilast.

Disclosures: This study received writing support from Amgen. Three authors declared being employees and stockholders of Amgen. The other authors reported ties with several sources, including Amgen.

Source: Mease PJ et al. Baseline disease activity predicts achievement of cDAPSA treatment targets with apremilast: Phase 3 results in DMARD-naive patients with psoriatic arthritis. J Rheumatol. 2022 (Apr 15). Doi: 10.3899/jrheum.210906

Key clinical point: Disease-modifying antirheumatic drug (DMARD)-naive patients with moderate vs high disease activity at baseline were more likely to achieve Clinical Disease Activity Index for Psoriatic Arthritis (PsA) treatment targets following apremilast therapy.

Major finding: At week 52, remission or low disease activity was achieved by approximately twice the number of patients with moderate vs high disease activity (61.7% vs 28.2%) at baseline, regardless of one or multiple PsA manifestations.

Study details: Findings are from a post hoc analysis of the phase 3 PALACE 4 study including 175 DMARD-naive patients with active PsA who received 30 mg apremilast.

Disclosures: This study received writing support from Amgen. Three authors declared being employees and stockholders of Amgen. The other authors reported ties with several sources, including Amgen.

Source: Mease PJ et al. Baseline disease activity predicts achievement of cDAPSA treatment targets with apremilast: Phase 3 results in DMARD-naive patients with psoriatic arthritis. J Rheumatol. 2022 (Apr 15). Doi: 10.3899/jrheum.210906

Key clinical point: Disease-modifying antirheumatic drug (DMARD)-naive patients with moderate vs high disease activity at baseline were more likely to achieve Clinical Disease Activity Index for Psoriatic Arthritis (PsA) treatment targets following apremilast therapy.

Major finding: At week 52, remission or low disease activity was achieved by approximately twice the number of patients with moderate vs high disease activity (61.7% vs 28.2%) at baseline, regardless of one or multiple PsA manifestations.

Study details: Findings are from a post hoc analysis of the phase 3 PALACE 4 study including 175 DMARD-naive patients with active PsA who received 30 mg apremilast.

Disclosures: This study received writing support from Amgen. Three authors declared being employees and stockholders of Amgen. The other authors reported ties with several sources, including Amgen.

Source: Mease PJ et al. Baseline disease activity predicts achievement of cDAPSA treatment targets with apremilast: Phase 3 results in DMARD-naive patients with psoriatic arthritis. J Rheumatol. 2022 (Apr 15). Doi: 10.3899/jrheum.210906

Key clinical point: Patients with psoriasis and concurrent psoriatic arthritis (PsA) reported more extensive skin disease than patients with only psoriasis, with psoriasis severity being significantly associated with higher odds of concurrent PsA.

Major finding: Body surface area scores were significantly higher in patients with psoriasis and concurrent PsA vs patients with only psoriasis (mean difference 5.31; 95% CI 1.78-8.83), with severe psoriasis being a significant predictor of concurrent PsA (odds ratio 3.34; P < .001).

Study details: This was a meta-analysis of 29 studies including adult patients with psoriasis with or without concurrent PsA or adult patients with psoriasis who developed PsA.

Disclosures: This study did not receive any funding. JM Laar declared receiving research grants and honoraria from several sources.

Source: Pouw JN et al. Do patients with psoriatic arthritis have more severe skin disease than patients with psoriasis only? A systematic review and meta-analysis. Dermatology. 2022 (May 12). Doi: 10.1159/000524231

Key clinical point: Patients with psoriasis and concurrent psoriatic arthritis (PsA) reported more extensive skin disease than patients with only psoriasis, with psoriasis severity being significantly associated with higher odds of concurrent PsA.

Major finding: Body surface area scores were significantly higher in patients with psoriasis and concurrent PsA vs patients with only psoriasis (mean difference 5.31; 95% CI 1.78-8.83), with severe psoriasis being a significant predictor of concurrent PsA (odds ratio 3.34; P < .001).

Study details: This was a meta-analysis of 29 studies including adult patients with psoriasis with or without concurrent PsA or adult patients with psoriasis who developed PsA.

Disclosures: This study did not receive any funding. JM Laar declared receiving research grants and honoraria from several sources.

Source: Pouw JN et al. Do patients with psoriatic arthritis have more severe skin disease than patients with psoriasis only? A systematic review and meta-analysis. Dermatology. 2022 (May 12). Doi: 10.1159/000524231

Key clinical point: Patients with psoriasis and concurrent psoriatic arthritis (PsA) reported more extensive skin disease than patients with only psoriasis, with psoriasis severity being significantly associated with higher odds of concurrent PsA.

Major finding: Body surface area scores were significantly higher in patients with psoriasis and concurrent PsA vs patients with only psoriasis (mean difference 5.31; 95% CI 1.78-8.83), with severe psoriasis being a significant predictor of concurrent PsA (odds ratio 3.34; P < .001).

Study details: This was a meta-analysis of 29 studies including adult patients with psoriasis with or without concurrent PsA or adult patients with psoriasis who developed PsA.

Disclosures: This study did not receive any funding. JM Laar declared receiving research grants and honoraria from several sources.

Source: Pouw JN et al. Do patients with psoriatic arthritis have more severe skin disease than patients with psoriasis only? A systematic review and meta-analysis. Dermatology. 2022 (May 12). Doi: 10.1159/000524231

Key clinical point: A substantial proportion of patients with psoriatic arthritis (PsA) who received biological disease-modifying antirheumatic drug (bDMARD) therapy showed osteoproliferative lesions on a lumbar radiograph, with osteophytes being the most common.

Major finding: Osteophytes were the most common lesions and were detected in 42.3% of patients, with 18.1% of patients being diagnosed with grade ≥2 osteophytes. At least one syndesmophyte was detected in 24.2% of patients, with 9.3% and 19.8% of patients showing bridging and corner syndesmophytes, respectively. Ambiguous lesions were detected in 7.1% of patients.

Study details: Findings are from an analysis of 182 patients with PsA who received bDMARD therapy and underwent lumbar radiography assessment.

Disclosures: This research was funded by Hacettepe Rheumatology Society, Turkey. The authors declared no conflicts of interest.

Source: Ayan G et al. Degenerative and inflammatory osteoproliferations in lumbar radiographs in psoriatic arthritis patients. J Clin Med. 2022;11(7):2009 (Apr 3). Doi: 10.3390/jcm11072009

Key clinical point: A substantial proportion of patients with psoriatic arthritis (PsA) who received biological disease-modifying antirheumatic drug (bDMARD) therapy showed osteoproliferative lesions on a lumbar radiograph, with osteophytes being the most common.

Major finding: Osteophytes were the most common lesions and were detected in 42.3% of patients, with 18.1% of patients being diagnosed with grade ≥2 osteophytes. At least one syndesmophyte was detected in 24.2% of patients, with 9.3% and 19.8% of patients showing bridging and corner syndesmophytes, respectively. Ambiguous lesions were detected in 7.1% of patients.

