Should a patient who has stopped Humira (adalimumab) and is requesting continuation of golimumab (a TNF inhibitor) be authorized for treatment, given the lack of essential documentation and potential contraindication with concurrent use of another TNF inhibitor?

Authorization for Golimumab Continuation After Adalimumab Discontinuation

Direct Recommendation

Golimumab continuation can be authorized for this patient who has stopped adalimumab, provided that essential documentation is obtained to confirm: (1) adalimumab has been fully discontinued, (2) objective disease activity measurements demonstrate inadequate response or loss of response to adalimumab, and (3) current disease activity scores show meaningful improvement on golimumab. 1

Critical Safety Clarification Required

The medication reconciliation must definitively confirm that adalimumab (Humira) has been discontinued before golimumab continuation is approved. 2

• Concurrent use of two TNF inhibitors (adalimumab and golimumab simultaneously) is explicitly contraindicated due to increased infection risk without added clinical benefit 2
• The FDA label for adalimumab specifically states: "Concomitant administration of adalimumab with other biologic DMARDS or other TNF blockers is not recommended based upon the possible increased risk for infections and other potential pharmacological interactions" 2
• If adalimumab was truly stopped, golimumab represents an appropriate therapeutic option as switching between TNF inhibitors is guideline-supported 1, 3

Evidence Supporting TNF Inhibitor Switching

Switching from one TNF inhibitor to another TNF inhibitor (adalimumab to golimumab) is supported by current guidelines and clinical evidence. 1

• The 2024 AGA guidelines recommend golimumab as a strong recommendation with moderate to high certainty evidence for moderate-to-severe ulcerative colitis 1
• Observational studies demonstrate that infliximab and golimumab are effective in inducing remission in patients with prior exposure to advanced therapies 1
• In patients with prior TNF inhibitor exposure, golimumab achieved ACR20 responses in 35-37% versus 18% with placebo at 14 weeks (P < 0.001) 4
• After adalimumab failure, switching to another TNF inhibitor like golimumab is explicitly recommended by treatment algorithms 3

Required Documentation for Authorization

Before approving continuation, the following objective measurements must be documented: 1

Baseline Disease Activity (Pre-Golimumab)

• Disease activity scores at time of adalimumab failure: DAS28, CDAI, SDAI, or Mayo score (for UC) 1
• Inflammatory markers: CRP and/or ESR 1
• Joint counts (tender and swollen) or endoscopic findings (for IBD) 1
• Functional assessment scores 1
• Documentation of why adalimumab was discontinued (primary failure, secondary loss of response, or intolerance) 1, 3

Current Response to Golimumab

• Current disease activity scores showing at least 20% improvement from baseline (ACR20 equivalent or EULAR response) 1, 4
• Updated inflammatory markers demonstrating improvement 1
• Time on golimumab therapy (minimum 8-14 weeks for adequate assessment) 1
• Objective evidence of clinical benefit justifying continuation 1

Combination Therapy Requirements

Golimumab should be combined with an immunomodulator (methotrexate or thiopurine) rather than used as monotherapy. 1

• The 2024 AGA guidelines suggest using adalimumab or golimumab in combination with an immunomodulator over monotherapy (conditional recommendation, low certainty of evidence) 1
• The 2015 Toronto Consensus strongly recommends that when starting anti-TNF therapy, it be combined with a thiopurine or methotrexate rather than used as monotherapy to induce complete remission (strong recommendation, moderate-quality evidence for azathioprine) 1
• Current medication list must document concurrent immunomodulator therapy 1
• If methotrexate was previously discontinued due to intolerance, alternative immunomodulators (azathioprine, 6-mercaptopurine) should be considered 1

Prior Treatment Documentation

Documentation must confirm adequate trial and failure of prior therapies before TNF inhibitor use. 1

• Evidence of adalimumab trial duration and dosing (standard dosing: 40 mg subcutaneously every 2 weeks for RA; induction and maintenance dosing for IBD) 2
• Therapeutic drug monitoring results if available (adalimumab trough levels and anti-drug antibodies) to distinguish between pharmacokinetic versus pharmacodynamic failure 1
• Documentation that adalimumab was optimized (dose escalation attempted if subtherapeutic levels or secondary loss of response) before switching 1
• For rheumatoid arthritis: confirmation of methotrexate optimization (≥25 mg/week for at least 3 months) prior to initial biologic use 1

Timeline for Response Assessment

Golimumab efficacy should be evaluated at specific timepoints to determine continuation. 1

• Initial assessment at 8-12 weeks for symptomatic response 1
• Definitive assessment at 14-16 weeks for objective response (ACR20 or equivalent) 1, 4
• If inadequate response by 14 weeks, therapy modification should be considered rather than indefinite continuation 1
• For ulcerative colitis specifically, evaluation at 8-14 weeks is recommended 1

Safety Monitoring Requirements

Ongoing safety monitoring must be documented for TNF inhibitor continuation. 1, 2

• Screening for latent tuberculosis completed before golimumab initiation 1
• Hepatitis B screening completed 1
• Monitoring for serious infections (occurred in 0-4.4% in golimumab trials versus 0.8-3.5% with placebo) 1
• Assessment for opportunistic infections, particularly if concurrent corticosteroid or immunosuppressant use 1
• Evaluation for malignancy risk, especially lymphoma (increased risk with anti-TNF monotherapy: IRR 2.23,95% CI 1.79-2.79) 5

Common Pitfalls to Avoid

Do not approve continuation without resolving the medication list discrepancy showing concurrent adalimumab. 2

Do not accept subjective improvement alone without objective disease activity measurements. 1

Do not continue golimumab monotherapy without documented immunomodulator combination therapy or valid contraindication to immunomodulators. 1

Do not approve indefinite continuation without time-limited reassessment showing sustained benefit (minimum 20% improvement in validated disease activity scores). 1, 4

Do not assume all TNF inhibitor failures are equivalent—distinguish between primary non-response, secondary loss of response, and intolerance, as this impacts subsequent treatment selection. 1, 3