Rates of new-onset psoriasis in patients with rheumatoid arthritis receiving anti-tumour necrosis factor α therapy: results from the British Society for Rheumatology Biologics Register

Harrison, Mark; Dixon, William G; Watson, Kath; King, Yvonne; Groves, Richard; Hyrich, Kimme L; Symmons, Deborah

doi:10.1136/ard.2007.087288

Cited by 196 publications

(159 citation statements)

References 33 publications

Supporting

Mentioning

136

Contrasting

Unclassified

Order By: Relevance

“…These factors, alone or in combination, could induce the clinical expression of GBS in patients who are immunogenetically susceptible [4]. The British Society of Rheumatology guidelines for prescribing TNF-α blockers recommend avoidance of these agents in patients with preexisting demyelinating disease [6]. There was no family history of demyelinating disease in our patient or his relatives.…”

Section: Discussionmentioning

confidence: 71%

“…There was no family history of demyelinating disease in our patient or his relatives. In patients without previous problems, they suggest withdrawal of therapy if demyelination occurs, but do not make a comment on whether it is appropriate to try an alternative anti-TNF-α agent [6]. A number of cases of demyelinating events of the CNS or aggravation of known MS have been reported in patients treated with anti-TNF-α [4][5][6][7][8].…”

Section: Discussionmentioning

confidence: 99%

“…The infusion schedule in patients who developed neuropathy varied from the standard induction regimen (weeks 0, 2, 6 and 14) to an interval of many months (e.g. 4 infusions in 2 years) [3][4][5][6][7][8]. The total number of infusions before the onset of neuropathy varied from 1 to 12 [7,8].…”

Section: Discussionmentioning

confidence: 99%

“…In patients without previous problems, they suggest withdrawal of therapy if demyelination occurs, but do not make a comment on whether it is appropriate to try an alternative anti-TNF-α agent [6]. A number of cases of demyelinating events of the CNS or aggravation of known MS have been reported in patients treated with anti-TNF-α [4][5][6][7][8]. Based on a retrospective study of a database, only 44 patients affected by demyelinating neuropathies have been reported thus far, including 20 cases of GBS, 11 patient with multifocalmotor neuropathy and 6 with chronic inflammatory polyradiculopathy [7].…”

Section: Discussionmentioning

confidence: 99%

See 3 more Smart Citations

Guillain-Barre Syndrome Developing During InfliximabTreatment for Psoriatic Arthritis: A Case Report

Tüfekçi¹

2016

Ann Clin Anal Med

View full text Add to dashboard Cite

Section: Discussionmentioning

confidence: 71%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

See 2 more Smart Citations

Guillain-Barre Syndrome Developing During InfliximabTreatment for Psoriatic Arthritis: A Case Report

Tüfekçi¹

2016

Ann Clin Anal Med

View full text Add to dashboard Cite

“…Аналогичная дина-мика стандартных индексов активности АС (BASDAI, MASES), функциональных наруше-ний (BASMI, BASFI) и показателей качества жизни (SF-36) установле-на как между исследуемыми препа-ратами BCD-055 и РЕМ, так и в сравнении с результатами ис-следований ASSЕRT и PLANETAS [20][21][22][23][24]. Все выявленные в ходе иссле-дования препарата BCD-055 НР яв-ляются ожидаемыми, отражены в инструкции по медицинскому применению РЕМ и по частоте и спектру соответствуют ранее опубликованным данным по рефе-рентному препарату [20,[24][25][26][27][28][29][30][31][32][33]. В рамках данного исследования на протяжении 54 нед лечения разли-чий в профиле безопасности изучае-мого биоаналога и РЕМ также не ус-тановлено.…”

Section: Discussionunclassified

Comparative Evaluation of the Long-Term Efficacy and Safety of the Infliximab Biosimilar BCD-055 and Reference Infliximab in Patients With Ankylosing Spondylitis: Results of the International Multicenter Randomized Double-Blind Phase Iii Clinical Study Asart-2

Лила¹,

Мазуров²,

Зонова³

et al. 2018

rsp

View full text Add to dashboard Cite

The paper gives data on the clinical efficiency and safety profile of long-term use of the infliximab (INF) biosimilar BCD-055 versus the reference drug Remicade® (REM) in a population of patients with active ankylosing spondylitis (AS).Subjects and methods. An international multicenter randomized double-blind Phase III clinical trial was conducted in 199 patients who were randomized into two groups in a 2:1 ratio and who received BCD-055 or REM at a dose of 5 mg/kg at 0, 2, and 6 weeks, then every 8 weeks. Efficiency assessment was made at 14, 30 and 54 weeks in patients who received at least one dose of INF [intent-to-treat (ITT)], as well as at 54 weeks in those who completed the study according to the Protocol (PP) (per protocol). The efficiency endpoints were the proportion of patients who had achieved ASAS20/ASAS40 responses; changes in BASDAI, BASMI, BASFI, MASES, and SF-36 scores. Immunogenicity was assessed by the proportion of patients in each group with identified binding and neutralizing antibodies (BAbs and NAbs) against INF. The safety analysis included the overall rate of adverse events (AEs), including those that met the respective criteria for serous AEs (SAEs), and grade 3–4 toxicity, as well as the number of cases of early termination of the study because of AEs and SAEs.Results and discussion. The ITT population included 199 patients and the PP one consisted of 161 people. The groups were not statistically different in the rate of and reasons for patient withdrawal from the study. A comparable number of patients achieved ASAS20/ASAS40 responses at 14, 30, 54 weeks (р ≥ 0.05). At 54 week, the proportion of patients who received BCD-055 and REM therapy and achieved an ASAS20 response was 67.42 and 52.24% in the ITT population (p = 0.053) and 80.91 and 68.63% in the PP population (p = 0.128). The BCD-055 and drug comparison groups achieved an ASAS40 response in 53.03 and 38.81% in the ITT population (p = 0.081) and in 63.64 and 50.98% in the PP one (p = 0.177). The proportion of persons with identified BAbs and NAbs was comparable: 21.26 and 3.15% in the BCD-055 group (p = 0.920) and 20.63 and 6.35% in the group REM (p = 0.443), respectively. It was found that the presence of NAbs did not affect the therapeutic response. Both groups did not differ in the detection rate and profile of AEs and SAEs or in the rate of patient withdrawal due to AEs. Most identified AEs were mild to moderate.Conclusion. The efficacy of the INF biosimilar BCD-055 used long in patients with AS did not significantly differ from that of the original drug REM; the safety profile of both drugs was comparable.