Study details: Findings are from an analysis of 182 patients with PsA who received bDMARD therapy and underwent lumbar radiography assessment.

Disclosures: This research was funded by Hacettepe Rheumatology Society, Turkey. The authors declared no conflicts of interest.

Source: Ayan G et al. Degenerative and inflammatory osteoproliferations in lumbar radiographs in psoriatic arthritis patients. J Clin Med. 2022;11(7):2009 (Apr 3). Doi: 10.3390/jcm11072009

Key clinical point: A substantial proportion of patients with psoriatic arthritis (PsA) who received biological disease-modifying antirheumatic drug (bDMARD) therapy showed osteoproliferative lesions on a lumbar radiograph, with osteophytes being the most common.

Major finding: Osteophytes were the most common lesions and were detected in 42.3% of patients, with 18.1% of patients being diagnosed with grade ≥2 osteophytes. At least one syndesmophyte was detected in 24.2% of patients, with 9.3% and 19.8% of patients showing bridging and corner syndesmophytes, respectively. Ambiguous lesions were detected in 7.1% of patients.

Study details: Findings are from an analysis of 182 patients with PsA who received bDMARD therapy and underwent lumbar radiography assessment.

Disclosures: This research was funded by Hacettepe Rheumatology Society, Turkey. The authors declared no conflicts of interest.

Source: Ayan G et al. Degenerative and inflammatory osteoproliferations in lumbar radiographs in psoriatic arthritis patients. J Clin Med. 2022;11(7):2009 (Apr 3). Doi: 10.3390/jcm11072009

Key clinical point: Having sent a pharyngeal sample for culture was associated with an increased risk for psoriatic arthritis (PsA) onset, indicating site of infection being associated with the increased PsA risk rather than the pathogen.

Major finding: Among all samples sent for culture, a pharyngeal sample was associated with a higher risk for PsA onset within first 50 days compared with a urine (hazard ratio [HR] 8.78; 95% CI 3.23-23.91), nasopharyngeal (HR 8.26; 95% CI 2.23-30.63), or blood (HR 25.22; 95% CI 3.12-204.13) sample; however, streptococcal infections in the pharynx or at any other site were not associated with an increased risk for PsA.

Study details: Findings are from a population-based cohort study including 313,235 bacterial cultures from 128,982 individuals.

Disclosures: The study was supported by the Landspitali University Hospital, Iceland. A Ogdie and T Love declared serving as consultants and receiving grants and reimbursement from several sources.

Source: Thrastardottir T et al. Strong site-specific association of pharyngeal cultures with the onset of psoriatic arthritis and psoriasis, regardless of pathogen. Rheumatology (Oxford). 2022 (Apr 23). Doi: 10.1093/rheumatology/keac253 

Key clinical point: Having sent a pharyngeal sample for culture was associated with an increased risk for psoriatic arthritis (PsA) onset, indicating site of infection being associated with the increased PsA risk rather than the pathogen.

Major finding: Among all samples sent for culture, a pharyngeal sample was associated with a higher risk for PsA onset within first 50 days compared with a urine (hazard ratio [HR] 8.78; 95% CI 3.23-23.91), nasopharyngeal (HR 8.26; 95% CI 2.23-30.63), or blood (HR 25.22; 95% CI 3.12-204.13) sample; however, streptococcal infections in the pharynx or at any other site were not associated with an increased risk for PsA.

Study details: Findings are from a population-based cohort study including 313,235 bacterial cultures from 128,982 individuals.

Disclosures: The study was supported by the Landspitali University Hospital, Iceland. A Ogdie and T Love declared serving as consultants and receiving grants and reimbursement from several sources.

Source: Thrastardottir T et al. Strong site-specific association of pharyngeal cultures with the onset of psoriatic arthritis and psoriasis, regardless of pathogen. Rheumatology (Oxford). 2022 (Apr 23). Doi: 10.1093/rheumatology/keac253 

Key clinical point: Having sent a pharyngeal sample for culture was associated with an increased risk for psoriatic arthritis (PsA) onset, indicating site of infection being associated with the increased PsA risk rather than the pathogen.

Major finding: Among all samples sent for culture, a pharyngeal sample was associated with a higher risk for PsA onset within first 50 days compared with a urine (hazard ratio [HR] 8.78; 95% CI 3.23-23.91), nasopharyngeal (HR 8.26; 95% CI 2.23-30.63), or blood (HR 25.22; 95% CI 3.12-204.13) sample; however, streptococcal infections in the pharynx or at any other site were not associated with an increased risk for PsA.

Study details: Findings are from a population-based cohort study including 313,235 bacterial cultures from 128,982 individuals.

Disclosures: The study was supported by the Landspitali University Hospital, Iceland. A Ogdie and T Love declared serving as consultants and receiving grants and reimbursement from several sources.

Source: Thrastardottir T et al. Strong site-specific association of pharyngeal cultures with the onset of psoriatic arthritis and psoriasis, regardless of pathogen. Rheumatology (Oxford). 2022 (Apr 23). Doi: 10.1093/rheumatology/keac253 

Key clinical point: Both first- and second-line secukinumab therapies demonstrated substantial improvement in disease activity, adequate retention rates, and a satisfactory safety profile in a real-world population of patients with psoriatic arthritis (PsA).

Major finding: Mean Disease Activity Score 28 using C-reactive protein decreased from 3.0 to 2.0 and 1.9 at the first and third years of follow-up, whereas the proportion of patients in remission/low disease activity increased from 52.1% and 71.4% to 100% after 2 years of the first- and second-line secukinumab treatments, respectively. The overall retention rates of secukinumab were 74.1%, 59.1%, and 54.2% in the first, second, and third years of treatment, respectively, with no new adverse events being reported.

Study details: This observational, retrospective analysis included 639 patients with PsA or axial spondyloarthritis from the BIOBADASER registry who had received secukinumab for >12 months. Of these patients, 350 had PsA.

Disclosures: This study was sponsored by Novartis Spain. C Sastré is an employee of Novartis. The other authors reported no conflicts of interest.

Source: Moreno-Ramos MJ et al. Real-world effectiveness and treatment retention of secukinumab in patients with psoriatic arthritis and axial spondyloarthritis: A descriptive observational analysis of the Spanish BIOBADASER Registry. Rheumatol Ther. 2022 (Apr 25). Doi: 10.1007/s40744-022-00446-9

Key clinical point: Both first- and second-line secukinumab therapies demonstrated substantial improvement in disease activity, adequate retention rates, and a satisfactory safety profile in a real-world population of patients with psoriatic arthritis (PsA).

Major finding: Mean Disease Activity Score 28 using C-reactive protein decreased from 3.0 to 2.0 and 1.9 at the first and third years of follow-up, whereas the proportion of patients in remission/low disease activity increased from 52.1% and 71.4% to 100% after 2 years of the first- and second-line secukinumab treatments, respectively. The overall retention rates of secukinumab were 74.1%, 59.1%, and 54.2% in the first, second, and third years of treatment, respectively, with no new adverse events being reported.

