Biologics combined with conventional systemic agents or phototherapy for the treatment of psoriasis: real-life data from PSONET registries.

BACKGROUND: Biologics have greatly improved psoriasis management. However, primary and secondary non-response to treatment requires innovative strategies to optimize outcomes. OBJECTIVE: To describe the use of combined treatment of biologics with conventional systemic agents or phototherapy in daily clinical practice. METHODS: We collected data on frequency of use, demographics, treatment characteristics and drug survival of biologics combined with conventional systemic agents or phototherapy in five PSONET registries. RESULTS: Of 9922 biologic treatment cycles, 982 (9.9%) were identified as combination treatment. 72.9% of treatment cycles concerned concomitant use of methotrexate, 25.3% concerned concomitant UVB therapy, acitretin or cyclosporin and 1.8% concerned combined treatment with PUVA, fumaric acids or a second biologic. Substantial variation was detected in type and frequency of combination treatments prescribed across registries. Patients initiated on combined treatment had generally severe disease and were affected with psoriasis for many years. The extent to which patients had been priory treated with biologic monotherapy and the proportion of patients affected with psoriatic arthritis differed between registries. Survival rates for etanercept, adalimumab, infliximab and ustekinumab with methotrexate ranged between 43 and 92%, 28 and 83%, 65 and 87% and 53 and 77%, respectively, across registries after one year with no consistent superior survival for a particular biologic. Longest survival on a biologic combined with methotrexate, acitretin or cyclosporin was 103, 78 and 34 months, respectively. CONCLUSION: Methotrexate was the most commonly used concomitant treatment for patients on a biologic. Wide geographical variations in treatment selection and persistence of combination treatment exist. Data derived from ongoing studies may help to determine whether combined treatment is superior to biologic monotherapy.

Biosimilars for psoriasis: preclinical analytical assessment to determine similarity.

Biosimilars, sometimes called 'generic biologics', are no longer a vision for the future but a present-day reality. Drug manufacturers and regulatory authorities are charged with ensuring that these products are safe and effective. Because biologically produced medications are large, complex proteins, many factors affect the quality of the end product, including glycosylation and presence of impurities, and thus many factors need to be compared between an emerging biosimilar and its originator biologic. Indeed, preclinical analytical assessments to determine similarity to an originator biologic are critical and are considered to be the foundation for regulatory approval of biosimilars. Here, the science behind the preclinical development of biosimilars is discussed by members of the International Psoriasis Council, and suggestions are put forth to try to ensure that future biosimilars are produced in a high quality and standardized manner.

Risk of Herpes zoster in patients with psoriasis treated with biologic drugs.

BACKGROUND: Little is known about the risk of herpes zoster (HZ), among patients with psoriasis treated with biologic drugs. OBJECTIVE: To determine the incidence of HZ in patients with psoriasis and the association between HZ and use of biologic drugs in these patients. METHODS: The study was performed utilizing the medical database of Clalit Health Services in Israel. The incidence of HZ events was calculated among patients with psoriasis treated with phototherapy, traditional systemic medications and biologic drugs. Incidence rates of HZ events were calculated for each medication, as well as hazard ratios adjusted for age, sex and healthcare utilization burden. RESULTS: Among 22,330 psoriasis patients (215,656 person-years), 1321 HZ cases were diagnosed. The crude incidence rates per 1000 person-years were 6.0 for UVB phototherapy (95% confidence interval (CI), 0-12.8), 10.1 for PUVΑ (1.3-19.0), 5.4 for acitretin (2.2-8.7), 17.0 for methotrexate (10.6-23.4), 13.9 for etanercept (0.3-27.4), 19.3 for infliximab (0-45.8) and 4.6 for controls (CI, 4.3-5.0). No cases of HZ were seen among patients treated with alefacept, efalizumab or adalimumab. In a multivariate analysis, age, female sex, healthcare utilization pattern and corticosteroid treatment were associated with the time to HZ infection. The association of HZ with infliximab approached statistical significance (Hazard ratio: 1.77, 95% CI: 0.92-3.43), but none of the other biologic drugs were significantly associated with the risk of HZ. CONCLUSION: Among patients with psoriasis, treatment with some biologic drugs was associated with a higher incidence of HZ compared with controls, though the difference was not statistically significant.