show abstract

Absolute and Relative Risk of New-Onset Psoriasis Associated With Tumor Necrosis Factor-α Inhibitor Treatment in Patients With Immune-Mediated Inflammatory Diseases

et al. 2022

View full text Add to dashboard Cite

ImportanceTumor necrosis factor-α inhibitor (TNFi)–associated psoriasis is a rare adverse event following TNFi treatment. Data on the risk of developing TNFi-associated psoriasis when treated with TNFi are sparse.ObjectiveTo investigate the associated risk between new-onset psoriasis and TNFi treatment compared with nonbiologic conventional treatment.Design, Setting, and ParticipantsUsing Danish national registries (1995-2018), this cohort study included patients with inflammatory bowel disease (IBD) and/or rheumatoid arthritis (RA) who received either conventional therapy or TNFi treatment. Patients may not have been diagnosed with psoriasis prior to initiation of treatment. Patients were followed up for up to 5 years. Cox regression models with robust variance were used to compare the risk of developing any type of psoriasis, nonpustular psoriasis, and pustular psoriasis. Patients receiving conventional therapy were used as reference. Data analysis was performed from January 1995 to December 2018.ExposuresFor the present study, the term conventional therapy was used for the nonbiological therapy. For biological therapy, a distinction was made between TNFi treatment and non-TNFi biological therapy.Main Outcomes and MeasuresThe outcome of psoriasis was defined as a registered International Statistical Classification of Diseases and Related Health Problems, Tenth Revision code of psoriasis and/or having 2 consecutive prescriptions of topical vitamin D analogues.ResultsThe study included 109 085 patients, of which 62% were female. Median (IQR) age was 50 (34-64) years. Of the included patients, 108 024 received conventional therapy and 20 910 received TNFi treatment. During follow-up, 1471 (1.4%) patients developed any type of psoriasis, of which 1332 developed nonpustular psoriasis, 127 patients developed palmoplantar pustulosis, and 12 patients developed generalized pustulosis. The incidence rates for developing any type of psoriasis per 1000 patient-years were 3.0 (95% CI, 2.9-3.2) for conventional therapy and 7.8 (95% CI, 7.5-8.9) for TNFi. During treatment with TNFi, the hazard ratio was 2.12 (95% CI, 1.87-2.40; P < .001) for developing nonpustular psoriasis and 6.50 (95% CI, 4.60-9.23; P < .001) for pustular psoriasis compared with conventional treatment. Exposure needed for 1 additional patient to be harmed was 241 patient-years for any type of TNFi-associated psoriasis, 342 patient-years for nonpustular psoriasis, and 909 patient-years for pustular psoriasis.Conclusions and RelevanceIn a Danish nationwide cohort of patients with immune-mediated inflammatory diseases treated with TFNi or conventional treatment and no history of psoriasis, in TFNi-treated patients, nonpustular types of psoriasis constituted the most events, whereas pustular types of psoriasis had the highest relative risk. Although the risk of new-onset psoriasis increased for both nonpustular and pustular types of psoriasis in TFNi-treated patients, the absolute risk remained modest at 241 patient-years of exposure need for 1 additional event and an estimated absolute risk difference around 5 per 1000 patient-years, indicating that the approach to treatment of patients in need of TNFi treatment should not change.

show abstract

Rates of new-onset psoriasis in patients with rheumatoid arthritis receiving anti-tumour necrosis factor α therapy: results from the British Society for Rheumatology Biologics Register

Cited by 196 publications

References 33 publications

Guillain-Barre Syndrome Developing During InfliximabTreatment for Psoriatic Arthritis: A Case Report

Guillain-Barre Syndrome Developing During InfliximabTreatment for Psoriatic Arthritis: A Case Report

Comparative Evaluation of the Long-Term Efficacy and Safety of the Infliximab Biosimilar BCD-055 and Reference Infliximab in Patients With Ankylosing Spondylitis: Results of the International Multicenter Randomized Double-Blind Phase Iii Clinical Study Asart-2

Absolute and Relative Risk of New-Onset Psoriasis Associated With Tumor Necrosis Factor-α Inhibitor Treatment in Patients With Immune-Mediated Inflammatory Diseases

Contact Info

Product

Resources

About