Study details: This observational, retrospective analysis included 639 patients with PsA or axial spondyloarthritis from the BIOBADASER registry who had received secukinumab for >12 months. Of these patients, 350 had PsA.

Disclosures: This study was sponsored by Novartis Spain. C Sastré is an employee of Novartis. The other authors reported no conflicts of interest.

Source: Moreno-Ramos MJ et al. Real-world effectiveness and treatment retention of secukinumab in patients with psoriatic arthritis and axial spondyloarthritis: A descriptive observational analysis of the Spanish BIOBADASER Registry. Rheumatol Ther. 2022 (Apr 25). Doi: 10.1007/s40744-022-00446-9

Key clinical point: Both first- and second-line secukinumab therapies demonstrated substantial improvement in disease activity, adequate retention rates, and a satisfactory safety profile in a real-world population of patients with psoriatic arthritis (PsA).

Major finding: Mean Disease Activity Score 28 using C-reactive protein decreased from 3.0 to 2.0 and 1.9 at the first and third years of follow-up, whereas the proportion of patients in remission/low disease activity increased from 52.1% and 71.4% to 100% after 2 years of the first- and second-line secukinumab treatments, respectively. The overall retention rates of secukinumab were 74.1%, 59.1%, and 54.2% in the first, second, and third years of treatment, respectively, with no new adverse events being reported.

Study details: This observational, retrospective analysis included 639 patients with PsA or axial spondyloarthritis from the BIOBADASER registry who had received secukinumab for >12 months. Of these patients, 350 had PsA.

Disclosures: This study was sponsored by Novartis Spain. C Sastré is an employee of Novartis. The other authors reported no conflicts of interest.

Source: Moreno-Ramos MJ et al. Real-world effectiveness and treatment retention of secukinumab in patients with psoriatic arthritis and axial spondyloarthritis: A descriptive observational analysis of the Spanish BIOBADASER Registry. Rheumatol Ther. 2022 (Apr 25). Doi: 10.1007/s40744-022-00446-9

Key clinical point: Men vs women with psoriatic arthritis (PsA) experienced significantly improved outcomes with methotrexate+etanercept combination therapy, whereas those with lower body mass index (BMI) experienced better outcomes with no indication of any pattern with treatment received.

Major finding: At week 24, a higher proportion of men vs women receiving methotrexate+etanercept achieved American College of Rheumatology 20% (ACR20; 71.5% vs. 58.3%; P = .0194) and minimal disease activity (MDA; 45.8% vs 25.2%; P = .0003), whereas a higher proportion of patients with a BMI of ≤30 vs >30 kg/m² in all treatment groups achieved MDA (all P < .05) and those in methotrexate+etanercept group achieved ACR20 (P = .0241).

Study details: This was a post hoc analysis of the phase 3 SEAM-PsA trial including 851 methotrexate/biologics naive patients with early PsA who were randomly assigned to receive methotrexate+placebo, etanercept+placebo, or methotrexate+etanercept.

Disclosures: This study was funded by Immunex, a subsidiary of Amgen. Two authors declared being employees of and owned stocks in Amgen. The other authors reported ties with various sources, including Amgen.

Source: Mease PJ et al. Potential impact of sex and body mass index on response to therapy in psoriatic arthritis: Post-hoc analysis of results from the SEAM-PsA trial. J Rheumatol. 2022 (Apr 15). Doi: 10.3899/jrheum.211037

Key clinical point: Men vs women with psoriatic arthritis (PsA) experienced significantly improved outcomes with methotrexate+etanercept combination therapy, whereas those with lower body mass index (BMI) experienced better outcomes with no indication of any pattern with treatment received.

Major finding: At week 24, a higher proportion of men vs women receiving methotrexate+etanercept achieved American College of Rheumatology 20% (ACR20; 71.5% vs. 58.3%; P = .0194) and minimal disease activity (MDA; 45.8% vs 25.2%; P = .0003), whereas a higher proportion of patients with a BMI of ≤30 vs >30 kg/m² in all treatment groups achieved MDA (all P < .05) and those in methotrexate+etanercept group achieved ACR20 (P = .0241).

Study details: This was a post hoc analysis of the phase 3 SEAM-PsA trial including 851 methotrexate/biologics naive patients with early PsA who were randomly assigned to receive methotrexate+placebo, etanercept+placebo, or methotrexate+etanercept.

Disclosures: This study was funded by Immunex, a subsidiary of Amgen. Two authors declared being employees of and owned stocks in Amgen. The other authors reported ties with various sources, including Amgen.

Source: Mease PJ et al. Potential impact of sex and body mass index on response to therapy in psoriatic arthritis: Post-hoc analysis of results from the SEAM-PsA trial. J Rheumatol. 2022 (Apr 15). Doi: 10.3899/jrheum.211037

Key clinical point: Men vs women with psoriatic arthritis (PsA) experienced significantly improved outcomes with methotrexate+etanercept combination therapy, whereas those with lower body mass index (BMI) experienced better outcomes with no indication of any pattern with treatment received.

Major finding: At week 24, a higher proportion of men vs women receiving methotrexate+etanercept achieved American College of Rheumatology 20% (ACR20; 71.5% vs. 58.3%; P = .0194) and minimal disease activity (MDA; 45.8% vs 25.2%; P = .0003), whereas a higher proportion of patients with a BMI of ≤30 vs >30 kg/m² in all treatment groups achieved MDA (all P < .05) and those in methotrexate+etanercept group achieved ACR20 (P = .0241).

Study details: This was a post hoc analysis of the phase 3 SEAM-PsA trial including 851 methotrexate/biologics naive patients with early PsA who were randomly assigned to receive methotrexate+placebo, etanercept+placebo, or methotrexate+etanercept.

Disclosures: This study was funded by Immunex, a subsidiary of Amgen. Two authors declared being employees of and owned stocks in Amgen. The other authors reported ties with various sources, including Amgen.

Source: Mease PJ et al. Potential impact of sex and body mass index on response to therapy in psoriatic arthritis: Post-hoc analysis of results from the SEAM-PsA trial. J Rheumatol. 2022 (Apr 15). Doi: 10.3899/jrheum.211037

Key clinical point: More than one-third of real-world patients with psoriatic arthritis (PsA) who were not in minimal disease activity (MDA) at secukinumab initiation achieved MDA after 6 months of initiating secukinumab along with improvement in other patient-reported outcomes.

Major finding: At 6 months, 36.6% of patients not in MDA at secukinumab initiation achieved MDA and 41.2%, 44.4%, 60.7%, and 75.0% of patients with ≥1 tender joint, ≥1 swollen joint, enthesitis, and dactylitis, respectively, at secukinumab initiation achieved symptom resolution along with improvement in pain, fatigue, and other scores.

Study details: Findings are from an analysis of 100 patients with PsA from the CorEvitas Psoriatic Arthritis/Spondyloarthritis Registry who initiated secukinumab and maintained the treatment at 6-month follow-up visit.

