Can you maintain response after biologic holiday?

Melinda Gooderham, M.D., MSc, FRCPCPatients might stop taking their biologic medications for a variety of reasons. When patients do stop their biologic therapy, clinicians need to consider that some biologic therapies are better at recapturing response than others.

READ: Biologic use beyond psoriasis

Speaking at the recent Dermatology Update in Ontario, Canada, Melinda Gooderham, M.D., MSc, FRCPC, explained that patients with psoriasis or psoriatic arthritis may need to interrupt their biologic therapy for a variety of reasons including expense, pregnancy, surgery, travel, the need for live vaccinations, and the presence of infections. Dr. Gooderham is the medical director of the Skin Centre for Dermatology in Peterborough, Ontario.

"We know that patients take drug holidays, whether it's on their own or whether we decide this with them," says Dr. Gooderham. "What happens when they re-start the biologic?"

Payment can be a barrier to continuous use of a biologic therapy, adds Dr. Gooderham. "Patients sometimes can't afford the co-payment or there is a problem with their [drug] insurance," she says. "They may just quietly stop taking their biologic, and then they tell you that after the psoriasis flares up."

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Patients may also stop their therapy because they experience clearance of their psoriasis and decide on their own that they no longer need biologic therapy, notes Dr. Gooderham.

Dr. Gooderham cites the Multinational Assessment of Psoriasis and Psoriatic Arthritis Survey, which found that respondents said they most often stopped their biologic therapy because of safety/tolerability issues and a lack or loss of efficacy of therapy.¹

The challenge in looking at recapturing efficacy if biologic therapy is not continuous is that studies have not been standardized, says Dr. Gooderham.

"The trials have been done differently, so more work needs to be done before we can draw meaningful conclusions," says Dr. Gooderham.

NEXT: Favorable response

Favorable response

Overall, re-starting biologic therapy after a gap in treatment typically produces a favorable response. "Patients may need to stop therapy, and for the most part, we are able to put them back on therapy with good results," says Dr. Gooderham.

Individual trials suggest that some biologic agents are better than others in producing a response if therapy is discontinued for a portion of time.

A trial with etanercept of long-term safety and efficacy in patients with psoriasis saw that patients continued to respond when treatment was interrupted.²

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"Patients did not recapture [response] as well at the lowest dose," says Dr. Gooderham.

Most patients in post-hoc analyses following a phase 3 randomized, controlled trial of adalimumab, where the endpoint was at least 75% improvement in Psoriasis Area and Severity Index, continued to respond to the biologic agent if they went off the therapy and later resumed therapy.³

"There is a subgroup of patients who really lose response [with treatment discontinuation], and when given the drug again, only 58% could maintain response," explains Dr. Gooderham. "Due to immunogenicity, these patients can't recapture their response rate."

NEXT: Talk to your patients

Talk to your patients

Dr. Gooderham suggests that clinicians have a discussion with their patients about cessation of adalimumab therapy and the possible risk of failure to recapture response after re-starting therapy.

Trial data suggest that patients who took the biologic infliximab on an as-needed basis start to lose response to the therapy if they are not taking the therapy on a continuous basis, according to Dr. Gooderham.⁴

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"This is why we don't use infliximab on an as-needed basis," says Dr. Gooderham. "It is a drug you don't want to stop taking. If you have someone on that drug, you want to try and keep that person on that drug as long as possible. It is not a good fit for intermittent therapy."

Newer biologic agents such as ustekinumab have demonstrated the ability to recapture response if there is a gap in treatment.⁵

"The majority of patients (taking ustekinumab) are able to recapture their response, particularly if they are on a higher dose (of ustekinumab)," says Dr. Gooderham.

Similarly, the newest biologic agent, secukinumab, has demonstrated very good recapture rates in terms of response.⁶

Disclosure: Dr. Gooderham has been a speaker, consultant and investigator for Janssen, Amgen, AbbVie and Novartis.

References:

1. Lebwohl MG, Bachelez H, Barker J, et al. Patient perspectives in the management of psoriasis: results from the population-based  Multinational Assessment of Psoriasis and Psoriatic Arthritis Survey. J Am AcadDermatol. 2014 May;70(5):871-81. e1-30.

2. Leonardi C, Strober B, Gottlieb AB, et al. J Drugs Dermatol. 2010 Aug;9(8):928-37.

3. Menter A, Gordon KB, Leonardi CL, Gu Y, Goldblum OM. Efficacy and safety of adalimumab across subgroups of patients with moderate to severe psoriasis wins. J Am Acad Dermatol. 2010 Sep;63(3):448-56.

4. Gottlieb AB, Evans R, Li S, et al. Infliximab induction therapy for patients with severe plaque-type psoriasis: a randomized, double-blind, placebo-controlled trial. J Am Acad Dermatol. 2004;51(4):534-42.

5. Kimball AB, Papp KA, Wasfi Y, et al. Long-term efficacy of ustekinumab in patients with moderate-to-severe psoriasis treated for up to 5 years in the PHOENIX 1 study.  J Eur Acad Dermatol Venereol. 2013; 27(12):1535-45.

6. Thaci D, Blauvelt A, Reich K, et al. Secukinumab is superior to ustekinumab in clearing skin of subjects with moderate to severe plaque psoriasis: CLEAR, a randomized controlled trial. J Am Acad Dermatol. 2015;73(3):400-9.