Disclosures: This study was sponsored by CorEvitas, LLC. Three authors declared being employees of CorEvitas. The other authors reported ties with several sources.

Source: Mease PJ et al. Effectiveness of 6-month use of secukinumab in patients with psoriatic arthritis in the CorEvitas Psoriatic Arthritis/Spondyloarthritis Registry. J Rheumatol. 2022 (Apr 15). Doi: 10.3899/jrheum.211033

Key clinical point: More than one-third of real-world patients with psoriatic arthritis (PsA) who were not in minimal disease activity (MDA) at secukinumab initiation achieved MDA after 6 months of initiating secukinumab along with improvement in other patient-reported outcomes.

Major finding: At 6 months, 36.6% of patients not in MDA at secukinumab initiation achieved MDA and 41.2%, 44.4%, 60.7%, and 75.0% of patients with ≥1 tender joint, ≥1 swollen joint, enthesitis, and dactylitis, respectively, at secukinumab initiation achieved symptom resolution along with improvement in pain, fatigue, and other scores.

Study details: Findings are from an analysis of 100 patients with PsA from the CorEvitas Psoriatic Arthritis/Spondyloarthritis Registry who initiated secukinumab and maintained the treatment at 6-month follow-up visit.

Disclosures: This study was sponsored by CorEvitas, LLC. Three authors declared being employees of CorEvitas. The other authors reported ties with several sources.

Source: Mease PJ et al. Effectiveness of 6-month use of secukinumab in patients with psoriatic arthritis in the CorEvitas Psoriatic Arthritis/Spondyloarthritis Registry. J Rheumatol. 2022 (Apr 15). Doi: 10.3899/jrheum.211033

Key clinical point: More than one-third of real-world patients with psoriatic arthritis (PsA) who were not in minimal disease activity (MDA) at secukinumab initiation achieved MDA after 6 months of initiating secukinumab along with improvement in other patient-reported outcomes.

Major finding: At 6 months, 36.6% of patients not in MDA at secukinumab initiation achieved MDA and 41.2%, 44.4%, 60.7%, and 75.0% of patients with ≥1 tender joint, ≥1 swollen joint, enthesitis, and dactylitis, respectively, at secukinumab initiation achieved symptom resolution along with improvement in pain, fatigue, and other scores.

Study details: Findings are from an analysis of 100 patients with PsA from the CorEvitas Psoriatic Arthritis/Spondyloarthritis Registry who initiated secukinumab and maintained the treatment at 6-month follow-up visit.

Disclosures: This study was sponsored by CorEvitas, LLC. Three authors declared being employees of CorEvitas. The other authors reported ties with several sources.

Source: Mease PJ et al. Effectiveness of 6-month use of secukinumab in patients with psoriatic arthritis in the CorEvitas Psoriatic Arthritis/Spondyloarthritis Registry. J Rheumatol. 2022 (Apr 15). Doi: 10.3899/jrheum.211033

The Food and Drug Administration has approved tapinarof cream, 1%, a steroid-free topical cream applied once a day, for the treatment of mild, moderate, or severe plaque psoriasis in adults, the manufacturer announced.

Tapinarof is an aryl hydrocarbon receptor agonist and is the first FDA-approved steroid-free topical medication in this class, according to a press release from the manufacturer, Dermavant.

Approval was based on results of three studies in a phase 3 clinical trial program (PSOARING 1, PSOARING 2), and an open-label extension study, (PSOARING 3), the company release said. In PSOARING 1 and 2, approximately 1,000 adults aged 18-75 years (median age, 51 years) with plaque psoriasis were randomized to once-daily topical tapinarof or placebo for up to 12 weeks; 85% were White and 57% were men. The study findings were published in the New England Journal of Medicine in December 2021.

The primary endpoint for both trials was the proportion of patients who achieved Physician Global Assessment (PGA) scores score of “clear” (0) or “almost clear” (1) and improvement of at least two grades from baseline.

After 12 weeks, 36% of the patients in PSOARING 1 and 40% in PSOARING 2 who received tapinarof met the primary outcome, compared with 6% of patients on placebo (P < .001 for both studies). Of these, a total of 73 patients from both studies who achieved PGA scores of 0 were entered in PSOARING 3, a 40-week open-label extension study, in which they stopped tapinarof treatment and retained PGA scores of 0 or 1 for approximately 4 months off treatment. An additional 312 patients who were enrolled in the PSOARING 3 extension study achieved PGA scores of 0 at least once during the study period, with “remittive” effects lasting a mean of 130 days off of treatment.

In addition, patients who received tapinarof in the PSOARING 1 and 2 studies showed significant improvement from baseline, compared with patients on placebo, across a range of secondary endpoints including a 75% or greater improvement in Psoriasis Area and Severity Index score (PASI 75).

In PSOARING 1, and 2, respectively, 36.1% and 47.6% of those on tapinarof achieved a PASI 75 response at week 12, compared with 10.2% and 6.9% of those on the vehicle (P < .001 for both).

Across all three studies, the majority adverse events were mild to moderate, and limited to the application site.

The most common adverse events reported by patients in the tapinarof groups were folliculitis, nasopharyngitis, and contact dermatitis. Headaches were more common among those treated with tapinarof than those on vehicle in the studies (3.8% vs. 2.4% in PSOARING 1, and 3.8% vs. 0.6% in PSOARING 2), leading to only three treatment discontinuations.

At the end of the PSOARING 3 study (at either week 40 or early termination), 599 participants responded to satisfaction questionnaires. Of these, 83.6% said they were satisfied with the results of tapinarof treatment, and 81.7% said it was more effective than previous topical treatments they had used, according to the company’s release.

Tapinarof cream can be used on all areas of the body, including the face, skin folds, neck, genitalia, anal crux, inflammatory areas, and axillae, according to the company release.

Full prescribing information is available here.

The Food and Drug Administration has approved tapinarof cream, 1%, a steroid-free topical cream applied once a day, for the treatment of mild, moderate, or severe plaque psoriasis in adults, the manufacturer announced.

Tapinarof is an aryl hydrocarbon receptor agonist and is the first FDA-approved steroid-free topical medication in this class, according to a press release from the manufacturer, Dermavant.

Approval was based on results of three studies in a phase 3 clinical trial program (PSOARING 1, PSOARING 2), and an open-label extension study, (PSOARING 3), the company release said. In PSOARING 1 and 2, approximately 1,000 adults aged 18-75 years (median age, 51 years) with plaque psoriasis were randomized to once-daily topical tapinarof or placebo for up to 12 weeks; 85% were White and 57% were men. The study findings were published in the New England Journal of Medicine in December 2021.

The primary endpoint for both trials was the proportion of patients who achieved Physician Global Assessment (PGA) scores score of “clear” (0) or “almost clear” (1) and improvement of at least two grades from baseline.

After 12 weeks, 36% of the patients in PSOARING 1 and 40% in PSOARING 2 who received tapinarof met the primary outcome, compared with 6% of patients on placebo (P < .001 for both studies). Of these, a total of 73 patients from both studies who achieved PGA scores of 0 were entered in PSOARING 3, a 40-week open-label extension study, in which they stopped tapinarof treatment and retained PGA scores of 0 or 1 for approximately 4 months off treatment. An additional 312 patients who were enrolled in the PSOARING 3 extension study achieved PGA scores of 0 at least once during the study period, with “remittive” effects lasting a mean of 130 days off of treatment.

In addition, patients who received tapinarof in the PSOARING 1 and 2 studies showed significant improvement from baseline, compared with patients on placebo, across a range of secondary endpoints including a 75% or greater improvement in Psoriasis Area and Severity Index score (PASI 75).

In PSOARING 1, and 2, respectively, 36.1% and 47.6% of those on tapinarof achieved a PASI 75 response at week 12, compared with 10.2% and 6.9% of those on the vehicle (P < .001 for both).

Across all three studies, the majority adverse events were mild to moderate, and limited to the application site.

The most common adverse events reported by patients in the tapinarof groups were folliculitis, nasopharyngitis, and contact dermatitis. Headaches were more common among those treated with tapinarof than those on vehicle in the studies (3.8% vs. 2.4% in PSOARING 1, and 3.8% vs. 0.6% in PSOARING 2), leading to only three treatment discontinuations.

At the end of the PSOARING 3 study (at either week 40 or early termination), 599 participants responded to satisfaction questionnaires. Of these, 83.6% said they were satisfied with the results of tapinarof treatment, and 81.7% said it was more effective than previous topical treatments they had used, according to the company’s release.

Tapinarof cream can be used on all areas of the body, including the face, skin folds, neck, genitalia, anal crux, inflammatory areas, and axillae, according to the company release.

Full prescribing information is available here.

The Food and Drug Administration has approved tapinarof cream, 1%, a steroid-free topical cream applied once a day, for the treatment of mild, moderate, or severe plaque psoriasis in adults, the manufacturer announced.

Tapinarof is an aryl hydrocarbon receptor agonist and is the first FDA-approved steroid-free topical medication in this class, according to a press release from the manufacturer, Dermavant.

Approval was based on results of three studies in a phase 3 clinical trial program (PSOARING 1, PSOARING 2), and an open-label extension study, (PSOARING 3), the company release said. In PSOARING 1 and 2, approximately 1,000 adults aged 18-75 years (median age, 51 years) with plaque psoriasis were randomized to once-daily topical tapinarof or placebo for up to 12 weeks; 85% were White and 57% were men. The study findings were published in the New England Journal of Medicine in December 2021.

The primary endpoint for both trials was the proportion of patients who achieved Physician Global Assessment (PGA) scores score of “clear” (0) or “almost clear” (1) and improvement of at least two grades from baseline.

After 12 weeks, 36% of the patients in PSOARING 1 and 40% in PSOARING 2 who received tapinarof met the primary outcome, compared with 6% of patients on placebo (P < .001 for both studies). Of these, a total of 73 patients from both studies who achieved PGA scores of 0 were entered in PSOARING 3, a 40-week open-label extension study, in which they stopped tapinarof treatment and retained PGA scores of 0 or 1 for approximately 4 months off treatment. An additional 312 patients who were enrolled in the PSOARING 3 extension study achieved PGA scores of 0 at least once during the study period, with “remittive” effects lasting a mean of 130 days off of treatment.

In addition, patients who received tapinarof in the PSOARING 1 and 2 studies showed significant improvement from baseline, compared with patients on placebo, across a range of secondary endpoints including a 75% or greater improvement in Psoriasis Area and Severity Index score (PASI 75).

In PSOARING 1, and 2, respectively, 36.1% and 47.6% of those on tapinarof achieved a PASI 75 response at week 12, compared with 10.2% and 6.9% of those on the vehicle (P < .001 for both).

Across all three studies, the majority adverse events were mild to moderate, and limited to the application site.

The most common adverse events reported by patients in the tapinarof groups were folliculitis, nasopharyngitis, and contact dermatitis. Headaches were more common among those treated with tapinarof than those on vehicle in the studies (3.8% vs. 2.4% in PSOARING 1, and 3.8% vs. 0.6% in PSOARING 2), leading to only three treatment discontinuations.

At the end of the PSOARING 3 study (at either week 40 or early termination), 599 participants responded to satisfaction questionnaires. Of these, 83.6% said they were satisfied with the results of tapinarof treatment, and 81.7% said it was more effective than previous topical treatments they had used, according to the company’s release.

Tapinarof cream can be used on all areas of the body, including the face, skin folds, neck, genitalia, anal crux, inflammatory areas, and axillae, according to the company release.

Full prescribing information is available here.

On the basis of history and presentation, this patient's psoriatic disease has probably evolved to psoriatic arthritis mutilans (PAM). PAM is considered the most severe form of psoriatic arthritis (PsA), causing joint destruction and functional disability. It is estimated to affect about 5% of patients with PsA, with an equal sex distribution. Psoriatic nail dystrophy, a hallmark of PsA, appears to be a clinical biomarker of PAM development. Patients with PAM are generally younger at diagnosis than those with less severe forms of disease. Disease-modifying antirheumatic drugs and anti-TNF therapy do not appear to prevent the development of PAM, as evidenced by the present case. 

In general, clinical presentation of PsA is heterogeneous and can be similar to that of other rheumatic diseases such as rheumatoid arthritis or osteoarthritis, complicating the differential diagnosis. The Classification Criteria for Psoriatic Arthritis (CASPAR) are considered the most sensitive diagnostic criteria, encompassing evidence of psoriasis; nail dystrophy; lab findings of typical autoantibodies (negative rheumatoid factor); and phenomena that are characteristic of PsA, like dactylitis.

Workup for PAM often includes radiography, ultrasound, and MRI or CT. With no established consensus, classification systems for the condition vary clinically and radiographically. Radiographic features suggestive of PAM include osteolysis or extended bone resorption; pencil-in-cup changes; joint subluxation; and, less often, ankylosis. Osteolysis has been defined as bone resorption with more than 50% loss of joint surface on both sides of the joint. Clinically, dissolution of the joint causes redundant, overlying skin with a telescoping motion of the digit. Other clinical features of PAM include digital shortening and flail joints. Of note, involvement of one small joint in the hands or feet is diagnostic of PAM.

In the setting of PsA, multiple genetic factors have been described, including presence of HLA-B27 and HLA-DRB1, but none are considered defining factors for the disease. A recent population-based study shows that presence of HLA-B27 was significantly increased among patients with PAM (45%) compared with patients with less severe PsA (13%) and healthy controls (13%). 

According to the American College of Rheumatology guidelines, first-line therapy in adult patients who have active PsA and are treatment-naive is a TNFi biologic agent. For the patient in this case, who has active PsA despite treatment with TNFi biologic monotherapy, switching to a different TNFi biologic may be appropriate; however, switching to an interleukin-17 inhibitor may also be considered because this patient has severe disease. Data on the comparative efficacy of different biological agents for treatment of PAM are not yet available.

Herbert S. Diamond, MD, Professor of Medicine (retired), Temple University School of Medicine, University of Pittsburgh; Chairman, Department of Medicine Emeritus, Western Pennsylvania Hospital, Pittsburgh, PA.

Herbert S. Diamond, MD, has disclosed no relevant financial relationships.

Image Quizzes are fictional or fictionalized clinical scenarios intended to provide evidence-based educational takeaways.

On the basis of history and presentation, this patient's psoriatic disease has probably evolved to psoriatic arthritis mutilans (PAM). PAM is considered the most severe form of psoriatic arthritis (PsA), causing joint destruction and functional disability. It is estimated to affect about 5% of patients with PsA, with an equal sex distribution. Psoriatic nail dystrophy, a hallmark of PsA, appears to be a clinical biomarker of PAM development. Patients with PAM are generally younger at diagnosis than those with less severe forms of disease. Disease-modifying antirheumatic drugs and anti-TNF therapy do not appear to prevent the development of PAM, as evidenced by the present case. 

In general, clinical presentation of PsA is heterogeneous and can be similar to that of other rheumatic diseases such as rheumatoid arthritis or osteoarthritis, complicating the differential diagnosis. The Classification Criteria for Psoriatic Arthritis (CASPAR) are considered the most sensitive diagnostic criteria, encompassing evidence of psoriasis; nail dystrophy; lab findings of typical autoantibodies (negative rheumatoid factor); and phenomena that are characteristic of PsA, like dactylitis.

Workup for PAM often includes radiography, ultrasound, and MRI or CT. With no established consensus, classification systems for the condition vary clinically and radiographically. Radiographic features suggestive of PAM include osteolysis or extended bone resorption; pencil-in-cup changes; joint subluxation; and, less often, ankylosis. Osteolysis has been defined as bone resorption with more than 50% loss of joint surface on both sides of the joint. Clinically, dissolution of the joint causes redundant, overlying skin with a telescoping motion of the digit. Other clinical features of PAM include digital shortening and flail joints. Of note, involvement of one small joint in the hands or feet is diagnostic of PAM.

In the setting of PsA, multiple genetic factors have been described, including presence of HLA-B27 and HLA-DRB1, but none are considered defining factors for the disease. A recent population-based study shows that presence of HLA-B27 was significantly increased among patients with PAM (45%) compared with patients with less severe PsA (13%) and healthy controls (13%). 

According to the American College of Rheumatology guidelines, first-line therapy in adult patients who have active PsA and are treatment-naive is a TNFi biologic agent. For the patient in this case, who has active PsA despite treatment with TNFi biologic monotherapy, switching to a different TNFi biologic may be appropriate; however, switching to an interleukin-17 inhibitor may also be considered because this patient has severe disease. Data on the comparative efficacy of different biological agents for treatment of PAM are not yet available.

Herbert S. Diamond, MD, Professor of Medicine (retired), Temple University School of Medicine, University of Pittsburgh; Chairman, Department of Medicine Emeritus, Western Pennsylvania Hospital, Pittsburgh, PA.

Herbert S. Diamond, MD, has disclosed no relevant financial relationships.

Image Quizzes are fictional or fictionalized clinical scenarios intended to provide evidence-based educational takeaways.

On the basis of history and presentation, this patient's psoriatic disease has probably evolved to psoriatic arthritis mutilans (PAM). PAM is considered the most severe form of psoriatic arthritis (PsA), causing joint destruction and functional disability. It is estimated to affect about 5% of patients with PsA, with an equal sex distribution. Psoriatic nail dystrophy, a hallmark of PsA, appears to be a clinical biomarker of PAM development. Patients with PAM are generally younger at diagnosis than those with less severe forms of disease. Disease-modifying antirheumatic drugs and anti-TNF therapy do not appear to prevent the development of PAM, as evidenced by the present case. 

In general, clinical presentation of PsA is heterogeneous and can be similar to that of other rheumatic diseases such as rheumatoid arthritis or osteoarthritis, complicating the differential diagnosis. The Classification Criteria for Psoriatic Arthritis (CASPAR) are considered the most sensitive diagnostic criteria, encompassing evidence of psoriasis; nail dystrophy; lab findings of typical autoantibodies (negative rheumatoid factor); and phenomena that are characteristic of PsA, like dactylitis.

Workup for PAM often includes radiography, ultrasound, and MRI or CT. With no established consensus, classification systems for the condition vary clinically and radiographically. Radiographic features suggestive of PAM include osteolysis or extended bone resorption; pencil-in-cup changes; joint subluxation; and, less often, ankylosis. Osteolysis has been defined as bone resorption with more than 50% loss of joint surface on both sides of the joint. Clinically, dissolution of the joint causes redundant, overlying skin with a telescoping motion of the digit. Other clinical features of PAM include digital shortening and flail joints. Of note, involvement of one small joint in the hands or feet is diagnostic of PAM.

In the setting of PsA, multiple genetic factors have been described, including presence of HLA-B27 and HLA-DRB1, but none are considered defining factors for the disease. A recent population-based study shows that presence of HLA-B27 was significantly increased among patients with PAM (45%) compared with patients with less severe PsA (13%) and healthy controls (13%). 

According to the American College of Rheumatology guidelines, first-line therapy in adult patients who have active PsA and are treatment-naive is a TNFi biologic agent. For the patient in this case, who has active PsA despite treatment with TNFi biologic monotherapy, switching to a different TNFi biologic may be appropriate; however, switching to an interleukin-17 inhibitor may also be considered because this patient has severe disease. Data on the comparative efficacy of different biological agents for treatment of PAM are not yet available.

Herbert S. Diamond, MD, Professor of Medicine (retired), Temple University School of Medicine, University of Pittsburgh; Chairman, Department of Medicine Emeritus, Western Pennsylvania Hospital, Pittsburgh, PA.

Herbert S. Diamond, MD, has disclosed no relevant financial relationships.

Image Quizzes are fictional or fictionalized clinical scenarios intended to provide evidence-based educational takeaways.

Patients with psoriasis have a significantly increased risk of severe and rare infections, compared with the general population, according to a population-based cohort study of nearly 95,000 patients.

Although previous studies have shown a higher risk for comorbid conditions in people with psoriasis, compared with those without psoriasis, data on the occurrence of severe and rare infections in patients with psoriasis are limited, wrote Nikolai Loft, MD, of the department of dermatology and allergy, Copenhagen University Hospital, Gentofte, and colleagues.

Psoriasis patients are often treated with immunosuppressive therapies that may promote or aggravate infections; therefore, a better understanding of psoriasis and risk of infections is needed, they said. In a study published in the British Journal of Dermatology, Dr. Loft and his coinvestigators reviewed data on adults aged 18 years and older from the Danish National Patient Register between Jan. 1, 1997 and Dec. 31, 2018. The study population included 94,450 adults with psoriasis and 566,700 matched controls. Patients with any type of psoriasis and any degree of severity were included.

The primary outcome was the occurrence of severe infections, defined as those requiring assessment at a hospital, and rare infections, defined as HIV, TB, HBV, and HCV. The median age of the participants was 52.3 years, and slightly more than half were women.

Overall, the incidence rate of severe and rare infections among patients with any type of psoriasis was 3,104.9 per 100,000 person-years, compared with 2,381.1 for controls, with a hazard ratio, adjusted for gender, age, ethnicity, socioeconomic status, alcohol-related conditions, and Charlson comorbidity index (aHR) of 1.29.

For any infections resulting in hospitalization, the incidence rate was 2,005.1 vs. 1,531.8 per 100,000 person-years for patients with any type of psoriasis and controls, respectively.

The results were similar when severe infections and rare infections were analyzed separately. The incidence rate of severe infections was 3,080.6 and 2,364.4 per 100,000 person-years for patients with any psoriasis, compared with controls; the incidence rate for rare infections was 42.9 and 31.8 for all psoriasis patients and controls, respectively.

When the data were examined by psoriasis severity, the incidence rate of severe and rare infections among patients with severe psoriasis was 3,847.7 per 100,000 person-years, compared with 2,351.9 per 100,000 person years among controls (aHR, 1.58) and also higher than in patients with mild psoriasis. The incidence rate of severe and rare infections in patients with mild psoriasis (2,979.1 per 100,000 person-years) also was higher than in controls (aHR, 1.26).

Factors that might explain the increased infection risk with severe psoriasis include the altered immune environment in these patients, the researchers wrote in their discussion of the findings. Also, “patients with severe psoriasis are defined by their eligibility for systemics, either conventional or biologic,” and their increased infection risk may stem from these treatments, rather than disease severity itself, they noted.

The study findings were limited by several factors including the lack of data on such confounders as weight, body mass index, and smoking status, they added. Other limitations included potential surveillance bias because of greater TB screening, and the use of prescriptions, rather than the Psoriasis Area Severity Index, to define severity. However, the results were strengthened by the large sample size, and suggest that patients with any type of psoriasis have higher rates of any infection, severe or rare, than the general population, the researchers concluded.

Data show need for clinician vigilance

Based on the 2020 Census data, an estimated 7.55 million adults in the United States have psoriasis, David Robles, MD, said in an interview. “Patients with psoriasis have a high risk for multiple comorbid conditions including metabolic syndrome, which is characterized by obesity, hypertension, and dyslipidemia,” said Dr. Robles, a dermatologist in private practice in Pomona, Calif., who was not involved in the study. “Although these complications were previously attributed to diet and obesity, it has become clear that the proinflammatory cytokines associated with psoriasis may be playing an important role underlying the pathologic basis of these other comorbidities.”

There is an emerging body of literature “indicating that psoriasis is associated with an increased risk of infections,” he added. Research in this area is particularly important because of the increased risk of infections associated with many biologic and immune-modulating treatments for psoriasis, Dr. Robles noted.

The study findings “indicate that, as the severity of psoriasis increases, so does the risk of severe and rare infections,” he said. “This makes it imperative for clinicians to be alert to the possibility of severe or rare infections in patients with psoriasis, especially those with severe psoriasis, so that early intervention can be initiated.”

As for additional research, “as an immunologist and dermatologist, I cannot help but think about the possible role the genetic and cytokine pathways involved in psoriasis may be playing in modulating the immune system and/or microbiome, and whether this contributes to a higher risk of infections,” Dr. Robles said. “Just as it was discovered that patients with atopic dermatitis have decreased levels of antimicrobial peptides in their skin, making them susceptible to recurrent bacterial skin infections, we may find that the genetic and immunological changes associated with psoriasis may independently contribute to infection susceptibility,” he noted. “More basic immunology and virology research may one day shed light on this observation.”

The study was supported by Novartis. Lead author Dr. Loft disclosed serving as a speaker for Eli Lilly and Janssen Cilag, other authors disclosed relationships with multiple companies including Novartis, and two authors are Novartis employees. Dr. Robles had no relevant financial disclosures.

Patients with psoriasis have a significantly increased risk of severe and rare infections, compared with the general population, according to a population-based cohort study of nearly 95,000 patients.

Although previous studies have shown a higher risk for comorbid conditions in people with psoriasis, compared with those without psoriasis, data on the occurrence of severe and rare infections in patients with psoriasis are limited, wrote Nikolai Loft, MD, of the department of dermatology and allergy, Copenhagen University Hospital, Gentofte, and colleagues.

Psoriasis patients are often treated with immunosuppressive therapies that may promote or aggravate infections; therefore, a better understanding of psoriasis and risk of infections is needed, they said. In a study published in the British Journal of Dermatology, Dr. Loft and his coinvestigators reviewed data on adults aged 18 years and older from the Danish National Patient Register between Jan. 1, 1997 and Dec. 31, 2018. The study population included 94,450 adults with psoriasis and 566,700 matched controls. Patients with any type of psoriasis and any degree of severity were included.

The primary outcome was the occurrence of severe infections, defined as those requiring assessment at a hospital, and rare infections, defined as HIV, TB, HBV, and HCV. The median age of the participants was 52.3 years, and slightly more than half were women.

Overall, the incidence rate of severe and rare infections among patients with any type of psoriasis was 3,104.9 per 100,000 person-years, compared with 2,381.1 for controls, with a hazard ratio, adjusted for gender, age, ethnicity, socioeconomic status, alcohol-related conditions, and Charlson comorbidity index (aHR) of 1.29.

For any infections resulting in hospitalization, the incidence rate was 2,005.1 vs. 1,531.8 per 100,000 person-years for patients with any type of psoriasis and controls, respectively.

The results were similar when severe infections and rare infections were analyzed separately. The incidence rate of severe infections was 3,080.6 and 2,364.4 per 100,000 person-years for patients with any psoriasis, compared with controls; the incidence rate for rare infections was 42.9 and 31.8 for all psoriasis patients and controls, respectively.

When the data were examined by psoriasis severity, the incidence rate of severe and rare infections among patients with severe psoriasis was 3,847.7 per 100,000 person-years, compared with 2,351.9 per 100,000 person years among controls (aHR, 1.58) and also higher than in patients with mild psoriasis. The incidence rate of severe and rare infections in patients with mild psoriasis (2,979.1 per 100,000 person-years) also was higher than in controls (aHR, 1.26).

Factors that might explain the increased infection risk with severe psoriasis include the altered immune environment in these patients, the researchers wrote in their discussion of the findings. Also, “patients with severe psoriasis are defined by their eligibility for systemics, either conventional or biologic,” and their increased infection risk may stem from these treatments, rather than disease severity itself, they noted.

The study findings were limited by several factors including the lack of data on such confounders as weight, body mass index, and smoking status, they added. Other limitations included potential surveillance bias because of greater TB screening, and the use of prescriptions, rather than the Psoriasis Area Severity Index, to define severity. However, the results were strengthened by the large sample size, and suggest that patients with any type of psoriasis have higher rates of any infection, severe or rare, than the general population, the researchers concluded.

Data show need for clinician vigilance

Based on the 2020 Census data, an estimated 7.55 million adults in the United States have psoriasis, David Robles, MD, said in an interview. “Patients with psoriasis have a high risk for multiple comorbid conditions including metabolic syndrome, which is characterized by obesity, hypertension, and dyslipidemia,” said Dr. Robles, a dermatologist in private practice in Pomona, Calif., who was not involved in the study. “Although these complications were previously attributed to diet and obesity, it has become clear that the proinflammatory cytokines associated with psoriasis may be playing an important role underlying the pathologic basis of these other comorbidities.”

There is an emerging body of literature “indicating that psoriasis is associated with an increased risk of infections,” he added. Research in this area is particularly important because of the increased risk of infections associated with many biologic and immune-modulating treatments for psoriasis, Dr. Robles noted.

The study findings “indicate that, as the severity of psoriasis increases, so does the risk of severe and rare infections,” he said. “This makes it imperative for clinicians to be alert to the possibility of severe or rare infections in patients with psoriasis, especially those with severe psoriasis, so that early intervention can be initiated.”

As for additional research, “as an immunologist and dermatologist, I cannot help but think about the possible role the genetic and cytokine pathways involved in psoriasis may be playing in modulating the immune system and/or microbiome, and whether this contributes to a higher risk of infections,” Dr. Robles said. “Just as it was discovered that patients with atopic dermatitis have decreased levels of antimicrobial peptides in their skin, making them susceptible to recurrent bacterial skin infections, we may find that the genetic and immunological changes associated with psoriasis may independently contribute to infection susceptibility,” he noted. “More basic immunology and virology research may one day shed light on this observation.”

The study was supported by Novartis. Lead author Dr. Loft disclosed serving as a speaker for Eli Lilly and Janssen Cilag, other authors disclosed relationships with multiple companies including Novartis, and two authors are Novartis employees. Dr. Robles had no relevant financial disclosures.

Patients with psoriasis have a significantly increased risk of severe and rare infections, compared with the general population, according to a population-based cohort study of nearly 95,000 patients.

Although previous studies have shown a higher risk for comorbid conditions in people with psoriasis, compared with those without psoriasis, data on the occurrence of severe and rare infections in patients with psoriasis are limited, wrote Nikolai Loft, MD, of the department of dermatology and allergy, Copenhagen University Hospital, Gentofte, and colleagues.

Psoriasis patients are often treated with immunosuppressive therapies that may promote or aggravate infections; therefore, a better understanding of psoriasis and risk of infections is needed, they said. In a study published in the British Journal of Dermatology, Dr. Loft and his coinvestigators reviewed data on adults aged 18 years and older from the Danish National Patient Register between Jan. 1, 1997 and Dec. 31, 2018. The study population included 94,450 adults with psoriasis and 566,700 matched controls. Patients with any type of psoriasis and any degree of severity were included.

The primary outcome was the occurrence of severe infections, defined as those requiring assessment at a hospital, and rare infections, defined as HIV, TB, HBV, and HCV. The median age of the participants was 52.3 years, and slightly more than half were women.

Overall, the incidence rate of severe and rare infections among patients with any type of psoriasis was 3,104.9 per 100,000 person-years, compared with 2,381.1 for controls, with a hazard ratio, adjusted for gender, age, ethnicity, socioeconomic status, alcohol-related conditions, and Charlson comorbidity index (aHR) of 1.29.

For any infections resulting in hospitalization, the incidence rate was 2,005.1 vs. 1,531.8 per 100,000 person-years for patients with any type of psoriasis and controls, respectively.

The results were similar when severe infections and rare infections were analyzed separately. The incidence rate of severe infections was 3,080.6 and 2,364.4 per 100,000 person-years for patients with any psoriasis, compared with controls; the incidence rate for rare infections was 42.9 and 31.8 for all psoriasis patients and controls, respectively.

When the data were examined by psoriasis severity, the incidence rate of severe and rare infections among patients with severe psoriasis was 3,847.7 per 100,000 person-years, compared with 2,351.9 per 100,000 person years among controls (aHR, 1.58) and also higher than in patients with mild psoriasis. The incidence rate of severe and rare infections in patients with mild psoriasis (2,979.1 per 100,000 person-years) also was higher than in controls (aHR, 1.26).

Factors that might explain the increased infection risk with severe psoriasis include the altered immune environment in these patients, the researchers wrote in their discussion of the findings. Also, “patients with severe psoriasis are defined by their eligibility for systemics, either conventional or biologic,” and their increased infection risk may stem from these treatments, rather than disease severity itself, they noted.

The study findings were limited by several factors including the lack of data on such confounders as weight, body mass index, and smoking status, they added. Other limitations included potential surveillance bias because of greater TB screening, and the use of prescriptions, rather than the Psoriasis Area Severity Index, to define severity. However, the results were strengthened by the large sample size, and suggest that patients with any type of psoriasis have higher rates of any infection, severe or rare, than the general population, the researchers concluded.

Data show need for clinician vigilance

Based on the 2020 Census data, an estimated 7.55 million adults in the United States have psoriasis, David Robles, MD, said in an interview. “Patients with psoriasis have a high risk for multiple comorbid conditions including metabolic syndrome, which is characterized by obesity, hypertension, and dyslipidemia,” said Dr. Robles, a dermatologist in private practice in Pomona, Calif., who was not involved in the study. “Although these complications were previously attributed to diet and obesity, it has become clear that the proinflammatory cytokines associated with psoriasis may be playing an important role underlying the pathologic basis of these other comorbidities.”

There is an emerging body of literature “indicating that psoriasis is associated with an increased risk of infections,” he added. Research in this area is particularly important because of the increased risk of infections associated with many biologic and immune-modulating treatments for psoriasis, Dr. Robles noted.

The study findings “indicate that, as the severity of psoriasis increases, so does the risk of severe and rare infections,” he said. “This makes it imperative for clinicians to be alert to the possibility of severe or rare infections in patients with psoriasis, especially those with severe psoriasis, so that early intervention can be initiated.”

As for additional research, “as an immunologist and dermatologist, I cannot help but think about the possible role the genetic and cytokine pathways involved in psoriasis may be playing in modulating the immune system and/or microbiome, and whether this contributes to a higher risk of infections,” Dr. Robles said. “Just as it was discovered that patients with atopic dermatitis have decreased levels of antimicrobial peptides in their skin, making them susceptible to recurrent bacterial skin infections, we may find that the genetic and immunological changes associated with psoriasis may independently contribute to infection susceptibility,” he noted. “More basic immunology and virology research may one day shed light on this observation.”

The study was supported by Novartis. Lead author Dr. Loft disclosed serving as a speaker for Eli Lilly and Janssen Cilag, other authors disclosed relationships with multiple companies including Novartis, and two authors are Novartis employees. Dr. Robles had no relevant financial disclosures.